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FindAStudy :: Human Studies @ UTHSCSA
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  •   Aging and Geriatric

    •   Cognitive and Functional Connectivity Effects of Methylene Blue in Healthy...
      Protocol No.
      HSC20150410H
      Official Title
      Cognitive and Functional Connectivity Effects of Methylene Blue in Healthy Aging, Mild Cognitive Impairment and Alzheimer’s Disease
      Description
      We will be studying both healthy, MCI (mildly cognitively impaired males and females) between the ages of 45-79, and subjects diagnosed with Alzheimer’s disease between the ages of 65-79 and will be looking at the effects of Methylene Blue on memory and cognition.
      Contact
      210-567-8173
      Locations
      UT Health Science Center
      Learn More About This Study

       

    •   Effect of mTOR Inhibition On Immunological Responses, Muscle Strength, And...
      Protocol No.
      HSC20120304H
      Official Title
      Effect of mTOR Inhibition and other Metabolism Modulating Interventions on the Elderly: Immune, Cognitive, and Fuctional Consequences.
      Description
      A research study of the mechanisms that are affected by the mTOR inhibition by Rapamycin. Rapamycin is a drug approved by the US Food and Drug Administration (FDA) for human use that has shown to increase lifespan in laboratory animals. In human medicine, Rapamycin is used is an immunosuppressant drug used to prevent rejection in organ transplantation; it is especially useful in kidney transplants. mTOR controls growth of cells in your body. Rapamycin reduced mTOR effects. The researchers hope to learn how mTOR inhibition affects humans by looking at how the immune system that is altered in normal aging and mTOR inhibition by Rapamycin. The information gained from these experiments will aid in understanding how mTOR inhibition works in humans and will provide new and important information on changes in age-related immune system regulation.
      Contact
      210-497-7279
      Locations
      UT Health Science Center
      Learn More About This Study

       

    •   Illness representations in elders living in the United States with Multiple...
      Protocol No.
      HSC20160103H
      Official Title
      Illness Representations in Elders Living in the United States with Multiple Chronic Conditions: A Mixed Methods Study
      Description
      Multiple Chronic Conditions (MCC) are two or more long-lasting conditions that may be controlled but not cured. Illness representation (IL) is how a person feels about and manages their chronic condition. Coping procedures are actions taken to manage a condition and appraisal represents the evaluation of how one manages their condition. Understanding IL,coping procedures and appraisals may help to improve management of multiple chronic conditions.
      Locations
      UT Health Science Center
      Learn More About This Study

       

    •   NF-Kappa B Activation by NADPH Oxidases (Project of a program entitled...
      Protocol No.
      HSC19949484H
      Official Title
      NF-Kappa B Activation by NADPH Oxidases (Project of a program entitled "Nuclear Factor Kappa B, Oxidative Stress and Aging)
      Description
      This study is a research project on the antibacterial function of white blood cells. We hope to learn how white blood cells work to prevent infection and how they respond after infection occurs.
      Contact
      210-562-4010
      Locations
      UT Health Science Center
      Learn More About This Study

       

    •   Study of the effects of intranasal oxytocin on sarcopenic obesity
      Protocol No.
      HSC20160661H
      Official Title
      The Physiologic Effects of Intranasal Oxytocin on Sarcopenic Obesity
      Description
      The primary purpose of the study is to study the effect of intranasal oxytocin on body weight, body fat, muscle mass and glucose tolerance in older adults. Eligible participants will administer oxytocin via intranasal spray 4 times a day for 8 weeks. The study will examine whether the intranasal oxytocin spray will promote weight loss and preserve muscle mass, thereby preserving and/or improving physical function in older subjects with sarcopenic obesity.
      Contact
      210-617-5300 Ext 15701
      Locations
      UT Health Science Center
      Learn More About This Study

       

    •   Targeted Removal of Pro-Inflammatory Cells: an open label human pilot study...
      Protocol No.
      HSC20170199H
      Official Title
      Targeted Removal of Pro-Inflammatory Cells: an open label human pilot study in idiopathic pulmonary fibrosis
      Description
      To reduce the abundance of pro-inflammatory cells over baseline within subjects following treatment with dasatinib and quercetin
      Locations
      UT Health Science Center
      Learn More About This Study

       

    •   Using Metformin to Prevent Frailty in Older Patients who have Pre-Diabetes
      Protocol No.
      HSC20150237H
      Official Title
      Metformin for Preventing Frailty in High-risk Older Adults
      Description
      Many older adults will become frail with age. Older adults with pre-diabetes are at the highest risk of becoming frail. This study will provide information on whether treatment with metformin will delay or prevent the onset of frailty. Participants will be followed for two years.
      Contact
      210-617-5190
      Locations
      UT Health Science Center
      Learn More About This Study

       

    •   Vascular Dysfunction in Age-Related Macular Degeneration
      Protocol No.
      HSC20150572H
      Official Title
      Vascular Dysfunction and Hypoxia in Macular Degeneration
      Description
      We are investigating Magnetic Resonance Imaging (MRI) to detect changes in the eye due to Age-Related Macular Degeneration (AMD), which we hope could help detect AMD patients at high-risk and to monitor their treatments. We need volunteers with AMD and with no eye disease, between the ages of 40-85.
      Contact
      210-567-8169
      Locations
      UT Health Science Center
      Learn More About This Study

       

  •   Behaviors and Mental Disorders

    •   A Comparison of Web-Prolonged Exposure and Present-Centered Therapy for PTSD
      Protocol No.
      HSC20150392H
      Official Title
      A Comparison of Web-Prolonged Exposure (Web-PE) and Present-Centered Therapy for PTSD among Active-Duty Military Personnel and Veterans: Efficacy and Biological Mechanisms
      Description
      This STRONG STAR study evaluates how 10 sessions of an internet-delivered treatment, Web-PE, compare to 10 sessions of a therapist-delivered treatment, PCT in the treatment of PTSD. The project will also evaluate if changes in PTSD symptoms are linked to changes in stress hormones. Eligible participants are active duty military personnel with PTSD who have deployed since 9/11 and who are stationed at Fort Hood, Texas.
      Contact
      254-449-3617
      Locations
      UT Health Science Center
      Learn More About This Study

       

    •   A Pilot Study of the Treatment for Trauma-Related Nightmares
      Protocol No.
      HSC20150396H
      Official Title
      A Pilot Randomized Controlled Trial of Treatment for Trauma-Related Nightmares In Active Duty Military Personnel
      Description
      The researchers hope to learn if a behavioral treatment for nightmares can significantly reduce nightmare frequency, nightmare severity, sleep problems, depression and anxiety in active duty military personnel. Eligible participants are active duty military personnel with Nightmare Disorder who are stationed at Fort Hood, Texas.
      Contact
      254-288-1360
      Locations
      UT Health Science Center
      Learn More About This Study

       

    •   A study of a new medicine for the treatment of...
      Protocol No.
      HSC20170700H
      Official Title
      A Phase 3, Randomized, Double-blind, Multicenter, Placebo-controlled, Fixed-Dose, Safety, and Efficacy Study of SHP465 in Children Aged 6-12 Years with Attention-Deficit/Hyperactivity Disorder (ADHD)
      Description
      Children aged 6 to 12 years of age will have an evaluation to determine if they have ADHD. They then will be selected at random (like a flip of a coin) to either receive a medicine for ADHD (SHP465) or a placebo (an empty pill) for four weeks.
      Contact
      210-450-8405
      Locations
      UT Health Science Center
      Learn More About This Study

       

    •   A study of a new medicine for the treatment of...
      Protocol No.
      HSC20170701H
      Official Title
      A Phase 3, Open-label, Multicenter, 12-Month Safety and Tolerability Study of SHP465 in Children Aged 4 to 12 Years Diagnosed with Attention-deficit/Hyperactivity Disorder
      Description
      Children aged 4 to 12 years of age will have an evaluation to determine if they have ADHD. This study will be using an investigational drug (SHP465) for the treatment of ADHD. Participation in this study will last about 52 weeks.
      Contact
      210-450-8405
      Locations
      UT Health Science Center
      Learn More About This Study

       

    •   An Open-Trial of Web-Prolonged Exposure (Web-PE) among Active-Duty Military...
      Protocol No.
      HSC20170600H
      Official Title
      An Open-Trial of Web-Prolonged Exposure (Web-PE) among Active-Duty Military Personnel and Veterans
      Description
      The purpose of this study is to improve access to treatment for posttraumatic stress disorder (PTSD) by evaluating whether 10 sessions of PE delivered via the Internet over 8 weeks (Web-PE) is effective in reducing PTSD symptoms. Eligible participants are active duty military personnel and veterans with PTSD who have deployed since 9/11.
      Contact
      254-245-9743
      Locations
      UT Health Science Center
      Learn More About This Study

       

    •   Brief treatment for Posttraumatic Stress Disorder: Enhancing treatment...
      Protocol No.
      HSC20150904H
      Official Title
      Brief Treatment for Posttraumatic Stress Disorder: Enhancing Treatment Engagement and Retention
      Description
      The purpose of this study is to investigate whether a brief written treatment for PTSD is equally effective as a more intensive treatment. Written Exposure Therapy (WET) is a brief, trauma-focused treatment that involves writing about your traumatic experiences. Cognitive Processing Therapy (CPT) is a more intensive, trauma-focused treatment that involves learning to recognize and challenge thoughts related to your traumatic experiences. Eligible participants are active duty military presonnel with PTSD who have deployed since 9/11 and who are stationed in the San Antonio area.
      Contact
      210-562-6726
      Locations
      UT Health Science Center
      Learn More About This Study

       

    •   Clinical Effectiveness Trial of In-Home Cognitive Processing Therapy for...
      Protocol No.
      HSC20140055H
      Official Title
      Clinical Effectiveness Trial of In-Home Cognitive Processing Therapy for Combat-Related PTSD
      Description
      This STRONG STAR research study will examine effective ways of delivering Cognitive Processing Therapy (CPT) for combat-related posttraumatic stress disorder (PTSD). CPT involves learning to recognize and challenge thoughts related to a traumatic experience and is typically done through face-to-face sessions in a mental health clinic. However, traveling into a clinic can be a potential barrier for some people. The goal of this study is to evaluate the effectiveness of administering CPT in one of the following treatment settings: 1) face-to-face in a clinic office, 2) face-to-face in the home setting, or 3) through telehealth (i.e., video sessions on your computer) in the home setting. Eligible participants are OIF/OEF/OND veterans with PTSD who reside in the San Antonio area.
      Contact
      210-562-6727
      Locations
      UT Health Science Center
      Learn More About This Study

       

    •   Cognitive and Functional Connectivity Effects of Methylene Blue in Healthy...
      Protocol No.
      HSC20150410H
      Official Title
      Cognitive and Functional Connectivity Effects of Methylene Blue in Healthy Aging, Mild Cognitive Impairment and Alzheimer’s Disease
      Description
      We will be studying both healthy, MCI (mildly cognitively impaired males and females) between the ages of 45-79, and subjects diagnosed with Alzheimer’s disease between the ages of 65-79 and will be looking at the effects of Methylene Blue on memory and cognition.
      Contact
      210-567-8173
      Locations
      UT Health Science Center
      Learn More About This Study

       

    •   Cognitive-Behavioral Therapy for Posttraumatic Headache
      Protocol No.
      HSC20140339H
      Official Title
      CAP - Consortium to Alleviate PTSD - STVHCS Project 7 entitled -Randomized Clinical Trial of Cognitive-Behavior Therapy for Posttraumatic Headache-
      Description
      This study will evaluate whether a leading cognitive behavioral therapy for migraine headaches is effective with posttraumatic headaches (PTHA) for those who also have symptoms of posttraumatic stress (PTS) or posttraumatic stress disorder (PTSD). Investigators also seek to determine if treatment for PTHA also alleviates symptoms of PTS/PTSD, and whether treatment for PTS/PTSD might also alleviate headache symptoms. Eligible participants are OIF/OEF/OND veterans with posttraumatic headache following a head injury and co-occurring symptoms of PTS/PTSD who reside in the San Antonio area.
      Contact
      210-562-6737
      Locations
      UT Health Science Center
      Learn More About This Study

       

    •   Functional neuroanatomy of social and perceived internal threat in anxious...
      Protocol No.
      HSC20170149H
      Official Title
      Functional neuroanatomy of social and perceived internal threat in anxious youth at high-risk for bipolar disorder
      Description
      We are looking for children ages 8-17 who are anxious or worry a lot AND who have a biological parent with Bipolar Disorder. We are also looking for healthy families in which the parents and child have not received psychiatric diagnoses. Mental health assessments and MRI will be completed.
      Contact
      210-450-8362
      Locations
      UT Health Science Center
      Learn More About This Study

       

    •   Genetic and Environmental Influences on Growth, Motor, Cognitive, Behavioral...
      Protocol No.
      HSC20090012H
      Official Title
      Genetic and Environmental Influences on Growth, Motor, Cognitive, Behavioral and Language Development of Premature Infants
      Description
      A research study to understand how genes and the environment affect premature birth and infant development.
      Contact
      210-567-5225
      Locations
      UT Health Science Center
      Learn More About This Study

       

    •   Identifying and Validating Complex Comorbidity Clusters in OEF-OIF Veterans
      Protocol No.
      HSC20100395H
      Official Title
      Trajectories of Resilience and Comorbidity Clusters in OEF-OIF Veterans (TRACC) Traumatic Brain Injury (TBI)
      Description
      The purpose of this study is to examine the kinds of health conditions that occur together (comorbidity clusters) in Veterans of wars in Afghanistan and Iraq (OEF/OIF) over time, and the types of experiences during military service and after military service that may be associated with these patterns.
      Contact
      210-617-5314
      Locations
      UT Health Science Center
      Learn More About This Study

       

    •   Improvements in Brain Function during Psychotherapy For Teens with Symptoms...
      Protocol No.
      HSC20160637H
      Official Title
      Improvements in Brain Function during Psychotherapy For Teens with Posttraumatic Stress
      Description
      The purpose of the study is to analyze how brain functioning improves when symptoms of posttraumatic stress improve during psychotherapy. Teens who have experienced trauma and are bothered by symptoms of stress will be provided with the ‘gold-standard’ psychotherapy for trauma, at no-cost. They will have brain scans using Magnetic Resonance Imaging (MRI) before, during, and after the treatment: a total of 4 brain scans over the 20-week treatment. MRI is safe and does not use radiation or injections.
      Contact
      210-567-8162
      Locations
      UT Health Science Center
      Learn More About This Study

       

    •   Maternal Opioid Morbidity Study (MOMS)
      Protocol No.
      HSC20160688H
      Official Title
      Maternal Opioid Morbidity Study (MOMS)
      Description
      Overdose by “ingestion of drugs” is the second leading cause of maternal mortality in the state of Texas. Maternal mortality is defined by the Centers for Disease Control and Prevention as a death occurring during pregnancy or within the first 365 days following the end of a pregnancy. Maternal overdose death in Texas is second only to maternal deaths caused by a cardiac event. Case records (including postmortem toxicology and police reports) indicate that most of these deaths involve the use of licit or illicit prescription opioids; however, little is known about the context of maternal overdose death. Therefore, we are recruiting women who have experienced an opioid use relapse and/or overdose as well as family members, friends and the significant others of women who died of a maternal overdose. We will be conducting private interviews and small group discussions to gain more insight into the circumstances that contribute to maternal overdose.
      Contact
      210-450-8161
      Locations
      UT Health Science Center
      Learn More About This Study

       

    •   Multi-Couple Group Intervention for PTSD
      Protocol No.
      HSC20160094H
      Official Title
      Multi-Couple Group Intervention for PTSD
      Description
      The purpose of this study is to evaluate whether a weekend-long therapy retreat for PTSD in military members, compared to the usual 15 week therapy sessions, will show improvements in the well-being of individuals and their relationships. The therapy sessions will be done in a weekend therapy retreat with multiple military couples and their partners.
      Contact
      (254) 258-3182
      Locations
      UT Health Science Center
      Learn More About This Study

       

    •   MYRIAD
      Protocol No.
      HSC20160051H
      Official Title
      A Validation Study to Measure the Impact of a Proteomic Assay in Distinguishing Bipolar I Disorder, Bipolar II Disorder, and Major Depressive Disorder in People Presenting with a Major Depressive Episode
      Description
      This research study is to investigate whether a blood test that measures blood proteins can correctly diagnose whether a depressed person has bipolar I disorder, bipolar II disorder, or major depressive disorder.
      Contact
      210-567-0780
      Locations
      UT Health Science Center
      Learn More About This Study

       

    •   Pilot study of Adaptive Disclosure therapy for Moral Injury and Traumatic Loss
      Protocol No.
      HSC20160473H
      Official Title
      Pilot Study of Adaptive Disclosure Behavioral Therapy for Moral Injury and Traumatic Loss
      Description
      Studying PTSD treatment called Adaptive Disclosure for Moral Injury and Loss (AD-MIL) therapy for active-duty military who experienced war-related trauma that violates their understanding of right/wrong(moral injury and/or loss).
      Contact
      254-288-1638
      Locations
      UT Health Science Center
      Learn More About This Study

       

    •   Project Remission: Maximizing Outcomes with Intensive Treatments for...
      Protocol No.
      HSC20160422H
      Official Title
      Project Remission: Maximizing Outcomes with Intensive Treatments for Combat-Related PTSD
      Description
      The purpose of this study is to examine whether 15 sessions of Massed-Prolonged Exposure (Massed-PE) delivered over 3-weeks is as effective as 15 days of an Intensive Outpatient Prolonged Exposure protocol (IOP-PE) delivered over 3-weeks in the treatment of combat-related PTSD. The researchers hope to learn if these programs improve treatment accessibility, patient retention, and treatment outcomes. Eligible participants are veterans and active duty military personnel with PTSD who have deployment since 9/11 and who are stationed in the San Antonio, Fort Hood, and Waco, Texas areas.
      Contact
      210-562-6726
      Locations
      UT Health Science Center
      Learn More About This Study

       

    •   Social Support in Women Using Opioids During Pregnancy
      Protocol No.
      HSC20170018H
      Official Title
      Social Support, Stress, and Depressive Symptoms in Opioid Using Pregnant Women: A Mixed Methods Study
      Description
      The use of opioids during pregnancy is on the rise, placing pregnant women at risk for negative outcomes. The purpose of this the study is to measure social support, stress, and look at mental health outcomes of women using opioids during their pregnancy
      Contact
      (210) 450-8161
      Locations
      UT Health Science Center
      Learn More About This Study

       

    •   Tooth Fairy Study
      Protocol No.
      HSC20110313H
      Official Title
      Potential Risk Factors Associated with Autism Spectrum Disorders
      Description
      Participate in the Tooth Fairy Study! Our research team recently discovered that toxins such as plastics, pesticides and medications are stored in baby teeth as they are forming during pregnancy and shortly thereafter. The cause of autism is unknown; however, genetic and environmental factors are both likely involved. This study is being done to learn if children with autism have been exposed to more environmental toxins than typically-developing children and to learn if their genes are more vulnerable to the toxins. We are currently enrolling biological mothers of children with autism, their siblings AND mothers of children developing normally. Participants will fill out a survey regarding nutrition and exposures (~30 minutes), and donate their child’s baby teeth. To be eligible for this study… • You must be the biological mother of a child who is 2 years or older. • Your child must either have an established or suspected diagnosis of autism OR be a typically-developing child with no chronic medical problems • You must have a tooth from your child in good condition (not too worn or large cavities/crowns) To learn more about this study… Contact Lynne Heilbrun, MPH at heilbrun@UTHSCSA.edu.
      Contact
      210-274-4009
      Locations
      UT Health Science Center
      Learn More About This Study

       

    •   Treatment of Comorbid Sleep Disorders and PTSD
      Protocol No.
      HSC20150900H
      Official Title
      Treatment of Comorbid Sleep Disorders and PTSD
      Description
      The researchers hope to learn if Cognitive-Behavioral Therapy of insomnia and nightmares and Cognitive Processing Therapy (CPT) of PTSD will reduce PTSD, and also result in improvements in other areas commonly affected by sleep disorders and PTSD. Eligible participants are Active duty military and recently discharged Veterans at Fort Hood’s Carl R. Darnall Army Medical Center (CRDAMC).
      Contact
      254-288-1360
      Locations
      UT Health Science Center
      Learn More About This Study

       

    •   Understanding the genetics of bipolar I disorder in adolescents
      Protocol No.
      HSC20150334H
      Official Title
      Application of induced pluripotent stem cells for the study of bipolar I disorder
      Description
      The purpose of this research is to develop a cell-based system to study adolescent bipolar I disorder to better understand genetic and epigenetic mechanisms associated with risk and develop new methods for treatment. We will perform MRI, neurocognitive and neuropsychiatric testing and draw blood.
      Contact
      210-258-9766
      Locations
      UT Health Science Center
      Learn More About This Study

       

  •   Cancers and Other Neoplasms

    •   Anus

      •   A Dose Regimen-Finding Study to Evaluate the Safety, Tolerability,...
        Protocol No.
        HSC20170102HU
        Official Title
        A Dose Regimen-Finding Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Activity of Oradoxel Monotherapy in Subjects with Advanced Malignancies (CTMS# 16-0069)
        Description
        Primary Objective: To determine the maximum tolerated dose (MTD) of Oradoxel based on dose-limiting toxicity (DLT) in subjects with advanced malignancies Secondary Objectives To determine the safety and tolerability of docetaxel as Oradoxel To determine the incidence of unacceptable toxicity with Oradoxel To determine the recommended Phase 2 dose (RP2D) of docetaxel as Oradoxel To characterize the pharmacokinetic (PK) profile of docetaxel as Oradoxel To evaluate tumor response
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   A Dose Regimen-Finding Study to Evaluate the Safety, Tolerability,...
        Protocol No.
        HSC20160087HU
        Official Title
        A Dose Regimen-Finding Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Activity of Oraxol in Subjects with Advanced Malignancies (CTMS# 15-2137)
        Description
        Primary Objective To determine the maximum tolerated dose (MTD) and dosing regimen of Oraxol in subjects with advanced malignancies Secondary Objectives To determine the recommended Phase 2 dose of paclitaxel as Oraxol To determine the safety and tolerability of paclitaxel as Oraxol To characterize the pharmacokinetic (PK) profile of paclitaxel as Oraxol To evaluate the tumor response
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   A Phase 1 Dose Escalation and Cohort Expansion Study of TSR-042, an...
        Protocol No.
        HSC20170110HU
        Official Title
        A Phase 1 Dose Escalation and Cohort Expansion Study of TSR-042, an anti-PD-1 Monoclonal Antibody, in Patients with Advanced Solid Tumors (CTMS# 16-0091)
        Description
        Primary Objectives: Part 1 Dose Escalation Cohorts: To evaluate the safety and tolerability of TSR-042 using Common Terminology Criteria for Adverse Events (CTCAE v.4.03) in patients with advanced solid tumors Part 2 Expansion Cohorts: To evaluate the antitumor activity of TSR-042 in patients with advanced solid tumors, in terms of objective response rate (ORR) as assessed by the Investigators using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 Part 1 and Part 2: To define the recommended Phase 2 dose (RP2D) and schedule Secondary Objectives: Part 1 Dose Escalation Cohorts: To characterize the pharmacodynamic (PDy) profile of TSR-042 To evaluate ORR as assessed by the Investigators using RECIST v1.1 Part 2 Expansion Cohorts: To characterize the safety and tolerability of TSR-042 using CTCAE v.4.03 Part 1 and Part 2: To characterize the pharmacokinetic (PK) profile of TSR-042 To evaluate the immunogenicity of TSR-042 To evaluate additional measures of clinical benefit, including: ORR by immune-related RECIST (irRECIST) Duration of response (DOR) by RECIST v 1.1 Disease control rate (DCR) by RECIST v 1.1 and by irRECIST Progression-free survival (PFS) by RECIST v 1.1 and by irRECIST Overall survival (OS)
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   A Phase 1 Study of CBL0137 in Patients with Metastatic or Unresectable...
        Protocol No.
        HSC20130328H
        Official Title
        A Phase 1 Trial of CBL0137 In patients With Metastatic or Unresectable Advanced Solid Neoplasms or Refractory Lymphomas (CTRC# 13-0031)
        Description
        This Phase 1 study is designed to determine the best dose of CBL0137 to use when treating patients with metastatic or unresectable advanced solid tumors or lymphoma. The study will enroll up to 48 patients from at least 2 cancer centers in the US. In addition to other conditions for enrollment, eligible patients have cancer that has not improved or has come back after prior treatment and are otherwise in good health. Patients who have a history of active infection, cancer involving the central nervous system, a particular EKG abnormality or other serious medical conditions may not be eligible to enroll.
        Contact
        210-450-5798
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   A Phase 1/2A, Multicenter, Open-Label Study of LYC-55716 in Adult Subjects...
        Protocol No.
        HSC20160617HU
        Official Title
        A Phase 1/2A, Multicenter, Open-Label Study of LYC-55716 in Adult Subjects with Locally Advanced or Metastatic Cancer (CTMS# 16-0099)
        Description
        Primary Objectives Phase 1 Evaluate the safety and tolerability of LYC-55716 Determine the maximum tolerated dose (MTD) and the recommended Phase 2 dose (RP2D) Phase 2a Determine the objective response rate according to response evaluation criteria in solid tumors (RECIST) v1.1 Secondary Objectives Phase 1 Evaluate the activity of LYC-55716 by objective response according to RECIST v1.1 Determine the durability of any observed objective response Phase 2a Determine the duration of response Determine progression-free survival (PFS) and overall survival (OS) Determine suitability of the RP2D for further study Characterize the pharmacokinetics (PK) of LYC-55716 Exploratory Objectives Assess tumor activity in subjects with locally advanced or metastatic cancer according to immune-related response evaluation criteria in solid tumors (irRECIST) Exploratory analysis of metabolite in plasma Assess changes in circulating tumor markers (eg, cytokines/chemokines)
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   A Phase 1b Study of Oraxol in Combination with Ramucirumab in Patients with...
        Protocol No.
        HSC20170188HU
        Official Title
        A Phase 1b Study of Oraxol in Combination with Ramucirumab in Patients with Gastric, Gastro-esophageal, or Esophageal Cancers (CTMS# 16-0089)
        Description
        Primary Objective: To determine the maximum tolerated dose (MTD) of Oraxol in patients with advanced stage gastric, gastro-esophageal, or esophageal cancers who are being treated with Oraxol in combination with ramucirumab Secondary Objectives: To determine the safety and tolerability of Oraxol in combination with ramucirumab To determine the recommended Phase 2 dose of Oraxol in combination with ramucirumab To characterize the pharmacokinetic (PK) profile of Oraxol in combination with ramucirumab To characterize preliminary activity of Oraxol plus ramucirumab as determined by response rate, progression-free survival, and overall survival
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   A Phase 1b/2 Study of ARRY-382 in Combination with Pembrolizumab, a...
        Protocol No.
        HSC20170071HU
        Official Title
        A Phase 1b/2 Study of ARRY-382 in Combination with Pembrolizumab, a Programmed Cell Death Receptor 1 (PD-1) Antibody, for the Treatment of Patients with Advanced Solid Tumors (CTMS# 16-0084)
        Description
        Primary objective: To determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of ARRY-382 in combination with pembrolizumab in patients with selected solid tumors Secondary objectives:  To describe the preliminary antitumor activity of the combination based on the Response Criteria In Solid Tumors, version 1.1 (RECIST v1.1).  To describe the preliminary antitumor activity of the combination based on immune-related response criteria (irRC).  To characterize the safety and tolerability of the combination, including acute and chronic toxicities. To evaluate the pharmacokinetics of ARRY-382 in combination with pembrolizumab Exploratory objective: To explore the effect of the combination on circulating biomarkers of immune response. To describe the preliminary antitumor activity of the combination in patients with PD-L1 positive non-small cell lung cancer (NSCLC), as determined using a United States Food and Drug Administration (FDA)-approved test, using RECIST. To describe the preliminary antitumor activity of the combination in patients with PD-L1 positive non-small cell lung cancer (NSCLC), as determined using an FDA approved test, using irRC
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   A Phase I, First-in-human, Open-label, Dose-escalation, Safety,...
        Protocol No.
        HSC20160554HU
        Official Title
        A Phase I, First-in-human, Open-label, Dose-escalation, Safety, Pharmacokinetic, and Pharmacodynamic Study of Oral TP-0903 Administered Daily for 21 Days to Patients with Advanced Solid Tumors (CTMS# 16-0092)
        Description
        Primary Objective: To determine the maximum tolerated dose (MTD) and dose-limiting toxicities (DLTs) of oral TP-0903 administered daily for the first 21 days every 4 weeks, over a range of doses in patients with advanced solid tumors. Secondary Objectives: To establish the pharmacokinetics of orally administered TP-0903 To observe patients for any evidence of antitumor activity of TP-0903 by objective radiographic assessment To study the pharmacodynamics of TP-0903 therapy by: assessing biomarkers in tumor tissue assessing biomarkers in peripheral blood mononuclear cells (PBMCs) and serum To establish the Recommended Phase 2 Dose (RP2D) for future studies with TP-0903
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
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      •   A Phase I, Multicenter, Open-Label Dose Escalation and Expansion Study of...
        Protocol No.
        HSC20150289HU
        Official Title
        A Phase I, Multicenter, Open-Label Dose Escalation and Expansion Study of PCA062, Administered Intravenously In Adult Patients With pCAD-Positive Tumors (CTMS# 14-2019)
        Description
        Primary Objective To determine the MTD/RDE of PCA062 in patients with pCAD-positive tumors in the dose escalation part. Secondary Objectives To characterize the safety and tolerability of PCA062 To characterize the pharmacokinetic profile of PCA062 To assess emergence of anti-PCA062 antibodies following one or more intravenous infusions of PCA062 To assess the preliminary anti-tumor activity of PCA062 in patients with pCAD-positive triple negative breast cancer (TBNC), head and neck squamous cell carcinoma (HNSCC) or esophageal cancer (squamous and adenocarcinoma)
        Contact
        210-450-5798
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
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      •   A Phase I/II, open label, multicenter study of the safety and efficacy of...
        Protocol No.
        HSC20150421HU
        Official Title
        A Phase I/II, open label, multicenter study of the safety and efficacy of LAG525 single agent and in combination with PDR001 administered to patients with advanced malignancies (CTMS #15-2054)
        Description
        Primary Objectives Phase I part To estimate the RP2D or MTD for the single agent LAG525 and the combination of LAG525 and PDR001. Phase II part To estimate the overall response rate per RECIST V1.1 for single agent LAG525 as well as for the combination of LAG525 and PDR001 Secondary Objectives: To characterize the safety and tolerability of single agent LAG525 given alone and in combination with PDR001 To characterize the pharmacokinetic profile of single agent LAG525 given alone and in combination with PDR001 To assess emergence of anti-LAG525, and anti-PDR001 antibodies following one or more intravenous (i.v.) infusions of single agent LAG525 given alone or in combination with PDR001 To assess potential predictors of efficacy of single agent LAG525 and the combination of LAG525 and PDR001 To evaluate the preliminary antitumor activity of single agent LAG525 given alone or in combination of PDR001 To investigate patient selection and pharmacodynamic biomarkers in tumor tissue samples
        Contact
        210-450-5798
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   A Phase I/II, Open-Label, Multi-Center Study of the Safety and Efficacy of...
        Protocol No.
        HSC20160420HU
        Official Title
        A Phase I/II, Open-Label, Multi-Center Study of the Safety and Efficacy of BLZ945 as Single Agent and In Combination with PDR001 in Adult Patients with Advanced Solid Tumors (CTMS# 16-0071)
        Description
        Primary Objective: Phase I: To characterize the safety and tolerability of BLZ945 as a single agent and in combination with PDR001 and to identify the Maximum Tolerated Dose (MTD)/Recommended Phase 2 Dose (RP2D). Phase II: To assess the anti-tumor activity of BLZ945 in combination with PDR001 (and as single agent if appropriate) in patients with advanced solid tumors. Secondary Objective: Phase I: To characterize the pharmacodynamics effect of BLZ945 as a single agent and in combination with PDR001. To characterize PK of BLZ945 as a single agent and in combination with PDR001. To assess the preliminary anti-tumor activity of BLZ945 as single agent and in combination with PDR001. Phase I and II: To assess emergence of anti-PDR001 antibodies when BLZ945 is administered in combination with PDR001.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
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      •   A Phase Ib Trial of Pembrolizumab (MK-3475) in Combination with Dinaciclib...
        Protocol No.
        HSC20170106HU
        Official Title
        A Phase Ib Trial of Pembrolizumab (MK-3475) in Combination with Dinaciclib (MK-7965) in Subjects with Hematologic Malignancies (KEYNOTE-155) (CTMS# 16-0009)
        Description
        Primary Objective Objective: In both the Dose Evaluation and Signal Detection phases, evaluate the safety and tolerability of the treatment combination. Objective: Within each disease type of the Signal Detection phase, evaluate objective response rate (ORR) according to investigator assessment using the disease specific criteria. Secondary Objective: Objective: To evaluate the Objective Response Rate (ORR; complete response [CR] + partial response [PR]) of the combination of pembrolizumab and dinaciclib within each disease type, ie, CLL based on iwCLL guidelines (Hallek, 2008) [1], MM based on IMWG criteria (Durie, 2006) [2] and DLBCL based on the Revised Response Criteria for Malignant Lymphoma (Cheson, 2007) [3]. Objective: Within each disease type of the Signal Detection phase, evaluate Duration of Response (DOR), Progression-Free Survival (PFS) according to investigator assessment using the disease specific criteria; and Overall Survival (OS).
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   ABTR01B1, A Children''s Oncology Group Protocol for Collecting and Banking...
        Protocol No.
        HSC20040131H
        Official Title
        ABTR01B1, A Children''s Oncology Group Protocol for Collecting and Banking Pediatric Research Specimens Including Rare Pediatric Tumors
        Description
        This study is collecting and storing malignant, borderline malignant neoplasms, and related biological samples from young patients with cancer. Collecting and storing samples of tumor tissue, blood, and bone marrow from patients with cancer to study in the laboratory may help the study of cancer in the future.
        Contact
        210-562-9149
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
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      •   ACCL15N1CD Use of Evidence-Based Supportive Care Clinical Practice...
        Protocol No.
        HSC20160673X
        Official Title
        ACCL15N1CD Use of Evidence-Based Supportive Care Clinical Practice Guidelines in Pediatric
        Description
        Primary and Secondary Aims Aim 1: Chart Review To measure the rate of adherence to selected COG-endorsed supportive care CPG recommendations at NCORP sites Aim 1a To describe the possible influence of NCORP site size and the number of patients enrolled in COG studies per site on the delivery of CPG-consistent care. Aim 1b To describe the clinical outcome of episodes during which patients receive CPG-consistent or CPG-inconsistent care Aim 2: Focus Groups To describe facilitators of and barriers to the use of CPGs elicited via focus group interviews with a diverse set of potential users (physician, nurse, nurse practitioner and pharmacists) who provide pediatric cancer care at NCORP sites. Aim 3: Interviews To improve how well CPG recommendations are understood by health care providers by refining the CPG recommendation format based on an iterative process of cognitive interviewing and formatting revisions. Understanding is defined as the correct interpretation of the course of action recommended or suggested by a CPG.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   ACCRN07 Protocol for the Enrollment on the Official COG Registry, The...
        Protocol No.
        HSC20080271X
        Official Title
        ACCRN07 Protocol for the Enrollment on the Official COG Registry, The Childhood Cancer Research Network (CCRN)
        Description
        The Children s Oncology Group has established a research network, the Childhood Cancer Research Network (CCRN), to collect information about children with cancer and other conditions that are benign but involve abnormal cell growth in order to help doctors and scientists better understand childhood cancer. The CCRN''s goal is to collect clinical information about every child diagnosed with cancer and similar conditions in the United States and Canada, to allow researchers to study patterns, characteristics, and causes of childhood cancer. The information can also help researchers study the causes of childhood cancer. To expand the CCRN, parents of children who have been diagnosed with cancer will be asked to provide information about themselves and their child for research purposes.   Objectives: To obtain informed consent from parents (and the child, when appropriate) of infants, children, adolescents, and young adults newly diagnosed with cancer to enter their names and certain information concerning their child into the Childhood Cancer Research Network. To obtain informed consent from parents (and the child, when appropriate) of infants, children, adolescents, and young adults newly diagnosed with cancer for permission to be contacted in the future to consider participating in non-therapeutic and prevention research studies involving the parents and/or the child.
        Contact
        210-562-9149
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
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      •   Adolescent and Young Adult Childhood Cancer Survivorship (CTMS#17-0088)
        Protocol No.
        HSC20170474HU
        Official Title
        Adolescent and Young Adult Childhood Cancer Survivorship (CTMS#17-0088)
        Description
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
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      •   ALTE05N1, Umbrella Long-Term Follow-Up Protocol
        Protocol No.
        HSC20090478X
        Official Title
        ALTE05N1, Umbrella Long-Term Follow-Up Protocol
        Description
        Umbrella Long-Term Follow-Up Protocol
        Contact
        210-562-9149
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
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      •   ALTE1621 Pharmacologic Reversal of Ventricular Remodeling in Childhood...
        Protocol No.
        HSC20160394X
        Official Title
        ALTE1621 Pharmacologic Reversal of Ventricular Remodeling in Childhood Cancer Survivors at Risk for Heart Failure (PREVENT-HF): A Phase 2b Randomized Placebo-Controlled (Carvedilol) Trial
        Description
        1.1 Primary Aim To determine the impact of a two-year course of low-dose carvedilol on surrogate echocardiographic indices of heart failure (HF) risk, including Left Ventricular (LV) Posterior Wall Thickness-Dimension Ratio (LV T-D) a well-established index of early myocardial remodeling and subsequent HF risk (primary endpoint).  LV systolic and diastolic function and afterload established echocardiographic indices associated with HF risk.  Natriuretic peptides, troponins, and Galectin-3 - circulating biomarkers associated with myocardial injury, and HF risk. 1.2 Secondary Aims 1.2.1 To establish safety and tolerability of this two-year course of low-dose carvedilol, assessing both objective measures (hepatic function) and patient reported outcomes. 1.2.2 To examine the modifying effect of demographic, clinical, and molecular characteristics on the risk: benefit ratio from this two-year carvedilol intervention. 1.3 Exploratory Aim To evaluate the long-term efficacy of carvedilol in preventing cardiomyopathy and/or heart failure in high-risk childhood cancer survivors.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   AN EARLY-PHASE, MULTICENTER, OPEN-LABEL STUDY OF THE SAFETY AND...
        Protocol No.
        HSC20150549H
        Official Title
        AN EARLY-PHASE, MULTICENTER, OPEN-LABEL STUDY OF THE SAFETY AND PHARMACOKINETICS OF ATEZOLIZUMAB (MPDL3280A) IN PEDIATRIC AND YOUNG ADULT PATIENTS WITH PREVIOUSLY TREATED SOLID TUMORS
        Description
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
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      •   An Open-Label Rollover Study to Evaluate the Long-Term Safety, Tolerability,...
        Protocol No.
        HSC20170197XT
        Official Title
        An Open-Label Rollover Study to Evaluate the Long-Term Safety, Tolerability, Biological Activity of Oral TVB-2640 in Patients With Solid Tumors Previously Enrolled in 3V2640-CLIN-002 (CTMS# 17-0046)
        Description
        Primary: To continue to characterize the safety profile of TVB-2640. Secondary: To identify any early signs of anti-tumor activity, where possible.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   An Open-Label, Dose Escalation, Phase 1, First-In-Human Study of TAK-659 in...
        Protocol No.
        HSC20150255HU
        Official Title
        An Open-Label, Dose Escalation, Phase 1, First-In-Human Study of TAK-659 in Adult Patients with Advanced Solid Tumors and Lymphoma Malignancies (CTMS# 14-2013)
        Description
        To determine the safety, tolerability, maximum tolerated dose (MTD)/recommended phase 2 dose (RP2D) ofTAK-659 administered orally on a daily dosing schedule in patients with advanced solid tumor and lymphoma who do not have effective standard treatment available
        Contact
        210-450-5798
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
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      •   APEC14B1, THE PROJECT: EVERYCHILD PROTOCOL: A REGISTRY, ELIGIBILITY...
        Protocol No.
        HSC20150870XT
        Official Title
        APEC14B1, THE PROJECT: EVERYCHILD PROTOCOL: A REGISTRY, ELIGIBILITY SCREENING, BIOLOGY AND OUTCOME STUDY
        Description
        1.1 To maintain a Childhood Cancer Registry1 for infants, children, adolescents, and young adults with cancer. 1.2 To utilize clinical and biological data to help determine eligibility or stratification, based on childhood cancer disease classification schemas, for potential enrollment of research subjects onto COG therapeutic clinical trials. 1.3 To develop a well annotated childhood cancer biorepository for current and future research through the collection of biospecimens (at diagnosis, time of progression, time of recurrence and/or post-mortem), including tumor, host and when feasible parental germline DNA; and key clinical data, including presentation, diagnostic, staging, summary treatment, and outcome information, from every child diagnosed with cancer at COG institutions. 1.4 To allow use of registry data for permission to be contacted in the future to consider participating in non-therapeutic and prevention research studies involving the child or their parents.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   Cancer Therapy and Research Center''s Institute for Drug Development Solid...
        Protocol No.
        HSC20070684H
        Official Title
        Cancer Therapy and Research Center''s Institute for Drug Development Solid Tumors and Hematological Malignancies Biorepository for Biomarker Discovery
        Description
        Samples are collected for the Cancer Therapy and Research Center''s Solid Tumors and Hematological Malignancies Biorepository for Biomarker Discovery
        Contact
        210-450-5798
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   Caris Molecular Intelligence® and Caris Centers of Excellence for...
        Protocol No.
        HSC20170144HU
        Official Title
        Caris Molecular Intelligence® and Caris Centers of Excellence for Precision Medicine NetworkTM Retrospective Outcomes-Associated Database (CTMS# 16-0145)
        Description
        The objective of this project is the development of the Caris Molecular Intelligence® and Caris Centers of Excellence for Precision Medicine NetworkTM Outcomes Associated Repository, a disease research database (hereinafter referred to as the Database ) for the purpose of: 1. Effecting change in disease treatment processes by advancing precision medicine and improving care for cancer through acquiring and sharing valuable molecular tumor profiling information and clinical outcomes in a collaborative, secure environment. 2. Performing prospective research studies involving analyses of quality of life studies as well as subject medical records including clinical presentation and outcomes. This eligible cohort includes select subjects having undergone Caris Molecular Intelligence® evaluation for diagnosis and/or treatment management. 3. Evaluate the frequency of specific clinical events in relation to risk factors, diagnosis and treatments provided via the collection of outcomes data through automated data capture systems provided by a third-party data entity and manually-entered data when needed. 4. Provide information access that is vital to research collaborators, including potential researchers from pharmaceutical companies, governmental agencies, academia, healthcare providers, and payors, with catalogued subject outcome data for the use of drug development discoveries, clinically relevant research trials, publications and posters, the implementation of future healthcare policies, characterization of trends in practice patterns and their relation to subject outcomes and the economic impact of differing evaluation, treatment, and management paradigms. 5. Cultivate a repository for assay development and validation of emerging technologies to enhance clinical cancer care.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   Caris Molecular Intelligence® and Caris Centers of Excellence for Precision...
        Protocol No.
        HSC20170353HU
        Official Title
        Caris Molecular Intelligence® and Caris Centers of Excellence for Precision Medicine NetworkTM Outcomes Associated Repository (CTMS# 17-0023)
        Description
        The objective of this project is the development of the Caris Molecular Intelligence® and Caris Centers of Excellence for Precision Medicine NetworkTM Outcomes Associated Repository, a disease research database (hereinafter referred to as the Database) for the purpose of: 1. Effecting change in disease treatment processes by advancing precision medicine and improving care for cancer through acquiring and sharing valuable molecular tumor profiling information and clinical outcomes in a collaborative, secure environment. 2. Performing prospective research studies involving analyses of quality of life studies as well as subject medical records including clinical presentation and outcomes. This eligible cohort includes select subjects having undergone Caris Molecular Intelligence® evaluation for diagnosis and/or treatment management. 3. Evaluate the frequency of specific clinical events in relation to risk factors, diagnosis and treatments provided via the collection of outcomes data through automated data capture systems provided by a third-party data entity and manually-entered data when needed. 4. Provide information access that is vital to research collaborators, including potential researchers from pharmaceutical companies, governmental agencies, academia, healthcare providers, and payors, with catalogued subject outcome data for the use of drug development discoveries, clinically relevant research trials, publications and posters, the implementation of future healthcare policies, characterization of trends in practice patterns and their relation to subject outcomes and the economic impact of differing evaluation, treatment, and management paradigms. 5. Cultivate a repository for assay development and validation of emerging technologies to enhance clinical cancer care.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   Clinical Trial of Lurbinectedin (PM01183) in Selected Advanced Solid Tumors
        Protocol No.
        HSC20150542HU
        Official Title
        A Multicenter Phase II Clinical Trial of Lurbinectedin (PM01183) in Selected Advanced Solid Tumors (CTMS# 15-2071)
        Description
        Primary: To assess the antitumor activity of lurbinectedin (PM01183) in terms of overall response rate (ORR), according to the Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1, in the following advanced solid tumors: small cell lung cancer (SCLC), head and neck carcinoma (H&N), neuroendocrine tumors (NETs), biliary tract carcinoma, endometrial carcinoma, BRCA 1/2-associated metastatic breast carcinoma, carcinoma of unknown primary site, germ cell tumors (GCTs), and Ewing¿s family of tumors (EFTs). Secondary: To further characterize the antitumor activity of PM01183 in terms of duration of response (DR), clinical benefit [ORR or stable disease (SD) lasting over four months (SD ¿ 4 months)], progression-free survival (PFS), and one year overall survival (1y-OS) in each cohort of advanced solid tumors. Characterize the plasma pharmacokinetics (PK) of PM01183. To conduct an exploratory pharmacogenomic (PGx) and pharmacogenetic analysis. To evaluate the safety profile of PM01183 in this patient population.
        Contact
        410-450-5798
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
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      •   Clinical trial to study the safety and efficacy of MBG453 given alone and in...
        Protocol No.
        HSC20150730HU
        Official Title
        A Phase I-Ib/II, Open-Label, Multi-Center Study of the Safety and Efficacy of MBG453 as Single Agent and in Combination with PDR001 in Adult Patients with Advanced Malignancies (CTMS# 15-2114)
        Description
        Primary Objectives: Phase I-Ib: To characterize the safety and tolerability of MBG453 as a single agent and in combination with PDR001 and to identify recommended doses for future studies. Phase I-Ib dose ranging: To further investigate the safety and tolerability of different doses of MBG453 alone or in combination with PDR001. Phase II: To estimate the anti-tumor activity of MBG453 alone in patients with solid tumors, and in combination with PDR001 in selected disease indications (melanoma, non-small cell lung cancer (NSCLC), renal cell carcinoma (RCC)). Secondary Objectives Evaluate the preliminary anti-tumor activity of MBG453 alone and in combination with PDR001. Make an initial comparison of safety, PK and efficacy for MBG453 and PDR001 administered in combination on a every 2 weeks (Q2W) and every 4 weeks (Q4W) dosing schedules. Characterize the pharmacokinetic profile of MBG453 alone and in combination with PDR001. Assess emergence of anti-MBG453 and anti-PDR001 antibodies. Assess potential predictors of efficacy of MBG453 single agent and in combination with PDR001 in tumor samples. Assess the pharmacodynamic effect of MBG453 as single agent and in combination with PDR001 in tumor samples. Describe the survival distribution of patients treated with MBG453 as single agent and in combination with PDR001 for each disease group.
        Contact
        410-450-5798
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
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      •   DCP-001, Use of a Clinical Trial Screening Tool to Address Cancer Health...
        Protocol No.
        HSC20160342XT
        Official Title
        DCP-001, Use of a Clinical Trial Screening Tool to Address Cancer Health Disparities in the NCI Community Oncology Research Program (NCORP)
        Description
        Objectives 1) Implement a screening tool in NCORP to collect broader demographic and clinical data to generate hypothesis and research questions in the following areas of research: cancer screening, cancer prevention, symptom science, cancer care disparities, comparative effectiveness and cancer care delivery research. 2) Collect expanded demographic and clinical data (e.g., SES, co-morbidities, method of diagnosis) across the NCORP network to help identify and best characterize patients that are screened but not enrolled and for patients that participate in NCI trials, to understand how these variables may impact outcomes. 3) Enhance an understanding of site- specific and trial-specific accrual barriers that will inform the development of effective strategies to improve accrual, particularly for minority and underserved populations. 4) Provide data for internal and external evaluation of NCORP s first RFA cycle and reissuance.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   GO29665, A PHASE I/II, MULTICENTER, OPEN-LABEL, DOSE-ESCALATION STUDY OF THE...
        Protocol No.
        HSC20160080H
        Official Title
        GO29665, A PHASE I/II, MULTICENTER, OPEN-LABEL, DOSE-ESCALATION STUDY OF THE SAFETY AND PHARMACOKINETICS OF COBIMETINIB IN PEDIATRIC AND YOUNG ADULT PATIENTS WITH PREVIOUSLY TREATED SOLID TUMORS (CTRC# 15-0005)
        Description
        CTRC#15-0005
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
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      •   Head and Neck Cancer Repository
        Protocol No.
        HSC20170218HR
        Official Title
        Head and Neck Cancer Repository
        Description
        To establish a repository of head and neck cancers and PDX models from our south Texas patient population.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
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      •   Health Effects after Anthracycline and Radiation Therapy (HEART):...
        Protocol No.
        HSC20140058X
        Official Title
        Health Effects after Anthracycline and Radiation Therapy (HEART): Dexrazoxane and Prevention of Anthracycline-related Cardiomyopathy A Limited Institution Non-Therapeutic Study
        Description
        This clinical trial studies the effects of dexrazoxane hydrochloride on biomarkers associated with cardiomyopathy and heart failure after cancer treatment. Studying samples of blood in the laboratory from patients receiving dexrazoxane hydrochloride may help doctors learn more about the effects of dexrazoxane hydrochloride on cells. It may also help doctors understand how well patients respond to treatment.
        Contact
        210-562-9149
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
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      •   Incidence and Factors Associated with the Development and Severity of Oral...
        Protocol No.
        HSC20050218H
        Official Title
        Incidence and Factors Associated with the Development and Severity of Oral Mucositis in Patients Undergoing High Dose Chemotherapy and Peripheral Stem Cell Transplantation
        Description
        Our study intends to evaluate prospectively the incidence and severity of oral mucositis in patients undergoing high-dose chemotherapy and hematopoietic stem cell transplantation, as well as to evaluate the potential influence of nutritional-, physical-, and transplant-related factors associated with the development of this complication and its grade of involvement. Research plan: This is a prospective cohort study with an observational basis that involves all of the patients undergoing high-dose chemotherapy and peripheral blood stem cell transplantation at the Audie L. Murphy VA Hospital Bone Marrow Transplant Unit and at the University Hospital Bone Marrow Transplant Unit. We expect to enroll 400 patients during a 5-year period. Methods: In order to answer the study questions, subjects will be assessed several times during the study period. The study involves a multidisciplinary group that will be evaluating and following the subjects. A baseline will be established by a physician and a nutritionist before the subjects start the high-dose chemotherapy regimen. The subjects will be followed with oral evaluations 3 times per week, beginning on the day of the transplant and ending when mucositis resolves, or the patient is discharged home, or 30 days post-transplant, whichever occurs first. At day 15 post-transplant, patients will be evaluated for the second time by the nutritionist. Further information such as blood values, use of medications and treatment complications, will be obtained by daily chart review.  
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   MATCH Treatment Subprotocol B: Phase II Study of Afatinib in Patients with...
        Protocol No.
        HSC20150831HU
        Official Title
        MATCH Treatment Subprotocol B: Phase II Study of Afatinib in Patients with Tumors with HER2 Activating Mutations (CTMS# 15-2107)
        Description
        Primary Objective To evaluate the proportion of patients with objective response (OR) to targeted study agent(s) in patients with advanced refractory cancers/lymphomas. Secondary Objectives To evaluate the proportion of patients alive and progression free at 6 months of treatment with targeted study agent in patients with advanced refractory cancers/lymphomas. To evaluate time until death or disease progression. To identify potential predictive biomarkers beyond the genomic alteration by which treatment is assigned or resistance mechanisms using additional genomic, RNA and protein-based assessment platforms.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
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      •   MATCH Treatment Subprotocol C1: EAY131-C1: Crizotinib in Patients with...
        Protocol No.
        HSC20160463HU
        Official Title
        MATCH Treatment Subprotocol C1: EAY131-C1: Crizotinib in Patients with Tumors with MET Amplification (CTMS# 16-0064)
        Description
        The purpose of this study is to test any good and bad effects of the study drug called crizotinib in patients whose cancer has MET genetic changes.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
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      •   MATCH Treatment Subprotocol F: Crizotinib in Patients with Tumors (other...
        Protocol No.
        HSC20150750HU
        Official Title
        MATCH Treatment Subprotocol F: Crizotinib in Patients with Tumors (other than adenocarcinoma of lung or ALCL) with ALK Translocations (CTMS# 15-2081)
        Description
        Primary Objective To evaluate the proportion of patients with objective response (OR) to targeted study agent(s) in patients with advanced refractory cancers/lymphomas. Secondary Objectives To evaluate the proportion of patients alive and progression free at 6 months of treatment with targeted study agent in patients with advanced refractory cancers/lymphomas. To evaluate time until death or disease progression. To identify potential predictive biomarkers beyond the genomic alteration by which treatment is assigned or resistance mechanisms using additional genomic, RNA and protein-based assessment platforms.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   MATCH Treatment Subprotocol S1: Phase II Study of Trametinib in Patients...
        Protocol No.
        HSC20160260HU
        Official Title
        MATCH Treatment Subprotocol S1: Phase II Study of Trametinib in Patients with Tumors with NF1 Mutations (CTMS# 16-0028)
        Description
        PRIMARY OBJECTIVES: I. To evaluate the proportion of patients with objective response (OR) to targeted study agent(s) in patients with advanced refractory cancers/lymphomas. SECONDARY OBJECTIVES: I. To evaluate the proportion of patients alive and progression free at 6 months of treatment with targeted study agent in patients with advanced refractory cancers/lymphomas. II. To evaluate time until death or disease progression. III. To identify potential predictive biomarkers beyond the genomic alteration by which treatment is assigned or resistance mechanisms using additional genomic, ribonucleic acid (RNA) and protein-based assessment platforms.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
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      •   MATCH Treatment Subprotocol U: VS-6063 (defactinib) in Patients with Tumors...
        Protocol No.
        HSC20150839HU
        Official Title
        MATCH Treatment Subprotocol U: VS-6063 (defactinib) in Patients with Tumors with NF2 Loss (CTMS# 15-2110)
        Description
        Primary Objective To evaluate the proportion of patients with objective response (OR) to targeted study agent(s) in patients with advanced refractory cancers/lymphomas. Secondary Objectives To evaluate the proportion of patients alive and progression free at 6 months of treatment with targeted study agent in patients with advanced refractory cancers/lymphomas. To evaluate time until death or disease progression. To identify potential predictive biomarkers beyond the genomic alteration by which treatment is assigned or resistance mechanisms using additional genomic, RNA and protein-based assessment platforms.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   MATCH Treatment Subprotocol W: EAY131-W: Phase II Study of AZD4547 in...
        Protocol No.
        HSC20160541HU
        Official Title
        MATCH Treatment Subprotocol W: EAY131-W: Phase II Study of AZD4547 in Patients with Tumors with Aberrations in the FGFR Pathway (CTMS# 16-0065)
        Description
        The purpose of this study is to test any good and bad effects of the study drug, AZD4547, in patients whose cancer has genetic changes called FGFR gene alterations.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   MATCH Treatment Subprotocol X: Phase II Study of Dasatinib in Patients with...
        Protocol No.
        HSC20160282HU
        Official Title
        MATCH Treatment Subprotocol X: Phase II Study of Dasatinib in Patients with Tumors with DDR2 Mutations (CTMS# 16-0032)
        Description
        PRIMARY OBJECTIVES: I. To evaluate the proportion of patients with objective response (OR) to targeted study agent(s) in patients with advanced refractory cancers/lymphomas. SECONDARY OBJECTIVES: I. To evaluate the proportion of patients alive and progression free at 6 months of treatment with targeted study agent in patients with advanced refractory cancers/lymphomas. II. To evaluate time until death or disease progression. III. To identify potential predictive biomarkers beyond the genomic alteration by which treatment is assigned or resistance mechanisms using additional genomic, ribonucleic acid (RNA) and protein-based assessment platforms.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   MATCH Treatment Subprotocol Z1A: EAY131-Z1A: Binimetinib in Patients with...
        Protocol No.
        HSC20160499HU
        Official Title
        MATCH Treatment Subprotocol Z1A: EAY131-Z1A: Binimetinib in Patients with Tumors (Other Than Melanoma) with NRAS Mutations (CTMS# 16-0066)
        Description
        The purpose of this study is to test any good and bad effects of the experimental study drug binimetinib in patients whose cancer has NRAS mutations.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   MATCH Treatment Subprotocol Z1B: EAY131-Z1B: Phase II Study of Palbociclib...
        Protocol No.
        HSC20160491HU
        Official Title
        MATCH Treatment Subprotocol Z1B: EAY131-Z1B: Phase II Study of Palbociclib (PD-0332991) in Patients with Tumors with CCND1, 2, 3 Amplification and Rb Protein Expression by IHC (CTMS# 16-0067)
        Description
        The purpose of this study is to test any good and bad effects of the study drug, palbociclib, in patients whose cancer has CCND1, 2 or 3 amplification and tested positive for a protein called Rb protein.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   Molecular Analysis for Therapy Choice (MATCH) / MATCH Treatment Subprotocol...
        Protocol No.
        HSC20170176HU
        Official Title
        Molecular Analysis for Therapy Choice (MATCH) / MATCH Treatment Subprotocol H: EAY131-H: Phase II Study of Dabrafenib and Trametinib in Patients with Tumors with BRAF V600E or V600K Mutations (Excluding Melanoma, Thyroid Cancer, and Colorectal Adenocarcinoma) (CTMS# 15-2083)
        Description
        Primary Objective To evaluate the proportion of patients with objective response (OR) to targeted study agent(s) in patients with advanced refractory cancers/lymphomas. Secondary Objectives To evaluate the proportion of patients alive and progression free at 6 months of treatment with targeted study agent in patients with advanced refractory cancers/lymphomas. To evaluate time until death or disease progression. To identify potential predictive biomarkers beyond the genomic alteration by which treatment is assigned or resistance mechanisms using additional genomic, RNA and protein-based assessment platforms.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   Molecular Analysis for Therapy Choice (NCI-MATCH)
        Protocol No.
        HSC20150719XT
        Official Title
        EAY131, Molecular Analysis for Therapy Choice (MATCH) (CTMS# 15-2080)
        Description
        Primary Objective To evaluate the proportion of patients with objective response (OR) to targeted study agent(s) in patients with advanced refractory cancers/lymphomas. Secondary Objectives To evaluate the proportion of patients alive and progression free at 6 months of treatment with targeted study agent in patients with advanced refractory cancers/lymphomas. To evaluate time until death or disease progression. To identify potential predictive biomarkers beyond the genomic alteration by which treatment is assigned or resistance mechanisms using additional genomic, RNA and protein-based assessment platforms.
        Contact
        410-450-5798
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   NRG-HN003, A PHASE I AND EXPANSION COHORT STUDY OF ADJUVANT CISPLATIN,...
        Protocol No.
        HSC20170206HU
        Official Title
        NRG-HN003, A PHASE I AND EXPANSION COHORT STUDY OF ADJUVANT CISPLATIN, INTENSITY-MODULATED RADIOTHERAPY, AND MK-3475 (PEMBROLIZUMAB) IN HIGH-RISK HEAD AND NECK SQUAMOUS CELL CARCINOMA (HNSCC) (CTMS# 17-0022)
        Description
        Primary Outcome Measures: DLT in patients with high-risk head and neck squamous cell carcinoma treated with adjuvant cisplatin, IMRT, and pembrolizumab [ Time Frame: Up to 4 weeks post IMRT ] Will be summarized using proportions for binary outcome per cohort.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   Phase I Clinical Trial of Camptothecin-20-O-Propionate hydrate (CZ48) (CTMS#...
        Protocol No.
        HSC20150748HU
        Official Title
        Phase I Clinical Trial of Camptothecin-20-O-Propionate hydrate (CZ48) (CTMS# 15-2103)
        Description
        PRIMARY: To describe the dose limiting toxicities and adverse event profile of Camptothecin-20-O-Propionate hydrate (CZ48) administered orally every day. To determine Phase II recommended dose of Camptothecin-20-O-Propionate hydrate (CZ48) administered orally every day. SECONDARY: To perform a pharmacokinetic study of orally administered CZ48. To assess responses by RECIST criteria when applicable. To follow patients for survival.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   Phase I study of carfilzomib in combination with cyclophosphamide and...
        Protocol No.
        HSC20160206HU
        Official Title
        Phase I study of carfilzomib in combination with cyclophosphamide and etoposide for children with relapsed and refractory solid tumors and leukemias (CTMS# 15-2097)
        Description
        Primary Objective: To determine the DLTs and MTD of carfilzomib given in combination with cyclophosphamide and etoposide in pediatric patients with relapsed/refractory leukemias and solid tumors Secondary Objectives: 1. To evaluate toxicities of carfilzomib in the pediatric population when combined with conventional chemotherapy 2. To gather preliminary efficacy data on the drug combination 3. To measure if circulating plasma proteasome (cProt) levels post treatment correlate with response to therapy and overall survival 4. To measure if the levels of proteasome activity and resistance to carfilzomib correlates with toxicity and/or response to treatment. 5. To measure if inhibition of proteasome activity by carfilzomib results in alteration in a number of autophagy and apoptosis related proteins, providing means to evaluate correlates of activity of carfilzomib. 6. To measure the level of proteasome inhibition in patient PBMCs before and during treatment by determination of the level of protein ubiquitination. 7. To determine in vitro sensitivity of patient leukemias and solid tumors to carfilzomib alone and in combination with study chemotherapeutic agents in order to generate a predictive model of drug sensitivity. 8. To expand patient leukemia and solid tumor samples in order to save tissue for future studies but also to serve as a pre-clinical in vivo model to be included in the generation and testing of a drug sensitivity predictive model. 9. To perform whole exome sequencing (WES) and RNA seq on patient leukemia and solid tumor samples and WES on germ line DNA in order to determine potential mechanisms of drug sensitivity or resistance as well as contribute to testing a computer `learning engine (Bionet) for predicting clinical responses from genomic and drug sensitivity data.
        Contact
        210-562-9149
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   Phase Ib, open-label, multi-center study to characterize the safety,...
        Protocol No.
        HSC20160552HU
        Official Title
        Phase Ib, open-label, multi-center study to characterize the safety, tolerability and pharmacodynamics (PD) of PDR001 in combination with LCL161, everolimus (RAD001) or panobinostat (LBH589) (CTMS# 16-0058)
        Description
        Primary Objectives: To characterize the safety and tolerability of PDR001 in combination with LCL161, everolimus (RAD001) or panobinostat (LBH589) and to identify recommended doses and schedules for future studies Secondary Objectives: To characterize changes in the immune infiltrate in tumors To further characterize the safety of PDR001 in combination with LCL161, everolimus or panobinostat (LBH589) To estimate the anti-tumor activity of PDR001 in combination with LCL161, everolimus or panobinostat (LBH589) To characterize the pharmacokinetics of all study drugs in combination To assess immunogenicity of PDR001
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   Phase II Trial of Eribulin and Lenvatinib in Advanced Solid Tumors (CTMS#...
        Protocol No.
        HSC20150891HU
        Official Title
        Phase II Trial of Eribulin and Lenvatinib in Advanced Solid Tumors (CTMS# 15-2139)
        Description
        The overall purpose of this study is to determine the overall response rate, efficacy and safety of the combination of eribulin and Lenvatinib.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   Prognostic and predictive markers in patients with advanced metastatic tumors
        Protocol No.
        HSC20130219H
        Official Title
        Numeration and Single-Cell Molecular Profiling of Circulating Tumor Cells as Prognostic and Predictive Marker In Patients with Advanced Metastatic Tumors (CTRC#13-0001)
        Description
        This study will research possible associations between circulating tumor cells (CTC) quantities or gene profile characteristics and clinical outcomes. The primary objective is to obtain blood samples from participants over an 8-week period for research analysis.  The study will enroll approximately 200 patients at the CTRC. In addition to other conditions for enrollment, eligible patients have advanced metastatic cancer.
        Contact
        210-450-5798
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   Prospective Comparative Effectiveness Trial for Malignant Bowel Obstruction...
        Protocol No.
        HSC20170491HU
        Official Title
        Prospective Comparative Effectiveness Trial for Malignant Bowel Obstruction (CTMS# 17-0081)
        Description
        Number of days alive and outside the hospital
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   S1609, Dart: Dual Anti-CTLA-4 and Anti-PD-1 Blockage in Rare Tumors (CTMS#...
        Protocol No.
        HSC20170145HU
        Official Title
        S1609, Dart: Dual Anti-CTLA-4 and Anti-PD-1 Blockage in Rare Tumors (CTMS# 17-0013)
        Description
        Primary Objective To evaluate the RECIST 1.1 overall response rate (ORR) in subsets of patients with advanced rare cancers treated with ipilimumab plus nivolumab combination immunotherapy. Secondary Objectives To evaluate toxicities in each cohort. To estimate overall survival (OS), progression-free survival (PFS), clinical benefit rate; and to estimate immune-related ORR (irORR), and immune-related PFS (irPFS) by unidimensional immune-related response criteria. To collect specimens for banking for use in future correlative biomarker research studies.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   Safety, Tolerability & PK of KX2-361 in Subjects with advanced malignancies...
        Protocol No.
        HSC20150481HU
        Official Title
        A Phase 1 Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetics of KX2-361 in Subjects with Advanced Malignancies that are Refractory to Conventional Therapies (CTMS# 15-2063)
        Description
        Study Objectives: Primary Objective: To define the maximum tolerated dose (MTD) of KX2-361 in subjects with advanced refractory malignancies when administered as single and multiple oral doses. Secondary Objectives: To determine the safety and tolerability of KX2-361 after single and multiple oral doses, in subjects with advanced refractory malignancies. To characterize the pharmacokinetic profile of KX2-361 after single and multiple oral doses. To evaluate the activity of KX2-361 in both the Dose Escalation Cohort and the Expansion Cohort of subjects with high-grade glioma.
        Contact
        210-450-5798
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   Study of the Genetic Epidemiology of Childhood Cancer
        Protocol No.
        HSC20080057H
        Official Title
        Study of the Genetic Epidemiology of Childhood Cancer
        Description
        Study of the Genetic Epidemiology of Childhood Cancer
        Contact
        210-562-9123
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

    •   Bones and joints

      •   A Dose Regimen-Finding Study to Evaluate the Safety, Tolerability,...
        Protocol No.
        HSC20170102HU
        Official Title
        A Dose Regimen-Finding Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Activity of Oradoxel Monotherapy in Subjects with Advanced Malignancies (CTMS# 16-0069)
        Description
        Primary Objective: To determine the maximum tolerated dose (MTD) of Oradoxel based on dose-limiting toxicity (DLT) in subjects with advanced malignancies Secondary Objectives To determine the safety and tolerability of docetaxel as Oradoxel To determine the incidence of unacceptable toxicity with Oradoxel To determine the recommended Phase 2 dose (RP2D) of docetaxel as Oradoxel To characterize the pharmacokinetic (PK) profile of docetaxel as Oradoxel To evaluate tumor response
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   A Dose Regimen-Finding Study to Evaluate the Safety, Tolerability,...
        Protocol No.
        HSC20160087HU
        Official Title
        A Dose Regimen-Finding Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Activity of Oraxol in Subjects with Advanced Malignancies (CTMS# 15-2137)
        Description
        Primary Objective To determine the maximum tolerated dose (MTD) and dosing regimen of Oraxol in subjects with advanced malignancies Secondary Objectives To determine the recommended Phase 2 dose of paclitaxel as Oraxol To determine the safety and tolerability of paclitaxel as Oraxol To characterize the pharmacokinetic (PK) profile of paclitaxel as Oraxol To evaluate the tumor response
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   A Phase 1 Dose Escalation and Cohort Expansion Study of TSR-042, an...
        Protocol No.
        HSC20170110HU
        Official Title
        A Phase 1 Dose Escalation and Cohort Expansion Study of TSR-042, an anti-PD-1 Monoclonal Antibody, in Patients with Advanced Solid Tumors (CTMS# 16-0091)
        Description
        Primary Objectives: Part 1 Dose Escalation Cohorts: To evaluate the safety and tolerability of TSR-042 using Common Terminology Criteria for Adverse Events (CTCAE v.4.03) in patients with advanced solid tumors Part 2 Expansion Cohorts: To evaluate the antitumor activity of TSR-042 in patients with advanced solid tumors, in terms of objective response rate (ORR) as assessed by the Investigators using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 Part 1 and Part 2: To define the recommended Phase 2 dose (RP2D) and schedule Secondary Objectives: Part 1 Dose Escalation Cohorts: To characterize the pharmacodynamic (PDy) profile of TSR-042 To evaluate ORR as assessed by the Investigators using RECIST v1.1 Part 2 Expansion Cohorts: To characterize the safety and tolerability of TSR-042 using CTCAE v.4.03 Part 1 and Part 2: To characterize the pharmacokinetic (PK) profile of TSR-042 To evaluate the immunogenicity of TSR-042 To evaluate additional measures of clinical benefit, including: ORR by immune-related RECIST (irRECIST) Duration of response (DOR) by RECIST v 1.1 Disease control rate (DCR) by RECIST v 1.1 and by irRECIST Progression-free survival (PFS) by RECIST v 1.1 and by irRECIST Overall survival (OS)
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   A Phase 1 Study of CBL0137 in Patients with Metastatic or Unresectable...
        Protocol No.
        HSC20130328H
        Official Title
        A Phase 1 Trial of CBL0137 In patients With Metastatic or Unresectable Advanced Solid Neoplasms or Refractory Lymphomas (CTRC# 13-0031)
        Description
        This Phase 1 study is designed to determine the best dose of CBL0137 to use when treating patients with metastatic or unresectable advanced solid tumors or lymphoma. The study will enroll up to 48 patients from at least 2 cancer centers in the US. In addition to other conditions for enrollment, eligible patients have cancer that has not improved or has come back after prior treatment and are otherwise in good health. Patients who have a history of active infection, cancer involving the central nervous system, a particular EKG abnormality or other serious medical conditions may not be eligible to enroll.
        Contact
        210-450-5798
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   A Phase 1/2A, Multicenter, Open-Label Study of LYC-55716 in Adult Subjects...
        Protocol No.
        HSC20160617HU
        Official Title
        A Phase 1/2A, Multicenter, Open-Label Study of LYC-55716 in Adult Subjects with Locally Advanced or Metastatic Cancer (CTMS# 16-0099)
        Description
        Primary Objectives Phase 1 Evaluate the safety and tolerability of LYC-55716 Determine the maximum tolerated dose (MTD) and the recommended Phase 2 dose (RP2D) Phase 2a Determine the objective response rate according to response evaluation criteria in solid tumors (RECIST) v1.1 Secondary Objectives Phase 1 Evaluate the activity of LYC-55716 by objective response according to RECIST v1.1 Determine the durability of any observed objective response Phase 2a Determine the duration of response Determine progression-free survival (PFS) and overall survival (OS) Determine suitability of the RP2D for further study Characterize the pharmacokinetics (PK) of LYC-55716 Exploratory Objectives Assess tumor activity in subjects with locally advanced or metastatic cancer according to immune-related response evaluation criteria in solid tumors (irRECIST) Exploratory analysis of metabolite in plasma Assess changes in circulating tumor markers (eg, cytokines/chemokines)
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   A Phase 1b Study of Oraxol in Combination with Ramucirumab in Patients with...
        Protocol No.
        HSC20170188HU
        Official Title
        A Phase 1b Study of Oraxol in Combination with Ramucirumab in Patients with Gastric, Gastro-esophageal, or Esophageal Cancers (CTMS# 16-0089)
        Description
        Primary Objective: To determine the maximum tolerated dose (MTD) of Oraxol in patients with advanced stage gastric, gastro-esophageal, or esophageal cancers who are being treated with Oraxol in combination with ramucirumab Secondary Objectives: To determine the safety and tolerability of Oraxol in combination with ramucirumab To determine the recommended Phase 2 dose of Oraxol in combination with ramucirumab To characterize the pharmacokinetic (PK) profile of Oraxol in combination with ramucirumab To characterize preliminary activity of Oraxol plus ramucirumab as determined by response rate, progression-free survival, and overall survival
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   A Phase 1b/2 Study of ARRY-382 in Combination with Pembrolizumab, a...
        Protocol No.
        HSC20170071HU
        Official Title
        A Phase 1b/2 Study of ARRY-382 in Combination with Pembrolizumab, a Programmed Cell Death Receptor 1 (PD-1) Antibody, for the Treatment of Patients with Advanced Solid Tumors (CTMS# 16-0084)
        Description
        Primary objective: To determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of ARRY-382 in combination with pembrolizumab in patients with selected solid tumors Secondary objectives:  To describe the preliminary antitumor activity of the combination based on the Response Criteria In Solid Tumors, version 1.1 (RECIST v1.1).  To describe the preliminary antitumor activity of the combination based on immune-related response criteria (irRC).  To characterize the safety and tolerability of the combination, including acute and chronic toxicities. To evaluate the pharmacokinetics of ARRY-382 in combination with pembrolizumab Exploratory objective: To explore the effect of the combination on circulating biomarkers of immune response. To describe the preliminary antitumor activity of the combination in patients with PD-L1 positive non-small cell lung cancer (NSCLC), as determined using a United States Food and Drug Administration (FDA)-approved test, using RECIST. To describe the preliminary antitumor activity of the combination in patients with PD-L1 positive non-small cell lung cancer (NSCLC), as determined using an FDA approved test, using irRC
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   A Phase I, First-in-human, Open-label, Dose-escalation, Safety,...
        Protocol No.
        HSC20160554HU
        Official Title
        A Phase I, First-in-human, Open-label, Dose-escalation, Safety, Pharmacokinetic, and Pharmacodynamic Study of Oral TP-0903 Administered Daily for 21 Days to Patients with Advanced Solid Tumors (CTMS# 16-0092)
        Description
        Primary Objective: To determine the maximum tolerated dose (MTD) and dose-limiting toxicities (DLTs) of oral TP-0903 administered daily for the first 21 days every 4 weeks, over a range of doses in patients with advanced solid tumors. Secondary Objectives: To establish the pharmacokinetics of orally administered TP-0903 To observe patients for any evidence of antitumor activity of TP-0903 by objective radiographic assessment To study the pharmacodynamics of TP-0903 therapy by: assessing biomarkers in tumor tissue assessing biomarkers in peripheral blood mononuclear cells (PBMCs) and serum To establish the Recommended Phase 2 Dose (RP2D) for future studies with TP-0903
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   A Phase I, Multicenter, Open-Label Dose Escalation and Expansion Study of...
        Protocol No.
        HSC20150289HU
        Official Title
        A Phase I, Multicenter, Open-Label Dose Escalation and Expansion Study of PCA062, Administered Intravenously In Adult Patients With pCAD-Positive Tumors (CTMS# 14-2019)
        Description
        Primary Objective To determine the MTD/RDE of PCA062 in patients with pCAD-positive tumors in the dose escalation part. Secondary Objectives To characterize the safety and tolerability of PCA062 To characterize the pharmacokinetic profile of PCA062 To assess emergence of anti-PCA062 antibodies following one or more intravenous infusions of PCA062 To assess the preliminary anti-tumor activity of PCA062 in patients with pCAD-positive triple negative breast cancer (TBNC), head and neck squamous cell carcinoma (HNSCC) or esophageal cancer (squamous and adenocarcinoma)
        Contact
        210-450-5798
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   A Phase I/II, open label, multicenter study of the safety and efficacy of...
        Protocol No.
        HSC20150421HU
        Official Title
        A Phase I/II, open label, multicenter study of the safety and efficacy of LAG525 single agent and in combination with PDR001 administered to patients with advanced malignancies (CTMS #15-2054)
        Description
        Primary Objectives Phase I part To estimate the RP2D or MTD for the single agent LAG525 and the combination of LAG525 and PDR001. Phase II part To estimate the overall response rate per RECIST V1.1 for single agent LAG525 as well as for the combination of LAG525 and PDR001 Secondary Objectives: To characterize the safety and tolerability of single agent LAG525 given alone and in combination with PDR001 To characterize the pharmacokinetic profile of single agent LAG525 given alone and in combination with PDR001 To assess emergence of anti-LAG525, and anti-PDR001 antibodies following one or more intravenous (i.v.) infusions of single agent LAG525 given alone or in combination with PDR001 To assess potential predictors of efficacy of single agent LAG525 and the combination of LAG525 and PDR001 To evaluate the preliminary antitumor activity of single agent LAG525 given alone or in combination of PDR001 To investigate patient selection and pharmacodynamic biomarkers in tumor tissue samples
        Contact
        210-450-5798
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   A Phase I/II, Open-Label, Multi-Center Study of the Safety and Efficacy of...
        Protocol No.
        HSC20160420HU
        Official Title
        A Phase I/II, Open-Label, Multi-Center Study of the Safety and Efficacy of BLZ945 as Single Agent and In Combination with PDR001 in Adult Patients with Advanced Solid Tumors (CTMS# 16-0071)
        Description
        Primary Objective: Phase I: To characterize the safety and tolerability of BLZ945 as a single agent and in combination with PDR001 and to identify the Maximum Tolerated Dose (MTD)/Recommended Phase 2 Dose (RP2D). Phase II: To assess the anti-tumor activity of BLZ945 in combination with PDR001 (and as single agent if appropriate) in patients with advanced solid tumors. Secondary Objective: Phase I: To characterize the pharmacodynamics effect of BLZ945 as a single agent and in combination with PDR001. To characterize PK of BLZ945 as a single agent and in combination with PDR001. To assess the preliminary anti-tumor activity of BLZ945 as single agent and in combination with PDR001. Phase I and II: To assess emergence of anti-PDR001 antibodies when BLZ945 is administered in combination with PDR001.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   A Phase Ib Trial of Pembrolizumab (MK-3475) in Combination with Dinaciclib...
        Protocol No.
        HSC20170106HU
        Official Title
        A Phase Ib Trial of Pembrolizumab (MK-3475) in Combination with Dinaciclib (MK-7965) in Subjects with Hematologic Malignancies (KEYNOTE-155) (CTMS# 16-0009)
        Description
        Primary Objective Objective: In both the Dose Evaluation and Signal Detection phases, evaluate the safety and tolerability of the treatment combination. Objective: Within each disease type of the Signal Detection phase, evaluate objective response rate (ORR) according to investigator assessment using the disease specific criteria. Secondary Objective: Objective: To evaluate the Objective Response Rate (ORR; complete response [CR] + partial response [PR]) of the combination of pembrolizumab and dinaciclib within each disease type, ie, CLL based on iwCLL guidelines (Hallek, 2008) [1], MM based on IMWG criteria (Durie, 2006) [2] and DLBCL based on the Revised Response Criteria for Malignant Lymphoma (Cheson, 2007) [3]. Objective: Within each disease type of the Signal Detection phase, evaluate Duration of Response (DOR), Progression-Free Survival (PFS) according to investigator assessment using the disease specific criteria; and Overall Survival (OS).
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   ABTR01B1, A Children''s Oncology Group Protocol for Collecting and Banking...
        Protocol No.
        HSC20040131H
        Official Title
        ABTR01B1, A Children''s Oncology Group Protocol for Collecting and Banking Pediatric Research Specimens Including Rare Pediatric Tumors
        Description
        This study is collecting and storing malignant, borderline malignant neoplasms, and related biological samples from young patients with cancer. Collecting and storing samples of tumor tissue, blood, and bone marrow from patients with cancer to study in the laboratory may help the study of cancer in the future.
        Contact
        210-562-9149
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   ACCL15N1CD Use of Evidence-Based Supportive Care Clinical Practice...
        Protocol No.
        HSC20160673X
        Official Title
        ACCL15N1CD Use of Evidence-Based Supportive Care Clinical Practice Guidelines in Pediatric
        Description
        Primary and Secondary Aims Aim 1: Chart Review To measure the rate of adherence to selected COG-endorsed supportive care CPG recommendations at NCORP sites Aim 1a To describe the possible influence of NCORP site size and the number of patients enrolled in COG studies per site on the delivery of CPG-consistent care. Aim 1b To describe the clinical outcome of episodes during which patients receive CPG-consistent or CPG-inconsistent care Aim 2: Focus Groups To describe facilitators of and barriers to the use of CPGs elicited via focus group interviews with a diverse set of potential users (physician, nurse, nurse practitioner and pharmacists) who provide pediatric cancer care at NCORP sites. Aim 3: Interviews To improve how well CPG recommendations are understood by health care providers by refining the CPG recommendation format based on an iterative process of cognitive interviewing and formatting revisions. Understanding is defined as the correct interpretation of the course of action recommended or suggested by a CPG.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   ACCRN07 Protocol for the Enrollment on the Official COG Registry, The...
        Protocol No.
        HSC20080271X
        Official Title
        ACCRN07 Protocol for the Enrollment on the Official COG Registry, The Childhood Cancer Research Network (CCRN)
        Description
        The Children s Oncology Group has established a research network, the Childhood Cancer Research Network (CCRN), to collect information about children with cancer and other conditions that are benign but involve abnormal cell growth in order to help doctors and scientists better understand childhood cancer. The CCRN''s goal is to collect clinical information about every child diagnosed with cancer and similar conditions in the United States and Canada, to allow researchers to study patterns, characteristics, and causes of childhood cancer. The information can also help researchers study the causes of childhood cancer. To expand the CCRN, parents of children who have been diagnosed with cancer will be asked to provide information about themselves and their child for research purposes.   Objectives: To obtain informed consent from parents (and the child, when appropriate) of infants, children, adolescents, and young adults newly diagnosed with cancer to enter their names and certain information concerning their child into the Childhood Cancer Research Network. To obtain informed consent from parents (and the child, when appropriate) of infants, children, adolescents, and young adults newly diagnosed with cancer for permission to be contacted in the future to consider participating in non-therapeutic and prevention research studies involving the parents and/or the child.
        Contact
        210-562-9149
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
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      •   Adolescent and Young Adult Childhood Cancer Survivorship (CTMS#17-0088)
        Protocol No.
        HSC20170474HU
        Official Title
        Adolescent and Young Adult Childhood Cancer Survivorship (CTMS#17-0088)
        Description
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   AEWS07B1, A COG Study for Collecting and Banking Ewing Sarcoma Specimens
        Protocol No.
        HSC20090244X
        Official Title
        AEWS07B1, A COG Study for Collecting and Banking Ewing Sarcoma Specimens
        Description
        This research study is collecting and storing samples of tumor tissue, bone marrow, and blood from patients with Ewing sarcoma. Collecting and storing samples of tumor tissue, bone marrow, and blood from patients with cancer to test in the laboratory may help the study of cancer in the future.
        Contact
        210-562-9149
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   AEWS1031 A Phase III Randomized Trial of Adding...
        Protocol No.
        HSC20110367X
        Official Title
        AEWS1031 A Phase III Randomized Trial of Adding Vincristine-topotecan-cyclophosphamide to Standard Chemotherapy in Initial Treatment of Non-metastatic Ewing Sarcoma
        Description
        This randomized phase III trial studies combination chemotherapy to see how well it works compared to combination chemotherapy with topotecan hydrochloride in treating patients with non-metastatic extracranial Ewing sarcoma. Drugs used in chemotherapy, such as vincristine sulfate, doxorubicin hydrochloride, cyclophosphamide, ifosfamide, etoposide, and topotecan hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. It is not yet known whether combination chemotherapy is more effective with topotecan hydrochloride in treating Ewing sarcoma.
        Contact
        210-562-9149
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
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      •   AEWS1221 - Randomized Phase II Trial Evaluating the Addition of the IGF-1R...
        Protocol No.
        HSC20150360X
        Official Title
        AEWS1221 - Randomized Phase II Trial Evaluating the Addition of the IGF-1R Monoclonal Antibody Ganitumab (AMG 479, NSC# 750008, IND# 120449) to Multiagent Chemotherapy for Patients with Newly Diagnosed Metastatic Ewing Sarcoma An Intergroup NCTN Phase II Study
        Description
        Primary Objective: To compare the event-free survival (EFS) in patients with newly diagnosed metastatic Ewing sarcoma treated with multiagent chemotherapy with and without the addition of ganitumab (AMG 479). Secondary Objective: To describe the toxicity of the addition of ganitumab to multimodality therapy for patients with newly diagnosed metastatic Ewing sarcoma. Exploratory Objectives: 1) To compare bone marrow response rates and overall survival in patients with newly diagnosed metastatic Ewing sarcoma treated with multiagent chemotherapy with and without the addition of ganitumab. 2) To describe the toxicity of 6 months of ganitumab monotherapy as Maintenance therapy following multimodality therapy in patients with newly diagnosed metastatic Ewing sarcoma. 3) To describe trough levels of ganitumab in a cohort of patients with Ewing sarcoma < 21 years of age treated with 18 mg/kg. 4) To describe the feasibility of and local failure rates following hypofractionated stereotactic body radiotherapy (SBRT) directed at bone metastases in patients with newly diagnosed metastatic Ewing sarcoma. 5) To determine if EFS, overall survival, bone marrow response rates, and toxicity differ based on serum markers of the IGF-1 pathway in patients with newly diagnosed metastatic Ewing sarcoma treated with interval compressed chemotherapy with and without the addition of ganitumab. 6) To determine if EFS, overall survival, and bone marrow response rates differ based on tumor IGF-1R, insulin receptor, and EGFR pathway components in patients with newly diagnosed metastatic Ewing sarcoma treated with interval compressed chemotherapy with and without the addition of ganitumab. 7) To evaluate bone marrow micrometastatic disease and tumor cell surface IGF-1R expression at diagnosis and after 3 and 6 cycles of study therapy in patients with newly diagnosed metastatic Ewing sarcoma. 8) To determine if the presence of germline polymorphisms in EGFR correlate with response to multiagent therapy with and without ganitumab. 9) To investigate the ability of FDG-PET to augment conventional response assessment of primary Ewing sarcoma tumors by MRI. 10) To explore FDG-PET response at the primary tumor as a prognostic marker and as a predictive biomarker of clinical activity of IGF-1R inhibition in patients with newly diagnosed metastatic Ewing sarcoma.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   ALTE05N1, Umbrella Long-Term Follow-Up Protocol
        Protocol No.
        HSC20090478X
        Official Title
        ALTE05N1, Umbrella Long-Term Follow-Up Protocol
        Description
        Umbrella Long-Term Follow-Up Protocol
        Contact
        210-562-9149
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   ALTE1621 Pharmacologic Reversal of Ventricular Remodeling in Childhood...
        Protocol No.
        HSC20160394X
        Official Title
        ALTE1621 Pharmacologic Reversal of Ventricular Remodeling in Childhood Cancer Survivors at Risk for Heart Failure (PREVENT-HF): A Phase 2b Randomized Placebo-Controlled (Carvedilol) Trial
        Description
        1.1 Primary Aim To determine the impact of a two-year course of low-dose carvedilol on surrogate echocardiographic indices of heart failure (HF) risk, including Left Ventricular (LV) Posterior Wall Thickness-Dimension Ratio (LV T-D) a well-established index of early myocardial remodeling and subsequent HF risk (primary endpoint).  LV systolic and diastolic function and afterload established echocardiographic indices associated with HF risk.  Natriuretic peptides, troponins, and Galectin-3 - circulating biomarkers associated with myocardial injury, and HF risk. 1.2 Secondary Aims 1.2.1 To establish safety and tolerability of this two-year course of low-dose carvedilol, assessing both objective measures (hepatic function) and patient reported outcomes. 1.2.2 To examine the modifying effect of demographic, clinical, and molecular characteristics on the risk: benefit ratio from this two-year carvedilol intervention. 1.3 Exploratory Aim To evaluate the long-term efficacy of carvedilol in preventing cardiomyopathy and/or heart failure in high-risk childhood cancer survivors.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   AN EARLY-PHASE, MULTICENTER, OPEN-LABEL STUDY OF THE SAFETY AND...
        Protocol No.
        HSC20150549H
        Official Title
        AN EARLY-PHASE, MULTICENTER, OPEN-LABEL STUDY OF THE SAFETY AND PHARMACOKINETICS OF ATEZOLIZUMAB (MPDL3280A) IN PEDIATRIC AND YOUNG ADULT PATIENTS WITH PREVIOUSLY TREATED SOLID TUMORS
        Description
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
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      •   An Open-Label Rollover Study to Evaluate the Long-Term Safety, Tolerability,...
        Protocol No.
        HSC20170197XT
        Official Title
        An Open-Label Rollover Study to Evaluate the Long-Term Safety, Tolerability, Biological Activity of Oral TVB-2640 in Patients With Solid Tumors Previously Enrolled in 3V2640-CLIN-002 (CTMS# 17-0046)
        Description
        Primary: To continue to characterize the safety profile of TVB-2640. Secondary: To identify any early signs of anti-tumor activity, where possible.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   An Open-Label, Dose Escalation, Phase 1, First-In-Human Study of TAK-659 in...
        Protocol No.
        HSC20150255HU
        Official Title
        An Open-Label, Dose Escalation, Phase 1, First-In-Human Study of TAK-659 in Adult Patients with Advanced Solid Tumors and Lymphoma Malignancies (CTMS# 14-2013)
        Description
        To determine the safety, tolerability, maximum tolerated dose (MTD)/recommended phase 2 dose (RP2D) ofTAK-659 administered orally on a daily dosing schedule in patients with advanced solid tumor and lymphoma who do not have effective standard treatment available
        Contact
        210-450-5798
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   AOST06B1 A Children''s Oncology Group Protocol for Collecting and Banking...
        Protocol No.
        HSC20090245X
        Official Title
        AOST06B1 A Children''s Oncology Group Protocol for Collecting and Banking Osteosarcoma Specimens
        Description
        RATIONALE: Collecting and storing samples of tumor tissue and blood from patients to test in the laboratory may help the study of cancer in the future. PURPOSE: The purpose of this study is to collect and store samples of blood and tumor tissue from patients with osteosarcoma.
        Contact
        210-562-9149
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
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      •   AOST1321 - Phase 2 Study of Denosumab (IND# 127430, NSC# 744010), a RANK...
        Protocol No.
        HSC20160209X
        Official Title
        AOST1321 - Phase 2 Study of Denosumab (IND# 127430, NSC# 744010), a RANK Ligand Antibody, for Recurrent or Refractory Osteosarcoma. An Intergroup NCTN Phase 2 Study
        Description
        Primary Aims 1.1.1 To determine whether denosumab therapy either increases the disease control rate at 4 months in patients with recurrent measurable osteosarcoma as compared to historical COG experience or denosumab therapy produces an objective response rate greater than 5% (Cohort 1). 1.1.2 To determine whether denosumab therapy increases the disease control rate at 12 months in patients with recurrent resected osteosarcoma as compared to historical COG experience (Cohort 2). Secondary Aims 1.2.1 To investigate the pharmacokinetics (PK) and pharmacodynamics (PD) of denosumab in subjects with recurrent osteosarcoma. 1.2.2 To describe the tolerability of denosumab in subjects with recurrent osteosarcoma. 1.2.3 To report the disease control rate and objective response rate for patients with recurrent osteosarcoma limited to bone. 1.2.4 To investigate biological markers potentially associated with response to denosumab in patients with recurrent osteosarcoma.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   AOST1421, A Phase II Study of Human-Mouse Chimeric Anti-Disialoganglioside...
        Protocol No.
        HSC20160053XT
        Official Title
        AOST1421, A Phase II Study of Human-Mouse Chimeric Anti-Disialoganglioside Monoclonal Antibody ch14.18 (Dinutuximab, NSC#764038, IND# 4308) in Combination with GM-CSF in Patients with Recurrent Osteosarcoma
        Description
        1.1 Primary Aims To determine the disease control rate in patients with completely resected recurrent osteosarcoma treated with ch14.18 (dinutuximab) in combination with sargramostim (GM-CSF) as compared to historical COG experience. 1.2 Secondary Aims 1.2.1 To characterize the pharmacokinetics of ch14.18 (dinutuximab) in patients with recurrent osteosarcoma in the proposed administration schedule. 1.2.2 To determine the occurrence of unacceptable toxicity (UT) in patients with recurrent osteosarcoma treated with ch14.18 (dinutuximab) in combination with sargramostim. 1.3 Exploratory Aims 1.3.1 To assess the relationship between probability of disease control and tumor GD2 expression. 1.3.2 To attempt banking of tumor samples for future research studies from patients enrolled on the study who undergo biopsy or resection of suspected metastatic disease recurrence while on protocol therapy or during the evaluation period. 1.3.3 To assess KIR and FcyR genotypes NKp30 isoforms and its circulating ligand, B7-H6 and their relationships to the probability of disease control. 1.3.4 To determine a descriptive profile of human anti-chimeric antibody (HACA) during immunotherapy.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   APEC14B1, THE PROJECT: EVERYCHILD PROTOCOL: A REGISTRY, ELIGIBILITY...
        Protocol No.
        HSC20150870XT
        Official Title
        APEC14B1, THE PROJECT: EVERYCHILD PROTOCOL: A REGISTRY, ELIGIBILITY SCREENING, BIOLOGY AND OUTCOME STUDY
        Description
        1.1 To maintain a Childhood Cancer Registry1 for infants, children, adolescents, and young adults with cancer. 1.2 To utilize clinical and biological data to help determine eligibility or stratification, based on childhood cancer disease classification schemas, for potential enrollment of research subjects onto COG therapeutic clinical trials. 1.3 To develop a well annotated childhood cancer biorepository for current and future research through the collection of biospecimens (at diagnosis, time of progression, time of recurrence and/or post-mortem), including tumor, host and when feasible parental germline DNA; and key clinical data, including presentation, diagnostic, staging, summary treatment, and outcome information, from every child diagnosed with cancer at COG institutions. 1.4 To allow use of registry data for permission to be contacted in the future to consider participating in non-therapeutic and prevention research studies involving the child or their parents.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   Cancer Therapy and Research Center''s Institute for Drug Development Solid...
        Protocol No.
        HSC20070684H
        Official Title
        Cancer Therapy and Research Center''s Institute for Drug Development Solid Tumors and Hematological Malignancies Biorepository for Biomarker Discovery
        Description
        Samples are collected for the Cancer Therapy and Research Center''s Solid Tumors and Hematological Malignancies Biorepository for Biomarker Discovery
        Contact
        210-450-5798
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   Caris Molecular Intelligence® and Caris Centers of Excellence for...
        Protocol No.
        HSC20170144HU
        Official Title
        Caris Molecular Intelligence® and Caris Centers of Excellence for Precision Medicine NetworkTM Retrospective Outcomes-Associated Database (CTMS# 16-0145)
        Description
        The objective of this project is the development of the Caris Molecular Intelligence® and Caris Centers of Excellence for Precision Medicine NetworkTM Outcomes Associated Repository, a disease research database (hereinafter referred to as the Database ) for the purpose of: 1. Effecting change in disease treatment processes by advancing precision medicine and improving care for cancer through acquiring and sharing valuable molecular tumor profiling information and clinical outcomes in a collaborative, secure environment. 2. Performing prospective research studies involving analyses of quality of life studies as well as subject medical records including clinical presentation and outcomes. This eligible cohort includes select subjects having undergone Caris Molecular Intelligence® evaluation for diagnosis and/or treatment management. 3. Evaluate the frequency of specific clinical events in relation to risk factors, diagnosis and treatments provided via the collection of outcomes data through automated data capture systems provided by a third-party data entity and manually-entered data when needed. 4. Provide information access that is vital to research collaborators, including potential researchers from pharmaceutical companies, governmental agencies, academia, healthcare providers, and payors, with catalogued subject outcome data for the use of drug development discoveries, clinically relevant research trials, publications and posters, the implementation of future healthcare policies, characterization of trends in practice patterns and their relation to subject outcomes and the economic impact of differing evaluation, treatment, and management paradigms. 5. Cultivate a repository for assay development and validation of emerging technologies to enhance clinical cancer care.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
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      •   Caris Molecular Intelligence® and Caris Centers of Excellence for Precision...
        Protocol No.
        HSC20170353HU
        Official Title
        Caris Molecular Intelligence® and Caris Centers of Excellence for Precision Medicine NetworkTM Outcomes Associated Repository (CTMS# 17-0023)
        Description
        The objective of this project is the development of the Caris Molecular Intelligence® and Caris Centers of Excellence for Precision Medicine NetworkTM Outcomes Associated Repository, a disease research database (hereinafter referred to as the Database) for the purpose of: 1. Effecting change in disease treatment processes by advancing precision medicine and improving care for cancer through acquiring and sharing valuable molecular tumor profiling information and clinical outcomes in a collaborative, secure environment. 2. Performing prospective research studies involving analyses of quality of life studies as well as subject medical records including clinical presentation and outcomes. This eligible cohort includes select subjects having undergone Caris Molecular Intelligence® evaluation for diagnosis and/or treatment management. 3. Evaluate the frequency of specific clinical events in relation to risk factors, diagnosis and treatments provided via the collection of outcomes data through automated data capture systems provided by a third-party data entity and manually-entered data when needed. 4. Provide information access that is vital to research collaborators, including potential researchers from pharmaceutical companies, governmental agencies, academia, healthcare providers, and payors, with catalogued subject outcome data for the use of drug development discoveries, clinically relevant research trials, publications and posters, the implementation of future healthcare policies, characterization of trends in practice patterns and their relation to subject outcomes and the economic impact of differing evaluation, treatment, and management paradigms. 5. Cultivate a repository for assay development and validation of emerging technologies to enhance clinical cancer care.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
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      •   Clinical Trial of Lurbinectedin (PM01183) in Selected Advanced Solid Tumors
        Protocol No.
        HSC20150542HU
        Official Title
        A Multicenter Phase II Clinical Trial of Lurbinectedin (PM01183) in Selected Advanced Solid Tumors (CTMS# 15-2071)
        Description
        Primary: To assess the antitumor activity of lurbinectedin (PM01183) in terms of overall response rate (ORR), according to the Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1, in the following advanced solid tumors: small cell lung cancer (SCLC), head and neck carcinoma (H&N), neuroendocrine tumors (NETs), biliary tract carcinoma, endometrial carcinoma, BRCA 1/2-associated metastatic breast carcinoma, carcinoma of unknown primary site, germ cell tumors (GCTs), and Ewing¿s family of tumors (EFTs). Secondary: To further characterize the antitumor activity of PM01183 in terms of duration of response (DR), clinical benefit [ORR or stable disease (SD) lasting over four months (SD ¿ 4 months)], progression-free survival (PFS), and one year overall survival (1y-OS) in each cohort of advanced solid tumors. Characterize the plasma pharmacokinetics (PK) of PM01183. To conduct an exploratory pharmacogenomic (PGx) and pharmacogenetic analysis. To evaluate the safety profile of PM01183 in this patient population.
        Contact
        410-450-5798
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   Clinical trial to study the safety and efficacy of MBG453 given alone and in...
        Protocol No.
        HSC20150730HU
        Official Title
        A Phase I-Ib/II, Open-Label, Multi-Center Study of the Safety and Efficacy of MBG453 as Single Agent and in Combination with PDR001 in Adult Patients with Advanced Malignancies (CTMS# 15-2114)
        Description
        Primary Objectives: Phase I-Ib: To characterize the safety and tolerability of MBG453 as a single agent and in combination with PDR001 and to identify recommended doses for future studies. Phase I-Ib dose ranging: To further investigate the safety and tolerability of different doses of MBG453 alone or in combination with PDR001. Phase II: To estimate the anti-tumor activity of MBG453 alone in patients with solid tumors, and in combination with PDR001 in selected disease indications (melanoma, non-small cell lung cancer (NSCLC), renal cell carcinoma (RCC)). Secondary Objectives Evaluate the preliminary anti-tumor activity of MBG453 alone and in combination with PDR001. Make an initial comparison of safety, PK and efficacy for MBG453 and PDR001 administered in combination on a every 2 weeks (Q2W) and every 4 weeks (Q4W) dosing schedules. Characterize the pharmacokinetic profile of MBG453 alone and in combination with PDR001. Assess emergence of anti-MBG453 and anti-PDR001 antibodies. Assess potential predictors of efficacy of MBG453 single agent and in combination with PDR001 in tumor samples. Assess the pharmacodynamic effect of MBG453 as single agent and in combination with PDR001 in tumor samples. Describe the survival distribution of patients treated with MBG453 as single agent and in combination with PDR001 for each disease group.
        Contact
        410-450-5798
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   DCP-001, Use of a Clinical Trial Screening Tool to Address Cancer Health...
        Protocol No.
        HSC20160342XT
        Official Title
        DCP-001, Use of a Clinical Trial Screening Tool to Address Cancer Health Disparities in the NCI Community Oncology Research Program (NCORP)
        Description
        Objectives 1) Implement a screening tool in NCORP to collect broader demographic and clinical data to generate hypothesis and research questions in the following areas of research: cancer screening, cancer prevention, symptom science, cancer care disparities, comparative effectiveness and cancer care delivery research. 2) Collect expanded demographic and clinical data (e.g., SES, co-morbidities, method of diagnosis) across the NCORP network to help identify and best characterize patients that are screened but not enrolled and for patients that participate in NCI trials, to understand how these variables may impact outcomes. 3) Enhance an understanding of site- specific and trial-specific accrual barriers that will inform the development of effective strategies to improve accrual, particularly for minority and underserved populations. 4) Provide data for internal and external evaluation of NCORP s first RFA cycle and reissuance.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   GO29665, A PHASE I/II, MULTICENTER, OPEN-LABEL, DOSE-ESCALATION STUDY OF THE...
        Protocol No.
        HSC20160080H
        Official Title
        GO29665, A PHASE I/II, MULTICENTER, OPEN-LABEL, DOSE-ESCALATION STUDY OF THE SAFETY AND PHARMACOKINETICS OF COBIMETINIB IN PEDIATRIC AND YOUNG ADULT PATIENTS WITH PREVIOUSLY TREATED SOLID TUMORS (CTRC# 15-0005)
        Description
        CTRC#15-0005
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   Head and Neck Cancer Repository
        Protocol No.
        HSC20170218HR
        Official Title
        Head and Neck Cancer Repository
        Description
        To establish a repository of head and neck cancers and PDX models from our south Texas patient population.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
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      •   Health Effects after Anthracycline and Radiation Therapy (HEART):...
        Protocol No.
        HSC20140058X
        Official Title
        Health Effects after Anthracycline and Radiation Therapy (HEART): Dexrazoxane and Prevention of Anthracycline-related Cardiomyopathy A Limited Institution Non-Therapeutic Study
        Description
        This clinical trial studies the effects of dexrazoxane hydrochloride on biomarkers associated with cardiomyopathy and heart failure after cancer treatment. Studying samples of blood in the laboratory from patients receiving dexrazoxane hydrochloride may help doctors learn more about the effects of dexrazoxane hydrochloride on cells. It may also help doctors understand how well patients respond to treatment.
        Contact
        210-562-9149
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   Incidence and Factors Associated with the Development and Severity of Oral...
        Protocol No.
        HSC20050218H
        Official Title
        Incidence and Factors Associated with the Development and Severity of Oral Mucositis in Patients Undergoing High Dose Chemotherapy and Peripheral Stem Cell Transplantation
        Description
        Our study intends to evaluate prospectively the incidence and severity of oral mucositis in patients undergoing high-dose chemotherapy and hematopoietic stem cell transplantation, as well as to evaluate the potential influence of nutritional-, physical-, and transplant-related factors associated with the development of this complication and its grade of involvement. Research plan: This is a prospective cohort study with an observational basis that involves all of the patients undergoing high-dose chemotherapy and peripheral blood stem cell transplantation at the Audie L. Murphy VA Hospital Bone Marrow Transplant Unit and at the University Hospital Bone Marrow Transplant Unit. We expect to enroll 400 patients during a 5-year period. Methods: In order to answer the study questions, subjects will be assessed several times during the study period. The study involves a multidisciplinary group that will be evaluating and following the subjects. A baseline will be established by a physician and a nutritionist before the subjects start the high-dose chemotherapy regimen. The subjects will be followed with oral evaluations 3 times per week, beginning on the day of the transplant and ending when mucositis resolves, or the patient is discharged home, or 30 days post-transplant, whichever occurs first. At day 15 post-transplant, patients will be evaluated for the second time by the nutritionist. Further information such as blood values, use of medications and treatment complications, will be obtained by daily chart review.  
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   MATCH Treatment Subprotocol B: Phase II Study of Afatinib in Patients with...
        Protocol No.
        HSC20150831HU
        Official Title
        MATCH Treatment Subprotocol B: Phase II Study of Afatinib in Patients with Tumors with HER2 Activating Mutations (CTMS# 15-2107)
        Description
        Primary Objective To evaluate the proportion of patients with objective response (OR) to targeted study agent(s) in patients with advanced refractory cancers/lymphomas. Secondary Objectives To evaluate the proportion of patients alive and progression free at 6 months of treatment with targeted study agent in patients with advanced refractory cancers/lymphomas. To evaluate time until death or disease progression. To identify potential predictive biomarkers beyond the genomic alteration by which treatment is assigned or resistance mechanisms using additional genomic, RNA and protein-based assessment platforms.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
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      •   MATCH Treatment Subprotocol C1: EAY131-C1: Crizotinib in Patients with...
        Protocol No.
        HSC20160463HU
        Official Title
        MATCH Treatment Subprotocol C1: EAY131-C1: Crizotinib in Patients with Tumors with MET Amplification (CTMS# 16-0064)
        Description
        The purpose of this study is to test any good and bad effects of the study drug called crizotinib in patients whose cancer has MET genetic changes.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
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      •   MATCH Treatment Subprotocol F: Crizotinib in Patients with Tumors (other...
        Protocol No.
        HSC20150750HU
        Official Title
        MATCH Treatment Subprotocol F: Crizotinib in Patients with Tumors (other than adenocarcinoma of lung or ALCL) with ALK Translocations (CTMS# 15-2081)
        Description
        Primary Objective To evaluate the proportion of patients with objective response (OR) to targeted study agent(s) in patients with advanced refractory cancers/lymphomas. Secondary Objectives To evaluate the proportion of patients alive and progression free at 6 months of treatment with targeted study agent in patients with advanced refractory cancers/lymphomas. To evaluate time until death or disease progression. To identify potential predictive biomarkers beyond the genomic alteration by which treatment is assigned or resistance mechanisms using additional genomic, RNA and protein-based assessment platforms.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
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      •   MATCH Treatment Subprotocol S1: Phase II Study of Trametinib in Patients...
        Protocol No.
        HSC20160260HU
        Official Title
        MATCH Treatment Subprotocol S1: Phase II Study of Trametinib in Patients with Tumors with NF1 Mutations (CTMS# 16-0028)
        Description
        PRIMARY OBJECTIVES: I. To evaluate the proportion of patients with objective response (OR) to targeted study agent(s) in patients with advanced refractory cancers/lymphomas. SECONDARY OBJECTIVES: I. To evaluate the proportion of patients alive and progression free at 6 months of treatment with targeted study agent in patients with advanced refractory cancers/lymphomas. II. To evaluate time until death or disease progression. III. To identify potential predictive biomarkers beyond the genomic alteration by which treatment is assigned or resistance mechanisms using additional genomic, ribonucleic acid (RNA) and protein-based assessment platforms.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   MATCH Treatment Subprotocol U: VS-6063 (defactinib) in Patients with Tumors...
        Protocol No.
        HSC20150839HU
        Official Title
        MATCH Treatment Subprotocol U: VS-6063 (defactinib) in Patients with Tumors with NF2 Loss (CTMS# 15-2110)
        Description
        Primary Objective To evaluate the proportion of patients with objective response (OR) to targeted study agent(s) in patients with advanced refractory cancers/lymphomas. Secondary Objectives To evaluate the proportion of patients alive and progression free at 6 months of treatment with targeted study agent in patients with advanced refractory cancers/lymphomas. To evaluate time until death or disease progression. To identify potential predictive biomarkers beyond the genomic alteration by which treatment is assigned or resistance mechanisms using additional genomic, RNA and protein-based assessment platforms.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   MATCH Treatment Subprotocol W: EAY131-W: Phase II Study of AZD4547 in...
        Protocol No.
        HSC20160541HU
        Official Title
        MATCH Treatment Subprotocol W: EAY131-W: Phase II Study of AZD4547 in Patients with Tumors with Aberrations in the FGFR Pathway (CTMS# 16-0065)
        Description
        The purpose of this study is to test any good and bad effects of the study drug, AZD4547, in patients whose cancer has genetic changes called FGFR gene alterations.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   MATCH Treatment Subprotocol X: Phase II Study of Dasatinib in Patients with...
        Protocol No.
        HSC20160282HU
        Official Title
        MATCH Treatment Subprotocol X: Phase II Study of Dasatinib in Patients with Tumors with DDR2 Mutations (CTMS# 16-0032)
        Description
        PRIMARY OBJECTIVES: I. To evaluate the proportion of patients with objective response (OR) to targeted study agent(s) in patients with advanced refractory cancers/lymphomas. SECONDARY OBJECTIVES: I. To evaluate the proportion of patients alive and progression free at 6 months of treatment with targeted study agent in patients with advanced refractory cancers/lymphomas. II. To evaluate time until death or disease progression. III. To identify potential predictive biomarkers beyond the genomic alteration by which treatment is assigned or resistance mechanisms using additional genomic, ribonucleic acid (RNA) and protein-based assessment platforms.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   MATCH Treatment Subprotocol Z1A: EAY131-Z1A: Binimetinib in Patients with...
        Protocol No.
        HSC20160499HU
        Official Title
        MATCH Treatment Subprotocol Z1A: EAY131-Z1A: Binimetinib in Patients with Tumors (Other Than Melanoma) with NRAS Mutations (CTMS# 16-0066)
        Description
        The purpose of this study is to test any good and bad effects of the experimental study drug binimetinib in patients whose cancer has NRAS mutations.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   MATCH Treatment Subprotocol Z1B: EAY131-Z1B: Phase II Study of Palbociclib...
        Protocol No.
        HSC20160491HU
        Official Title
        MATCH Treatment Subprotocol Z1B: EAY131-Z1B: Phase II Study of Palbociclib (PD-0332991) in Patients with Tumors with CCND1, 2, 3 Amplification and Rb Protein Expression by IHC (CTMS# 16-0067)
        Description
        The purpose of this study is to test any good and bad effects of the study drug, palbociclib, in patients whose cancer has CCND1, 2 or 3 amplification and tested positive for a protein called Rb protein.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   Molecular Analysis for Therapy Choice (MATCH) / MATCH Treatment Subprotocol...
        Protocol No.
        HSC20170176HU
        Official Title
        Molecular Analysis for Therapy Choice (MATCH) / MATCH Treatment Subprotocol H: EAY131-H: Phase II Study of Dabrafenib and Trametinib in Patients with Tumors with BRAF V600E or V600K Mutations (Excluding Melanoma, Thyroid Cancer, and Colorectal Adenocarcinoma) (CTMS# 15-2083)
        Description
        Primary Objective To evaluate the proportion of patients with objective response (OR) to targeted study agent(s) in patients with advanced refractory cancers/lymphomas. Secondary Objectives To evaluate the proportion of patients alive and progression free at 6 months of treatment with targeted study agent in patients with advanced refractory cancers/lymphomas. To evaluate time until death or disease progression. To identify potential predictive biomarkers beyond the genomic alteration by which treatment is assigned or resistance mechanisms using additional genomic, RNA and protein-based assessment platforms.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   Molecular Analysis for Therapy Choice (NCI-MATCH)
        Protocol No.
        HSC20150719XT
        Official Title
        EAY131, Molecular Analysis for Therapy Choice (MATCH) (CTMS# 15-2080)
        Description
        Primary Objective To evaluate the proportion of patients with objective response (OR) to targeted study agent(s) in patients with advanced refractory cancers/lymphomas. Secondary Objectives To evaluate the proportion of patients alive and progression free at 6 months of treatment with targeted study agent in patients with advanced refractory cancers/lymphomas. To evaluate time until death or disease progression. To identify potential predictive biomarkers beyond the genomic alteration by which treatment is assigned or resistance mechanisms using additional genomic, RNA and protein-based assessment platforms.
        Contact
        410-450-5798
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   NRG-HN003, A PHASE I AND EXPANSION COHORT STUDY OF ADJUVANT CISPLATIN,...
        Protocol No.
        HSC20170206HU
        Official Title
        NRG-HN003, A PHASE I AND EXPANSION COHORT STUDY OF ADJUVANT CISPLATIN, INTENSITY-MODULATED RADIOTHERAPY, AND MK-3475 (PEMBROLIZUMAB) IN HIGH-RISK HEAD AND NECK SQUAMOUS CELL CARCINOMA (HNSCC) (CTMS# 17-0022)
        Description
        Primary Outcome Measures: DLT in patients with high-risk head and neck squamous cell carcinoma treated with adjuvant cisplatin, IMRT, and pembrolizumab [ Time Frame: Up to 4 weeks post IMRT ] Will be summarized using proportions for binary outcome per cohort.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   Phase I Clinical Trial of Camptothecin-20-O-Propionate hydrate (CZ48) (CTMS#...
        Protocol No.
        HSC20150748HU
        Official Title
        Phase I Clinical Trial of Camptothecin-20-O-Propionate hydrate (CZ48) (CTMS# 15-2103)
        Description
        PRIMARY: To describe the dose limiting toxicities and adverse event profile of Camptothecin-20-O-Propionate hydrate (CZ48) administered orally every day. To determine Phase II recommended dose of Camptothecin-20-O-Propionate hydrate (CZ48) administered orally every day. SECONDARY: To perform a pharmacokinetic study of orally administered CZ48. To assess responses by RECIST criteria when applicable. To follow patients for survival.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   Phase I study of carfilzomib in combination with cyclophosphamide and...
        Protocol No.
        HSC20160206HU
        Official Title
        Phase I study of carfilzomib in combination with cyclophosphamide and etoposide for children with relapsed and refractory solid tumors and leukemias (CTMS# 15-2097)
        Description
        Primary Objective: To determine the DLTs and MTD of carfilzomib given in combination with cyclophosphamide and etoposide in pediatric patients with relapsed/refractory leukemias and solid tumors Secondary Objectives: 1. To evaluate toxicities of carfilzomib in the pediatric population when combined with conventional chemotherapy 2. To gather preliminary efficacy data on the drug combination 3. To measure if circulating plasma proteasome (cProt) levels post treatment correlate with response to therapy and overall survival 4. To measure if the levels of proteasome activity and resistance to carfilzomib correlates with toxicity and/or response to treatment. 5. To measure if inhibition of proteasome activity by carfilzomib results in alteration in a number of autophagy and apoptosis related proteins, providing means to evaluate correlates of activity of carfilzomib. 6. To measure the level of proteasome inhibition in patient PBMCs before and during treatment by determination of the level of protein ubiquitination. 7. To determine in vitro sensitivity of patient leukemias and solid tumors to carfilzomib alone and in combination with study chemotherapeutic agents in order to generate a predictive model of drug sensitivity. 8. To expand patient leukemia and solid tumor samples in order to save tissue for future studies but also to serve as a pre-clinical in vivo model to be included in the generation and testing of a drug sensitivity predictive model. 9. To perform whole exome sequencing (WES) and RNA seq on patient leukemia and solid tumor samples and WES on germ line DNA in order to determine potential mechanisms of drug sensitivity or resistance as well as contribute to testing a computer `learning engine (Bionet) for predicting clinical responses from genomic and drug sensitivity data.
        Contact
        210-562-9149
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   Phase Ib, open-label, multi-center study to characterize the safety,...
        Protocol No.
        HSC20160552HU
        Official Title
        Phase Ib, open-label, multi-center study to characterize the safety, tolerability and pharmacodynamics (PD) of PDR001 in combination with LCL161, everolimus (RAD001) or panobinostat (LBH589) (CTMS# 16-0058)
        Description
        Primary Objectives: To characterize the safety and tolerability of PDR001 in combination with LCL161, everolimus (RAD001) or panobinostat (LBH589) and to identify recommended doses and schedules for future studies Secondary Objectives: To characterize changes in the immune infiltrate in tumors To further characterize the safety of PDR001 in combination with LCL161, everolimus or panobinostat (LBH589) To estimate the anti-tumor activity of PDR001 in combination with LCL161, everolimus or panobinostat (LBH589) To characterize the pharmacokinetics of all study drugs in combination To assess immunogenicity of PDR001
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   Phase II Trial of Eribulin and Lenvatinib in Advanced Solid Tumors (CTMS#...
        Protocol No.
        HSC20150891HU
        Official Title
        Phase II Trial of Eribulin and Lenvatinib in Advanced Solid Tumors (CTMS# 15-2139)
        Description
        The overall purpose of this study is to determine the overall response rate, efficacy and safety of the combination of eribulin and Lenvatinib.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   Prognostic and predictive markers in patients with advanced metastatic tumors
        Protocol No.
        HSC20130219H
        Official Title
        Numeration and Single-Cell Molecular Profiling of Circulating Tumor Cells as Prognostic and Predictive Marker In Patients with Advanced Metastatic Tumors (CTRC#13-0001)
        Description
        This study will research possible associations between circulating tumor cells (CTC) quantities or gene profile characteristics and clinical outcomes. The primary objective is to obtain blood samples from participants over an 8-week period for research analysis.  The study will enroll approximately 200 patients at the CTRC. In addition to other conditions for enrollment, eligible patients have advanced metastatic cancer.
        Contact
        210-450-5798
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   Prospective Comparative Effectiveness Trial for Malignant Bowel Obstruction...
        Protocol No.
        HSC20170491HU
        Official Title
        Prospective Comparative Effectiveness Trial for Malignant Bowel Obstruction (CTMS# 17-0081)
        Description
        Number of days alive and outside the hospital
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   S1609, Dart: Dual Anti-CTLA-4 and Anti-PD-1 Blockage in Rare Tumors (CTMS#...
        Protocol No.
        HSC20170145HU
        Official Title
        S1609, Dart: Dual Anti-CTLA-4 and Anti-PD-1 Blockage in Rare Tumors (CTMS# 17-0013)
        Description
        Primary Objective To evaluate the RECIST 1.1 overall response rate (ORR) in subsets of patients with advanced rare cancers treated with ipilimumab plus nivolumab combination immunotherapy. Secondary Objectives To evaluate toxicities in each cohort. To estimate overall survival (OS), progression-free survival (PFS), clinical benefit rate; and to estimate immune-related ORR (irORR), and immune-related PFS (irPFS) by unidimensional immune-related response criteria. To collect specimens for banking for use in future correlative biomarker research studies.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   Safety, Tolerability & PK of KX2-361 in Subjects with advanced malignancies...
        Protocol No.
        HSC20150481HU
        Official Title
        A Phase 1 Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetics of KX2-361 in Subjects with Advanced Malignancies that are Refractory to Conventional Therapies (CTMS# 15-2063)
        Description
        Study Objectives: Primary Objective: To define the maximum tolerated dose (MTD) of KX2-361 in subjects with advanced refractory malignancies when administered as single and multiple oral doses. Secondary Objectives: To determine the safety and tolerability of KX2-361 after single and multiple oral doses, in subjects with advanced refractory malignancies. To characterize the pharmacokinetic profile of KX2-361 after single and multiple oral doses. To evaluate the activity of KX2-361 in both the Dose Escalation Cohort and the Expansion Cohort of subjects with high-grade glioma.
        Contact
        210-450-5798
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   Study of the Genetic Epidemiology of Childhood Cancer
        Protocol No.
        HSC20080057H
        Official Title
        Study of the Genetic Epidemiology of Childhood Cancer
        Description
        Study of the Genetic Epidemiology of Childhood Cancer
        Contact
        210-562-9123
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

    •   Brain & Nervous System

      •   A Dose Regimen-Finding Study to Evaluate the Safety, Tolerability,...
        Protocol No.
        HSC20170102HU
        Official Title
        A Dose Regimen-Finding Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Activity of Oradoxel Monotherapy in Subjects with Advanced Malignancies (CTMS# 16-0069)
        Description
        Primary Objective: To determine the maximum tolerated dose (MTD) of Oradoxel based on dose-limiting toxicity (DLT) in subjects with advanced malignancies Secondary Objectives To determine the safety and tolerability of docetaxel as Oradoxel To determine the incidence of unacceptable toxicity with Oradoxel To determine the recommended Phase 2 dose (RP2D) of docetaxel as Oradoxel To characterize the pharmacokinetic (PK) profile of docetaxel as Oradoxel To evaluate tumor response
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   A Dose Regimen-Finding Study to Evaluate the Safety, Tolerability,...
        Protocol No.
        HSC20160087HU
        Official Title
        A Dose Regimen-Finding Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Activity of Oraxol in Subjects with Advanced Malignancies (CTMS# 15-2137)
        Description
        Primary Objective To determine the maximum tolerated dose (MTD) and dosing regimen of Oraxol in subjects with advanced malignancies Secondary Objectives To determine the recommended Phase 2 dose of paclitaxel as Oraxol To determine the safety and tolerability of paclitaxel as Oraxol To characterize the pharmacokinetic (PK) profile of paclitaxel as Oraxol To evaluate the tumor response
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   A Dual Phase 1/2, Investigator Initiated Study to Determine the Maximum...
        Protocol No.
        HSC20140450X
        Official Title
        A Dual Phase 1/2, Investigator Initiated Study to Determine the Maximum Tolerated Dose, Safety, and Efficacy of Rhenium Nanoliposomes (RNL) in Recurrent Glioblastoma (CTRC# 12-02)
        Description
        While radiation is an essential component to the treatment of glioblastoma, it''s use is limited due to toxicity when higher doses are attempted. Rhenium is a compound which releases radiation in small particles that are absorbed after only a fraction of an inch. This limited penetration means that high doses potentially can be given without the toxicity of other forms of radiation. In order for the radiation to be retained within the tumor, it has been packaged in microscopic fat-like particles termed nanoliposomes. These facilitate the uptake of the radiation particles by the tumor. In order to better characterize this form of radiation therapy, it is being administered in patients who have failed other forms of therapy for glioblastoma. The treatment is administered by tubing inserted into the center of the tumor in the operating room. There are two portions to this study. The first involves progressively increasing doses until the most tolerable dose can be identified. The second portion of the study involves a larger number of patients being treated at the determined most tolerable dose to better evaluate how well the treatment works.
        Contact
        210-450-5798
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   A Phase 1 Dose Escalation and Cohort Expansion Study of TSR-042, an...
        Protocol No.
        HSC20170110HU
        Official Title
        A Phase 1 Dose Escalation and Cohort Expansion Study of TSR-042, an anti-PD-1 Monoclonal Antibody, in Patients with Advanced Solid Tumors (CTMS# 16-0091)
        Description
        Primary Objectives: Part 1 Dose Escalation Cohorts: To evaluate the safety and tolerability of TSR-042 using Common Terminology Criteria for Adverse Events (CTCAE v.4.03) in patients with advanced solid tumors Part 2 Expansion Cohorts: To evaluate the antitumor activity of TSR-042 in patients with advanced solid tumors, in terms of objective response rate (ORR) as assessed by the Investigators using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 Part 1 and Part 2: To define the recommended Phase 2 dose (RP2D) and schedule Secondary Objectives: Part 1 Dose Escalation Cohorts: To characterize the pharmacodynamic (PDy) profile of TSR-042 To evaluate ORR as assessed by the Investigators using RECIST v1.1 Part 2 Expansion Cohorts: To characterize the safety and tolerability of TSR-042 using CTCAE v.4.03 Part 1 and Part 2: To characterize the pharmacokinetic (PK) profile of TSR-042 To evaluate the immunogenicity of TSR-042 To evaluate additional measures of clinical benefit, including: ORR by immune-related RECIST (irRECIST) Duration of response (DOR) by RECIST v 1.1 Disease control rate (DCR) by RECIST v 1.1 and by irRECIST Progression-free survival (PFS) by RECIST v 1.1 and by irRECIST Overall survival (OS)
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   A Phase 1 Study of CBL0137 in Patients with Metastatic or Unresectable...
        Protocol No.
        HSC20130328H
        Official Title
        A Phase 1 Trial of CBL0137 In patients With Metastatic or Unresectable Advanced Solid Neoplasms or Refractory Lymphomas (CTRC# 13-0031)
        Description
        This Phase 1 study is designed to determine the best dose of CBL0137 to use when treating patients with metastatic or unresectable advanced solid tumors or lymphoma. The study will enroll up to 48 patients from at least 2 cancer centers in the US. In addition to other conditions for enrollment, eligible patients have cancer that has not improved or has come back after prior treatment and are otherwise in good health. Patients who have a history of active infection, cancer involving the central nervous system, a particular EKG abnormality or other serious medical conditions may not be eligible to enroll.
        Contact
        210-450-5798
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   A Phase 1/2A, Multicenter, Open-Label Study of LYC-55716 in Adult Subjects...
        Protocol No.
        HSC20160617HU
        Official Title
        A Phase 1/2A, Multicenter, Open-Label Study of LYC-55716 in Adult Subjects with Locally Advanced or Metastatic Cancer (CTMS# 16-0099)
        Description
        Primary Objectives Phase 1 Evaluate the safety and tolerability of LYC-55716 Determine the maximum tolerated dose (MTD) and the recommended Phase 2 dose (RP2D) Phase 2a Determine the objective response rate according to response evaluation criteria in solid tumors (RECIST) v1.1 Secondary Objectives Phase 1 Evaluate the activity of LYC-55716 by objective response according to RECIST v1.1 Determine the durability of any observed objective response Phase 2a Determine the duration of response Determine progression-free survival (PFS) and overall survival (OS) Determine suitability of the RP2D for further study Characterize the pharmacokinetics (PK) of LYC-55716 Exploratory Objectives Assess tumor activity in subjects with locally advanced or metastatic cancer according to immune-related response evaluation criteria in solid tumors (irRECIST) Exploratory analysis of metabolite in plasma Assess changes in circulating tumor markers (eg, cytokines/chemokines)
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   A Phase 1b Study of Oraxol in Combination with Ramucirumab in Patients with...
        Protocol No.
        HSC20170188HU
        Official Title
        A Phase 1b Study of Oraxol in Combination with Ramucirumab in Patients with Gastric, Gastro-esophageal, or Esophageal Cancers (CTMS# 16-0089)
        Description
        Primary Objective: To determine the maximum tolerated dose (MTD) of Oraxol in patients with advanced stage gastric, gastro-esophageal, or esophageal cancers who are being treated with Oraxol in combination with ramucirumab Secondary Objectives: To determine the safety and tolerability of Oraxol in combination with ramucirumab To determine the recommended Phase 2 dose of Oraxol in combination with ramucirumab To characterize the pharmacokinetic (PK) profile of Oraxol in combination with ramucirumab To characterize preliminary activity of Oraxol plus ramucirumab as determined by response rate, progression-free survival, and overall survival
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   A Phase 1b/2 Study of ARRY-382 in Combination with Pembrolizumab, a...
        Protocol No.
        HSC20170071HU
        Official Title
        A Phase 1b/2 Study of ARRY-382 in Combination with Pembrolizumab, a Programmed Cell Death Receptor 1 (PD-1) Antibody, for the Treatment of Patients with Advanced Solid Tumors (CTMS# 16-0084)
        Description
        Primary objective: To determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of ARRY-382 in combination with pembrolizumab in patients with selected solid tumors Secondary objectives:  To describe the preliminary antitumor activity of the combination based on the Response Criteria In Solid Tumors, version 1.1 (RECIST v1.1).  To describe the preliminary antitumor activity of the combination based on immune-related response criteria (irRC).  To characterize the safety and tolerability of the combination, including acute and chronic toxicities. To evaluate the pharmacokinetics of ARRY-382 in combination with pembrolizumab Exploratory objective: To explore the effect of the combination on circulating biomarkers of immune response. To describe the preliminary antitumor activity of the combination in patients with PD-L1 positive non-small cell lung cancer (NSCLC), as determined using a United States Food and Drug Administration (FDA)-approved test, using RECIST. To describe the preliminary antitumor activity of the combination in patients with PD-L1 positive non-small cell lung cancer (NSCLC), as determined using an FDA approved test, using irRC
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   A Phase 2 Investigator Initiated Study to Determine the Efficacy and Safety...
        Protocol No.
        HSC20170090HU
        Official Title
        A Phase 2 Investigator Initiated Study to Determine the Efficacy and Safety of TVB-2640 in Combination with Bevacizumab in Patients with First Relapse of High Grade Astrocytoma (CTMS# 16-0136)
        Description
        Primary Objective(s): To determine if the progression-free survival of patients with High Grade Astrocytoma who are treated with TVB-2640 in combination with bevacizumab is superior to treatment with bevacizumab alone. Secondary Objective(s): To evaluate the safety of TVB-2640 in combination with bevacizumab in patients with High Grade Astrocytoma. Exploratory Objective: To determine the extent by which TVB-2640 is able to penetrate the blood brain barrier where it might have the opportunity to affect tumor tissue metabolism.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
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      •   A Phase I, First-in-human, Open-label, Dose-escalation, Safety,...
        Protocol No.
        HSC20160554HU
        Official Title
        A Phase I, First-in-human, Open-label, Dose-escalation, Safety, Pharmacokinetic, and Pharmacodynamic Study of Oral TP-0903 Administered Daily for 21 Days to Patients with Advanced Solid Tumors (CTMS# 16-0092)
        Description
        Primary Objective: To determine the maximum tolerated dose (MTD) and dose-limiting toxicities (DLTs) of oral TP-0903 administered daily for the first 21 days every 4 weeks, over a range of doses in patients with advanced solid tumors. Secondary Objectives: To establish the pharmacokinetics of orally administered TP-0903 To observe patients for any evidence of antitumor activity of TP-0903 by objective radiographic assessment To study the pharmacodynamics of TP-0903 therapy by: assessing biomarkers in tumor tissue assessing biomarkers in peripheral blood mononuclear cells (PBMCs) and serum To establish the Recommended Phase 2 Dose (RP2D) for future studies with TP-0903
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   A Phase I, Multicenter, Open-Label Dose Escalation and Expansion Study of...
        Protocol No.
        HSC20150289HU
        Official Title
        A Phase I, Multicenter, Open-Label Dose Escalation and Expansion Study of PCA062, Administered Intravenously In Adult Patients With pCAD-Positive Tumors (CTMS# 14-2019)
        Description
        Primary Objective To determine the MTD/RDE of PCA062 in patients with pCAD-positive tumors in the dose escalation part. Secondary Objectives To characterize the safety and tolerability of PCA062 To characterize the pharmacokinetic profile of PCA062 To assess emergence of anti-PCA062 antibodies following one or more intravenous infusions of PCA062 To assess the preliminary anti-tumor activity of PCA062 in patients with pCAD-positive triple negative breast cancer (TBNC), head and neck squamous cell carcinoma (HNSCC) or esophageal cancer (squamous and adenocarcinoma)
        Contact
        210-450-5798
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   A Phase I/II, open label, multicenter study of the safety and efficacy of...
        Protocol No.
        HSC20150421HU
        Official Title
        A Phase I/II, open label, multicenter study of the safety and efficacy of LAG525 single agent and in combination with PDR001 administered to patients with advanced malignancies (CTMS #15-2054)
        Description
        Primary Objectives Phase I part To estimate the RP2D or MTD for the single agent LAG525 and the combination of LAG525 and PDR001. Phase II part To estimate the overall response rate per RECIST V1.1 for single agent LAG525 as well as for the combination of LAG525 and PDR001 Secondary Objectives: To characterize the safety and tolerability of single agent LAG525 given alone and in combination with PDR001 To characterize the pharmacokinetic profile of single agent LAG525 given alone and in combination with PDR001 To assess emergence of anti-LAG525, and anti-PDR001 antibodies following one or more intravenous (i.v.) infusions of single agent LAG525 given alone or in combination with PDR001 To assess potential predictors of efficacy of single agent LAG525 and the combination of LAG525 and PDR001 To evaluate the preliminary antitumor activity of single agent LAG525 given alone or in combination of PDR001 To investigate patient selection and pharmacodynamic biomarkers in tumor tissue samples
        Contact
        210-450-5798
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   A Phase I/II, Open-Label, Multi-Center Study of the Safety and Efficacy of...
        Protocol No.
        HSC20160420HU
        Official Title
        A Phase I/II, Open-Label, Multi-Center Study of the Safety and Efficacy of BLZ945 as Single Agent and In Combination with PDR001 in Adult Patients with Advanced Solid Tumors (CTMS# 16-0071)
        Description
        Primary Objective: Phase I: To characterize the safety and tolerability of BLZ945 as a single agent and in combination with PDR001 and to identify the Maximum Tolerated Dose (MTD)/Recommended Phase 2 Dose (RP2D). Phase II: To assess the anti-tumor activity of BLZ945 in combination with PDR001 (and as single agent if appropriate) in patients with advanced solid tumors. Secondary Objective: Phase I: To characterize the pharmacodynamics effect of BLZ945 as a single agent and in combination with PDR001. To characterize PK of BLZ945 as a single agent and in combination with PDR001. To assess the preliminary anti-tumor activity of BLZ945 as single agent and in combination with PDR001. Phase I and II: To assess emergence of anti-PDR001 antibodies when BLZ945 is administered in combination with PDR001.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
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      •   A Phase Ib Trial of Pembrolizumab (MK-3475) in Combination with Dinaciclib...
        Protocol No.
        HSC20170106HU
        Official Title
        A Phase Ib Trial of Pembrolizumab (MK-3475) in Combination with Dinaciclib (MK-7965) in Subjects with Hematologic Malignancies (KEYNOTE-155) (CTMS# 16-0009)
        Description
        Primary Objective Objective: In both the Dose Evaluation and Signal Detection phases, evaluate the safety and tolerability of the treatment combination. Objective: Within each disease type of the Signal Detection phase, evaluate objective response rate (ORR) according to investigator assessment using the disease specific criteria. Secondary Objective: Objective: To evaluate the Objective Response Rate (ORR; complete response [CR] + partial response [PR]) of the combination of pembrolizumab and dinaciclib within each disease type, ie, CLL based on iwCLL guidelines (Hallek, 2008) [1], MM based on IMWG criteria (Durie, 2006) [2] and DLBCL based on the Revised Response Criteria for Malignant Lymphoma (Cheson, 2007) [3]. Objective: Within each disease type of the Signal Detection phase, evaluate Duration of Response (DOR), Progression-Free Survival (PFS) according to investigator assessment using the disease specific criteria; and Overall Survival (OS).
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
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      •   ABTR01B1, A Children''s Oncology Group Protocol for Collecting and Banking...
        Protocol No.
        HSC20040131H
        Official Title
        ABTR01B1, A Children''s Oncology Group Protocol for Collecting and Banking Pediatric Research Specimens Including Rare Pediatric Tumors
        Description
        This study is collecting and storing malignant, borderline malignant neoplasms, and related biological samples from young patients with cancer. Collecting and storing samples of tumor tissue, blood, and bone marrow from patients with cancer to study in the laboratory may help the study of cancer in the future.
        Contact
        210-562-9149
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   ACCL10P1 - Computerized Cognitive Training for Pediatric Brain Tumor...
        Protocol No.
        HSC20140435X
        Official Title
        ACCL10P1 - Computerized Cognitive Training for Pediatric Brain Tumor Patients: A Pilot Study A Limited-Institution Pilot Study
        Description
        This randomized clinical trial studies how well an adaptive computerized cognitive training program works compared to a non-adaptive computerized cognitive training program in treating younger patients with brain tumor who underwent radiation therapy. Providing a computer training program may improve the well-being and quality of life of patients with cognitive (physical and mental) function difficulties caused by radiation therapy to the brain.
        Contact
        210-562-9149
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   ACCL15N1CD Use of Evidence-Based Supportive Care Clinical Practice...
        Protocol No.
        HSC20160673X
        Official Title
        ACCL15N1CD Use of Evidence-Based Supportive Care Clinical Practice Guidelines in Pediatric
        Description
        Primary and Secondary Aims Aim 1: Chart Review To measure the rate of adherence to selected COG-endorsed supportive care CPG recommendations at NCORP sites Aim 1a To describe the possible influence of NCORP site size and the number of patients enrolled in COG studies per site on the delivery of CPG-consistent care. Aim 1b To describe the clinical outcome of episodes during which patients receive CPG-consistent or CPG-inconsistent care Aim 2: Focus Groups To describe facilitators of and barriers to the use of CPGs elicited via focus group interviews with a diverse set of potential users (physician, nurse, nurse practitioner and pharmacists) who provide pediatric cancer care at NCORP sites. Aim 3: Interviews To improve how well CPG recommendations are understood by health care providers by refining the CPG recommendation format based on an iterative process of cognitive interviewing and formatting revisions. Understanding is defined as the correct interpretation of the course of action recommended or suggested by a CPG.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   ACCRN07 Protocol for the Enrollment on the Official COG Registry, The...
        Protocol No.
        HSC20080271X
        Official Title
        ACCRN07 Protocol for the Enrollment on the Official COG Registry, The Childhood Cancer Research Network (CCRN)
        Description
        The Children s Oncology Group has established a research network, the Childhood Cancer Research Network (CCRN), to collect information about children with cancer and other conditions that are benign but involve abnormal cell growth in order to help doctors and scientists better understand childhood cancer. The CCRN''s goal is to collect clinical information about every child diagnosed with cancer and similar conditions in the United States and Canada, to allow researchers to study patterns, characteristics, and causes of childhood cancer. The information can also help researchers study the causes of childhood cancer. To expand the CCRN, parents of children who have been diagnosed with cancer will be asked to provide information about themselves and their child for research purposes.   Objectives: To obtain informed consent from parents (and the child, when appropriate) of infants, children, adolescents, and young adults newly diagnosed with cancer to enter their names and certain information concerning their child into the Childhood Cancer Research Network. To obtain informed consent from parents (and the child, when appropriate) of infants, children, adolescents, and young adults newly diagnosed with cancer for permission to be contacted in the future to consider participating in non-therapeutic and prevention research studies involving the parents and/or the child.
        Contact
        210-562-9149
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
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      •   ACNS02B3: A CHILDREN''S ONCOLOGY GROUP PROTOCOL FOR COLLECTING AND BANKING...
        Protocol No.
        HSC20040266H
        Official Title
        ACNS02B3: A CHILDREN''S ONCOLOGY GROUP PROTOCOL FOR COLLECTING AND BANKING PEDIATRIC BRAIN TUMOR RESEARCH SPECIMENS
        Description
        he purpose of this study is to collect and store brain tissue samples and blood from children with brain cancer that will be tested in the laboratory. Collecting and storing samples of tumor tissue and blood from patients to test in the laboratory may help the study of cancer in the future.
        Contact
        210-562-9149
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   ACNS0831 Phase III Randomized Trial of Post-Radiation Chemotherapy in...
        Protocol No.
        HSC20110258X
        Official Title
        ACNS0831 Phase III Randomized Trial of Post-Radiation Chemotherapy in Patients with Newly Diagnosed Ependymoma Ages 1 to 21 years
        Description
        This randomized phase III trial is studying maintenance chemotherapy to see how well it works compared to observation following induction chemotherapy and radiation therapy in treating young patients with newly diagnosed ependymoma. Drugs used in chemotherapy, such as vincristine sulfate, carboplatin, cyclophosphamide, etoposide, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Radiation therapy uses high-energy x-rays to kill tumor cells. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Giving chemotherapy with radiation therapy may kill more tumor cells and allow doctors to save the part of the body where the cancer started.
        Contact
        210-562-9149
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   ACNS1123 : Phase 2 Trial of Response-Based Radiation Therapy for Patients...
        Protocol No.
        HSC20130346X
        Official Title
        ACNS1123 : Phase 2 Trial of Response-Based Radiation Therapy for Patients with Localized Central Nervous System Germ Cell Tumors (CNS GCT)
        Description
        Drugs used as chemotherapy, such as carboplatin, etoposide, and ifosfamide work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x rays to kill tumor cells. Giving chemotherapy with radiation therapy may kill more tumor cells. This phase II trial studies how well chemotherapy and radiation therapy work in treating younger patients with newly diagnosed central nervous system germ cell tumors.
        Contact
        210-562-9149
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   ACNS1221, A Phase II Study For The Treatment Of Non-Metastatic Nodular...
        Protocol No.
        HSC20160159XT
        Official Title
        ACNS1221, A Phase II Study For The Treatment Of Non-Metastatic Nodular Desmoplastic Medulloblastoma In Children Less Than 4 Years Of Age
        Description
        1.1 Primary Aims Estimate of the PFS distribution for patients 0-
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
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      •   Adolescent and Young Adult Childhood Cancer Survivorship (CTMS#17-0088)
        Protocol No.
        HSC20170474HU
        Official Title
        Adolescent and Young Adult Childhood Cancer Survivorship (CTMS#17-0088)
        Description
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
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      •   ALTE05N1, Umbrella Long-Term Follow-Up Protocol
        Protocol No.
        HSC20090478X
        Official Title
        ALTE05N1, Umbrella Long-Term Follow-Up Protocol
        Description
        Umbrella Long-Term Follow-Up Protocol
        Contact
        210-562-9149
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
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      •   ALTE07C1 Neuropsychological, Social, Emotional, and Behavioral Outcomes in...
        Protocol No.
        HSC20090042X
        Official Title
        ALTE07C1 Neuropsychological, Social, Emotional, and Behavioral Outcomes in Children with Cancer
        Description
        This research trial studies neuropsychological (learning, remembering or thinking) and behavioral testing in younger patients with cancer. Collecting information over time from a series of tests may help doctors develop effective tests to measure neuropsychological and behavioral function of patients with cancer. Parent and child participants complete the COG Standard Neuropsychological and Behavioral Battery testing at 9, 30, and 60 months post-diagnosis in a 1-hour session conducted by a neuropsychologist or psychologist. The Battery consists of tests of intelligence, processing speed/attention, memory, language preference, general developmental progress, attention and behavior/social/emotional function, executive function, adoptive function, and quality of life. Additionally, parents complete a parent-report questionnaire to gather information about patient''s function in terms of attention, memory, executive abilities, and behavioral, social, and emotional adaption.
        Contact
        210-562-9149
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
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      •   ALTE1621 Pharmacologic Reversal of Ventricular Remodeling in Childhood...
        Protocol No.
        HSC20160394X
        Official Title
        ALTE1621 Pharmacologic Reversal of Ventricular Remodeling in Childhood Cancer Survivors at Risk for Heart Failure (PREVENT-HF): A Phase 2b Randomized Placebo-Controlled (Carvedilol) Trial
        Description
        1.1 Primary Aim To determine the impact of a two-year course of low-dose carvedilol on surrogate echocardiographic indices of heart failure (HF) risk, including Left Ventricular (LV) Posterior Wall Thickness-Dimension Ratio (LV T-D) a well-established index of early myocardial remodeling and subsequent HF risk (primary endpoint).  LV systolic and diastolic function and afterload established echocardiographic indices associated with HF risk.  Natriuretic peptides, troponins, and Galectin-3 - circulating biomarkers associated with myocardial injury, and HF risk. 1.2 Secondary Aims 1.2.1 To establish safety and tolerability of this two-year course of low-dose carvedilol, assessing both objective measures (hepatic function) and patient reported outcomes. 1.2.2 To examine the modifying effect of demographic, clinical, and molecular characteristics on the risk: benefit ratio from this two-year carvedilol intervention. 1.3 Exploratory Aim To evaluate the long-term efficacy of carvedilol in preventing cardiomyopathy and/or heart failure in high-risk childhood cancer survivors.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
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      •   AN EARLY-PHASE, MULTICENTER, OPEN-LABEL STUDY OF THE SAFETY AND...
        Protocol No.
        HSC20150549H
        Official Title
        AN EARLY-PHASE, MULTICENTER, OPEN-LABEL STUDY OF THE SAFETY AND PHARMACOKINETICS OF ATEZOLIZUMAB (MPDL3280A) IN PEDIATRIC AND YOUNG ADULT PATIENTS WITH PREVIOUSLY TREATED SOLID TUMORS
        Description
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   An Open-Label Non-Randomized, Multi-Center Phase-2 Study of...
        Protocol No.
        HSC20160689HU
        Official Title
        An Open-Label Non-Randomized, Multi-Center Phase-2 Study of Convection-Enhanced Delivery (CED) of MDNA55 in Adults with Glioblastoma at First Recurrence or Progression (CTMS# 16-0088)
        Description
        Primary To determine the objective response rate (ORR) per iRANO criteria following intra- and peritumoral infusion using CED of MDNA55 in adult subjects with GB at first recurrence following standard therapy Secondary To assess the safety of MDNA55 following CED in adult subjects with GB at first recurrence following standard therapy. To assess overall survival (OS) in these subjects To assess progression-free survival (PFS; using iRANO criteria) in these subjects Exploratory To assess the pharmacokinetics (PK) of MDNA55 in peripheral plasma as measured by enzyme-linked immunosorbent assay (ELISA) To assess anti-MDNA55 antibody titer and, if anti-MDNA55 titer is observed, determine neutralizing antibody titer and its effect on the safety and efficacy of MDNA55 To perform additional ad hoc efficacy and safety analyses as needed based on the data acquired in this study
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
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      •   An Open-Label Rollover Study to Evaluate the Long-Term Safety, Tolerability,...
        Protocol No.
        HSC20170197XT
        Official Title
        An Open-Label Rollover Study to Evaluate the Long-Term Safety, Tolerability, Biological Activity of Oral TVB-2640 in Patients With Solid Tumors Previously Enrolled in 3V2640-CLIN-002 (CTMS# 17-0046)
        Description
        Primary: To continue to characterize the safety profile of TVB-2640. Secondary: To identify any early signs of anti-tumor activity, where possible.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
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      •   An Open-Label, Dose Escalation, Phase 1, First-In-Human Study of TAK-659 in...
        Protocol No.
        HSC20150255HU
        Official Title
        An Open-Label, Dose Escalation, Phase 1, First-In-Human Study of TAK-659 in Adult Patients with Advanced Solid Tumors and Lymphoma Malignancies (CTMS# 14-2013)
        Description
        To determine the safety, tolerability, maximum tolerated dose (MTD)/recommended phase 2 dose (RP2D) ofTAK-659 administered orally on a daily dosing schedule in patients with advanced solid tumor and lymphoma who do not have effective standard treatment available
        Contact
        210-450-5798
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
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      •   APEC14B1, THE PROJECT: EVERYCHILD PROTOCOL: A REGISTRY, ELIGIBILITY...
        Protocol No.
        HSC20150870XT
        Official Title
        APEC14B1, THE PROJECT: EVERYCHILD PROTOCOL: A REGISTRY, ELIGIBILITY SCREENING, BIOLOGY AND OUTCOME STUDY
        Description
        1.1 To maintain a Childhood Cancer Registry1 for infants, children, adolescents, and young adults with cancer. 1.2 To utilize clinical and biological data to help determine eligibility or stratification, based on childhood cancer disease classification schemas, for potential enrollment of research subjects onto COG therapeutic clinical trials. 1.3 To develop a well annotated childhood cancer biorepository for current and future research through the collection of biospecimens (at diagnosis, time of progression, time of recurrence and/or post-mortem), including tumor, host and when feasible parental germline DNA; and key clinical data, including presentation, diagnostic, staging, summary treatment, and outcome information, from every child diagnosed with cancer at COG institutions. 1.4 To allow use of registry data for permission to be contacted in the future to consider participating in non-therapeutic and prevention research studies involving the child or their parents.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
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      •   Cancer Therapy and Research Center''s Institute for Drug Development Solid...
        Protocol No.
        HSC20070684H
        Official Title
        Cancer Therapy and Research Center''s Institute for Drug Development Solid Tumors and Hematological Malignancies Biorepository for Biomarker Discovery
        Description
        Samples are collected for the Cancer Therapy and Research Center''s Solid Tumors and Hematological Malignancies Biorepository for Biomarker Discovery
        Contact
        210-450-5798
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   Caris Molecular Intelligence® and Caris Centers of Excellence for...
        Protocol No.
        HSC20170144HU
        Official Title
        Caris Molecular Intelligence® and Caris Centers of Excellence for Precision Medicine NetworkTM Retrospective Outcomes-Associated Database (CTMS# 16-0145)
        Description
        The objective of this project is the development of the Caris Molecular Intelligence® and Caris Centers of Excellence for Precision Medicine NetworkTM Outcomes Associated Repository, a disease research database (hereinafter referred to as the Database ) for the purpose of: 1. Effecting change in disease treatment processes by advancing precision medicine and improving care for cancer through acquiring and sharing valuable molecular tumor profiling information and clinical outcomes in a collaborative, secure environment. 2. Performing prospective research studies involving analyses of quality of life studies as well as subject medical records including clinical presentation and outcomes. This eligible cohort includes select subjects having undergone Caris Molecular Intelligence® evaluation for diagnosis and/or treatment management. 3. Evaluate the frequency of specific clinical events in relation to risk factors, diagnosis and treatments provided via the collection of outcomes data through automated data capture systems provided by a third-party data entity and manually-entered data when needed. 4. Provide information access that is vital to research collaborators, including potential researchers from pharmaceutical companies, governmental agencies, academia, healthcare providers, and payors, with catalogued subject outcome data for the use of drug development discoveries, clinically relevant research trials, publications and posters, the implementation of future healthcare policies, characterization of trends in practice patterns and their relation to subject outcomes and the economic impact of differing evaluation, treatment, and management paradigms. 5. Cultivate a repository for assay development and validation of emerging technologies to enhance clinical cancer care.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   Caris Molecular Intelligence® and Caris Centers of Excellence for Precision...
        Protocol No.
        HSC20170353HU
        Official Title
        Caris Molecular Intelligence® and Caris Centers of Excellence for Precision Medicine NetworkTM Outcomes Associated Repository (CTMS# 17-0023)
        Description
        The objective of this project is the development of the Caris Molecular Intelligence® and Caris Centers of Excellence for Precision Medicine NetworkTM Outcomes Associated Repository, a disease research database (hereinafter referred to as the Database) for the purpose of: 1. Effecting change in disease treatment processes by advancing precision medicine and improving care for cancer through acquiring and sharing valuable molecular tumor profiling information and clinical outcomes in a collaborative, secure environment. 2. Performing prospective research studies involving analyses of quality of life studies as well as subject medical records including clinical presentation and outcomes. This eligible cohort includes select subjects having undergone Caris Molecular Intelligence® evaluation for diagnosis and/or treatment management. 3. Evaluate the frequency of specific clinical events in relation to risk factors, diagnosis and treatments provided via the collection of outcomes data through automated data capture systems provided by a third-party data entity and manually-entered data when needed. 4. Provide information access that is vital to research collaborators, including potential researchers from pharmaceutical companies, governmental agencies, academia, healthcare providers, and payors, with catalogued subject outcome data for the use of drug development discoveries, clinically relevant research trials, publications and posters, the implementation of future healthcare policies, characterization of trends in practice patterns and their relation to subject outcomes and the economic impact of differing evaluation, treatment, and management paradigms. 5. Cultivate a repository for assay development and validation of emerging technologies to enhance clinical cancer care.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   Clinical Trial of Lurbinectedin (PM01183) in Selected Advanced Solid Tumors
        Protocol No.
        HSC20150542HU
        Official Title
        A Multicenter Phase II Clinical Trial of Lurbinectedin (PM01183) in Selected Advanced Solid Tumors (CTMS# 15-2071)
        Description
        Primary: To assess the antitumor activity of lurbinectedin (PM01183) in terms of overall response rate (ORR), according to the Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1, in the following advanced solid tumors: small cell lung cancer (SCLC), head and neck carcinoma (H&N), neuroendocrine tumors (NETs), biliary tract carcinoma, endometrial carcinoma, BRCA 1/2-associated metastatic breast carcinoma, carcinoma of unknown primary site, germ cell tumors (GCTs), and Ewing¿s family of tumors (EFTs). Secondary: To further characterize the antitumor activity of PM01183 in terms of duration of response (DR), clinical benefit [ORR or stable disease (SD) lasting over four months (SD ¿ 4 months)], progression-free survival (PFS), and one year overall survival (1y-OS) in each cohort of advanced solid tumors. Characterize the plasma pharmacokinetics (PK) of PM01183. To conduct an exploratory pharmacogenomic (PGx) and pharmacogenetic analysis. To evaluate the safety profile of PM01183 in this patient population.
        Contact
        410-450-5798
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
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      •   Clinical trial to study the safety and efficacy of MBG453 given alone and in...
        Protocol No.
        HSC20150730HU
        Official Title
        A Phase I-Ib/II, Open-Label, Multi-Center Study of the Safety and Efficacy of MBG453 as Single Agent and in Combination with PDR001 in Adult Patients with Advanced Malignancies (CTMS# 15-2114)
        Description
        Primary Objectives: Phase I-Ib: To characterize the safety and tolerability of MBG453 as a single agent and in combination with PDR001 and to identify recommended doses for future studies. Phase I-Ib dose ranging: To further investigate the safety and tolerability of different doses of MBG453 alone or in combination with PDR001. Phase II: To estimate the anti-tumor activity of MBG453 alone in patients with solid tumors, and in combination with PDR001 in selected disease indications (melanoma, non-small cell lung cancer (NSCLC), renal cell carcinoma (RCC)). Secondary Objectives Evaluate the preliminary anti-tumor activity of MBG453 alone and in combination with PDR001. Make an initial comparison of safety, PK and efficacy for MBG453 and PDR001 administered in combination on a every 2 weeks (Q2W) and every 4 weeks (Q4W) dosing schedules. Characterize the pharmacokinetic profile of MBG453 alone and in combination with PDR001. Assess emergence of anti-MBG453 and anti-PDR001 antibodies. Assess potential predictors of efficacy of MBG453 single agent and in combination with PDR001 in tumor samples. Assess the pharmacodynamic effect of MBG453 as single agent and in combination with PDR001 in tumor samples. Describe the survival distribution of patients treated with MBG453 as single agent and in combination with PDR001 for each disease group.
        Contact
        410-450-5798
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   COG ANBLOOB1: Neuroblastoma Biology Studies
        Protocol No.
        HSC20010176X
        Official Title
        COG ANBLOOB1: Neuroblastoma Biology Studies
        Description
        This research trial studies biomarkers in tumor tissue samples from patients with newly diagnosed neuroblastoma or ganglioneuroblastoma. Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer.
        Contact
        210-562-9149
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   DCP-001, Use of a Clinical Trial Screening Tool to Address Cancer Health...
        Protocol No.
        HSC20160342XT
        Official Title
        DCP-001, Use of a Clinical Trial Screening Tool to Address Cancer Health Disparities in the NCI Community Oncology Research Program (NCORP)
        Description
        Objectives 1) Implement a screening tool in NCORP to collect broader demographic and clinical data to generate hypothesis and research questions in the following areas of research: cancer screening, cancer prevention, symptom science, cancer care disparities, comparative effectiveness and cancer care delivery research. 2) Collect expanded demographic and clinical data (e.g., SES, co-morbidities, method of diagnosis) across the NCORP network to help identify and best characterize patients that are screened but not enrolled and for patients that participate in NCI trials, to understand how these variables may impact outcomes. 3) Enhance an understanding of site- specific and trial-specific accrual barriers that will inform the development of effective strategies to improve accrual, particularly for minority and underserved populations. 4) Provide data for internal and external evaluation of NCORP s first RFA cycle and reissuance.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
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      •   EAF151: Change in Relative Cerebral Blood Volume as a Biomarker for Early...
        Protocol No.
        HSC20170313HU
        Official Title
        EAF151: Change in Relative Cerebral Blood Volume as a Biomarker for Early Response to Bevacizumab in Patients with Recurrent Glioblastoma (CTMS# 17-0041)
        Description
        Primary Aims To determine whether binary changes (increase vs. decrease) in normalized rCBV within enhancing tumor from baseline to 2 weeks after initiation of anti-angiogenic therapy is associated with overall survival (OS).
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
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      •   GO29665, A PHASE I/II, MULTICENTER, OPEN-LABEL, DOSE-ESCALATION STUDY OF THE...
        Protocol No.
        HSC20160080H
        Official Title
        GO29665, A PHASE I/II, MULTICENTER, OPEN-LABEL, DOSE-ESCALATION STUDY OF THE SAFETY AND PHARMACOKINETICS OF COBIMETINIB IN PEDIATRIC AND YOUNG ADULT PATIENTS WITH PREVIOUSLY TREATED SOLID TUMORS (CTRC# 15-0005)
        Description
        CTRC#15-0005
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   Head and Neck Cancer Repository
        Protocol No.
        HSC20170218HR
        Official Title
        Head and Neck Cancer Repository
        Description
        To establish a repository of head and neck cancers and PDX models from our south Texas patient population.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   Health Effects after Anthracycline and Radiation Therapy (HEART):...
        Protocol No.
        HSC20140058X
        Official Title
        Health Effects after Anthracycline and Radiation Therapy (HEART): Dexrazoxane and Prevention of Anthracycline-related Cardiomyopathy A Limited Institution Non-Therapeutic Study
        Description
        This clinical trial studies the effects of dexrazoxane hydrochloride on biomarkers associated with cardiomyopathy and heart failure after cancer treatment. Studying samples of blood in the laboratory from patients receiving dexrazoxane hydrochloride may help doctors learn more about the effects of dexrazoxane hydrochloride on cells. It may also help doctors understand how well patients respond to treatment.
        Contact
        210-562-9149
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   Incidence and Factors Associated with the Development and Severity of Oral...
        Protocol No.
        HSC20050218H
        Official Title
        Incidence and Factors Associated with the Development and Severity of Oral Mucositis in Patients Undergoing High Dose Chemotherapy and Peripheral Stem Cell Transplantation
        Description
        Our study intends to evaluate prospectively the incidence and severity of oral mucositis in patients undergoing high-dose chemotherapy and hematopoietic stem cell transplantation, as well as to evaluate the potential influence of nutritional-, physical-, and transplant-related factors associated with the development of this complication and its grade of involvement. Research plan: This is a prospective cohort study with an observational basis that involves all of the patients undergoing high-dose chemotherapy and peripheral blood stem cell transplantation at the Audie L. Murphy VA Hospital Bone Marrow Transplant Unit and at the University Hospital Bone Marrow Transplant Unit. We expect to enroll 400 patients during a 5-year period. Methods: In order to answer the study questions, subjects will be assessed several times during the study period. The study involves a multidisciplinary group that will be evaluating and following the subjects. A baseline will be established by a physician and a nutritionist before the subjects start the high-dose chemotherapy regimen. The subjects will be followed with oral evaluations 3 times per week, beginning on the day of the transplant and ending when mucositis resolves, or the patient is discharged home, or 30 days post-transplant, whichever occurs first. At day 15 post-transplant, patients will be evaluated for the second time by the nutritionist. Further information such as blood values, use of medications and treatment complications, will be obtained by daily chart review.  
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   MATCH Treatment Subprotocol B: Phase II Study of Afatinib in Patients with...
        Protocol No.
        HSC20150831HU
        Official Title
        MATCH Treatment Subprotocol B: Phase II Study of Afatinib in Patients with Tumors with HER2 Activating Mutations (CTMS# 15-2107)
        Description
        Primary Objective To evaluate the proportion of patients with objective response (OR) to targeted study agent(s) in patients with advanced refractory cancers/lymphomas. Secondary Objectives To evaluate the proportion of patients alive and progression free at 6 months of treatment with targeted study agent in patients with advanced refractory cancers/lymphomas. To evaluate time until death or disease progression. To identify potential predictive biomarkers beyond the genomic alteration by which treatment is assigned or resistance mechanisms using additional genomic, RNA and protein-based assessment platforms.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   MATCH Treatment Subprotocol C1: EAY131-C1: Crizotinib in Patients with...
        Protocol No.
        HSC20160463HU
        Official Title
        MATCH Treatment Subprotocol C1: EAY131-C1: Crizotinib in Patients with Tumors with MET Amplification (CTMS# 16-0064)
        Description
        The purpose of this study is to test any good and bad effects of the study drug called crizotinib in patients whose cancer has MET genetic changes.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   MATCH Treatment Subprotocol F: Crizotinib in Patients with Tumors (other...
        Protocol No.
        HSC20150750HU
        Official Title
        MATCH Treatment Subprotocol F: Crizotinib in Patients with Tumors (other than adenocarcinoma of lung or ALCL) with ALK Translocations (CTMS# 15-2081)
        Description
        Primary Objective To evaluate the proportion of patients with objective response (OR) to targeted study agent(s) in patients with advanced refractory cancers/lymphomas. Secondary Objectives To evaluate the proportion of patients alive and progression free at 6 months of treatment with targeted study agent in patients with advanced refractory cancers/lymphomas. To evaluate time until death or disease progression. To identify potential predictive biomarkers beyond the genomic alteration by which treatment is assigned or resistance mechanisms using additional genomic, RNA and protein-based assessment platforms.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   MATCH Treatment Subprotocol S1: Phase II Study of Trametinib in Patients...
        Protocol No.
        HSC20160260HU
        Official Title
        MATCH Treatment Subprotocol S1: Phase II Study of Trametinib in Patients with Tumors with NF1 Mutations (CTMS# 16-0028)
        Description
        PRIMARY OBJECTIVES: I. To evaluate the proportion of patients with objective response (OR) to targeted study agent(s) in patients with advanced refractory cancers/lymphomas. SECONDARY OBJECTIVES: I. To evaluate the proportion of patients alive and progression free at 6 months of treatment with targeted study agent in patients with advanced refractory cancers/lymphomas. II. To evaluate time until death or disease progression. III. To identify potential predictive biomarkers beyond the genomic alteration by which treatment is assigned or resistance mechanisms using additional genomic, ribonucleic acid (RNA) and protein-based assessment platforms.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   MATCH Treatment Subprotocol U: VS-6063 (defactinib) in Patients with Tumors...
        Protocol No.
        HSC20150839HU
        Official Title
        MATCH Treatment Subprotocol U: VS-6063 (defactinib) in Patients with Tumors with NF2 Loss (CTMS# 15-2110)
        Description
        Primary Objective To evaluate the proportion of patients with objective response (OR) to targeted study agent(s) in patients with advanced refractory cancers/lymphomas. Secondary Objectives To evaluate the proportion of patients alive and progression free at 6 months of treatment with targeted study agent in patients with advanced refractory cancers/lymphomas. To evaluate time until death or disease progression. To identify potential predictive biomarkers beyond the genomic alteration by which treatment is assigned or resistance mechanisms using additional genomic, RNA and protein-based assessment platforms.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   MATCH Treatment Subprotocol W: EAY131-W: Phase II Study of AZD4547 in...
        Protocol No.
        HSC20160541HU
        Official Title
        MATCH Treatment Subprotocol W: EAY131-W: Phase II Study of AZD4547 in Patients with Tumors with Aberrations in the FGFR Pathway (CTMS# 16-0065)
        Description
        The purpose of this study is to test any good and bad effects of the study drug, AZD4547, in patients whose cancer has genetic changes called FGFR gene alterations.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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        Learn More About This Study

         

      •   MATCH Treatment Subprotocol X: Phase II Study of Dasatinib in Patients with...
        Protocol No.
        HSC20160282HU
        Official Title
        MATCH Treatment Subprotocol X: Phase II Study of Dasatinib in Patients with Tumors with DDR2 Mutations (CTMS# 16-0032)
        Description
        PRIMARY OBJECTIVES: I. To evaluate the proportion of patients with objective response (OR) to targeted study agent(s) in patients with advanced refractory cancers/lymphomas. SECONDARY OBJECTIVES: I. To evaluate the proportion of patients alive and progression free at 6 months of treatment with targeted study agent in patients with advanced refractory cancers/lymphomas. II. To evaluate time until death or disease progression. III. To identify potential predictive biomarkers beyond the genomic alteration by which treatment is assigned or resistance mechanisms using additional genomic, ribonucleic acid (RNA) and protein-based assessment platforms.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   MATCH Treatment Subprotocol Z1A: EAY131-Z1A: Binimetinib in Patients with...
        Protocol No.
        HSC20160499HU
        Official Title
        MATCH Treatment Subprotocol Z1A: EAY131-Z1A: Binimetinib in Patients with Tumors (Other Than Melanoma) with NRAS Mutations (CTMS# 16-0066)
        Description
        The purpose of this study is to test any good and bad effects of the experimental study drug binimetinib in patients whose cancer has NRAS mutations.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   MATCH Treatment Subprotocol Z1B: EAY131-Z1B: Phase II Study of Palbociclib...
        Protocol No.
        HSC20160491HU
        Official Title
        MATCH Treatment Subprotocol Z1B: EAY131-Z1B: Phase II Study of Palbociclib (PD-0332991) in Patients with Tumors with CCND1, 2, 3 Amplification and Rb Protein Expression by IHC (CTMS# 16-0067)
        Description
        The purpose of this study is to test any good and bad effects of the study drug, palbociclib, in patients whose cancer has CCND1, 2 or 3 amplification and tested positive for a protein called Rb protein.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   Molecular Analysis for Therapy Choice (MATCH) / MATCH Treatment Subprotocol...
        Protocol No.
        HSC20170176HU
        Official Title
        Molecular Analysis for Therapy Choice (MATCH) / MATCH Treatment Subprotocol H: EAY131-H: Phase II Study of Dabrafenib and Trametinib in Patients with Tumors with BRAF V600E or V600K Mutations (Excluding Melanoma, Thyroid Cancer, and Colorectal Adenocarcinoma) (CTMS# 15-2083)
        Description
        Primary Objective To evaluate the proportion of patients with objective response (OR) to targeted study agent(s) in patients with advanced refractory cancers/lymphomas. Secondary Objectives To evaluate the proportion of patients alive and progression free at 6 months of treatment with targeted study agent in patients with advanced refractory cancers/lymphomas. To evaluate time until death or disease progression. To identify potential predictive biomarkers beyond the genomic alteration by which treatment is assigned or resistance mechanisms using additional genomic, RNA and protein-based assessment platforms.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   Molecular Analysis for Therapy Choice (NCI-MATCH)
        Protocol No.
        HSC20150719XT
        Official Title
        EAY131, Molecular Analysis for Therapy Choice (MATCH) (CTMS# 15-2080)
        Description
        Primary Objective To evaluate the proportion of patients with objective response (OR) to targeted study agent(s) in patients with advanced refractory cancers/lymphomas. Secondary Objectives To evaluate the proportion of patients alive and progression free at 6 months of treatment with targeted study agent in patients with advanced refractory cancers/lymphomas. To evaluate time until death or disease progression. To identify potential predictive biomarkers beyond the genomic alteration by which treatment is assigned or resistance mechanisms using additional genomic, RNA and protein-based assessment platforms.
        Contact
        410-450-5798
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   NRG-HN003, A PHASE I AND EXPANSION COHORT STUDY OF ADJUVANT CISPLATIN,...
        Protocol No.
        HSC20170206HU
        Official Title
        NRG-HN003, A PHASE I AND EXPANSION COHORT STUDY OF ADJUVANT CISPLATIN, INTENSITY-MODULATED RADIOTHERAPY, AND MK-3475 (PEMBROLIZUMAB) IN HIGH-RISK HEAD AND NECK SQUAMOUS CELL CARCINOMA (HNSCC) (CTMS# 17-0022)
        Description
        Primary Outcome Measures: DLT in patients with high-risk head and neck squamous cell carcinoma treated with adjuvant cisplatin, IMRT, and pembrolizumab [ Time Frame: Up to 4 weeks post IMRT ] Will be summarized using proportions for binary outcome per cohort.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   Phase I Clinical Trial of Camptothecin-20-O-Propionate hydrate (CZ48) (CTMS#...
        Protocol No.
        HSC20150748HU
        Official Title
        Phase I Clinical Trial of Camptothecin-20-O-Propionate hydrate (CZ48) (CTMS# 15-2103)
        Description
        PRIMARY: To describe the dose limiting toxicities and adverse event profile of Camptothecin-20-O-Propionate hydrate (CZ48) administered orally every day. To determine Phase II recommended dose of Camptothecin-20-O-Propionate hydrate (CZ48) administered orally every day. SECONDARY: To perform a pharmacokinetic study of orally administered CZ48. To assess responses by RECIST criteria when applicable. To follow patients for survival.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
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      •   Phase I study of carfilzomib in combination with cyclophosphamide and...
        Protocol No.
        HSC20160206HU
        Official Title
        Phase I study of carfilzomib in combination with cyclophosphamide and etoposide for children with relapsed and refractory solid tumors and leukemias (CTMS# 15-2097)
        Description
        Primary Objective: To determine the DLTs and MTD of carfilzomib given in combination with cyclophosphamide and etoposide in pediatric patients with relapsed/refractory leukemias and solid tumors Secondary Objectives: 1. To evaluate toxicities of carfilzomib in the pediatric population when combined with conventional chemotherapy 2. To gather preliminary efficacy data on the drug combination 3. To measure if circulating plasma proteasome (cProt) levels post treatment correlate with response to therapy and overall survival 4. To measure if the levels of proteasome activity and resistance to carfilzomib correlates with toxicity and/or response to treatment. 5. To measure if inhibition of proteasome activity by carfilzomib results in alteration in a number of autophagy and apoptosis related proteins, providing means to evaluate correlates of activity of carfilzomib. 6. To measure the level of proteasome inhibition in patient PBMCs before and during treatment by determination of the level of protein ubiquitination. 7. To determine in vitro sensitivity of patient leukemias and solid tumors to carfilzomib alone and in combination with study chemotherapeutic agents in order to generate a predictive model of drug sensitivity. 8. To expand patient leukemia and solid tumor samples in order to save tissue for future studies but also to serve as a pre-clinical in vivo model to be included in the generation and testing of a drug sensitivity predictive model. 9. To perform whole exome sequencing (WES) and RNA seq on patient leukemia and solid tumor samples and WES on germ line DNA in order to determine potential mechanisms of drug sensitivity or resistance as well as contribute to testing a computer `learning engine (Bionet) for predicting clinical responses from genomic and drug sensitivity data.
        Contact
        210-562-9149
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
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      •   Phase Ib, open-label, multi-center study to characterize the safety,...
        Protocol No.
        HSC20160552HU
        Official Title
        Phase Ib, open-label, multi-center study to characterize the safety, tolerability and pharmacodynamics (PD) of PDR001 in combination with LCL161, everolimus (RAD001) or panobinostat (LBH589) (CTMS# 16-0058)
        Description
        Primary Objectives: To characterize the safety and tolerability of PDR001 in combination with LCL161, everolimus (RAD001) or panobinostat (LBH589) and to identify recommended doses and schedules for future studies Secondary Objectives: To characterize changes in the immune infiltrate in tumors To further characterize the safety of PDR001 in combination with LCL161, everolimus or panobinostat (LBH589) To estimate the anti-tumor activity of PDR001 in combination with LCL161, everolimus or panobinostat (LBH589) To characterize the pharmacokinetics of all study drugs in combination To assess immunogenicity of PDR001
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   Phase II Trial of Eribulin and Lenvatinib in Advanced Solid Tumors (CTMS#...
        Protocol No.
        HSC20150891HU
        Official Title
        Phase II Trial of Eribulin and Lenvatinib in Advanced Solid Tumors (CTMS# 15-2139)
        Description
        The overall purpose of this study is to determine the overall response rate, efficacy and safety of the combination of eribulin and Lenvatinib.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
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      •   Prognostic and predictive markers in patients with advanced metastatic tumors
        Protocol No.
        HSC20130219H
        Official Title
        Numeration and Single-Cell Molecular Profiling of Circulating Tumor Cells as Prognostic and Predictive Marker In Patients with Advanced Metastatic Tumors (CTRC#13-0001)
        Description
        This study will research possible associations between circulating tumor cells (CTC) quantities or gene profile characteristics and clinical outcomes. The primary objective is to obtain blood samples from participants over an 8-week period for research analysis.  The study will enroll approximately 200 patients at the CTRC. In addition to other conditions for enrollment, eligible patients have advanced metastatic cancer.
        Contact
        210-450-5798
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   Prospective Comparative Effectiveness Trial for Malignant Bowel Obstruction...
        Protocol No.
        HSC20170491HU
        Official Title
        Prospective Comparative Effectiveness Trial for Malignant Bowel Obstruction (CTMS# 17-0081)
        Description
        Number of days alive and outside the hospital
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   Proton Beam Radiation Therapy vs. Conventional Beam Radiation Therapy: ...
        Protocol No.
        HSC20140495H
        Official Title
        Proton Beam Radiation Therapy vs. Conventional Beam Radiation Therapy: Toxicities During and After Craniospinal Radiation Therapy in Children
        Description
        The number of survivors of pediatric brain tumors has greatly increased in the past two decades making it apparent that many are left with life- long   physical  and  neurodevelopmental  impairments  secondary  to  life-  saving  treatments  (particularly  radiotherapy)  received  for  their  disease.  An  emerging  radiotherapy  technology  using  protons  (Proton  Beam  Radiation  Therapy;  PBRT)  rather  than  conventional  photons  or  x-  rays  promises  to  reduce  toxicity  burden  and  improve  outcomes  and  quality  of  life  in  survivors.  Many  herald  the  clinical  potential  of  PBRT  to  minimize  damage  to  healthy  brain  tissue  and  other  organs  of  the  body  without  sacrificing  disease  control. Still, there are no published reports to date of neurocognitive outcomes following PBRT for pediatric brain tumor. In this study, we propose to evaluate the full range of side- effects (e.g. fatigue, nausea/vomiting, hearing loss, cognitive skills, behavioral and emotional adjustment) experienced by children undergoing PBRT in the first year after initiation of treatment, and comparing these to the side effects experienced by children receiving conventional radiation therapy (CRT). We will also compare the financial costs associated with the two types of radiotherapy. This line of research will guide clinicians on the range of outcomes that can be expected following PBRT and stands to influence clinical care in four contexts: 1) decision making, 2) cost, 3) access, and 4) intervention.  
        Contact
        210-450-5924
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   S1609, Dart: Dual Anti-CTLA-4 and Anti-PD-1 Blockage in Rare Tumors (CTMS#...
        Protocol No.
        HSC20170145HU
        Official Title
        S1609, Dart: Dual Anti-CTLA-4 and Anti-PD-1 Blockage in Rare Tumors (CTMS# 17-0013)
        Description
        Primary Objective To evaluate the RECIST 1.1 overall response rate (ORR) in subsets of patients with advanced rare cancers treated with ipilimumab plus nivolumab combination immunotherapy. Secondary Objectives To evaluate toxicities in each cohort. To estimate overall survival (OS), progression-free survival (PFS), clinical benefit rate; and to estimate immune-related ORR (irORR), and immune-related PFS (irPFS) by unidimensional immune-related response criteria. To collect specimens for banking for use in future correlative biomarker research studies.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
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      •   Safety, Tolerability & PK of KX2-361 in Subjects with advanced malignancies...
        Protocol No.
        HSC20150481HU
        Official Title
        A Phase 1 Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetics of KX2-361 in Subjects with Advanced Malignancies that are Refractory to Conventional Therapies (CTMS# 15-2063)
        Description
        Study Objectives: Primary Objective: To define the maximum tolerated dose (MTD) of KX2-361 in subjects with advanced refractory malignancies when administered as single and multiple oral doses. Secondary Objectives: To determine the safety and tolerability of KX2-361 after single and multiple oral doses, in subjects with advanced refractory malignancies. To characterize the pharmacokinetic profile of KX2-361 after single and multiple oral doses. To evaluate the activity of KX2-361 in both the Dose Escalation Cohort and the Expansion Cohort of subjects with high-grade glioma.
        Contact
        210-450-5798
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
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      •   SCUSF0901 [ACCL0922] A Phase II Placebo-Controlled Trial of Modafinil to...
        Protocol No.
        HSC20130255X
        Official Title
        SCUSF0901 [ACCL0922] A Phase II Placebo-Controlled Trial of Modafinil to Improve Neurocognitive Deficits in Children Treated for a Primary Brain Tumor
        Description
        RATIONALE: Modafinil may help improve memory, attention, and fatigue caused by cancer treatment. PURPOSE: This phase II randomized trial studies how well modafinil works in treating children with memory and attention problems caused by cancer treatment for a brain tumor.
        Contact
        210-562-9149
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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        Learn More About This Study

         

      •   Study of the Genetic Epidemiology of Childhood Cancer
        Protocol No.
        HSC20080057H
        Official Title
        Study of the Genetic Epidemiology of Childhood Cancer
        Description
        Study of the Genetic Epidemiology of Childhood Cancer
        Contact
        210-562-9123
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

    •   Breast

      •   A Dose Regimen-Finding Study to Evaluate the Safety, Tolerability,...
        Protocol No.
        HSC20170102HU
        Official Title
        A Dose Regimen-Finding Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Activity of Oradoxel Monotherapy in Subjects with Advanced Malignancies (CTMS# 16-0069)
        Description
        Primary Objective: To determine the maximum tolerated dose (MTD) of Oradoxel based on dose-limiting toxicity (DLT) in subjects with advanced malignancies Secondary Objectives To determine the safety and tolerability of docetaxel as Oradoxel To determine the incidence of unacceptable toxicity with Oradoxel To determine the recommended Phase 2 dose (RP2D) of docetaxel as Oradoxel To characterize the pharmacokinetic (PK) profile of docetaxel as Oradoxel To evaluate tumor response
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   A Dose Regimen-Finding Study to Evaluate the Safety, Tolerability,...
        Protocol No.
        HSC20160087HU
        Official Title
        A Dose Regimen-Finding Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Activity of Oraxol in Subjects with Advanced Malignancies (CTMS# 15-2137)
        Description
        Primary Objective To determine the maximum tolerated dose (MTD) and dosing regimen of Oraxol in subjects with advanced malignancies Secondary Objectives To determine the recommended Phase 2 dose of paclitaxel as Oraxol To determine the safety and tolerability of paclitaxel as Oraxol To characterize the pharmacokinetic (PK) profile of paclitaxel as Oraxol To evaluate the tumor response
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   A Phase 0, Investigator Initiated Study, Evaluating the Impact of Omega 3...
        Protocol No.
        HSC20150602HU
        Official Title
        A Phase 0, Investigator Initiated Study, Evaluating the Impact of Omega 3 Fatty Acid Supplementation on Aromatase in Obese Subjects (CTMS# 15-2100)
        Description
        Primary Objectives Assess the impact of dietary (omega 3 FFA) or pharmacological (ASA) COX-2 inhibitors on: patient serum-induced expression of PGE2 and aromatase by neoplastic mammary epithelial cells circulating levels of pro-inflammatory cytokines (i.e. IL-6, TNF- , IGF-1), steroids (i.e. estrogen and testosterone) and lipids (omega-6 and omega-3 PUFAs) Secondary Objectives Correlation for body mass index impact on response to COX2 inhibition.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   A Phase 0, Investigator Initiated Study, Evaluating the Impact of Omega 3...
        Protocol No.
        HSC20160665HU
        Official Title
        A Phase 0, Investigator Initiated Study, Evaluating the Impact of Omega 3 Free Fatty Acid Supplementation on Breast Cancer (CTMS# 16-0119)
        Description
        Primary Objectives Assess the impact of dietary omega 3 FFA: Serum CSF-1 levels patient serum-induced expression of PGE2 by neoplastic mammary epithelial cells, OM3/OM6 circulating levels of pro-inflammatory cytokines (i.e. IL-6, TNF- , IGF-1), steroids (i.e. estrogen and testosterone) and lipids (omega-6 and omega-3 PUFAs) Secondary Objectives Tissue expression of aromatase, CSF1/CSF1R and infiltrating macrophage number and polarity.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   A Phase 1 Dose Escalation and Cohort Expansion Study of TSR-042, an...
        Protocol No.
        HSC20170110HU
        Official Title
        A Phase 1 Dose Escalation and Cohort Expansion Study of TSR-042, an anti-PD-1 Monoclonal Antibody, in Patients with Advanced Solid Tumors (CTMS# 16-0091)
        Description
        Primary Objectives: Part 1 Dose Escalation Cohorts: To evaluate the safety and tolerability of TSR-042 using Common Terminology Criteria for Adverse Events (CTCAE v.4.03) in patients with advanced solid tumors Part 2 Expansion Cohorts: To evaluate the antitumor activity of TSR-042 in patients with advanced solid tumors, in terms of objective response rate (ORR) as assessed by the Investigators using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 Part 1 and Part 2: To define the recommended Phase 2 dose (RP2D) and schedule Secondary Objectives: Part 1 Dose Escalation Cohorts: To characterize the pharmacodynamic (PDy) profile of TSR-042 To evaluate ORR as assessed by the Investigators using RECIST v1.1 Part 2 Expansion Cohorts: To characterize the safety and tolerability of TSR-042 using CTCAE v.4.03 Part 1 and Part 2: To characterize the pharmacokinetic (PK) profile of TSR-042 To evaluate the immunogenicity of TSR-042 To evaluate additional measures of clinical benefit, including: ORR by immune-related RECIST (irRECIST) Duration of response (DOR) by RECIST v 1.1 Disease control rate (DCR) by RECIST v 1.1 and by irRECIST Progression-free survival (PFS) by RECIST v 1.1 and by irRECIST Overall survival (OS)
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   A Phase 1 Study of CBL0137 in Patients with Metastatic or Unresectable...
        Protocol No.
        HSC20130328H
        Official Title
        A Phase 1 Trial of CBL0137 In patients With Metastatic or Unresectable Advanced Solid Neoplasms or Refractory Lymphomas (CTRC# 13-0031)
        Description
        This Phase 1 study is designed to determine the best dose of CBL0137 to use when treating patients with metastatic or unresectable advanced solid tumors or lymphoma. The study will enroll up to 48 patients from at least 2 cancer centers in the US. In addition to other conditions for enrollment, eligible patients have cancer that has not improved or has come back after prior treatment and are otherwise in good health. Patients who have a history of active infection, cancer involving the central nervous system, a particular EKG abnormality or other serious medical conditions may not be eligible to enroll.
        Contact
        210-450-5798
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   A Phase 1/2A, Multicenter, Open-Label Study of LYC-55716 in Adult Subjects...
        Protocol No.
        HSC20160617HU
        Official Title
        A Phase 1/2A, Multicenter, Open-Label Study of LYC-55716 in Adult Subjects with Locally Advanced or Metastatic Cancer (CTMS# 16-0099)
        Description
        Primary Objectives Phase 1 Evaluate the safety and tolerability of LYC-55716 Determine the maximum tolerated dose (MTD) and the recommended Phase 2 dose (RP2D) Phase 2a Determine the objective response rate according to response evaluation criteria in solid tumors (RECIST) v1.1 Secondary Objectives Phase 1 Evaluate the activity of LYC-55716 by objective response according to RECIST v1.1 Determine the durability of any observed objective response Phase 2a Determine the duration of response Determine progression-free survival (PFS) and overall survival (OS) Determine suitability of the RP2D for further study Characterize the pharmacokinetics (PK) of LYC-55716 Exploratory Objectives Assess tumor activity in subjects with locally advanced or metastatic cancer according to immune-related response evaluation criteria in solid tumors (irRECIST) Exploratory analysis of metabolite in plasma Assess changes in circulating tumor markers (eg, cytokines/chemokines)
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   A Phase 1b Study of Oraxol in Combination with Ramucirumab in Patients with...
        Protocol No.
        HSC20170188HU
        Official Title
        A Phase 1b Study of Oraxol in Combination with Ramucirumab in Patients with Gastric, Gastro-esophageal, or Esophageal Cancers (CTMS# 16-0089)
        Description
        Primary Objective: To determine the maximum tolerated dose (MTD) of Oraxol in patients with advanced stage gastric, gastro-esophageal, or esophageal cancers who are being treated with Oraxol in combination with ramucirumab Secondary Objectives: To determine the safety and tolerability of Oraxol in combination with ramucirumab To determine the recommended Phase 2 dose of Oraxol in combination with ramucirumab To characterize the pharmacokinetic (PK) profile of Oraxol in combination with ramucirumab To characterize preliminary activity of Oraxol plus ramucirumab as determined by response rate, progression-free survival, and overall survival
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   A Phase 1b/2 Study of ARRY-382 in Combination with Pembrolizumab, a...
        Protocol No.
        HSC20170071HU
        Official Title
        A Phase 1b/2 Study of ARRY-382 in Combination with Pembrolizumab, a Programmed Cell Death Receptor 1 (PD-1) Antibody, for the Treatment of Patients with Advanced Solid Tumors (CTMS# 16-0084)
        Description
        Primary objective: To determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of ARRY-382 in combination with pembrolizumab in patients with selected solid tumors Secondary objectives:  To describe the preliminary antitumor activity of the combination based on the Response Criteria In Solid Tumors, version 1.1 (RECIST v1.1).  To describe the preliminary antitumor activity of the combination based on immune-related response criteria (irRC).  To characterize the safety and tolerability of the combination, including acute and chronic toxicities. To evaluate the pharmacokinetics of ARRY-382 in combination with pembrolizumab Exploratory objective: To explore the effect of the combination on circulating biomarkers of immune response. To describe the preliminary antitumor activity of the combination in patients with PD-L1 positive non-small cell lung cancer (NSCLC), as determined using a United States Food and Drug Administration (FDA)-approved test, using RECIST. To describe the preliminary antitumor activity of the combination in patients with PD-L1 positive non-small cell lung cancer (NSCLC), as determined using an FDA approved test, using irRC
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
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      •   A Phase 2 Study of Poziotinib in Patients with HER2-Positive Metastatic...
        Protocol No.
        HSC20160122HU
        Official Title
        A Phase 2 Study of Poziotinib in Patients with HER2-Positive Metastatic Breast Cancer (MBC) Who Have Received Prior HER2 Regimens for MBC (CTMS# 16-0003)
        Description
        Primary Objective To evaluate the Objective Response Rate (ORR) of poziotinib in patients with HER2-positive metastatic breast cancer (MBC) Secondary Objectives To assess the safety and tolerability of poziotinib in patients with HER2-positive MBC To evaluate other efficacy variables of poziotinib in patients with HER2-positive MBC, including the following: Progression-Free Survival (PFS) Disease Control Rate (DCR) Overall Survival (OS) Time to Progression (TTP)
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
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      •   A Phase I, First-in-human, Open-label, Dose-escalation, Safety,...
        Protocol No.
        HSC20160554HU
        Official Title
        A Phase I, First-in-human, Open-label, Dose-escalation, Safety, Pharmacokinetic, and Pharmacodynamic Study of Oral TP-0903 Administered Daily for 21 Days to Patients with Advanced Solid Tumors (CTMS# 16-0092)
        Description
        Primary Objective: To determine the maximum tolerated dose (MTD) and dose-limiting toxicities (DLTs) of oral TP-0903 administered daily for the first 21 days every 4 weeks, over a range of doses in patients with advanced solid tumors. Secondary Objectives: To establish the pharmacokinetics of orally administered TP-0903 To observe patients for any evidence of antitumor activity of TP-0903 by objective radiographic assessment To study the pharmacodynamics of TP-0903 therapy by: assessing biomarkers in tumor tissue assessing biomarkers in peripheral blood mononuclear cells (PBMCs) and serum To establish the Recommended Phase 2 Dose (RP2D) for future studies with TP-0903
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
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      •   A Phase I, Multicenter, Open-Label Dose Escalation and Expansion Study of...
        Protocol No.
        HSC20150289HU
        Official Title
        A Phase I, Multicenter, Open-Label Dose Escalation and Expansion Study of PCA062, Administered Intravenously In Adult Patients With pCAD-Positive Tumors (CTMS# 14-2019)
        Description
        Primary Objective To determine the MTD/RDE of PCA062 in patients with pCAD-positive tumors in the dose escalation part. Secondary Objectives To characterize the safety and tolerability of PCA062 To characterize the pharmacokinetic profile of PCA062 To assess emergence of anti-PCA062 antibodies following one or more intravenous infusions of PCA062 To assess the preliminary anti-tumor activity of PCA062 in patients with pCAD-positive triple negative breast cancer (TBNC), head and neck squamous cell carcinoma (HNSCC) or esophageal cancer (squamous and adenocarcinoma)
        Contact
        210-450-5798
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
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      •   A Phase I, Multicenter, Open-Label, Two-Part, Dose-escalation Study of...
        Protocol No.
        HSC20150372HU
        Official Title
        A Phase I, Multicenter, Open-Label, Two-Part, Dose-escalation Study of RAD1901 in Postmenopausal Women with Advanced Estrogen Receptor Positive and HER2-Negative Breast Cancer (CTMS #15-2042)
        Description
        The primary objective is to determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of RAD1901 in patients with advanced ER+HER2- breast cancer The secondary objectives of this study are: To assess the safety and tolerability of RAD1901 To evaluate the pharmacokinetics (PK) of RAD1901 To evaluate the preliminary anti-tumor effect of RAD1901 The exploratory objectives of this study are: To explore the relationship between ER gene expression in circulating tumor cells (CTCs) and clinical response To explore the relationship between ER gene expression in tumor biopsies and clinical response (safety expansion cohort only)
        Contact
        210-450-5798
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   A Phase I/II, open label, multicenter study of the safety and efficacy of...
        Protocol No.
        HSC20150421HU
        Official Title
        A Phase I/II, open label, multicenter study of the safety and efficacy of LAG525 single agent and in combination with PDR001 administered to patients with advanced malignancies (CTMS #15-2054)
        Description
        Primary Objectives Phase I part To estimate the RP2D or MTD for the single agent LAG525 and the combination of LAG525 and PDR001. Phase II part To estimate the overall response rate per RECIST V1.1 for single agent LAG525 as well as for the combination of LAG525 and PDR001 Secondary Objectives: To characterize the safety and tolerability of single agent LAG525 given alone and in combination with PDR001 To characterize the pharmacokinetic profile of single agent LAG525 given alone and in combination with PDR001 To assess emergence of anti-LAG525, and anti-PDR001 antibodies following one or more intravenous (i.v.) infusions of single agent LAG525 given alone or in combination with PDR001 To assess potential predictors of efficacy of single agent LAG525 and the combination of LAG525 and PDR001 To evaluate the preliminary antitumor activity of single agent LAG525 given alone or in combination of PDR001 To investigate patient selection and pharmacodynamic biomarkers in tumor tissue samples
        Contact
        210-450-5798
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   A Phase I/II, Open-Label, Multi-Center Study of the Safety and Efficacy of...
        Protocol No.
        HSC20160420HU
        Official Title
        A Phase I/II, Open-Label, Multi-Center Study of the Safety and Efficacy of BLZ945 as Single Agent and In Combination with PDR001 in Adult Patients with Advanced Solid Tumors (CTMS# 16-0071)
        Description
        Primary Objective: Phase I: To characterize the safety and tolerability of BLZ945 as a single agent and in combination with PDR001 and to identify the Maximum Tolerated Dose (MTD)/Recommended Phase 2 Dose (RP2D). Phase II: To assess the anti-tumor activity of BLZ945 in combination with PDR001 (and as single agent if appropriate) in patients with advanced solid tumors. Secondary Objective: Phase I: To characterize the pharmacodynamics effect of BLZ945 as a single agent and in combination with PDR001. To characterize PK of BLZ945 as a single agent and in combination with PDR001. To assess the preliminary anti-tumor activity of BLZ945 as single agent and in combination with PDR001. Phase I and II: To assess emergence of anti-PDR001 antibodies when BLZ945 is administered in combination with PDR001.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
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      •   A Phase Ib Trial of Pembrolizumab (MK-3475) in Combination with Dinaciclib...
        Protocol No.
        HSC20170106HU
        Official Title
        A Phase Ib Trial of Pembrolizumab (MK-3475) in Combination with Dinaciclib (MK-7965) in Subjects with Hematologic Malignancies (KEYNOTE-155) (CTMS# 16-0009)
        Description
        Primary Objective Objective: In both the Dose Evaluation and Signal Detection phases, evaluate the safety and tolerability of the treatment combination. Objective: Within each disease type of the Signal Detection phase, evaluate objective response rate (ORR) according to investigator assessment using the disease specific criteria. Secondary Objective: Objective: To evaluate the Objective Response Rate (ORR; complete response [CR] + partial response [PR]) of the combination of pembrolizumab and dinaciclib within each disease type, ie, CLL based on iwCLL guidelines (Hallek, 2008) [1], MM based on IMWG criteria (Durie, 2006) [2] and DLBCL based on the Revised Response Criteria for Malignant Lymphoma (Cheson, 2007) [3]. Objective: Within each disease type of the Signal Detection phase, evaluate Duration of Response (DOR), Progression-Free Survival (PFS) according to investigator assessment using the disease specific criteria; and Overall Survival (OS).
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   A PILOT STUDY OF HYDROXYTYROSOL, A COMPONENT OF OLIVE OIL FOR BREAST CANCER...
        Protocol No.
        HSC20160660HU
        Official Title
        A PILOT STUDY OF HYDROXYTYROSOL, A COMPONENT OF OLIVE OIL FOR BREAST CANCER PREVENTION IN WOMEN AT HIGH RISK OF BREAST CANCER (CTMS# 16-0068)
        Description
        Primary To conduct a pilot breast cancer prevention study of hydroxytyrosol in women at increased risk of breast cancer. To assess whether mammographic density is reduced in pre or post menopausal women at high risk of breast cancer taking hydroxytyrosol for 1 year compared with baseline. Secondary To assess the toxicity of hydroxytyrosol
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
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      •   A Pre-surgical Clinical Trial of Therapy with S-equol in Women with Triple...
        Protocol No.
        HSC20150231H
        Official Title
        A Pre-surgical Clinical Trial of Therapy with S-equol in Women with Triple Negative Breast Cancer (CTMS# 14-2018)
        Description
        After a baseline breast tumor core biopsy, eligible women with triple negative breast cancer (ER- alpha, PR and HER-2 receptor negative) will be treated with S-equol at a dose of 50 mg twice daily for a period of about 14 days (10-21 day range). After completion of treatment, a second breast tumor sample will be obtained to compare molecular changes between the two specimens. The second pathology specimen may be from the surgical resection of the breast tumor, or a repeat core needle biopsy, if no further surgery is planned. The primary endpoint will be the absolute change in the Ki67, which is a validated marker of tumor proliferation in breast cancer. Secondary endpoints will include assessment of total ER-beta and pY36 levels as measured by immunohistochemical staining and their correlation with S-equol effects. Further treatment after surgical resection or second core needle biopsy of the tumor will be guided by tumor size, nodal status and other standard parameters, and is at the discretion of the treating physician. The Investigator hypothesizes that S-equol will cause a measurable decrease in Ki-67 in estrogen receptor beta expressing triple negative breast cancers, indicating its potential efficacy in this tumor type.
        Contact
        210-450-5798
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
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      •   A Randomized Phase II Study of Partial Breast Irradiation and Sequential vs....
        Protocol No.
        HSC20170532HU
        Official Title
        A Randomized Phase II Study of Partial Breast Irradiation and Sequential vs. Concurrent Chemotherapy in Women with Early Stage Breast Cancer (PBI 3.0) (CTMS# 17-0048)
        Description
        Primary Objective Non-inferiority of partial breast irradiation (PBI) and concurrent compared to sequential chemotherapy with respect to acute grade 3-4 radiation toxicity.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   A study attempting to improve the comfort during screening mammography...
        Protocol No.
        HSC20160392HU
        Official Title
        A study attempting to improve the comfort during screening mammography (CTMS# 16-0045)
        Description
        To determine in a randomized trial whether it is possible to decrease the discomfort and anxiety of mammography by using the local analgesic lidocaine, or by using calming music in patients receiving a mammogram.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   ABTR01B1, A Children''s Oncology Group Protocol for Collecting and Banking...
        Protocol No.
        HSC20040131H
        Official Title
        ABTR01B1, A Children''s Oncology Group Protocol for Collecting and Banking Pediatric Research Specimens Including Rare Pediatric Tumors
        Description
        This study is collecting and storing malignant, borderline malignant neoplasms, and related biological samples from young patients with cancer. Collecting and storing samples of tumor tissue, blood, and bone marrow from patients with cancer to study in the laboratory may help the study of cancer in the future.
        Contact
        210-562-9149
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
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      •   ACCL15N1CD Use of Evidence-Based Supportive Care Clinical Practice...
        Protocol No.
        HSC20160673X
        Official Title
        ACCL15N1CD Use of Evidence-Based Supportive Care Clinical Practice Guidelines in Pediatric
        Description
        Primary and Secondary Aims Aim 1: Chart Review To measure the rate of adherence to selected COG-endorsed supportive care CPG recommendations at NCORP sites Aim 1a To describe the possible influence of NCORP site size and the number of patients enrolled in COG studies per site on the delivery of CPG-consistent care. Aim 1b To describe the clinical outcome of episodes during which patients receive CPG-consistent or CPG-inconsistent care Aim 2: Focus Groups To describe facilitators of and barriers to the use of CPGs elicited via focus group interviews with a diverse set of potential users (physician, nurse, nurse practitioner and pharmacists) who provide pediatric cancer care at NCORP sites. Aim 3: Interviews To improve how well CPG recommendations are understood by health care providers by refining the CPG recommendation format based on an iterative process of cognitive interviewing and formatting revisions. Understanding is defined as the correct interpretation of the course of action recommended or suggested by a CPG.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   ACCRN07 Protocol for the Enrollment on the Official COG Registry, The...
        Protocol No.
        HSC20080271X
        Official Title
        ACCRN07 Protocol for the Enrollment on the Official COG Registry, The Childhood Cancer Research Network (CCRN)
        Description
        The Children s Oncology Group has established a research network, the Childhood Cancer Research Network (CCRN), to collect information about children with cancer and other conditions that are benign but involve abnormal cell growth in order to help doctors and scientists better understand childhood cancer. The CCRN''s goal is to collect clinical information about every child diagnosed with cancer and similar conditions in the United States and Canada, to allow researchers to study patterns, characteristics, and causes of childhood cancer. The information can also help researchers study the causes of childhood cancer. To expand the CCRN, parents of children who have been diagnosed with cancer will be asked to provide information about themselves and their child for research purposes.   Objectives: To obtain informed consent from parents (and the child, when appropriate) of infants, children, adolescents, and young adults newly diagnosed with cancer to enter their names and certain information concerning their child into the Childhood Cancer Research Network. To obtain informed consent from parents (and the child, when appropriate) of infants, children, adolescents, and young adults newly diagnosed with cancer for permission to be contacted in the future to consider participating in non-therapeutic and prevention research studies involving the parents and/or the child.
        Contact
        210-562-9149
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   Adolescent and Young Adult Childhood Cancer Survivorship (CTMS#17-0088)
        Protocol No.
        HSC20170474HU
        Official Title
        Adolescent and Young Adult Childhood Cancer Survivorship (CTMS#17-0088)
        Description
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   Aging mammary stem cells and breast cancer prevention (CTMS# 15-2096)
        Protocol No.
        HSC20150556HU
        Official Title
        Aging mammary stem cells and breast cancer prevention (CTMS# 15-2096)
        Description
        To examine whether aging increases human mammary stem/progenitor cells (MaSC) with aberrant phenotypes and if rapamycin can reduce malignant markers and MaSC number in surgical specimens.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   Alliance A011401 Randomized Phase III Trial Evaluating the Role of Weight...
        Protocol No.
        HSC20160530XT
        Official Title
        Alliance A011401 Randomized Phase III Trial Evaluating the Role of Weight Loss in Adjuvant Treatment of Overweight and Obese Women with Early Breast Cancer
        Description
        Primary Objective To compare the effect of a supervised weight loss intervention plus health education materials versus health education materials alone upon invasive disease free survival (iDFS) in overweight (BMI 27-29.9 kg/m2) and obese (BMI 30kg/m2) women diagnosed with HER-2 negative, stage II and III breast cancer. Secondary Objectives To determine the relationship between changes in weight and iDFS, and to explore interaction between the level of clinical benefit from weight loss and the intervention. To evaluate the effect of a supervised weight loss intervention upon: a) Overall survival b) Distant disease free survival c) Weight d) Body composition (as measured by waist and hip circumference) e) Insulin Resistance Syndrome associated conditions diabetes, hospitalization for CV disease To determine the impact of a supervised weight loss intervention on IDFS within subgroups of women with 1) hormone receptor positive breast cancer and 2) hormone receptor negative breast cancer. To determine the impact of a supervised weight loss intervention on IDFS within subgroups of 1) premenopausal women and 2) post-menopausal women.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   ALTE05N1, Umbrella Long-Term Follow-Up Protocol
        Protocol No.
        HSC20090478X
        Official Title
        ALTE05N1, Umbrella Long-Term Follow-Up Protocol
        Description
        Umbrella Long-Term Follow-Up Protocol
        Contact
        210-562-9149
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
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      •   ALTE1621 Pharmacologic Reversal of Ventricular Remodeling in Childhood...
        Protocol No.
        HSC20160394X
        Official Title
        ALTE1621 Pharmacologic Reversal of Ventricular Remodeling in Childhood Cancer Survivors at Risk for Heart Failure (PREVENT-HF): A Phase 2b Randomized Placebo-Controlled (Carvedilol) Trial
        Description
        1.1 Primary Aim To determine the impact of a two-year course of low-dose carvedilol on surrogate echocardiographic indices of heart failure (HF) risk, including Left Ventricular (LV) Posterior Wall Thickness-Dimension Ratio (LV T-D) a well-established index of early myocardial remodeling and subsequent HF risk (primary endpoint).  LV systolic and diastolic function and afterload established echocardiographic indices associated with HF risk.  Natriuretic peptides, troponins, and Galectin-3 - circulating biomarkers associated with myocardial injury, and HF risk. 1.2 Secondary Aims 1.2.1 To establish safety and tolerability of this two-year course of low-dose carvedilol, assessing both objective measures (hepatic function) and patient reported outcomes. 1.2.2 To examine the modifying effect of demographic, clinical, and molecular characteristics on the risk: benefit ratio from this two-year carvedilol intervention. 1.3 Exploratory Aim To evaluate the long-term efficacy of carvedilol in preventing cardiomyopathy and/or heart failure in high-risk childhood cancer survivors.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   AN EARLY-PHASE, MULTICENTER, OPEN-LABEL STUDY OF THE SAFETY AND...
        Protocol No.
        HSC20150549H
        Official Title
        AN EARLY-PHASE, MULTICENTER, OPEN-LABEL STUDY OF THE SAFETY AND PHARMACOKINETICS OF ATEZOLIZUMAB (MPDL3280A) IN PEDIATRIC AND YOUNG ADULT PATIENTS WITH PREVIOUSLY TREATED SOLID TUMORS
        Description
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   An Open-Label Rollover Study to Evaluate the Long-Term Safety, Tolerability,...
        Protocol No.
        HSC20170197XT
        Official Title
        An Open-Label Rollover Study to Evaluate the Long-Term Safety, Tolerability, Biological Activity of Oral TVB-2640 in Patients With Solid Tumors Previously Enrolled in 3V2640-CLIN-002 (CTMS# 17-0046)
        Description
        Primary: To continue to characterize the safety profile of TVB-2640. Secondary: To identify any early signs of anti-tumor activity, where possible.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   An Open-Label, Dose Escalation, Phase 1, First-In-Human Study of TAK-659 in...
        Protocol No.
        HSC20150255HU
        Official Title
        An Open-Label, Dose Escalation, Phase 1, First-In-Human Study of TAK-659 in Adult Patients with Advanced Solid Tumors and Lymphoma Malignancies (CTMS# 14-2013)
        Description
        To determine the safety, tolerability, maximum tolerated dose (MTD)/recommended phase 2 dose (RP2D) ofTAK-659 administered orally on a daily dosing schedule in patients with advanced solid tumor and lymphoma who do not have effective standard treatment available
        Contact
        210-450-5798
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
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      •   APEC14B1, THE PROJECT: EVERYCHILD PROTOCOL: A REGISTRY, ELIGIBILITY...
        Protocol No.
        HSC20150870XT
        Official Title
        APEC14B1, THE PROJECT: EVERYCHILD PROTOCOL: A REGISTRY, ELIGIBILITY SCREENING, BIOLOGY AND OUTCOME STUDY
        Description
        1.1 To maintain a Childhood Cancer Registry1 for infants, children, adolescents, and young adults with cancer. 1.2 To utilize clinical and biological data to help determine eligibility or stratification, based on childhood cancer disease classification schemas, for potential enrollment of research subjects onto COG therapeutic clinical trials. 1.3 To develop a well annotated childhood cancer biorepository for current and future research through the collection of biospecimens (at diagnosis, time of progression, time of recurrence and/or post-mortem), including tumor, host and when feasible parental germline DNA; and key clinical data, including presentation, diagnostic, staging, summary treatment, and outcome information, from every child diagnosed with cancer at COG institutions. 1.4 To allow use of registry data for permission to be contacted in the future to consider participating in non-therapeutic and prevention research studies involving the child or their parents.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
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      •   Breast Epithelial Cells from High-Risk Women for Breast Cancer #14-0041
        Protocol No.
        HSC20150001H
        Official Title
        Breast Epithelial Cells from High-Risk Women for Breast Cancer #14-0041
        Description
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
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      •   Cancer Therapy and Research Center''s Institute for Drug Development Solid...
        Protocol No.
        HSC20070684H
        Official Title
        Cancer Therapy and Research Center''s Institute for Drug Development Solid Tumors and Hematological Malignancies Biorepository for Biomarker Discovery
        Description
        Samples are collected for the Cancer Therapy and Research Center''s Solid Tumors and Hematological Malignancies Biorepository for Biomarker Discovery
        Contact
        210-450-5798
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   Caris Molecular Intelligence® and Caris Centers of Excellence for...
        Protocol No.
        HSC20170144HU
        Official Title
        Caris Molecular Intelligence® and Caris Centers of Excellence for Precision Medicine NetworkTM Retrospective Outcomes-Associated Database (CTMS# 16-0145)
        Description
        The objective of this project is the development of the Caris Molecular Intelligence® and Caris Centers of Excellence for Precision Medicine NetworkTM Outcomes Associated Repository, a disease research database (hereinafter referred to as the Database ) for the purpose of: 1. Effecting change in disease treatment processes by advancing precision medicine and improving care for cancer through acquiring and sharing valuable molecular tumor profiling information and clinical outcomes in a collaborative, secure environment. 2. Performing prospective research studies involving analyses of quality of life studies as well as subject medical records including clinical presentation and outcomes. This eligible cohort includes select subjects having undergone Caris Molecular Intelligence® evaluation for diagnosis and/or treatment management. 3. Evaluate the frequency of specific clinical events in relation to risk factors, diagnosis and treatments provided via the collection of outcomes data through automated data capture systems provided by a third-party data entity and manually-entered data when needed. 4. Provide information access that is vital to research collaborators, including potential researchers from pharmaceutical companies, governmental agencies, academia, healthcare providers, and payors, with catalogued subject outcome data for the use of drug development discoveries, clinically relevant research trials, publications and posters, the implementation of future healthcare policies, characterization of trends in practice patterns and their relation to subject outcomes and the economic impact of differing evaluation, treatment, and management paradigms. 5. Cultivate a repository for assay development and validation of emerging technologies to enhance clinical cancer care.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   Caris Molecular Intelligence® and Caris Centers of Excellence for Precision...
        Protocol No.
        HSC20170353HU
        Official Title
        Caris Molecular Intelligence® and Caris Centers of Excellence for Precision Medicine NetworkTM Outcomes Associated Repository (CTMS# 17-0023)
        Description
        The objective of this project is the development of the Caris Molecular Intelligence® and Caris Centers of Excellence for Precision Medicine NetworkTM Outcomes Associated Repository, a disease research database (hereinafter referred to as the Database) for the purpose of: 1. Effecting change in disease treatment processes by advancing precision medicine and improving care for cancer through acquiring and sharing valuable molecular tumor profiling information and clinical outcomes in a collaborative, secure environment. 2. Performing prospective research studies involving analyses of quality of life studies as well as subject medical records including clinical presentation and outcomes. This eligible cohort includes select subjects having undergone Caris Molecular Intelligence® evaluation for diagnosis and/or treatment management. 3. Evaluate the frequency of specific clinical events in relation to risk factors, diagnosis and treatments provided via the collection of outcomes data through automated data capture systems provided by a third-party data entity and manually-entered data when needed. 4. Provide information access that is vital to research collaborators, including potential researchers from pharmaceutical companies, governmental agencies, academia, healthcare providers, and payors, with catalogued subject outcome data for the use of drug development discoveries, clinically relevant research trials, publications and posters, the implementation of future healthcare policies, characterization of trends in practice patterns and their relation to subject outcomes and the economic impact of differing evaluation, treatment, and management paradigms. 5. Cultivate a repository for assay development and validation of emerging technologies to enhance clinical cancer care.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   Clinical Trial of Lurbinectedin (PM01183) in Selected Advanced Solid Tumors
        Protocol No.
        HSC20150542HU
        Official Title
        A Multicenter Phase II Clinical Trial of Lurbinectedin (PM01183) in Selected Advanced Solid Tumors (CTMS# 15-2071)
        Description
        Primary: To assess the antitumor activity of lurbinectedin (PM01183) in terms of overall response rate (ORR), according to the Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1, in the following advanced solid tumors: small cell lung cancer (SCLC), head and neck carcinoma (H&N), neuroendocrine tumors (NETs), biliary tract carcinoma, endometrial carcinoma, BRCA 1/2-associated metastatic breast carcinoma, carcinoma of unknown primary site, germ cell tumors (GCTs), and Ewing¿s family of tumors (EFTs). Secondary: To further characterize the antitumor activity of PM01183 in terms of duration of response (DR), clinical benefit [ORR or stable disease (SD) lasting over four months (SD ¿ 4 months)], progression-free survival (PFS), and one year overall survival (1y-OS) in each cohort of advanced solid tumors. Characterize the plasma pharmacokinetics (PK) of PM01183. To conduct an exploratory pharmacogenomic (PGx) and pharmacogenetic analysis. To evaluate the safety profile of PM01183 in this patient population.
        Contact
        410-450-5798
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   Clinical trial to study the efficacy and safety of Eribulin Mesylate taken...
        Protocol No.
        HSC20150568HU
        Official Title
        An Open-Label, Single-Arm Multicenter Phase 1b/2 Study to Evaluate the Efficacy and Safety of Eribulin Mesylate in Combination with Pembrolizumab in Subjects with Metastatic Triple-Negative Breast Cancer (mTNBC) (CTMS# 15-2079)
        Description
        Primary Objectives For the Phase 1b part to determine safety and tolerability of eribulin mesylate in combination with pembrolizumab in subjects with metastatic triple-negative breast cancer previously treated with 0 to 2 lines of chemotherapy in the metastatic setting. For the Phase 2 part to evaluate objective response rate, based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, of eribulin mesylate in combination with pembrolizumab in subjects with metastatic triple-negative breast cancer previously treated with 0 to 2 lines of chemotherapy in the metastatic setting. Secondary Objectives To evaluate Progression-Free Survival (PFS) To evaluate Overall Survival (OS) To evaluate Duration of Response (DOR) To evaluate efficacy in a subset defined by PD-L1 (programmed death receptor-ligand 1) expression. To evaluate the safety and tolerability Exploratory Objectives To evaluate Clinical Benefit Rate (CBR) To evaluate exposure-response relationship To explore potential effects of pembrolizumab co-administration on the pharmacokinetics (PK) of eribulin mesylate To explore ORR, PFS, DOR, and CBR using the immune-related response criteria in solid tumors (irRECIST)
        Contact
        410-450-5798
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   Clinical trial to study the safety and efficacy of MBG453 given alone and in...
        Protocol No.
        HSC20150730HU
        Official Title
        A Phase I-Ib/II, Open-Label, Multi-Center Study of the Safety and Efficacy of MBG453 as Single Agent and in Combination with PDR001 in Adult Patients with Advanced Malignancies (CTMS# 15-2114)
        Description
        Primary Objectives: Phase I-Ib: To characterize the safety and tolerability of MBG453 as a single agent and in combination with PDR001 and to identify recommended doses for future studies. Phase I-Ib dose ranging: To further investigate the safety and tolerability of different doses of MBG453 alone or in combination with PDR001. Phase II: To estimate the anti-tumor activity of MBG453 alone in patients with solid tumors, and in combination with PDR001 in selected disease indications (melanoma, non-small cell lung cancer (NSCLC), renal cell carcinoma (RCC)). Secondary Objectives Evaluate the preliminary anti-tumor activity of MBG453 alone and in combination with PDR001. Make an initial comparison of safety, PK and efficacy for MBG453 and PDR001 administered in combination on a every 2 weeks (Q2W) and every 4 weeks (Q4W) dosing schedules. Characterize the pharmacokinetic profile of MBG453 alone and in combination with PDR001. Assess emergence of anti-MBG453 and anti-PDR001 antibodies. Assess potential predictors of efficacy of MBG453 single agent and in combination with PDR001 in tumor samples. Assess the pharmacodynamic effect of MBG453 as single agent and in combination with PDR001 in tumor samples. Describe the survival distribution of patients treated with MBG453 as single agent and in combination with PDR001 for each disease group.
        Contact
        410-450-5798
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   DCP-001, Use of a Clinical Trial Screening Tool to Address Cancer Health...
        Protocol No.
        HSC20160342XT
        Official Title
        DCP-001, Use of a Clinical Trial Screening Tool to Address Cancer Health Disparities in the NCI Community Oncology Research Program (NCORP)
        Description
        Objectives 1) Implement a screening tool in NCORP to collect broader demographic and clinical data to generate hypothesis and research questions in the following areas of research: cancer screening, cancer prevention, symptom science, cancer care disparities, comparative effectiveness and cancer care delivery research. 2) Collect expanded demographic and clinical data (e.g., SES, co-morbidities, method of diagnosis) across the NCORP network to help identify and best characterize patients that are screened but not enrolled and for patients that participate in NCI trials, to understand how these variables may impact outcomes. 3) Enhance an understanding of site- specific and trial-specific accrual barriers that will inform the development of effective strategies to improve accrual, particularly for minority and underserved populations. 4) Provide data for internal and external evaluation of NCORP s first RFA cycle and reissuance.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   Doxorubicin Hydrochloride and Cyclophosphamide Followed by Paclitaxel With...
        Protocol No.
        HSC20150697HU
        Official Title
        NRG-BR003, A Randomized Phase III Trial of Adjuvant Therapy Comparing Doxorubicin Plus Cyclophosphamide Followed by Weekly Paclitaxel with or without Carboplatin for Node-Positive or High-Risk Node-Negative Triple-Negative Invasive Breast Cancer (CTMS# 15-2089)
        Description
        Primary Objective To determine whether the addition of carboplatin to an adjuvant chemotherapy regimen of doxorubicin/cyclophosphamide followed by paclitaxel will improve the invasive disease-free survival (IDFS) compared to doxorubicin/cyclophosphamide followed by paclitaxel when administered to patients with operable node-positive or high-risk node-negative triple-negative breast cancer. Secondary Objectives To determine whether the addition of carboplatin to an adjuvant chemotherapy regimen of doxorubicin/cyclophosphamide followed by paclitaxel will improve the overall survival (OS) compared to doxorubicin/cyclophosphamide followed by paclitaxel when administered to patients with operable node-positive or high-risk node-negative triple-negative breast cancer. To determine whether the addition of carboplatin to an adjuvant chemotherapy regimen of doxorubicin/cyclophosphamide followed by paclitaxel will improve the breast cancer-free survival (BCFS) compared to doxorubicin/cyclophosphamide followed by paclitaxel when administered to patients with operable node-positive or high-risk node-negative triple-negative breast cancer. To determine whether the addition of carboplatin to an adjuvant chemotherapy regimen of doxorubicin/cyclophosphamide followed by paclitaxel will improve the recurrence-free interval (RFI) compared to doxorubicin/cyclophosphamide followed by paclitaxel when administered to patients with operable node-positive or high-risk node-negative triple-negative breast cancer. To determine whether the addition of carboplatin to an adjuvant chemotherapy regimen of doxorubicin/cyclophosphamide followed by paclitaxel will improve the distant recurrence-free interval (DRFI) compared to doxorubicin/cyclophosphamide followed by paclitaxel when administered to patients with operable node-positive or high-risk node-negative triple-negative breast cancer. To determine the toxicity of doxorubicin/cyclophosphamide followed by paclitaxel administered concurrently with carboplatin compared to the toxicity of doxorubicin/cyclophosphamide followed by paclitaxel alone. To determine if germline BRCA status is associated with benefit in IDFS or OS from the addition of carboplatin to an adjuvant chemotherapy regimen of doxorubicin/cyclophosphamide followed by paclitaxel in patients with operable node-positive or high-risk node-negative triple-negative breast cancer. To determine if the addition of carboplatin will improve the RFI among the homologous recombination (HR) deficient patients as determined by the homologous recombination deficiency (HRD) score. To determine whether the efficacy of carboplatin on RFI in HR-deficient patients differs from that in patients who are not HR-deficient. To collect tissue and blood samples at several occasions for future biomarkers development in predicting risk of breast cancer recurrence in patients with operable node-positive or high-risk node-negative triple-negative breast cancer treated with doxorubicin/cyclophosphamide followed by paclitaxel with or without carboplatin and predicting benefit from the addition of carboplatin among these patients.
        Contact
        410-450-5798
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   Factors influencing decision on prophylactic surgery in Hispanic high risk...
        Protocol No.
        HSC20170066HU
        Official Title
        Factors influencing decision on prophylactic surgery in Hispanic high risk breast cancer patients of South Texas and their health care providers (CTMS# 16-0095)
        Description
        Identify the factors that play a role in decision-making regarding RRPM in Hispanic women of GRACIAS Texas compared with non-Hispanic whites Assess the patient/provider communication regarding RRPM in South Texas Determine if differences in understanding and barriers to RRPM differ between Hispanic and Non-Hispanic white women.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   GO29665, A PHASE I/II, MULTICENTER, OPEN-LABEL, DOSE-ESCALATION STUDY OF THE...
        Protocol No.
        HSC20160080H
        Official Title
        GO29665, A PHASE I/II, MULTICENTER, OPEN-LABEL, DOSE-ESCALATION STUDY OF THE SAFETY AND PHARMACOKINETICS OF COBIMETINIB IN PEDIATRIC AND YOUNG ADULT PATIENTS WITH PREVIOUSLY TREATED SOLID TUMORS (CTRC# 15-0005)
        Description
        CTRC#15-0005
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
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      •   Head and Neck Cancer Repository
        Protocol No.
        HSC20170218HR
        Official Title
        Head and Neck Cancer Repository
        Description
        To establish a repository of head and neck cancers and PDX models from our south Texas patient population.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   Health Effects after Anthracycline and Radiation Therapy (HEART):...
        Protocol No.
        HSC20140058X
        Official Title
        Health Effects after Anthracycline and Radiation Therapy (HEART): Dexrazoxane and Prevention of Anthracycline-related Cardiomyopathy A Limited Institution Non-Therapeutic Study
        Description
        This clinical trial studies the effects of dexrazoxane hydrochloride on biomarkers associated with cardiomyopathy and heart failure after cancer treatment. Studying samples of blood in the laboratory from patients receiving dexrazoxane hydrochloride may help doctors learn more about the effects of dexrazoxane hydrochloride on cells. It may also help doctors understand how well patients respond to treatment.
        Contact
        210-562-9149
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   Incidence and Factors Associated with the Development and Severity of Oral...
        Protocol No.
        HSC20050218H
        Official Title
        Incidence and Factors Associated with the Development and Severity of Oral Mucositis in Patients Undergoing High Dose Chemotherapy and Peripheral Stem Cell Transplantation
        Description
        Our study intends to evaluate prospectively the incidence and severity of oral mucositis in patients undergoing high-dose chemotherapy and hematopoietic stem cell transplantation, as well as to evaluate the potential influence of nutritional-, physical-, and transplant-related factors associated with the development of this complication and its grade of involvement. Research plan: This is a prospective cohort study with an observational basis that involves all of the patients undergoing high-dose chemotherapy and peripheral blood stem cell transplantation at the Audie L. Murphy VA Hospital Bone Marrow Transplant Unit and at the University Hospital Bone Marrow Transplant Unit. We expect to enroll 400 patients during a 5-year period. Methods: In order to answer the study questions, subjects will be assessed several times during the study period. The study involves a multidisciplinary group that will be evaluating and following the subjects. A baseline will be established by a physician and a nutritionist before the subjects start the high-dose chemotherapy regimen. The subjects will be followed with oral evaluations 3 times per week, beginning on the day of the transplant and ending when mucositis resolves, or the patient is discharged home, or 30 days post-transplant, whichever occurs first. At day 15 post-transplant, patients will be evaluated for the second time by the nutritionist. Further information such as blood values, use of medications and treatment complications, will be obtained by daily chart review.  
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   MATCH Treatment Subprotocol B: Phase II Study of Afatinib in Patients with...
        Protocol No.
        HSC20150831HU
        Official Title
        MATCH Treatment Subprotocol B: Phase II Study of Afatinib in Patients with Tumors with HER2 Activating Mutations (CTMS# 15-2107)
        Description
        Primary Objective To evaluate the proportion of patients with objective response (OR) to targeted study agent(s) in patients with advanced refractory cancers/lymphomas. Secondary Objectives To evaluate the proportion of patients alive and progression free at 6 months of treatment with targeted study agent in patients with advanced refractory cancers/lymphomas. To evaluate time until death or disease progression. To identify potential predictive biomarkers beyond the genomic alteration by which treatment is assigned or resistance mechanisms using additional genomic, RNA and protein-based assessment platforms.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   MATCH Treatment Subprotocol C1: EAY131-C1: Crizotinib in Patients with...
        Protocol No.
        HSC20160463HU
        Official Title
        MATCH Treatment Subprotocol C1: EAY131-C1: Crizotinib in Patients with Tumors with MET Amplification (CTMS# 16-0064)
        Description
        The purpose of this study is to test any good and bad effects of the study drug called crizotinib in patients whose cancer has MET genetic changes.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   MATCH Treatment Subprotocol F: Crizotinib in Patients with Tumors (other...
        Protocol No.
        HSC20150750HU
        Official Title
        MATCH Treatment Subprotocol F: Crizotinib in Patients with Tumors (other than adenocarcinoma of lung or ALCL) with ALK Translocations (CTMS# 15-2081)
        Description
        Primary Objective To evaluate the proportion of patients with objective response (OR) to targeted study agent(s) in patients with advanced refractory cancers/lymphomas. Secondary Objectives To evaluate the proportion of patients alive and progression free at 6 months of treatment with targeted study agent in patients with advanced refractory cancers/lymphomas. To evaluate time until death or disease progression. To identify potential predictive biomarkers beyond the genomic alteration by which treatment is assigned or resistance mechanisms using additional genomic, RNA and protein-based assessment platforms.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   MATCH Treatment Subprotocol S1: Phase II Study of Trametinib in Patients...
        Protocol No.
        HSC20160260HU
        Official Title
        MATCH Treatment Subprotocol S1: Phase II Study of Trametinib in Patients with Tumors with NF1 Mutations (CTMS# 16-0028)
        Description
        PRIMARY OBJECTIVES: I. To evaluate the proportion of patients with objective response (OR) to targeted study agent(s) in patients with advanced refractory cancers/lymphomas. SECONDARY OBJECTIVES: I. To evaluate the proportion of patients alive and progression free at 6 months of treatment with targeted study agent in patients with advanced refractory cancers/lymphomas. II. To evaluate time until death or disease progression. III. To identify potential predictive biomarkers beyond the genomic alteration by which treatment is assigned or resistance mechanisms using additional genomic, ribonucleic acid (RNA) and protein-based assessment platforms.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   MATCH Treatment Subprotocol U: VS-6063 (defactinib) in Patients with Tumors...
        Protocol No.
        HSC20150839HU
        Official Title
        MATCH Treatment Subprotocol U: VS-6063 (defactinib) in Patients with Tumors with NF2 Loss (CTMS# 15-2110)
        Description
        Primary Objective To evaluate the proportion of patients with objective response (OR) to targeted study agent(s) in patients with advanced refractory cancers/lymphomas. Secondary Objectives To evaluate the proportion of patients alive and progression free at 6 months of treatment with targeted study agent in patients with advanced refractory cancers/lymphomas. To evaluate time until death or disease progression. To identify potential predictive biomarkers beyond the genomic alteration by which treatment is assigned or resistance mechanisms using additional genomic, RNA and protein-based assessment platforms.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   MATCH Treatment Subprotocol W: EAY131-W: Phase II Study of AZD4547 in...
        Protocol No.
        HSC20160541HU
        Official Title
        MATCH Treatment Subprotocol W: EAY131-W: Phase II Study of AZD4547 in Patients with Tumors with Aberrations in the FGFR Pathway (CTMS# 16-0065)
        Description
        The purpose of this study is to test any good and bad effects of the study drug, AZD4547, in patients whose cancer has genetic changes called FGFR gene alterations.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   MATCH Treatment Subprotocol X: Phase II Study of Dasatinib in Patients with...
        Protocol No.
        HSC20160282HU
        Official Title
        MATCH Treatment Subprotocol X: Phase II Study of Dasatinib in Patients with Tumors with DDR2 Mutations (CTMS# 16-0032)
        Description
        PRIMARY OBJECTIVES: I. To evaluate the proportion of patients with objective response (OR) to targeted study agent(s) in patients with advanced refractory cancers/lymphomas. SECONDARY OBJECTIVES: I. To evaluate the proportion of patients alive and progression free at 6 months of treatment with targeted study agent in patients with advanced refractory cancers/lymphomas. II. To evaluate time until death or disease progression. III. To identify potential predictive biomarkers beyond the genomic alteration by which treatment is assigned or resistance mechanisms using additional genomic, ribonucleic acid (RNA) and protein-based assessment platforms.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   MATCH Treatment Subprotocol Z1A: EAY131-Z1A: Binimetinib in Patients with...
        Protocol No.
        HSC20160499HU
        Official Title
        MATCH Treatment Subprotocol Z1A: EAY131-Z1A: Binimetinib in Patients with Tumors (Other Than Melanoma) with NRAS Mutations (CTMS# 16-0066)
        Description
        The purpose of this study is to test any good and bad effects of the experimental study drug binimetinib in patients whose cancer has NRAS mutations.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   MATCH Treatment Subprotocol Z1B: EAY131-Z1B: Phase II Study of Palbociclib...
        Protocol No.
        HSC20160491HU
        Official Title
        MATCH Treatment Subprotocol Z1B: EAY131-Z1B: Phase II Study of Palbociclib (PD-0332991) in Patients with Tumors with CCND1, 2, 3 Amplification and Rb Protein Expression by IHC (CTMS# 16-0067)
        Description
        The purpose of this study is to test any good and bad effects of the study drug, palbociclib, in patients whose cancer has CCND1, 2 or 3 amplification and tested positive for a protein called Rb protein.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   Molecular Analysis for Therapy Choice (MATCH) / MATCH Treatment Subprotocol...
        Protocol No.
        HSC20170176HU
        Official Title
        Molecular Analysis for Therapy Choice (MATCH) / MATCH Treatment Subprotocol H: EAY131-H: Phase II Study of Dabrafenib and Trametinib in Patients with Tumors with BRAF V600E or V600K Mutations (Excluding Melanoma, Thyroid Cancer, and Colorectal Adenocarcinoma) (CTMS# 15-2083)
        Description
        Primary Objective To evaluate the proportion of patients with objective response (OR) to targeted study agent(s) in patients with advanced refractory cancers/lymphomas. Secondary Objectives To evaluate the proportion of patients alive and progression free at 6 months of treatment with targeted study agent in patients with advanced refractory cancers/lymphomas. To evaluate time until death or disease progression. To identify potential predictive biomarkers beyond the genomic alteration by which treatment is assigned or resistance mechanisms using additional genomic, RNA and protein-based assessment platforms.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   Molecular Analysis for Therapy Choice (NCI-MATCH)
        Protocol No.
        HSC20150719XT
        Official Title
        EAY131, Molecular Analysis for Therapy Choice (MATCH) (CTMS# 15-2080)
        Description
        Primary Objective To evaluate the proportion of patients with objective response (OR) to targeted study agent(s) in patients with advanced refractory cancers/lymphomas. Secondary Objectives To evaluate the proportion of patients alive and progression free at 6 months of treatment with targeted study agent in patients with advanced refractory cancers/lymphomas. To evaluate time until death or disease progression. To identify potential predictive biomarkers beyond the genomic alteration by which treatment is assigned or resistance mechanisms using additional genomic, RNA and protein-based assessment platforms.
        Contact
        410-450-5798
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   NRG-HN003, A PHASE I AND EXPANSION COHORT STUDY OF ADJUVANT CISPLATIN,...
        Protocol No.
        HSC20170206HU
        Official Title
        NRG-HN003, A PHASE I AND EXPANSION COHORT STUDY OF ADJUVANT CISPLATIN, INTENSITY-MODULATED RADIOTHERAPY, AND MK-3475 (PEMBROLIZUMAB) IN HIGH-RISK HEAD AND NECK SQUAMOUS CELL CARCINOMA (HNSCC) (CTMS# 17-0022)
        Description
        Primary Outcome Measures: DLT in patients with high-risk head and neck squamous cell carcinoma treated with adjuvant cisplatin, IMRT, and pembrolizumab [ Time Frame: Up to 4 weeks post IMRT ] Will be summarized using proportions for binary outcome per cohort.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
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      •   NSABP B-51 A Randomized Phase III Clinical Trial Evaluating Post-Mastectomy...
        Protocol No.
        HSC20150021X
        Official Title
        NSABP B-51 A Randomized Phase III Clinical Trial Evaluating Post-Mastectomy Chestwall and Regional Nodal XRT and Post-Lumpectomy Regional Nodal XRT in Patients with Positive Axillary Nodes Before Neoadjuvant Chemotherapy Who Convert to Pathologically Negative Axillary Nodes After Neoadjuvant Chemotherapy
        Description
        To evaluate whether the addition of chest wall + regional nodal radiation therapy (XRT) after mastectomy or breast + regional nodal XRT after breast conserving surgery will significantly reduce the rate of events for invasive breast cancer recurrence-free interval (IBC-RFI) in patients who present with histologically positive axillary nodes but convert to histologically negative axillary nodes following neoadjuvant chemotherapy.
        Contact
        210-450-5924
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   Phase 2 Randomized, Double-Blinded, Controlled Study of Tucatinib vs....
        Protocol No.
        HSC20160505HU
        Official Title
        Phase 2 Randomized, Double-Blinded, Controlled Study of Tucatinib vs. Placebo in Combination with Capecitabine and Trastuzumab in Patients with Pretreated Unresectable Locally Advanced or Metastatic HER2+ Breast Carcinoma (HER2CLIMB) (CTMS# 16-0014)
        Description
        Primary Objective To assess the effect of ONT-380 vs. placebo in combination with capecitabine and trastuzumab on bi-compartmental [both central nervous system (CNS) and non-CNS] progression-free survival (PFS) based on independent central review Secondary Objectives To assess the effect of ONT-380 vs. placebo in combination with capecitabine and trastuzumab on bi-compartmental PFS based on investigator assessment To assess the effect of ONT-380 vs. placebo in combination with capecitabine and trastuzumab on PFS, separately in the CNS and non-CNS compartments To assess the effects of ONT-380 vs. placebo in combination with capecitabine and trastuzumab on time to CNS progression To assess the effects of ONT-380 vs. placebo in combination with capecitabine and trastuzumab on objective response rate (ORR), separately in the CNS and non-CNS compartments To assess the duration of response of ONT-380 in combination with capecitabine and trastuzumab, separately in the CNS and non-CNS compartments To assess the clinical benefit rate (CBR) [stable disease (SD) for 6 months, or best response of complete response (CR) or partial response (PR)] of ONT-380 vs. placebo in combination with capecitabine and trastuzumab, separately in the CNS and non-CNS compartments To assess the effects of ONT-380 vs. placebo in combination with capecitabine and trastuzumab on overall survival (OS) To assess the safety and tolerability of ONT-380 in combination with capecitabine and trastuzumab
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   Phase I Clinical Trial of Camptothecin-20-O-Propionate hydrate (CZ48) (CTMS#...
        Protocol No.
        HSC20150748HU
        Official Title
        Phase I Clinical Trial of Camptothecin-20-O-Propionate hydrate (CZ48) (CTMS# 15-2103)
        Description
        PRIMARY: To describe the dose limiting toxicities and adverse event profile of Camptothecin-20-O-Propionate hydrate (CZ48) administered orally every day. To determine Phase II recommended dose of Camptothecin-20-O-Propionate hydrate (CZ48) administered orally every day. SECONDARY: To perform a pharmacokinetic study of orally administered CZ48. To assess responses by RECIST criteria when applicable. To follow patients for survival.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   Phase I study of carfilzomib in combination with cyclophosphamide and...
        Protocol No.
        HSC20160206HU
        Official Title
        Phase I study of carfilzomib in combination with cyclophosphamide and etoposide for children with relapsed and refractory solid tumors and leukemias (CTMS# 15-2097)
        Description
        Primary Objective: To determine the DLTs and MTD of carfilzomib given in combination with cyclophosphamide and etoposide in pediatric patients with relapsed/refractory leukemias and solid tumors Secondary Objectives: 1. To evaluate toxicities of carfilzomib in the pediatric population when combined with conventional chemotherapy 2. To gather preliminary efficacy data on the drug combination 3. To measure if circulating plasma proteasome (cProt) levels post treatment correlate with response to therapy and overall survival 4. To measure if the levels of proteasome activity and resistance to carfilzomib correlates with toxicity and/or response to treatment. 5. To measure if inhibition of proteasome activity by carfilzomib results in alteration in a number of autophagy and apoptosis related proteins, providing means to evaluate correlates of activity of carfilzomib. 6. To measure the level of proteasome inhibition in patient PBMCs before and during treatment by determination of the level of protein ubiquitination. 7. To determine in vitro sensitivity of patient leukemias and solid tumors to carfilzomib alone and in combination with study chemotherapeutic agents in order to generate a predictive model of drug sensitivity. 8. To expand patient leukemia and solid tumor samples in order to save tissue for future studies but also to serve as a pre-clinical in vivo model to be included in the generation and testing of a drug sensitivity predictive model. 9. To perform whole exome sequencing (WES) and RNA seq on patient leukemia and solid tumor samples and WES on germ line DNA in order to determine potential mechanisms of drug sensitivity or resistance as well as contribute to testing a computer `learning engine (Bionet) for predicting clinical responses from genomic and drug sensitivity data.
        Contact
        210-562-9149
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   Phase Ib, open-label, multi-center study to characterize the safety,...
        Protocol No.
        HSC20160552HU
        Official Title
        Phase Ib, open-label, multi-center study to characterize the safety, tolerability and pharmacodynamics (PD) of PDR001 in combination with LCL161, everolimus (RAD001) or panobinostat (LBH589) (CTMS# 16-0058)
        Description
        Primary Objectives: To characterize the safety and tolerability of PDR001 in combination with LCL161, everolimus (RAD001) or panobinostat (LBH589) and to identify recommended doses and schedules for future studies Secondary Objectives: To characterize changes in the immune infiltrate in tumors To further characterize the safety of PDR001 in combination with LCL161, everolimus or panobinostat (LBH589) To estimate the anti-tumor activity of PDR001 in combination with LCL161, everolimus or panobinostat (LBH589) To characterize the pharmacokinetics of all study drugs in combination To assess immunogenicity of PDR001
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   Phase II Trial of Eribulin and Lenvatinib in Advanced Solid Tumors (CTMS#...
        Protocol No.
        HSC20150891HU
        Official Title
        Phase II Trial of Eribulin and Lenvatinib in Advanced Solid Tumors (CTMS# 15-2139)
        Description
        The overall purpose of this study is to determine the overall response rate, efficacy and safety of the combination of eribulin and Lenvatinib.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   Prognostic and predictive markers in patients with advanced metastatic tumors
        Protocol No.
        HSC20130219H
        Official Title
        Numeration and Single-Cell Molecular Profiling of Circulating Tumor Cells as Prognostic and Predictive Marker In Patients with Advanced Metastatic Tumors (CTRC#13-0001)
        Description
        This study will research possible associations between circulating tumor cells (CTC) quantities or gene profile characteristics and clinical outcomes. The primary objective is to obtain blood samples from participants over an 8-week period for research analysis.  The study will enroll approximately 200 patients at the CTRC. In addition to other conditions for enrollment, eligible patients have advanced metastatic cancer.
        Contact
        210-450-5798
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
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      •   Prospective Comparative Effectiveness Trial for Malignant Bowel Obstruction...
        Protocol No.
        HSC20170491HU
        Official Title
        Prospective Comparative Effectiveness Trial for Malignant Bowel Obstruction (CTMS# 17-0081)
        Description
        Number of days alive and outside the hospital
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
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      •   S1207 - Hormone Therapy With or Without Everolimus in Treating Patients with...
        Protocol No.
        HSC20140060X
        Official Title
        S1207, Phase III Randomized, Placebo-Controlled Clinical Trial Evaluating the Use of Adjuvant Endocrine Therapy +/- One Year of Everolimus in Patients with High-Risk, Hormone Receptor-Positive and HER2/neu Negative Breast Cancer (CTRC# 13-0002)
        Description
        The purpose of this study is to determine whether adding a year of everolimus to standard adjuvant hormonal therapy improves disease-free interval in patients with hormone-receptor-positive and HER2-negative breast cancer. Eligible adult patients (either sex) have a diagnosis of breast cancer and have completed surgery, radiation therapy, and/or adjuvant or neoadjuvant chemotherapy and have no evidence of disease at time of study entry. Patients with inflammatory breast cancer or metastatic disease, serious cardiac disease, uncontrolled diabetes, hepatitis, uncontrolled pulmonary disease, or impaired gastrointestinal function are not eligible. Estimated Enrollment: 3500 patients from multiple cancer centers in the US.
        Contact
        210-450-5798
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   S1609, Dart: Dual Anti-CTLA-4 and Anti-PD-1 Blockage in Rare Tumors (CTMS#...
        Protocol No.
        HSC20170145HU
        Official Title
        S1609, Dart: Dual Anti-CTLA-4 and Anti-PD-1 Blockage in Rare Tumors (CTMS# 17-0013)
        Description
        Primary Objective To evaluate the RECIST 1.1 overall response rate (ORR) in subsets of patients with advanced rare cancers treated with ipilimumab plus nivolumab combination immunotherapy. Secondary Objectives To evaluate toxicities in each cohort. To estimate overall survival (OS), progression-free survival (PFS), clinical benefit rate; and to estimate immune-related ORR (irORR), and immune-related PFS (irPFS) by unidimensional immune-related response criteria. To collect specimens for banking for use in future correlative biomarker research studies.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   Safety and Pharmacokinetics of Atezolizumab in Combination With Trastuzumab...
        Protocol No.
        HSC20150769HU
        Official Title
        A Phase Ib, Open-Label, Study Evaluating the Safety and Pharmacokinetics of Atezolizumab (anti-PD-L1 Antibody) in Combination with Trastuzumab Emtansine or With Trastuzumab and Pertuzumab (With and Without Docetaxel) in Patients with HER2-Positive Breast Cancer and Atezolizumb with Doxorubicin and Cyclophosphamide in HER2-Negative Breast Cancer (CTMS# 15-2125)
        Description
        Efficacy Objectives The primary efficacy objective for this study is to evaluate the safety and tolerability of the following combination treatments administered q3w to patients with HER2-positive MBC or operable LABC or inflammatory EBC: Atezolizumab in combination with trastuzumab and pertuzumab Atezolizumab in combination with trastuzumab emtansine Pharmacokinetic Objectives The pharmacokinetic (PK) objectives for this study are as follows: To characterize the pharmacokinetics of atezolizumab, trastuzumab, and pertuzumab when administered concurrently in treatment-naive patients with both metastatic and operable LABC or inflammatory EBC To characterize the pharmacokinetics of atezolizumab and trastuzumab emtansine when administered concurrently in treatment-naive patients with both metastatic and operable LABC or inflammatory EBC Exploratory Clinical Activity Objectives The exploratory clinical activity objectives of this study for patients in the safety-evaluation cohorts are as follows: To assess the clinical activity of atezolizumab when administered with either trastuzumab and pertuzumab or trastuzumab emtansine in patients with MBC, as measured by PFS, ORR, and duration of objective response (DOR) among patients with an OR per investigator assessment using RECIST v1.1 To assess the clinical activity of atezolizumab when administered with either trastuzumab and pertuzumab or trastuzumab emtansine in patients with MBC, as measured by PFS, ORR, and DOR per immune-modified RECIST To assess the clinical activity of atezolizumab when administered with either trastuzumab and pertuzumab or trastuzumab emtansine in patients with operable LABC or inflammatory EBC as measured by the rate of pathologic complete response (pCR; i.e., ypT0/Tis ypN0 in the current AJCC staging system) at breast surgery following completion of neoadjuvant systemic therapy. Exploratory Biomarker Objectives The exploratory objectives for this study are as follows: To identify candidate biomarkers that correlate with safety signals To assess changes in expression levels of biomarker or biomarker panels during and after investigational treatment with atezolizumab, trastuzumab, and pertuzumab, and atezolizumab plus trastuzumab emtansine
        Contact
        210-450-5798
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   Safety, Tolerability & PK of KX2-361 in Subjects with advanced malignancies...
        Protocol No.
        HSC20150481HU
        Official Title
        A Phase 1 Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetics of KX2-361 in Subjects with Advanced Malignancies that are Refractory to Conventional Therapies (CTMS# 15-2063)
        Description
        Study Objectives: Primary Objective: To define the maximum tolerated dose (MTD) of KX2-361 in subjects with advanced refractory malignancies when administered as single and multiple oral doses. Secondary Objectives: To determine the safety and tolerability of KX2-361 after single and multiple oral doses, in subjects with advanced refractory malignancies. To characterize the pharmacokinetic profile of KX2-361 after single and multiple oral doses. To evaluate the activity of KX2-361 in both the Dose Escalation Cohort and the Expansion Cohort of subjects with high-grade glioma.
        Contact
        210-450-5798
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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        Learn More About This Study

         

      •   Study of the Genetic Epidemiology of Childhood Cancer
        Protocol No.
        HSC20080057H
        Official Title
        Study of the Genetic Epidemiology of Childhood Cancer
        Description
        Study of the Genetic Epidemiology of Childhood Cancer
        Contact
        210-562-9123
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

    •   Breast Neoplasm

      •   A Dose Regimen-Finding Study to Evaluate the Safety, Tolerability,...
        Protocol No.
        HSC20170102HU
        Official Title
        A Dose Regimen-Finding Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Activity of Oradoxel Monotherapy in Subjects with Advanced Malignancies (CTMS# 16-0069)
        Description
        Primary Objective: To determine the maximum tolerated dose (MTD) of Oradoxel based on dose-limiting toxicity (DLT) in subjects with advanced malignancies Secondary Objectives To determine the safety and tolerability of docetaxel as Oradoxel To determine the incidence of unacceptable toxicity with Oradoxel To determine the recommended Phase 2 dose (RP2D) of docetaxel as Oradoxel To characterize the pharmacokinetic (PK) profile of docetaxel as Oradoxel To evaluate tumor response
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
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      •   A Dose Regimen-Finding Study to Evaluate the Safety, Tolerability,...
        Protocol No.
        HSC20160087HU
        Official Title
        A Dose Regimen-Finding Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Activity of Oraxol in Subjects with Advanced Malignancies (CTMS# 15-2137)
        Description
        Primary Objective To determine the maximum tolerated dose (MTD) and dosing regimen of Oraxol in subjects with advanced malignancies Secondary Objectives To determine the recommended Phase 2 dose of paclitaxel as Oraxol To determine the safety and tolerability of paclitaxel as Oraxol To characterize the pharmacokinetic (PK) profile of paclitaxel as Oraxol To evaluate the tumor response
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   A Phase 1 Dose Escalation and Cohort Expansion Study of TSR-042, an...
        Protocol No.
        HSC20170110HU
        Official Title
        A Phase 1 Dose Escalation and Cohort Expansion Study of TSR-042, an anti-PD-1 Monoclonal Antibody, in Patients with Advanced Solid Tumors (CTMS# 16-0091)
        Description
        Primary Objectives: Part 1 Dose Escalation Cohorts: To evaluate the safety and tolerability of TSR-042 using Common Terminology Criteria for Adverse Events (CTCAE v.4.03) in patients with advanced solid tumors Part 2 Expansion Cohorts: To evaluate the antitumor activity of TSR-042 in patients with advanced solid tumors, in terms of objective response rate (ORR) as assessed by the Investigators using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 Part 1 and Part 2: To define the recommended Phase 2 dose (RP2D) and schedule Secondary Objectives: Part 1 Dose Escalation Cohorts: To characterize the pharmacodynamic (PDy) profile of TSR-042 To evaluate ORR as assessed by the Investigators using RECIST v1.1 Part 2 Expansion Cohorts: To characterize the safety and tolerability of TSR-042 using CTCAE v.4.03 Part 1 and Part 2: To characterize the pharmacokinetic (PK) profile of TSR-042 To evaluate the immunogenicity of TSR-042 To evaluate additional measures of clinical benefit, including: ORR by immune-related RECIST (irRECIST) Duration of response (DOR) by RECIST v 1.1 Disease control rate (DCR) by RECIST v 1.1 and by irRECIST Progression-free survival (PFS) by RECIST v 1.1 and by irRECIST Overall survival (OS)
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
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      •   A Phase 1 Study of CBL0137 in Patients with Metastatic or Unresectable...
        Protocol No.
        HSC20130328H
        Official Title
        A Phase 1 Trial of CBL0137 In patients With Metastatic or Unresectable Advanced Solid Neoplasms or Refractory Lymphomas (CTRC# 13-0031)
        Description
        This Phase 1 study is designed to determine the best dose of CBL0137 to use when treating patients with metastatic or unresectable advanced solid tumors or lymphoma. The study will enroll up to 48 patients from at least 2 cancer centers in the US. In addition to other conditions for enrollment, eligible patients have cancer that has not improved or has come back after prior treatment and are otherwise in good health. Patients who have a history of active infection, cancer involving the central nervous system, a particular EKG abnormality or other serious medical conditions may not be eligible to enroll.
        Contact
        210-450-5798
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   A Phase 1/2A, Multicenter, Open-Label Study of LYC-55716 in Adult Subjects...
        Protocol No.
        HSC20160617HU
        Official Title
        A Phase 1/2A, Multicenter, Open-Label Study of LYC-55716 in Adult Subjects with Locally Advanced or Metastatic Cancer (CTMS# 16-0099)
        Description
        Primary Objectives Phase 1 Evaluate the safety and tolerability of LYC-55716 Determine the maximum tolerated dose (MTD) and the recommended Phase 2 dose (RP2D) Phase 2a Determine the objective response rate according to response evaluation criteria in solid tumors (RECIST) v1.1 Secondary Objectives Phase 1 Evaluate the activity of LYC-55716 by objective response according to RECIST v1.1 Determine the durability of any observed objective response Phase 2a Determine the duration of response Determine progression-free survival (PFS) and overall survival (OS) Determine suitability of the RP2D for further study Characterize the pharmacokinetics (PK) of LYC-55716 Exploratory Objectives Assess tumor activity in subjects with locally advanced or metastatic cancer according to immune-related response evaluation criteria in solid tumors (irRECIST) Exploratory analysis of metabolite in plasma Assess changes in circulating tumor markers (eg, cytokines/chemokines)
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   A Phase 1b Study of Oraxol in Combination with Ramucirumab in Patients with...
        Protocol No.
        HSC20170188HU
        Official Title
        A Phase 1b Study of Oraxol in Combination with Ramucirumab in Patients with Gastric, Gastro-esophageal, or Esophageal Cancers (CTMS# 16-0089)
        Description
        Primary Objective: To determine the maximum tolerated dose (MTD) of Oraxol in patients with advanced stage gastric, gastro-esophageal, or esophageal cancers who are being treated with Oraxol in combination with ramucirumab Secondary Objectives: To determine the safety and tolerability of Oraxol in combination with ramucirumab To determine the recommended Phase 2 dose of Oraxol in combination with ramucirumab To characterize the pharmacokinetic (PK) profile of Oraxol in combination with ramucirumab To characterize preliminary activity of Oraxol plus ramucirumab as determined by response rate, progression-free survival, and overall survival
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   A Phase 1b/2 Study of ARRY-382 in Combination with Pembrolizumab, a...
        Protocol No.
        HSC20170071HU
        Official Title
        A Phase 1b/2 Study of ARRY-382 in Combination with Pembrolizumab, a Programmed Cell Death Receptor 1 (PD-1) Antibody, for the Treatment of Patients with Advanced Solid Tumors (CTMS# 16-0084)
        Description
        Primary objective: To determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of ARRY-382 in combination with pembrolizumab in patients with selected solid tumors Secondary objectives:  To describe the preliminary antitumor activity of the combination based on the Response Criteria In Solid Tumors, version 1.1 (RECIST v1.1).  To describe the preliminary antitumor activity of the combination based on immune-related response criteria (irRC).  To characterize the safety and tolerability of the combination, including acute and chronic toxicities. To evaluate the pharmacokinetics of ARRY-382 in combination with pembrolizumab Exploratory objective: To explore the effect of the combination on circulating biomarkers of immune response. To describe the preliminary antitumor activity of the combination in patients with PD-L1 positive non-small cell lung cancer (NSCLC), as determined using a United States Food and Drug Administration (FDA)-approved test, using RECIST. To describe the preliminary antitumor activity of the combination in patients with PD-L1 positive non-small cell lung cancer (NSCLC), as determined using an FDA approved test, using irRC
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
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      •   A Phase I, First-in-human, Open-label, Dose-escalation, Safety,...
        Protocol No.
        HSC20160554HU
        Official Title
        A Phase I, First-in-human, Open-label, Dose-escalation, Safety, Pharmacokinetic, and Pharmacodynamic Study of Oral TP-0903 Administered Daily for 21 Days to Patients with Advanced Solid Tumors (CTMS# 16-0092)
        Description
        Primary Objective: To determine the maximum tolerated dose (MTD) and dose-limiting toxicities (DLTs) of oral TP-0903 administered daily for the first 21 days every 4 weeks, over a range of doses in patients with advanced solid tumors. Secondary Objectives: To establish the pharmacokinetics of orally administered TP-0903 To observe patients for any evidence of antitumor activity of TP-0903 by objective radiographic assessment To study the pharmacodynamics of TP-0903 therapy by: assessing biomarkers in tumor tissue assessing biomarkers in peripheral blood mononuclear cells (PBMCs) and serum To establish the Recommended Phase 2 Dose (RP2D) for future studies with TP-0903
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   A Phase I, Multicenter, Open-Label Dose Escalation and Expansion Study of...
        Protocol No.
        HSC20150289HU
        Official Title
        A Phase I, Multicenter, Open-Label Dose Escalation and Expansion Study of PCA062, Administered Intravenously In Adult Patients With pCAD-Positive Tumors (CTMS# 14-2019)
        Description
        Primary Objective To determine the MTD/RDE of PCA062 in patients with pCAD-positive tumors in the dose escalation part. Secondary Objectives To characterize the safety and tolerability of PCA062 To characterize the pharmacokinetic profile of PCA062 To assess emergence of anti-PCA062 antibodies following one or more intravenous infusions of PCA062 To assess the preliminary anti-tumor activity of PCA062 in patients with pCAD-positive triple negative breast cancer (TBNC), head and neck squamous cell carcinoma (HNSCC) or esophageal cancer (squamous and adenocarcinoma)
        Contact
        210-450-5798
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   A Phase I/II, open label, multicenter study of the safety and efficacy of...
        Protocol No.
        HSC20150421HU
        Official Title
        A Phase I/II, open label, multicenter study of the safety and efficacy of LAG525 single agent and in combination with PDR001 administered to patients with advanced malignancies (CTMS #15-2054)
        Description
        Primary Objectives Phase I part To estimate the RP2D or MTD for the single agent LAG525 and the combination of LAG525 and PDR001. Phase II part To estimate the overall response rate per RECIST V1.1 for single agent LAG525 as well as for the combination of LAG525 and PDR001 Secondary Objectives: To characterize the safety and tolerability of single agent LAG525 given alone and in combination with PDR001 To characterize the pharmacokinetic profile of single agent LAG525 given alone and in combination with PDR001 To assess emergence of anti-LAG525, and anti-PDR001 antibodies following one or more intravenous (i.v.) infusions of single agent LAG525 given alone or in combination with PDR001 To assess potential predictors of efficacy of single agent LAG525 and the combination of LAG525 and PDR001 To evaluate the preliminary antitumor activity of single agent LAG525 given alone or in combination of PDR001 To investigate patient selection and pharmacodynamic biomarkers in tumor tissue samples
        Contact
        210-450-5798
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   A Phase I/II, Open-Label, Multi-Center Study of the Safety and Efficacy of...
        Protocol No.
        HSC20160420HU
        Official Title
        A Phase I/II, Open-Label, Multi-Center Study of the Safety and Efficacy of BLZ945 as Single Agent and In Combination with PDR001 in Adult Patients with Advanced Solid Tumors (CTMS# 16-0071)
        Description
        Primary Objective: Phase I: To characterize the safety and tolerability of BLZ945 as a single agent and in combination with PDR001 and to identify the Maximum Tolerated Dose (MTD)/Recommended Phase 2 Dose (RP2D). Phase II: To assess the anti-tumor activity of BLZ945 in combination with PDR001 (and as single agent if appropriate) in patients with advanced solid tumors. Secondary Objective: Phase I: To characterize the pharmacodynamics effect of BLZ945 as a single agent and in combination with PDR001. To characterize PK of BLZ945 as a single agent and in combination with PDR001. To assess the preliminary anti-tumor activity of BLZ945 as single agent and in combination with PDR001. Phase I and II: To assess emergence of anti-PDR001 antibodies when BLZ945 is administered in combination with PDR001.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
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      •   A Phase Ib Trial of Pembrolizumab (MK-3475) in Combination with Dinaciclib...
        Protocol No.
        HSC20170106HU
        Official Title
        A Phase Ib Trial of Pembrolizumab (MK-3475) in Combination with Dinaciclib (MK-7965) in Subjects with Hematologic Malignancies (KEYNOTE-155) (CTMS# 16-0009)
        Description
        Primary Objective Objective: In both the Dose Evaluation and Signal Detection phases, evaluate the safety and tolerability of the treatment combination. Objective: Within each disease type of the Signal Detection phase, evaluate objective response rate (ORR) according to investigator assessment using the disease specific criteria. Secondary Objective: Objective: To evaluate the Objective Response Rate (ORR; complete response [CR] + partial response [PR]) of the combination of pembrolizumab and dinaciclib within each disease type, ie, CLL based on iwCLL guidelines (Hallek, 2008) [1], MM based on IMWG criteria (Durie, 2006) [2] and DLBCL based on the Revised Response Criteria for Malignant Lymphoma (Cheson, 2007) [3]. Objective: Within each disease type of the Signal Detection phase, evaluate Duration of Response (DOR), Progression-Free Survival (PFS) according to investigator assessment using the disease specific criteria; and Overall Survival (OS).
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   ABTR01B1, A Children''s Oncology Group Protocol for Collecting and Banking...
        Protocol No.
        HSC20040131H
        Official Title
        ABTR01B1, A Children''s Oncology Group Protocol for Collecting and Banking Pediatric Research Specimens Including Rare Pediatric Tumors
        Description
        This study is collecting and storing malignant, borderline malignant neoplasms, and related biological samples from young patients with cancer. Collecting and storing samples of tumor tissue, blood, and bone marrow from patients with cancer to study in the laboratory may help the study of cancer in the future.
        Contact
        210-562-9149
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   ACCL15N1CD Use of Evidence-Based Supportive Care Clinical Practice...
        Protocol No.
        HSC20160673X
        Official Title
        ACCL15N1CD Use of Evidence-Based Supportive Care Clinical Practice Guidelines in Pediatric
        Description
        Primary and Secondary Aims Aim 1: Chart Review To measure the rate of adherence to selected COG-endorsed supportive care CPG recommendations at NCORP sites Aim 1a To describe the possible influence of NCORP site size and the number of patients enrolled in COG studies per site on the delivery of CPG-consistent care. Aim 1b To describe the clinical outcome of episodes during which patients receive CPG-consistent or CPG-inconsistent care Aim 2: Focus Groups To describe facilitators of and barriers to the use of CPGs elicited via focus group interviews with a diverse set of potential users (physician, nurse, nurse practitioner and pharmacists) who provide pediatric cancer care at NCORP sites. Aim 3: Interviews To improve how well CPG recommendations are understood by health care providers by refining the CPG recommendation format based on an iterative process of cognitive interviewing and formatting revisions. Understanding is defined as the correct interpretation of the course of action recommended or suggested by a CPG.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   ACCRN07 Protocol for the Enrollment on the Official COG Registry, The...
        Protocol No.
        HSC20080271X
        Official Title
        ACCRN07 Protocol for the Enrollment on the Official COG Registry, The Childhood Cancer Research Network (CCRN)
        Description
        The Children s Oncology Group has established a research network, the Childhood Cancer Research Network (CCRN), to collect information about children with cancer and other conditions that are benign but involve abnormal cell growth in order to help doctors and scientists better understand childhood cancer. The CCRN''s goal is to collect clinical information about every child diagnosed with cancer and similar conditions in the United States and Canada, to allow researchers to study patterns, characteristics, and causes of childhood cancer. The information can also help researchers study the causes of childhood cancer. To expand the CCRN, parents of children who have been diagnosed with cancer will be asked to provide information about themselves and their child for research purposes.   Objectives: To obtain informed consent from parents (and the child, when appropriate) of infants, children, adolescents, and young adults newly diagnosed with cancer to enter their names and certain information concerning their child into the Childhood Cancer Research Network. To obtain informed consent from parents (and the child, when appropriate) of infants, children, adolescents, and young adults newly diagnosed with cancer for permission to be contacted in the future to consider participating in non-therapeutic and prevention research studies involving the parents and/or the child.
        Contact
        210-562-9149
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
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      •   Adolescent and Young Adult Childhood Cancer Survivorship (CTMS#17-0088)
        Protocol No.
        HSC20170474HU
        Official Title
        Adolescent and Young Adult Childhood Cancer Survivorship (CTMS#17-0088)
        Description
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   ALTE05N1, Umbrella Long-Term Follow-Up Protocol
        Protocol No.
        HSC20090478X
        Official Title
        ALTE05N1, Umbrella Long-Term Follow-Up Protocol
        Description
        Umbrella Long-Term Follow-Up Protocol
        Contact
        210-562-9149
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   ALTE1621 Pharmacologic Reversal of Ventricular Remodeling in Childhood...
        Protocol No.
        HSC20160394X
        Official Title
        ALTE1621 Pharmacologic Reversal of Ventricular Remodeling in Childhood Cancer Survivors at Risk for Heart Failure (PREVENT-HF): A Phase 2b Randomized Placebo-Controlled (Carvedilol) Trial
        Description
        1.1 Primary Aim To determine the impact of a two-year course of low-dose carvedilol on surrogate echocardiographic indices of heart failure (HF) risk, including Left Ventricular (LV) Posterior Wall Thickness-Dimension Ratio (LV T-D) a well-established index of early myocardial remodeling and subsequent HF risk (primary endpoint).  LV systolic and diastolic function and afterload established echocardiographic indices associated with HF risk.  Natriuretic peptides, troponins, and Galectin-3 - circulating biomarkers associated with myocardial injury, and HF risk. 1.2 Secondary Aims 1.2.1 To establish safety and tolerability of this two-year course of low-dose carvedilol, assessing both objective measures (hepatic function) and patient reported outcomes. 1.2.2 To examine the modifying effect of demographic, clinical, and molecular characteristics on the risk: benefit ratio from this two-year carvedilol intervention. 1.3 Exploratory Aim To evaluate the long-term efficacy of carvedilol in preventing cardiomyopathy and/or heart failure in high-risk childhood cancer survivors.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   AN EARLY-PHASE, MULTICENTER, OPEN-LABEL STUDY OF THE SAFETY AND...
        Protocol No.
        HSC20150549H
        Official Title
        AN EARLY-PHASE, MULTICENTER, OPEN-LABEL STUDY OF THE SAFETY AND PHARMACOKINETICS OF ATEZOLIZUMAB (MPDL3280A) IN PEDIATRIC AND YOUNG ADULT PATIENTS WITH PREVIOUSLY TREATED SOLID TUMORS
        Description
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   An Open-Label Rollover Study to Evaluate the Long-Term Safety, Tolerability,...
        Protocol No.
        HSC20170197XT
        Official Title
        An Open-Label Rollover Study to Evaluate the Long-Term Safety, Tolerability, Biological Activity of Oral TVB-2640 in Patients With Solid Tumors Previously Enrolled in 3V2640-CLIN-002 (CTMS# 17-0046)
        Description
        Primary: To continue to characterize the safety profile of TVB-2640. Secondary: To identify any early signs of anti-tumor activity, where possible.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   An Open-Label, Dose Escalation, Phase 1, First-In-Human Study of TAK-659 in...
        Protocol No.
        HSC20150255HU
        Official Title
        An Open-Label, Dose Escalation, Phase 1, First-In-Human Study of TAK-659 in Adult Patients with Advanced Solid Tumors and Lymphoma Malignancies (CTMS# 14-2013)
        Description
        To determine the safety, tolerability, maximum tolerated dose (MTD)/recommended phase 2 dose (RP2D) ofTAK-659 administered orally on a daily dosing schedule in patients with advanced solid tumor and lymphoma who do not have effective standard treatment available
        Contact
        210-450-5798
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   APEC14B1, THE PROJECT: EVERYCHILD PROTOCOL: A REGISTRY, ELIGIBILITY...
        Protocol No.
        HSC20150870XT
        Official Title
        APEC14B1, THE PROJECT: EVERYCHILD PROTOCOL: A REGISTRY, ELIGIBILITY SCREENING, BIOLOGY AND OUTCOME STUDY
        Description
        1.1 To maintain a Childhood Cancer Registry1 for infants, children, adolescents, and young adults with cancer. 1.2 To utilize clinical and biological data to help determine eligibility or stratification, based on childhood cancer disease classification schemas, for potential enrollment of research subjects onto COG therapeutic clinical trials. 1.3 To develop a well annotated childhood cancer biorepository for current and future research through the collection of biospecimens (at diagnosis, time of progression, time of recurrence and/or post-mortem), including tumor, host and when feasible parental germline DNA; and key clinical data, including presentation, diagnostic, staging, summary treatment, and outcome information, from every child diagnosed with cancer at COG institutions. 1.4 To allow use of registry data for permission to be contacted in the future to consider participating in non-therapeutic and prevention research studies involving the child or their parents.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
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      •   Cancer Therapy and Research Center''s Institute for Drug Development Solid...
        Protocol No.
        HSC20070684H
        Official Title
        Cancer Therapy and Research Center''s Institute for Drug Development Solid Tumors and Hematological Malignancies Biorepository for Biomarker Discovery
        Description
        Samples are collected for the Cancer Therapy and Research Center''s Solid Tumors and Hematological Malignancies Biorepository for Biomarker Discovery
        Contact
        210-450-5798
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
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      •   Caris Molecular Intelligence® and Caris Centers of Excellence for...
        Protocol No.
        HSC20170144HU
        Official Title
        Caris Molecular Intelligence® and Caris Centers of Excellence for Precision Medicine NetworkTM Retrospective Outcomes-Associated Database (CTMS# 16-0145)
        Description
        The objective of this project is the development of the Caris Molecular Intelligence® and Caris Centers of Excellence for Precision Medicine NetworkTM Outcomes Associated Repository, a disease research database (hereinafter referred to as the Database ) for the purpose of: 1. Effecting change in disease treatment processes by advancing precision medicine and improving care for cancer through acquiring and sharing valuable molecular tumor profiling information and clinical outcomes in a collaborative, secure environment. 2. Performing prospective research studies involving analyses of quality of life studies as well as subject medical records including clinical presentation and outcomes. This eligible cohort includes select subjects having undergone Caris Molecular Intelligence® evaluation for diagnosis and/or treatment management. 3. Evaluate the frequency of specific clinical events in relation to risk factors, diagnosis and treatments provided via the collection of outcomes data through automated data capture systems provided by a third-party data entity and manually-entered data when needed. 4. Provide information access that is vital to research collaborators, including potential researchers from pharmaceutical companies, governmental agencies, academia, healthcare providers, and payors, with catalogued subject outcome data for the use of drug development discoveries, clinically relevant research trials, publications and posters, the implementation of future healthcare policies, characterization of trends in practice patterns and their relation to subject outcomes and the economic impact of differing evaluation, treatment, and management paradigms. 5. Cultivate a repository for assay development and validation of emerging technologies to enhance clinical cancer care.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   Caris Molecular Intelligence® and Caris Centers of Excellence for Precision...
        Protocol No.
        HSC20170353HU
        Official Title
        Caris Molecular Intelligence® and Caris Centers of Excellence for Precision Medicine NetworkTM Outcomes Associated Repository (CTMS# 17-0023)
        Description
        The objective of this project is the development of the Caris Molecular Intelligence® and Caris Centers of Excellence for Precision Medicine NetworkTM Outcomes Associated Repository, a disease research database (hereinafter referred to as the Database) for the purpose of: 1. Effecting change in disease treatment processes by advancing precision medicine and improving care for cancer through acquiring and sharing valuable molecular tumor profiling information and clinical outcomes in a collaborative, secure environment. 2. Performing prospective research studies involving analyses of quality of life studies as well as subject medical records including clinical presentation and outcomes. This eligible cohort includes select subjects having undergone Caris Molecular Intelligence® evaluation for diagnosis and/or treatment management. 3. Evaluate the frequency of specific clinical events in relation to risk factors, diagnosis and treatments provided via the collection of outcomes data through automated data capture systems provided by a third-party data entity and manually-entered data when needed. 4. Provide information access that is vital to research collaborators, including potential researchers from pharmaceutical companies, governmental agencies, academia, healthcare providers, and payors, with catalogued subject outcome data for the use of drug development discoveries, clinically relevant research trials, publications and posters, the implementation of future healthcare policies, characterization of trends in practice patterns and their relation to subject outcomes and the economic impact of differing evaluation, treatment, and management paradigms. 5. Cultivate a repository for assay development and validation of emerging technologies to enhance clinical cancer care.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   Clinical Trial of Lurbinectedin (PM01183) in Selected Advanced Solid Tumors
        Protocol No.
        HSC20150542HU
        Official Title
        A Multicenter Phase II Clinical Trial of Lurbinectedin (PM01183) in Selected Advanced Solid Tumors (CTMS# 15-2071)
        Description
        Primary: To assess the antitumor activity of lurbinectedin (PM01183) in terms of overall response rate (ORR), according to the Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1, in the following advanced solid tumors: small cell lung cancer (SCLC), head and neck carcinoma (H&N), neuroendocrine tumors (NETs), biliary tract carcinoma, endometrial carcinoma, BRCA 1/2-associated metastatic breast carcinoma, carcinoma of unknown primary site, germ cell tumors (GCTs), and Ewing¿s family of tumors (EFTs). Secondary: To further characterize the antitumor activity of PM01183 in terms of duration of response (DR), clinical benefit [ORR or stable disease (SD) lasting over four months (SD ¿ 4 months)], progression-free survival (PFS), and one year overall survival (1y-OS) in each cohort of advanced solid tumors. Characterize the plasma pharmacokinetics (PK) of PM01183. To conduct an exploratory pharmacogenomic (PGx) and pharmacogenetic analysis. To evaluate the safety profile of PM01183 in this patient population.
        Contact
        410-450-5798
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
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      •   Clinical trial to study the safety and efficacy of MBG453 given alone and in...
        Protocol No.
        HSC20150730HU
        Official Title
        A Phase I-Ib/II, Open-Label, Multi-Center Study of the Safety and Efficacy of MBG453 as Single Agent and in Combination with PDR001 in Adult Patients with Advanced Malignancies (CTMS# 15-2114)
        Description
        Primary Objectives: Phase I-Ib: To characterize the safety and tolerability of MBG453 as a single agent and in combination with PDR001 and to identify recommended doses for future studies. Phase I-Ib dose ranging: To further investigate the safety and tolerability of different doses of MBG453 alone or in combination with PDR001. Phase II: To estimate the anti-tumor activity of MBG453 alone in patients with solid tumors, and in combination with PDR001 in selected disease indications (melanoma, non-small cell lung cancer (NSCLC), renal cell carcinoma (RCC)). Secondary Objectives Evaluate the preliminary anti-tumor activity of MBG453 alone and in combination with PDR001. Make an initial comparison of safety, PK and efficacy for MBG453 and PDR001 administered in combination on a every 2 weeks (Q2W) and every 4 weeks (Q4W) dosing schedules. Characterize the pharmacokinetic profile of MBG453 alone and in combination with PDR001. Assess emergence of anti-MBG453 and anti-PDR001 antibodies. Assess potential predictors of efficacy of MBG453 single agent and in combination with PDR001 in tumor samples. Assess the pharmacodynamic effect of MBG453 as single agent and in combination with PDR001 in tumor samples. Describe the survival distribution of patients treated with MBG453 as single agent and in combination with PDR001 for each disease group.
        Contact
        410-450-5798
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   DCP-001, Use of a Clinical Trial Screening Tool to Address Cancer Health...
        Protocol No.
        HSC20160342XT
        Official Title
        DCP-001, Use of a Clinical Trial Screening Tool to Address Cancer Health Disparities in the NCI Community Oncology Research Program (NCORP)
        Description
        Objectives 1) Implement a screening tool in NCORP to collect broader demographic and clinical data to generate hypothesis and research questions in the following areas of research: cancer screening, cancer prevention, symptom science, cancer care disparities, comparative effectiveness and cancer care delivery research. 2) Collect expanded demographic and clinical data (e.g., SES, co-morbidities, method of diagnosis) across the NCORP network to help identify and best characterize patients that are screened but not enrolled and for patients that participate in NCI trials, to understand how these variables may impact outcomes. 3) Enhance an understanding of site- specific and trial-specific accrual barriers that will inform the development of effective strategies to improve accrual, particularly for minority and underserved populations. 4) Provide data for internal and external evaluation of NCORP s first RFA cycle and reissuance.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
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      •   GO29665, A PHASE I/II, MULTICENTER, OPEN-LABEL, DOSE-ESCALATION STUDY OF THE...
        Protocol No.
        HSC20160080H
        Official Title
        GO29665, A PHASE I/II, MULTICENTER, OPEN-LABEL, DOSE-ESCALATION STUDY OF THE SAFETY AND PHARMACOKINETICS OF COBIMETINIB IN PEDIATRIC AND YOUNG ADULT PATIENTS WITH PREVIOUSLY TREATED SOLID TUMORS (CTRC# 15-0005)
        Description
        CTRC#15-0005
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
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      •   Head and Neck Cancer Repository
        Protocol No.
        HSC20170218HR
        Official Title
        Head and Neck Cancer Repository
        Description
        To establish a repository of head and neck cancers and PDX models from our south Texas patient population.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   Health Effects after Anthracycline and Radiation Therapy (HEART):...
        Protocol No.
        HSC20140058X
        Official Title
        Health Effects after Anthracycline and Radiation Therapy (HEART): Dexrazoxane and Prevention of Anthracycline-related Cardiomyopathy A Limited Institution Non-Therapeutic Study
        Description
        This clinical trial studies the effects of dexrazoxane hydrochloride on biomarkers associated with cardiomyopathy and heart failure after cancer treatment. Studying samples of blood in the laboratory from patients receiving dexrazoxane hydrochloride may help doctors learn more about the effects of dexrazoxane hydrochloride on cells. It may also help doctors understand how well patients respond to treatment.
        Contact
        210-562-9149
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
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      •   Incidence and Factors Associated with the Development and Severity of Oral...
        Protocol No.
        HSC20050218H
        Official Title
        Incidence and Factors Associated with the Development and Severity of Oral Mucositis in Patients Undergoing High Dose Chemotherapy and Peripheral Stem Cell Transplantation
        Description
        Our study intends to evaluate prospectively the incidence and severity of oral mucositis in patients undergoing high-dose chemotherapy and hematopoietic stem cell transplantation, as well as to evaluate the potential influence of nutritional-, physical-, and transplant-related factors associated with the development of this complication and its grade of involvement. Research plan: This is a prospective cohort study with an observational basis that involves all of the patients undergoing high-dose chemotherapy and peripheral blood stem cell transplantation at the Audie L. Murphy VA Hospital Bone Marrow Transplant Unit and at the University Hospital Bone Marrow Transplant Unit. We expect to enroll 400 patients during a 5-year period. Methods: In order to answer the study questions, subjects will be assessed several times during the study period. The study involves a multidisciplinary group that will be evaluating and following the subjects. A baseline will be established by a physician and a nutritionist before the subjects start the high-dose chemotherapy regimen. The subjects will be followed with oral evaluations 3 times per week, beginning on the day of the transplant and ending when mucositis resolves, or the patient is discharged home, or 30 days post-transplant, whichever occurs first. At day 15 post-transplant, patients will be evaluated for the second time by the nutritionist. Further information such as blood values, use of medications and treatment complications, will be obtained by daily chart review.  
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
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      •   MATCH Treatment Subprotocol B: Phase II Study of Afatinib in Patients with...
        Protocol No.
        HSC20150831HU
        Official Title
        MATCH Treatment Subprotocol B: Phase II Study of Afatinib in Patients with Tumors with HER2 Activating Mutations (CTMS# 15-2107)
        Description
        Primary Objective To evaluate the proportion of patients with objective response (OR) to targeted study agent(s) in patients with advanced refractory cancers/lymphomas. Secondary Objectives To evaluate the proportion of patients alive and progression free at 6 months of treatment with targeted study agent in patients with advanced refractory cancers/lymphomas. To evaluate time until death or disease progression. To identify potential predictive biomarkers beyond the genomic alteration by which treatment is assigned or resistance mechanisms using additional genomic, RNA and protein-based assessment platforms.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   MATCH Treatment Subprotocol C1: EAY131-C1: Crizotinib in Patients with...
        Protocol No.
        HSC20160463HU
        Official Title
        MATCH Treatment Subprotocol C1: EAY131-C1: Crizotinib in Patients with Tumors with MET Amplification (CTMS# 16-0064)
        Description
        The purpose of this study is to test any good and bad effects of the study drug called crizotinib in patients whose cancer has MET genetic changes.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
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      •   MATCH Treatment Subprotocol F: Crizotinib in Patients with Tumors (other...
        Protocol No.
        HSC20150750HU
        Official Title
        MATCH Treatment Subprotocol F: Crizotinib in Patients with Tumors (other than adenocarcinoma of lung or ALCL) with ALK Translocations (CTMS# 15-2081)
        Description
        Primary Objective To evaluate the proportion of patients with objective response (OR) to targeted study agent(s) in patients with advanced refractory cancers/lymphomas. Secondary Objectives To evaluate the proportion of patients alive and progression free at 6 months of treatment with targeted study agent in patients with advanced refractory cancers/lymphomas. To evaluate time until death or disease progression. To identify potential predictive biomarkers beyond the genomic alteration by which treatment is assigned or resistance mechanisms using additional genomic, RNA and protein-based assessment platforms.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   MATCH Treatment Subprotocol S1: Phase II Study of Trametinib in Patients...
        Protocol No.
        HSC20160260HU
        Official Title
        MATCH Treatment Subprotocol S1: Phase II Study of Trametinib in Patients with Tumors with NF1 Mutations (CTMS# 16-0028)
        Description
        PRIMARY OBJECTIVES: I. To evaluate the proportion of patients with objective response (OR) to targeted study agent(s) in patients with advanced refractory cancers/lymphomas. SECONDARY OBJECTIVES: I. To evaluate the proportion of patients alive and progression free at 6 months of treatment with targeted study agent in patients with advanced refractory cancers/lymphomas. II. To evaluate time until death or disease progression. III. To identify potential predictive biomarkers beyond the genomic alteration by which treatment is assigned or resistance mechanisms using additional genomic, ribonucleic acid (RNA) and protein-based assessment platforms.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   MATCH Treatment Subprotocol U: VS-6063 (defactinib) in Patients with Tumors...
        Protocol No.
        HSC20150839HU
        Official Title
        MATCH Treatment Subprotocol U: VS-6063 (defactinib) in Patients with Tumors with NF2 Loss (CTMS# 15-2110)
        Description
        Primary Objective To evaluate the proportion of patients with objective response (OR) to targeted study agent(s) in patients with advanced refractory cancers/lymphomas. Secondary Objectives To evaluate the proportion of patients alive and progression free at 6 months of treatment with targeted study agent in patients with advanced refractory cancers/lymphomas. To evaluate time until death or disease progression. To identify potential predictive biomarkers beyond the genomic alteration by which treatment is assigned or resistance mechanisms using additional genomic, RNA and protein-based assessment platforms.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   MATCH Treatment Subprotocol W: EAY131-W: Phase II Study of AZD4547 in...
        Protocol No.
        HSC20160541HU
        Official Title
        MATCH Treatment Subprotocol W: EAY131-W: Phase II Study of AZD4547 in Patients with Tumors with Aberrations in the FGFR Pathway (CTMS# 16-0065)
        Description
        The purpose of this study is to test any good and bad effects of the study drug, AZD4547, in patients whose cancer has genetic changes called FGFR gene alterations.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   MATCH Treatment Subprotocol X: Phase II Study of Dasatinib in Patients with...
        Protocol No.
        HSC20160282HU
        Official Title
        MATCH Treatment Subprotocol X: Phase II Study of Dasatinib in Patients with Tumors with DDR2 Mutations (CTMS# 16-0032)
        Description
        PRIMARY OBJECTIVES: I. To evaluate the proportion of patients with objective response (OR) to targeted study agent(s) in patients with advanced refractory cancers/lymphomas. SECONDARY OBJECTIVES: I. To evaluate the proportion of patients alive and progression free at 6 months of treatment with targeted study agent in patients with advanced refractory cancers/lymphomas. II. To evaluate time until death or disease progression. III. To identify potential predictive biomarkers beyond the genomic alteration by which treatment is assigned or resistance mechanisms using additional genomic, ribonucleic acid (RNA) and protein-based assessment platforms.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   MATCH Treatment Subprotocol Z1A: EAY131-Z1A: Binimetinib in Patients with...
        Protocol No.
        HSC20160499HU
        Official Title
        MATCH Treatment Subprotocol Z1A: EAY131-Z1A: Binimetinib in Patients with Tumors (Other Than Melanoma) with NRAS Mutations (CTMS# 16-0066)
        Description
        The purpose of this study is to test any good and bad effects of the experimental study drug binimetinib in patients whose cancer has NRAS mutations.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   MATCH Treatment Subprotocol Z1B: EAY131-Z1B: Phase II Study of Palbociclib...
        Protocol No.
        HSC20160491HU
        Official Title
        MATCH Treatment Subprotocol Z1B: EAY131-Z1B: Phase II Study of Palbociclib (PD-0332991) in Patients with Tumors with CCND1, 2, 3 Amplification and Rb Protein Expression by IHC (CTMS# 16-0067)
        Description
        The purpose of this study is to test any good and bad effects of the study drug, palbociclib, in patients whose cancer has CCND1, 2 or 3 amplification and tested positive for a protein called Rb protein.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
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      •   Molecular Analysis for Therapy Choice (MATCH) / MATCH Treatment Subprotocol...
        Protocol No.
        HSC20170176HU
        Official Title
        Molecular Analysis for Therapy Choice (MATCH) / MATCH Treatment Subprotocol H: EAY131-H: Phase II Study of Dabrafenib and Trametinib in Patients with Tumors with BRAF V600E or V600K Mutations (Excluding Melanoma, Thyroid Cancer, and Colorectal Adenocarcinoma) (CTMS# 15-2083)
        Description
        Primary Objective To evaluate the proportion of patients with objective response (OR) to targeted study agent(s) in patients with advanced refractory cancers/lymphomas. Secondary Objectives To evaluate the proportion of patients alive and progression free at 6 months of treatment with targeted study agent in patients with advanced refractory cancers/lymphomas. To evaluate time until death or disease progression. To identify potential predictive biomarkers beyond the genomic alteration by which treatment is assigned or resistance mechanisms using additional genomic, RNA and protein-based assessment platforms.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   Molecular Analysis for Therapy Choice (NCI-MATCH)
        Protocol No.
        HSC20150719XT
        Official Title
        EAY131, Molecular Analysis for Therapy Choice (MATCH) (CTMS# 15-2080)
        Description
        Primary Objective To evaluate the proportion of patients with objective response (OR) to targeted study agent(s) in patients with advanced refractory cancers/lymphomas. Secondary Objectives To evaluate the proportion of patients alive and progression free at 6 months of treatment with targeted study agent in patients with advanced refractory cancers/lymphomas. To evaluate time until death or disease progression. To identify potential predictive biomarkers beyond the genomic alteration by which treatment is assigned or resistance mechanisms using additional genomic, RNA and protein-based assessment platforms.
        Contact
        410-450-5798
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   NRG-HN003, A PHASE I AND EXPANSION COHORT STUDY OF ADJUVANT CISPLATIN,...
        Protocol No.
        HSC20170206HU
        Official Title
        NRG-HN003, A PHASE I AND EXPANSION COHORT STUDY OF ADJUVANT CISPLATIN, INTENSITY-MODULATED RADIOTHERAPY, AND MK-3475 (PEMBROLIZUMAB) IN HIGH-RISK HEAD AND NECK SQUAMOUS CELL CARCINOMA (HNSCC) (CTMS# 17-0022)
        Description
        Primary Outcome Measures: DLT in patients with high-risk head and neck squamous cell carcinoma treated with adjuvant cisplatin, IMRT, and pembrolizumab [ Time Frame: Up to 4 weeks post IMRT ] Will be summarized using proportions for binary outcome per cohort.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
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      •   Phase I Clinical Trial of Camptothecin-20-O-Propionate hydrate (CZ48) (CTMS#...
        Protocol No.
        HSC20150748HU
        Official Title
        Phase I Clinical Trial of Camptothecin-20-O-Propionate hydrate (CZ48) (CTMS# 15-2103)
        Description
        PRIMARY: To describe the dose limiting toxicities and adverse event profile of Camptothecin-20-O-Propionate hydrate (CZ48) administered orally every day. To determine Phase II recommended dose of Camptothecin-20-O-Propionate hydrate (CZ48) administered orally every day. SECONDARY: To perform a pharmacokinetic study of orally administered CZ48. To assess responses by RECIST criteria when applicable. To follow patients for survival.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
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      •   Phase I study of carfilzomib in combination with cyclophosphamide and...
        Protocol No.
        HSC20160206HU
        Official Title
        Phase I study of carfilzomib in combination with cyclophosphamide and etoposide for children with relapsed and refractory solid tumors and leukemias (CTMS# 15-2097)
        Description
        Primary Objective: To determine the DLTs and MTD of carfilzomib given in combination with cyclophosphamide and etoposide in pediatric patients with relapsed/refractory leukemias and solid tumors Secondary Objectives: 1. To evaluate toxicities of carfilzomib in the pediatric population when combined with conventional chemotherapy 2. To gather preliminary efficacy data on the drug combination 3. To measure if circulating plasma proteasome (cProt) levels post treatment correlate with response to therapy and overall survival 4. To measure if the levels of proteasome activity and resistance to carfilzomib correlates with toxicity and/or response to treatment. 5. To measure if inhibition of proteasome activity by carfilzomib results in alteration in a number of autophagy and apoptosis related proteins, providing means to evaluate correlates of activity of carfilzomib. 6. To measure the level of proteasome inhibition in patient PBMCs before and during treatment by determination of the level of protein ubiquitination. 7. To determine in vitro sensitivity of patient leukemias and solid tumors to carfilzomib alone and in combination with study chemotherapeutic agents in order to generate a predictive model of drug sensitivity. 8. To expand patient leukemia and solid tumor samples in order to save tissue for future studies but also to serve as a pre-clinical in vivo model to be included in the generation and testing of a drug sensitivity predictive model. 9. To perform whole exome sequencing (WES) and RNA seq on patient leukemia and solid tumor samples and WES on germ line DNA in order to determine potential mechanisms of drug sensitivity or resistance as well as contribute to testing a computer `learning engine (Bionet) for predicting clinical responses from genomic and drug sensitivity data.
        Contact
        210-562-9149
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
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      •   Phase Ib, open-label, multi-center study to characterize the safety,...
        Protocol No.
        HSC20160552HU
        Official Title
        Phase Ib, open-label, multi-center study to characterize the safety, tolerability and pharmacodynamics (PD) of PDR001 in combination with LCL161, everolimus (RAD001) or panobinostat (LBH589) (CTMS# 16-0058)
        Description
        Primary Objectives: To characterize the safety and tolerability of PDR001 in combination with LCL161, everolimus (RAD001) or panobinostat (LBH589) and to identify recommended doses and schedules for future studies Secondary Objectives: To characterize changes in the immune infiltrate in tumors To further characterize the safety of PDR001 in combination with LCL161, everolimus or panobinostat (LBH589) To estimate the anti-tumor activity of PDR001 in combination with LCL161, everolimus or panobinostat (LBH589) To characterize the pharmacokinetics of all study drugs in combination To assess immunogenicity of PDR001
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   Phase II Trial of Eribulin and Lenvatinib in Advanced Solid Tumors (CTMS#...
        Protocol No.
        HSC20150891HU
        Official Title
        Phase II Trial of Eribulin and Lenvatinib in Advanced Solid Tumors (CTMS# 15-2139)
        Description
        The overall purpose of this study is to determine the overall response rate, efficacy and safety of the combination of eribulin and Lenvatinib.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
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      •   Prognostic and predictive markers in patients with advanced metastatic tumors
        Protocol No.
        HSC20130219H
        Official Title
        Numeration and Single-Cell Molecular Profiling of Circulating Tumor Cells as Prognostic and Predictive Marker In Patients with Advanced Metastatic Tumors (CTRC#13-0001)
        Description
        This study will research possible associations between circulating tumor cells (CTC) quantities or gene profile characteristics and clinical outcomes. The primary objective is to obtain blood samples from participants over an 8-week period for research analysis.  The study will enroll approximately 200 patients at the CTRC. In addition to other conditions for enrollment, eligible patients have advanced metastatic cancer.
        Contact
        210-450-5798
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   Prospective Comparative Effectiveness Trial for Malignant Bowel Obstruction...
        Protocol No.
        HSC20170491HU
        Official Title
        Prospective Comparative Effectiveness Trial for Malignant Bowel Obstruction (CTMS# 17-0081)
        Description
        Number of days alive and outside the hospital
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
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      •   S1609, Dart: Dual Anti-CTLA-4 and Anti-PD-1 Blockage in Rare Tumors (CTMS#...
        Protocol No.
        HSC20170145HU
        Official Title
        S1609, Dart: Dual Anti-CTLA-4 and Anti-PD-1 Blockage in Rare Tumors (CTMS# 17-0013)
        Description
        Primary Objective To evaluate the RECIST 1.1 overall response rate (ORR) in subsets of patients with advanced rare cancers treated with ipilimumab plus nivolumab combination immunotherapy. Secondary Objectives To evaluate toxicities in each cohort. To estimate overall survival (OS), progression-free survival (PFS), clinical benefit rate; and to estimate immune-related ORR (irORR), and immune-related PFS (irPFS) by unidimensional immune-related response criteria. To collect specimens for banking for use in future correlative biomarker research studies.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
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      •   Safety, Tolerability & PK of KX2-361 in Subjects with advanced malignancies...
        Protocol No.
        HSC20150481HU
        Official Title
        A Phase 1 Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetics of KX2-361 in Subjects with Advanced Malignancies that are Refractory to Conventional Therapies (CTMS# 15-2063)
        Description
        Study Objectives: Primary Objective: To define the maximum tolerated dose (MTD) of KX2-361 in subjects with advanced refractory malignancies when administered as single and multiple oral doses. Secondary Objectives: To determine the safety and tolerability of KX2-361 after single and multiple oral doses, in subjects with advanced refractory malignancies. To characterize the pharmacokinetic profile of KX2-361 after single and multiple oral doses. To evaluate the activity of KX2-361 in both the Dose Escalation Cohort and the Expansion Cohort of subjects with high-grade glioma.
        Contact
        210-450-5798
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   Study of the Genetic Epidemiology of Childhood Cancer
        Protocol No.
        HSC20080057H
        Official Title
        Study of the Genetic Epidemiology of Childhood Cancer
        Description
        Study of the Genetic Epidemiology of Childhood Cancer
        Contact
        210-562-9123
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
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    •   Cervix

      •   A Dose Regimen-Finding Study to Evaluate the Safety, Tolerability,...
        Protocol No.
        HSC20170102HU
        Official Title
        A Dose Regimen-Finding Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Activity of Oradoxel Monotherapy in Subjects with Advanced Malignancies (CTMS# 16-0069)
        Description
        Primary Objective: To determine the maximum tolerated dose (MTD) of Oradoxel based on dose-limiting toxicity (DLT) in subjects with advanced malignancies Secondary Objectives To determine the safety and tolerability of docetaxel as Oradoxel To determine the incidence of unacceptable toxicity with Oradoxel To determine the recommended Phase 2 dose (RP2D) of docetaxel as Oradoxel To characterize the pharmacokinetic (PK) profile of docetaxel as Oradoxel To evaluate tumor response
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
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      •   A Dose Regimen-Finding Study to Evaluate the Safety, Tolerability,...
        Protocol No.
        HSC20160087HU
        Official Title
        A Dose Regimen-Finding Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Activity of Oraxol in Subjects with Advanced Malignancies (CTMS# 15-2137)
        Description
        Primary Objective To determine the maximum tolerated dose (MTD) and dosing regimen of Oraxol in subjects with advanced malignancies Secondary Objectives To determine the recommended Phase 2 dose of paclitaxel as Oraxol To determine the safety and tolerability of paclitaxel as Oraxol To characterize the pharmacokinetic (PK) profile of paclitaxel as Oraxol To evaluate the tumor response
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   A Phase 1 Dose Escalation and Cohort Expansion Study of TSR-042, an...
        Protocol No.
        HSC20170110HU
        Official Title
        A Phase 1 Dose Escalation and Cohort Expansion Study of TSR-042, an anti-PD-1 Monoclonal Antibody, in Patients with Advanced Solid Tumors (CTMS# 16-0091)
        Description
        Primary Objectives: Part 1 Dose Escalation Cohorts: To evaluate the safety and tolerability of TSR-042 using Common Terminology Criteria for Adverse Events (CTCAE v.4.03) in patients with advanced solid tumors Part 2 Expansion Cohorts: To evaluate the antitumor activity of TSR-042 in patients with advanced solid tumors, in terms of objective response rate (ORR) as assessed by the Investigators using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 Part 1 and Part 2: To define the recommended Phase 2 dose (RP2D) and schedule Secondary Objectives: Part 1 Dose Escalation Cohorts: To characterize the pharmacodynamic (PDy) profile of TSR-042 To evaluate ORR as assessed by the Investigators using RECIST v1.1 Part 2 Expansion Cohorts: To characterize the safety and tolerability of TSR-042 using CTCAE v.4.03 Part 1 and Part 2: To characterize the pharmacokinetic (PK) profile of TSR-042 To evaluate the immunogenicity of TSR-042 To evaluate additional measures of clinical benefit, including: ORR by immune-related RECIST (irRECIST) Duration of response (DOR) by RECIST v 1.1 Disease control rate (DCR) by RECIST v 1.1 and by irRECIST Progression-free survival (PFS) by RECIST v 1.1 and by irRECIST Overall survival (OS)
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   A Phase 1 Study of CBL0137 in Patients with Metastatic or Unresectable...
        Protocol No.
        HSC20130328H
        Official Title
        A Phase 1 Trial of CBL0137 In patients With Metastatic or Unresectable Advanced Solid Neoplasms or Refractory Lymphomas (CTRC# 13-0031)
        Description
        This Phase 1 study is designed to determine the best dose of CBL0137 to use when treating patients with metastatic or unresectable advanced solid tumors or lymphoma. The study will enroll up to 48 patients from at least 2 cancer centers in the US. In addition to other conditions for enrollment, eligible patients have cancer that has not improved or has come back after prior treatment and are otherwise in good health. Patients who have a history of active infection, cancer involving the central nervous system, a particular EKG abnormality or other serious medical conditions may not be eligible to enroll.
        Contact
        210-450-5798
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
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      •   A Phase 1/2A, Multicenter, Open-Label Study of LYC-55716 in Adult Subjects...
        Protocol No.
        HSC20160617HU
        Official Title
        A Phase 1/2A, Multicenter, Open-Label Study of LYC-55716 in Adult Subjects with Locally Advanced or Metastatic Cancer (CTMS# 16-0099)
        Description
        Primary Objectives Phase 1 Evaluate the safety and tolerability of LYC-55716 Determine the maximum tolerated dose (MTD) and the recommended Phase 2 dose (RP2D) Phase 2a Determine the objective response rate according to response evaluation criteria in solid tumors (RECIST) v1.1 Secondary Objectives Phase 1 Evaluate the activity of LYC-55716 by objective response according to RECIST v1.1 Determine the durability of any observed objective response Phase 2a Determine the duration of response Determine progression-free survival (PFS) and overall survival (OS) Determine suitability of the RP2D for further study Characterize the pharmacokinetics (PK) of LYC-55716 Exploratory Objectives Assess tumor activity in subjects with locally advanced or metastatic cancer according to immune-related response evaluation criteria in solid tumors (irRECIST) Exploratory analysis of metabolite in plasma Assess changes in circulating tumor markers (eg, cytokines/chemokines)
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
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      •   A Phase 1b Study of Oraxol in Combination with Ramucirumab in Patients with...
        Protocol No.
        HSC20170188HU
        Official Title
        A Phase 1b Study of Oraxol in Combination with Ramucirumab in Patients with Gastric, Gastro-esophageal, or Esophageal Cancers (CTMS# 16-0089)
        Description
        Primary Objective: To determine the maximum tolerated dose (MTD) of Oraxol in patients with advanced stage gastric, gastro-esophageal, or esophageal cancers who are being treated with Oraxol in combination with ramucirumab Secondary Objectives: To determine the safety and tolerability of Oraxol in combination with ramucirumab To determine the recommended Phase 2 dose of Oraxol in combination with ramucirumab To characterize the pharmacokinetic (PK) profile of Oraxol in combination with ramucirumab To characterize preliminary activity of Oraxol plus ramucirumab as determined by response rate, progression-free survival, and overall survival
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
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      •   A Phase 1b/2 Study of ARRY-382 in Combination with Pembrolizumab, a...
        Protocol No.
        HSC20170071HU
        Official Title
        A Phase 1b/2 Study of ARRY-382 in Combination with Pembrolizumab, a Programmed Cell Death Receptor 1 (PD-1) Antibody, for the Treatment of Patients with Advanced Solid Tumors (CTMS# 16-0084)
        Description
        Primary objective: To determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of ARRY-382 in combination with pembrolizumab in patients with selected solid tumors Secondary objectives:  To describe the preliminary antitumor activity of the combination based on the Response Criteria In Solid Tumors, version 1.1 (RECIST v1.1).  To describe the preliminary antitumor activity of the combination based on immune-related response criteria (irRC).  To characterize the safety and tolerability of the combination, including acute and chronic toxicities. To evaluate the pharmacokinetics of ARRY-382 in combination with pembrolizumab Exploratory objective: To explore the effect of the combination on circulating biomarkers of immune response. To describe the preliminary antitumor activity of the combination in patients with PD-L1 positive non-small cell lung cancer (NSCLC), as determined using a United States Food and Drug Administration (FDA)-approved test, using RECIST. To describe the preliminary antitumor activity of the combination in patients with PD-L1 positive non-small cell lung cancer (NSCLC), as determined using an FDA approved test, using irRC
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
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      •   A Phase I, First-in-human, Open-label, Dose-escalation, Safety,...
        Protocol No.
        HSC20160554HU
        Official Title
        A Phase I, First-in-human, Open-label, Dose-escalation, Safety, Pharmacokinetic, and Pharmacodynamic Study of Oral TP-0903 Administered Daily for 21 Days to Patients with Advanced Solid Tumors (CTMS# 16-0092)
        Description
        Primary Objective: To determine the maximum tolerated dose (MTD) and dose-limiting toxicities (DLTs) of oral TP-0903 administered daily for the first 21 days every 4 weeks, over a range of doses in patients with advanced solid tumors. Secondary Objectives: To establish the pharmacokinetics of orally administered TP-0903 To observe patients for any evidence of antitumor activity of TP-0903 by objective radiographic assessment To study the pharmacodynamics of TP-0903 therapy by: assessing biomarkers in tumor tissue assessing biomarkers in peripheral blood mononuclear cells (PBMCs) and serum To establish the Recommended Phase 2 Dose (RP2D) for future studies with TP-0903
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
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      •   A Phase I, Multicenter, Open-Label Dose Escalation and Expansion Study of...
        Protocol No.
        HSC20150289HU
        Official Title
        A Phase I, Multicenter, Open-Label Dose Escalation and Expansion Study of PCA062, Administered Intravenously In Adult Patients With pCAD-Positive Tumors (CTMS# 14-2019)
        Description
        Primary Objective To determine the MTD/RDE of PCA062 in patients with pCAD-positive tumors in the dose escalation part. Secondary Objectives To characterize the safety and tolerability of PCA062 To characterize the pharmacokinetic profile of PCA062 To assess emergence of anti-PCA062 antibodies following one or more intravenous infusions of PCA062 To assess the preliminary anti-tumor activity of PCA062 in patients with pCAD-positive triple negative breast cancer (TBNC), head and neck squamous cell carcinoma (HNSCC) or esophageal cancer (squamous and adenocarcinoma)
        Contact
        210-450-5798
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   A Phase I/II, open label, multicenter study of the safety and efficacy of...
        Protocol No.
        HSC20150421HU
        Official Title
        A Phase I/II, open label, multicenter study of the safety and efficacy of LAG525 single agent and in combination with PDR001 administered to patients with advanced malignancies (CTMS #15-2054)
        Description
        Primary Objectives Phase I part To estimate the RP2D or MTD for the single agent LAG525 and the combination of LAG525 and PDR001. Phase II part To estimate the overall response rate per RECIST V1.1 for single agent LAG525 as well as for the combination of LAG525 and PDR001 Secondary Objectives: To characterize the safety and tolerability of single agent LAG525 given alone and in combination with PDR001 To characterize the pharmacokinetic profile of single agent LAG525 given alone and in combination with PDR001 To assess emergence of anti-LAG525, and anti-PDR001 antibodies following one or more intravenous (i.v.) infusions of single agent LAG525 given alone or in combination with PDR001 To assess potential predictors of efficacy of single agent LAG525 and the combination of LAG525 and PDR001 To evaluate the preliminary antitumor activity of single agent LAG525 given alone or in combination of PDR001 To investigate patient selection and pharmacodynamic biomarkers in tumor tissue samples
        Contact
        210-450-5798
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
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      •   A Phase I/II, Open-Label, Multi-Center Study of the Safety and Efficacy of...
        Protocol No.
        HSC20160420HU
        Official Title
        A Phase I/II, Open-Label, Multi-Center Study of the Safety and Efficacy of BLZ945 as Single Agent and In Combination with PDR001 in Adult Patients with Advanced Solid Tumors (CTMS# 16-0071)
        Description
        Primary Objective: Phase I: To characterize the safety and tolerability of BLZ945 as a single agent and in combination with PDR001 and to identify the Maximum Tolerated Dose (MTD)/Recommended Phase 2 Dose (RP2D). Phase II: To assess the anti-tumor activity of BLZ945 in combination with PDR001 (and as single agent if appropriate) in patients with advanced solid tumors. Secondary Objective: Phase I: To characterize the pharmacodynamics effect of BLZ945 as a single agent and in combination with PDR001. To characterize PK of BLZ945 as a single agent and in combination with PDR001. To assess the preliminary anti-tumor activity of BLZ945 as single agent and in combination with PDR001. Phase I and II: To assess emergence of anti-PDR001 antibodies when BLZ945 is administered in combination with PDR001.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
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      •   A Phase Ib Trial of Pembrolizumab (MK-3475) in Combination with Dinaciclib...
        Protocol No.
        HSC20170106HU
        Official Title
        A Phase Ib Trial of Pembrolizumab (MK-3475) in Combination with Dinaciclib (MK-7965) in Subjects with Hematologic Malignancies (KEYNOTE-155) (CTMS# 16-0009)
        Description
        Primary Objective Objective: In both the Dose Evaluation and Signal Detection phases, evaluate the safety and tolerability of the treatment combination. Objective: Within each disease type of the Signal Detection phase, evaluate objective response rate (ORR) according to investigator assessment using the disease specific criteria. Secondary Objective: Objective: To evaluate the Objective Response Rate (ORR; complete response [CR] + partial response [PR]) of the combination of pembrolizumab and dinaciclib within each disease type, ie, CLL based on iwCLL guidelines (Hallek, 2008) [1], MM based on IMWG criteria (Durie, 2006) [2] and DLBCL based on the Revised Response Criteria for Malignant Lymphoma (Cheson, 2007) [3]. Objective: Within each disease type of the Signal Detection phase, evaluate Duration of Response (DOR), Progression-Free Survival (PFS) according to investigator assessment using the disease specific criteria; and Overall Survival (OS).
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   ABTR01B1, A Children''s Oncology Group Protocol for Collecting and Banking...
        Protocol No.
        HSC20040131H
        Official Title
        ABTR01B1, A Children''s Oncology Group Protocol for Collecting and Banking Pediatric Research Specimens Including Rare Pediatric Tumors
        Description
        This study is collecting and storing malignant, borderline malignant neoplasms, and related biological samples from young patients with cancer. Collecting and storing samples of tumor tissue, blood, and bone marrow from patients with cancer to study in the laboratory may help the study of cancer in the future.
        Contact
        210-562-9149
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
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      •   ACCL15N1CD Use of Evidence-Based Supportive Care Clinical Practice...
        Protocol No.
        HSC20160673X
        Official Title
        ACCL15N1CD Use of Evidence-Based Supportive Care Clinical Practice Guidelines in Pediatric
        Description
        Primary and Secondary Aims Aim 1: Chart Review To measure the rate of adherence to selected COG-endorsed supportive care CPG recommendations at NCORP sites Aim 1a To describe the possible influence of NCORP site size and the number of patients enrolled in COG studies per site on the delivery of CPG-consistent care. Aim 1b To describe the clinical outcome of episodes during which patients receive CPG-consistent or CPG-inconsistent care Aim 2: Focus Groups To describe facilitators of and barriers to the use of CPGs elicited via focus group interviews with a diverse set of potential users (physician, nurse, nurse practitioner and pharmacists) who provide pediatric cancer care at NCORP sites. Aim 3: Interviews To improve how well CPG recommendations are understood by health care providers by refining the CPG recommendation format based on an iterative process of cognitive interviewing and formatting revisions. Understanding is defined as the correct interpretation of the course of action recommended or suggested by a CPG.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   ACCRN07 Protocol for the Enrollment on the Official COG Registry, The...
        Protocol No.
        HSC20080271X
        Official Title
        ACCRN07 Protocol for the Enrollment on the Official COG Registry, The Childhood Cancer Research Network (CCRN)
        Description
        The Children s Oncology Group has established a research network, the Childhood Cancer Research Network (CCRN), to collect information about children with cancer and other conditions that are benign but involve abnormal cell growth in order to help doctors and scientists better understand childhood cancer. The CCRN''s goal is to collect clinical information about every child diagnosed with cancer and similar conditions in the United States and Canada, to allow researchers to study patterns, characteristics, and causes of childhood cancer. The information can also help researchers study the causes of childhood cancer. To expand the CCRN, parents of children who have been diagnosed with cancer will be asked to provide information about themselves and their child for research purposes.   Objectives: To obtain informed consent from parents (and the child, when appropriate) of infants, children, adolescents, and young adults newly diagnosed with cancer to enter their names and certain information concerning their child into the Childhood Cancer Research Network. To obtain informed consent from parents (and the child, when appropriate) of infants, children, adolescents, and young adults newly diagnosed with cancer for permission to be contacted in the future to consider participating in non-therapeutic and prevention research studies involving the parents and/or the child.
        Contact
        210-562-9149
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
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      •   Adolescent and Young Adult Childhood Cancer Survivorship (CTMS#17-0088)
        Protocol No.
        HSC20170474HU
        Official Title
        Adolescent and Young Adult Childhood Cancer Survivorship (CTMS#17-0088)
        Description
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   ALTE05N1, Umbrella Long-Term Follow-Up Protocol
        Protocol No.
        HSC20090478X
        Official Title
        ALTE05N1, Umbrella Long-Term Follow-Up Protocol
        Description
        Umbrella Long-Term Follow-Up Protocol
        Contact
        210-562-9149
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   ALTE1621 Pharmacologic Reversal of Ventricular Remodeling in Childhood...
        Protocol No.
        HSC20160394X
        Official Title
        ALTE1621 Pharmacologic Reversal of Ventricular Remodeling in Childhood Cancer Survivors at Risk for Heart Failure (PREVENT-HF): A Phase 2b Randomized Placebo-Controlled (Carvedilol) Trial
        Description
        1.1 Primary Aim To determine the impact of a two-year course of low-dose carvedilol on surrogate echocardiographic indices of heart failure (HF) risk, including Left Ventricular (LV) Posterior Wall Thickness-Dimension Ratio (LV T-D) a well-established index of early myocardial remodeling and subsequent HF risk (primary endpoint).  LV systolic and diastolic function and afterload established echocardiographic indices associated with HF risk.  Natriuretic peptides, troponins, and Galectin-3 - circulating biomarkers associated with myocardial injury, and HF risk. 1.2 Secondary Aims 1.2.1 To establish safety and tolerability of this two-year course of low-dose carvedilol, assessing both objective measures (hepatic function) and patient reported outcomes. 1.2.2 To examine the modifying effect of demographic, clinical, and molecular characteristics on the risk: benefit ratio from this two-year carvedilol intervention. 1.3 Exploratory Aim To evaluate the long-term efficacy of carvedilol in preventing cardiomyopathy and/or heart failure in high-risk childhood cancer survivors.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   AN EARLY-PHASE, MULTICENTER, OPEN-LABEL STUDY OF THE SAFETY AND...
        Protocol No.
        HSC20150549H
        Official Title
        AN EARLY-PHASE, MULTICENTER, OPEN-LABEL STUDY OF THE SAFETY AND PHARMACOKINETICS OF ATEZOLIZUMAB (MPDL3280A) IN PEDIATRIC AND YOUNG ADULT PATIENTS WITH PREVIOUSLY TREATED SOLID TUMORS
        Description
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   An Open-Label Rollover Study to Evaluate the Long-Term Safety, Tolerability,...
        Protocol No.
        HSC20170197XT
        Official Title
        An Open-Label Rollover Study to Evaluate the Long-Term Safety, Tolerability, Biological Activity of Oral TVB-2640 in Patients With Solid Tumors Previously Enrolled in 3V2640-CLIN-002 (CTMS# 17-0046)
        Description
        Primary: To continue to characterize the safety profile of TVB-2640. Secondary: To identify any early signs of anti-tumor activity, where possible.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   An Open-Label, Dose Escalation, Phase 1, First-In-Human Study of TAK-659 in...
        Protocol No.
        HSC20150255HU
        Official Title
        An Open-Label, Dose Escalation, Phase 1, First-In-Human Study of TAK-659 in Adult Patients with Advanced Solid Tumors and Lymphoma Malignancies (CTMS# 14-2013)
        Description
        To determine the safety, tolerability, maximum tolerated dose (MTD)/recommended phase 2 dose (RP2D) ofTAK-659 administered orally on a daily dosing schedule in patients with advanced solid tumor and lymphoma who do not have effective standard treatment available
        Contact
        210-450-5798
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
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      •   APEC14B1, THE PROJECT: EVERYCHILD PROTOCOL: A REGISTRY, ELIGIBILITY...
        Protocol No.
        HSC20150870XT
        Official Title
        APEC14B1, THE PROJECT: EVERYCHILD PROTOCOL: A REGISTRY, ELIGIBILITY SCREENING, BIOLOGY AND OUTCOME STUDY
        Description
        1.1 To maintain a Childhood Cancer Registry1 for infants, children, adolescents, and young adults with cancer. 1.2 To utilize clinical and biological data to help determine eligibility or stratification, based on childhood cancer disease classification schemas, for potential enrollment of research subjects onto COG therapeutic clinical trials. 1.3 To develop a well annotated childhood cancer biorepository for current and future research through the collection of biospecimens (at diagnosis, time of progression, time of recurrence and/or post-mortem), including tumor, host and when feasible parental germline DNA; and key clinical data, including presentation, diagnostic, staging, summary treatment, and outcome information, from every child diagnosed with cancer at COG institutions. 1.4 To allow use of registry data for permission to be contacted in the future to consider participating in non-therapeutic and prevention research studies involving the child or their parents.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   Cancer Therapy and Research Center''s Institute for Drug Development Solid...
        Protocol No.
        HSC20070684H
        Official Title
        Cancer Therapy and Research Center''s Institute for Drug Development Solid Tumors and Hematological Malignancies Biorepository for Biomarker Discovery
        Description
        Samples are collected for the Cancer Therapy and Research Center''s Solid Tumors and Hematological Malignancies Biorepository for Biomarker Discovery
        Contact
        210-450-5798
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   Caris Molecular Intelligence® and Caris Centers of Excellence for...
        Protocol No.
        HSC20170144HU
        Official Title
        Caris Molecular Intelligence® and Caris Centers of Excellence for Precision Medicine NetworkTM Retrospective Outcomes-Associated Database (CTMS# 16-0145)
        Description
        The objective of this project is the development of the Caris Molecular Intelligence® and Caris Centers of Excellence for Precision Medicine NetworkTM Outcomes Associated Repository, a disease research database (hereinafter referred to as the Database ) for the purpose of: 1. Effecting change in disease treatment processes by advancing precision medicine and improving care for cancer through acquiring and sharing valuable molecular tumor profiling information and clinical outcomes in a collaborative, secure environment. 2. Performing prospective research studies involving analyses of quality of life studies as well as subject medical records including clinical presentation and outcomes. This eligible cohort includes select subjects having undergone Caris Molecular Intelligence® evaluation for diagnosis and/or treatment management. 3. Evaluate the frequency of specific clinical events in relation to risk factors, diagnosis and treatments provided via the collection of outcomes data through automated data capture systems provided by a third-party data entity and manually-entered data when needed. 4. Provide information access that is vital to research collaborators, including potential researchers from pharmaceutical companies, governmental agencies, academia, healthcare providers, and payors, with catalogued subject outcome data for the use of drug development discoveries, clinically relevant research trials, publications and posters, the implementation of future healthcare policies, characterization of trends in practice patterns and their relation to subject outcomes and the economic impact of differing evaluation, treatment, and management paradigms. 5. Cultivate a repository for assay development and validation of emerging technologies to enhance clinical cancer care.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   Caris Molecular Intelligence® and Caris Centers of Excellence for Precision...
        Protocol No.
        HSC20170353HU
        Official Title
        Caris Molecular Intelligence® and Caris Centers of Excellence for Precision Medicine NetworkTM Outcomes Associated Repository (CTMS# 17-0023)
        Description
        The objective of this project is the development of the Caris Molecular Intelligence® and Caris Centers of Excellence for Precision Medicine NetworkTM Outcomes Associated Repository, a disease research database (hereinafter referred to as the Database) for the purpose of: 1. Effecting change in disease treatment processes by advancing precision medicine and improving care for cancer through acquiring and sharing valuable molecular tumor profiling information and clinical outcomes in a collaborative, secure environment. 2. Performing prospective research studies involving analyses of quality of life studies as well as subject medical records including clinical presentation and outcomes. This eligible cohort includes select subjects having undergone Caris Molecular Intelligence® evaluation for diagnosis and/or treatment management. 3. Evaluate the frequency of specific clinical events in relation to risk factors, diagnosis and treatments provided via the collection of outcomes data through automated data capture systems provided by a third-party data entity and manually-entered data when needed. 4. Provide information access that is vital to research collaborators, including potential researchers from pharmaceutical companies, governmental agencies, academia, healthcare providers, and payors, with catalogued subject outcome data for the use of drug development discoveries, clinically relevant research trials, publications and posters, the implementation of future healthcare policies, characterization of trends in practice patterns and their relation to subject outcomes and the economic impact of differing evaluation, treatment, and management paradigms. 5. Cultivate a repository for assay development and validation of emerging technologies to enhance clinical cancer care.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   Clinical Trial of Lurbinectedin (PM01183) in Selected Advanced Solid Tumors
        Protocol No.
        HSC20150542HU
        Official Title
        A Multicenter Phase II Clinical Trial of Lurbinectedin (PM01183) in Selected Advanced Solid Tumors (CTMS# 15-2071)
        Description
        Primary: To assess the antitumor activity of lurbinectedin (PM01183) in terms of overall response rate (ORR), according to the Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1, in the following advanced solid tumors: small cell lung cancer (SCLC), head and neck carcinoma (H&N), neuroendocrine tumors (NETs), biliary tract carcinoma, endometrial carcinoma, BRCA 1/2-associated metastatic breast carcinoma, carcinoma of unknown primary site, germ cell tumors (GCTs), and Ewing¿s family of tumors (EFTs). Secondary: To further characterize the antitumor activity of PM01183 in terms of duration of response (DR), clinical benefit [ORR or stable disease (SD) lasting over four months (SD ¿ 4 months)], progression-free survival (PFS), and one year overall survival (1y-OS) in each cohort of advanced solid tumors. Characterize the plasma pharmacokinetics (PK) of PM01183. To conduct an exploratory pharmacogenomic (PGx) and pharmacogenetic analysis. To evaluate the safety profile of PM01183 in this patient population.
        Contact
        410-450-5798
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   Clinical trial to study the safety and efficacy of MBG453 given alone and in...
        Protocol No.
        HSC20150730HU
        Official Title
        A Phase I-Ib/II, Open-Label, Multi-Center Study of the Safety and Efficacy of MBG453 as Single Agent and in Combination with PDR001 in Adult Patients with Advanced Malignancies (CTMS# 15-2114)
        Description
        Primary Objectives: Phase I-Ib: To characterize the safety and tolerability of MBG453 as a single agent and in combination with PDR001 and to identify recommended doses for future studies. Phase I-Ib dose ranging: To further investigate the safety and tolerability of different doses of MBG453 alone or in combination with PDR001. Phase II: To estimate the anti-tumor activity of MBG453 alone in patients with solid tumors, and in combination with PDR001 in selected disease indications (melanoma, non-small cell lung cancer (NSCLC), renal cell carcinoma (RCC)). Secondary Objectives Evaluate the preliminary anti-tumor activity of MBG453 alone and in combination with PDR001. Make an initial comparison of safety, PK and efficacy for MBG453 and PDR001 administered in combination on a every 2 weeks (Q2W) and every 4 weeks (Q4W) dosing schedules. Characterize the pharmacokinetic profile of MBG453 alone and in combination with PDR001. Assess emergence of anti-MBG453 and anti-PDR001 antibodies. Assess potential predictors of efficacy of MBG453 single agent and in combination with PDR001 in tumor samples. Assess the pharmacodynamic effect of MBG453 as single agent and in combination with PDR001 in tumor samples. Describe the survival distribution of patients treated with MBG453 as single agent and in combination with PDR001 for each disease group.
        Contact
        410-450-5798
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   Cultural Barriers to Cervical Cancer Prevention among Hispanic Women
        Protocol No.
        HSC20160050H
        Official Title
        Cultural Barriers to Cervical Cancer Prevention among Hispanic Women
        Description
        Aim 1: To identify the interactions of health literacy, culture and language as they relate to cervical cancer screening practices and behaviors among Hispanic women. Aim 2: To investigate the relationships between health literacy, demographic and social variables, sources of information and cervical cancer screening practices among Hispanic women.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   DCP-001, Use of a Clinical Trial Screening Tool to Address Cancer Health...
        Protocol No.
        HSC20160342XT
        Official Title
        DCP-001, Use of a Clinical Trial Screening Tool to Address Cancer Health Disparities in the NCI Community Oncology Research Program (NCORP)
        Description
        Objectives 1) Implement a screening tool in NCORP to collect broader demographic and clinical data to generate hypothesis and research questions in the following areas of research: cancer screening, cancer prevention, symptom science, cancer care disparities, comparative effectiveness and cancer care delivery research. 2) Collect expanded demographic and clinical data (e.g., SES, co-morbidities, method of diagnosis) across the NCORP network to help identify and best characterize patients that are screened but not enrolled and for patients that participate in NCI trials, to understand how these variables may impact outcomes. 3) Enhance an understanding of site- specific and trial-specific accrual barriers that will inform the development of effective strategies to improve accrual, particularly for minority and underserved populations. 4) Provide data for internal and external evaluation of NCORP s first RFA cycle and reissuance.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
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      •   GO29665, A PHASE I/II, MULTICENTER, OPEN-LABEL, DOSE-ESCALATION STUDY OF THE...
        Protocol No.
        HSC20160080H
        Official Title
        GO29665, A PHASE I/II, MULTICENTER, OPEN-LABEL, DOSE-ESCALATION STUDY OF THE SAFETY AND PHARMACOKINETICS OF COBIMETINIB IN PEDIATRIC AND YOUNG ADULT PATIENTS WITH PREVIOUSLY TREATED SOLID TUMORS (CTRC# 15-0005)
        Description
        CTRC#15-0005
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
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      •   Head and Neck Cancer Repository
        Protocol No.
        HSC20170218HR
        Official Title
        Head and Neck Cancer Repository
        Description
        To establish a repository of head and neck cancers and PDX models from our south Texas patient population.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   Health Effects after Anthracycline and Radiation Therapy (HEART):...
        Protocol No.
        HSC20140058X
        Official Title
        Health Effects after Anthracycline and Radiation Therapy (HEART): Dexrazoxane and Prevention of Anthracycline-related Cardiomyopathy A Limited Institution Non-Therapeutic Study
        Description
        This clinical trial studies the effects of dexrazoxane hydrochloride on biomarkers associated with cardiomyopathy and heart failure after cancer treatment. Studying samples of blood in the laboratory from patients receiving dexrazoxane hydrochloride may help doctors learn more about the effects of dexrazoxane hydrochloride on cells. It may also help doctors understand how well patients respond to treatment.
        Contact
        210-562-9149
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   Incidence and Factors Associated with the Development and Severity of Oral...
        Protocol No.
        HSC20050218H
        Official Title
        Incidence and Factors Associated with the Development and Severity of Oral Mucositis in Patients Undergoing High Dose Chemotherapy and Peripheral Stem Cell Transplantation
        Description
        Our study intends to evaluate prospectively the incidence and severity of oral mucositis in patients undergoing high-dose chemotherapy and hematopoietic stem cell transplantation, as well as to evaluate the potential influence of nutritional-, physical-, and transplant-related factors associated with the development of this complication and its grade of involvement. Research plan: This is a prospective cohort study with an observational basis that involves all of the patients undergoing high-dose chemotherapy and peripheral blood stem cell transplantation at the Audie L. Murphy VA Hospital Bone Marrow Transplant Unit and at the University Hospital Bone Marrow Transplant Unit. We expect to enroll 400 patients during a 5-year period. Methods: In order to answer the study questions, subjects will be assessed several times during the study period. The study involves a multidisciplinary group that will be evaluating and following the subjects. A baseline will be established by a physician and a nutritionist before the subjects start the high-dose chemotherapy regimen. The subjects will be followed with oral evaluations 3 times per week, beginning on the day of the transplant and ending when mucositis resolves, or the patient is discharged home, or 30 days post-transplant, whichever occurs first. At day 15 post-transplant, patients will be evaluated for the second time by the nutritionist. Further information such as blood values, use of medications and treatment complications, will be obtained by daily chart review.  
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
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      •   Los Dones - Hispanic Men''s Health Literacy Related to their female...
        Protocol No.
        HSC20160049H
        Official Title
        Los Dones - Hispanic Men''s Health Literacy Related to their female counterparts cervical cancer prevention practices
        Description
        To investigate the relationships between Hispanic men''s health literacy, demographic, social variable, sources of information, and their female counterpart cervical cancer prevention practices
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   MATCH Treatment Subprotocol B: Phase II Study of Afatinib in Patients with...
        Protocol No.
        HSC20150831HU
        Official Title
        MATCH Treatment Subprotocol B: Phase II Study of Afatinib in Patients with Tumors with HER2 Activating Mutations (CTMS# 15-2107)
        Description
        Primary Objective To evaluate the proportion of patients with objective response (OR) to targeted study agent(s) in patients with advanced refractory cancers/lymphomas. Secondary Objectives To evaluate the proportion of patients alive and progression free at 6 months of treatment with targeted study agent in patients with advanced refractory cancers/lymphomas. To evaluate time until death or disease progression. To identify potential predictive biomarkers beyond the genomic alteration by which treatment is assigned or resistance mechanisms using additional genomic, RNA and protein-based assessment platforms.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   MATCH Treatment Subprotocol C1: EAY131-C1: Crizotinib in Patients with...
        Protocol No.
        HSC20160463HU
        Official Title
        MATCH Treatment Subprotocol C1: EAY131-C1: Crizotinib in Patients with Tumors with MET Amplification (CTMS# 16-0064)
        Description
        The purpose of this study is to test any good and bad effects of the study drug called crizotinib in patients whose cancer has MET genetic changes.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   MATCH Treatment Subprotocol F: Crizotinib in Patients with Tumors (other...
        Protocol No.
        HSC20150750HU
        Official Title
        MATCH Treatment Subprotocol F: Crizotinib in Patients with Tumors (other than adenocarcinoma of lung or ALCL) with ALK Translocations (CTMS# 15-2081)
        Description
        Primary Objective To evaluate the proportion of patients with objective response (OR) to targeted study agent(s) in patients with advanced refractory cancers/lymphomas. Secondary Objectives To evaluate the proportion of patients alive and progression free at 6 months of treatment with targeted study agent in patients with advanced refractory cancers/lymphomas. To evaluate time until death or disease progression. To identify potential predictive biomarkers beyond the genomic alteration by which treatment is assigned or resistance mechanisms using additional genomic, RNA and protein-based assessment platforms.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   MATCH Treatment Subprotocol S1: Phase II Study of Trametinib in Patients...
        Protocol No.
        HSC20160260HU
        Official Title
        MATCH Treatment Subprotocol S1: Phase II Study of Trametinib in Patients with Tumors with NF1 Mutations (CTMS# 16-0028)
        Description
        PRIMARY OBJECTIVES: I. To evaluate the proportion of patients with objective response (OR) to targeted study agent(s) in patients with advanced refractory cancers/lymphomas. SECONDARY OBJECTIVES: I. To evaluate the proportion of patients alive and progression free at 6 months of treatment with targeted study agent in patients with advanced refractory cancers/lymphomas. II. To evaluate time until death or disease progression. III. To identify potential predictive biomarkers beyond the genomic alteration by which treatment is assigned or resistance mechanisms using additional genomic, ribonucleic acid (RNA) and protein-based assessment platforms.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   MATCH Treatment Subprotocol U: VS-6063 (defactinib) in Patients with Tumors...
        Protocol No.
        HSC20150839HU
        Official Title
        MATCH Treatment Subprotocol U: VS-6063 (defactinib) in Patients with Tumors with NF2 Loss (CTMS# 15-2110)
        Description
        Primary Objective To evaluate the proportion of patients with objective response (OR) to targeted study agent(s) in patients with advanced refractory cancers/lymphomas. Secondary Objectives To evaluate the proportion of patients alive and progression free at 6 months of treatment with targeted study agent in patients with advanced refractory cancers/lymphomas. To evaluate time until death or disease progression. To identify potential predictive biomarkers beyond the genomic alteration by which treatment is assigned or resistance mechanisms using additional genomic, RNA and protein-based assessment platforms.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   MATCH Treatment Subprotocol W: EAY131-W: Phase II Study of AZD4547 in...
        Protocol No.
        HSC20160541HU
        Official Title
        MATCH Treatment Subprotocol W: EAY131-W: Phase II Study of AZD4547 in Patients with Tumors with Aberrations in the FGFR Pathway (CTMS# 16-0065)
        Description
        The purpose of this study is to test any good and bad effects of the study drug, AZD4547, in patients whose cancer has genetic changes called FGFR gene alterations.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   MATCH Treatment Subprotocol X: Phase II Study of Dasatinib in Patients with...
        Protocol No.
        HSC20160282HU
        Official Title
        MATCH Treatment Subprotocol X: Phase II Study of Dasatinib in Patients with Tumors with DDR2 Mutations (CTMS# 16-0032)
        Description
        PRIMARY OBJECTIVES: I. To evaluate the proportion of patients with objective response (OR) to targeted study agent(s) in patients with advanced refractory cancers/lymphomas. SECONDARY OBJECTIVES: I. To evaluate the proportion of patients alive and progression free at 6 months of treatment with targeted study agent in patients with advanced refractory cancers/lymphomas. II. To evaluate time until death or disease progression. III. To identify potential predictive biomarkers beyond the genomic alteration by which treatment is assigned or resistance mechanisms using additional genomic, ribonucleic acid (RNA) and protein-based assessment platforms.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   MATCH Treatment Subprotocol Z1A: EAY131-Z1A: Binimetinib in Patients with...
        Protocol No.
        HSC20160499HU
        Official Title
        MATCH Treatment Subprotocol Z1A: EAY131-Z1A: Binimetinib in Patients with Tumors (Other Than Melanoma) with NRAS Mutations (CTMS# 16-0066)
        Description
        The purpose of this study is to test any good and bad effects of the experimental study drug binimetinib in patients whose cancer has NRAS mutations.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   MATCH Treatment Subprotocol Z1B: EAY131-Z1B: Phase II Study of Palbociclib...
        Protocol No.
        HSC20160491HU
        Official Title
        MATCH Treatment Subprotocol Z1B: EAY131-Z1B: Phase II Study of Palbociclib (PD-0332991) in Patients with Tumors with CCND1, 2, 3 Amplification and Rb Protein Expression by IHC (CTMS# 16-0067)
        Description
        The purpose of this study is to test any good and bad effects of the study drug, palbociclib, in patients whose cancer has CCND1, 2 or 3 amplification and tested positive for a protein called Rb protein.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   Molecular Analysis for Therapy Choice (MATCH) / MATCH Treatment Subprotocol...
        Protocol No.
        HSC20170176HU
        Official Title
        Molecular Analysis for Therapy Choice (MATCH) / MATCH Treatment Subprotocol H: EAY131-H: Phase II Study of Dabrafenib and Trametinib in Patients with Tumors with BRAF V600E or V600K Mutations (Excluding Melanoma, Thyroid Cancer, and Colorectal Adenocarcinoma) (CTMS# 15-2083)
        Description
        Primary Objective To evaluate the proportion of patients with objective response (OR) to targeted study agent(s) in patients with advanced refractory cancers/lymphomas. Secondary Objectives To evaluate the proportion of patients alive and progression free at 6 months of treatment with targeted study agent in patients with advanced refractory cancers/lymphomas. To evaluate time until death or disease progression. To identify potential predictive biomarkers beyond the genomic alteration by which treatment is assigned or resistance mechanisms using additional genomic, RNA and protein-based assessment platforms.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   Molecular Analysis for Therapy Choice (NCI-MATCH)
        Protocol No.
        HSC20150719XT
        Official Title
        EAY131, Molecular Analysis for Therapy Choice (MATCH) (CTMS# 15-2080)
        Description
        Primary Objective To evaluate the proportion of patients with objective response (OR) to targeted study agent(s) in patients with advanced refractory cancers/lymphomas. Secondary Objectives To evaluate the proportion of patients alive and progression free at 6 months of treatment with targeted study agent in patients with advanced refractory cancers/lymphomas. To evaluate time until death or disease progression. To identify potential predictive biomarkers beyond the genomic alteration by which treatment is assigned or resistance mechanisms using additional genomic, RNA and protein-based assessment platforms.
        Contact
        410-450-5798
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   NRG-HN003, A PHASE I AND EXPANSION COHORT STUDY OF ADJUVANT CISPLATIN,...
        Protocol No.
        HSC20170206HU
        Official Title
        NRG-HN003, A PHASE I AND EXPANSION COHORT STUDY OF ADJUVANT CISPLATIN, INTENSITY-MODULATED RADIOTHERAPY, AND MK-3475 (PEMBROLIZUMAB) IN HIGH-RISK HEAD AND NECK SQUAMOUS CELL CARCINOMA (HNSCC) (CTMS# 17-0022)
        Description
        Primary Outcome Measures: DLT in patients with high-risk head and neck squamous cell carcinoma treated with adjuvant cisplatin, IMRT, and pembrolizumab [ Time Frame: Up to 4 weeks post IMRT ] Will be summarized using proportions for binary outcome per cohort.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
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      •   Phase I Clinical Trial of Camptothecin-20-O-Propionate hydrate (CZ48) (CTMS#...
        Protocol No.
        HSC20150748HU
        Official Title
        Phase I Clinical Trial of Camptothecin-20-O-Propionate hydrate (CZ48) (CTMS# 15-2103)
        Description
        PRIMARY: To describe the dose limiting toxicities and adverse event profile of Camptothecin-20-O-Propionate hydrate (CZ48) administered orally every day. To determine Phase II recommended dose of Camptothecin-20-O-Propionate hydrate (CZ48) administered orally every day. SECONDARY: To perform a pharmacokinetic study of orally administered CZ48. To assess responses by RECIST criteria when applicable. To follow patients for survival.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   Phase I study of carfilzomib in combination with cyclophosphamide and...
        Protocol No.
        HSC20160206HU
        Official Title
        Phase I study of carfilzomib in combination with cyclophosphamide and etoposide for children with relapsed and refractory solid tumors and leukemias (CTMS# 15-2097)
        Description
        Primary Objective: To determine the DLTs and MTD of carfilzomib given in combination with cyclophosphamide and etoposide in pediatric patients with relapsed/refractory leukemias and solid tumors Secondary Objectives: 1. To evaluate toxicities of carfilzomib in the pediatric population when combined with conventional chemotherapy 2. To gather preliminary efficacy data on the drug combination 3. To measure if circulating plasma proteasome (cProt) levels post treatment correlate with response to therapy and overall survival 4. To measure if the levels of proteasome activity and resistance to carfilzomib correlates with toxicity and/or response to treatment. 5. To measure if inhibition of proteasome activity by carfilzomib results in alteration in a number of autophagy and apoptosis related proteins, providing means to evaluate correlates of activity of carfilzomib. 6. To measure the level of proteasome inhibition in patient PBMCs before and during treatment by determination of the level of protein ubiquitination. 7. To determine in vitro sensitivity of patient leukemias and solid tumors to carfilzomib alone and in combination with study chemotherapeutic agents in order to generate a predictive model of drug sensitivity. 8. To expand patient leukemia and solid tumor samples in order to save tissue for future studies but also to serve as a pre-clinical in vivo model to be included in the generation and testing of a drug sensitivity predictive model. 9. To perform whole exome sequencing (WES) and RNA seq on patient leukemia and solid tumor samples and WES on germ line DNA in order to determine potential mechanisms of drug sensitivity or resistance as well as contribute to testing a computer `learning engine (Bionet) for predicting clinical responses from genomic and drug sensitivity data.
        Contact
        210-562-9149
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   Phase Ib, open-label, multi-center study to characterize the safety,...
        Protocol No.
        HSC20160552HU
        Official Title
        Phase Ib, open-label, multi-center study to characterize the safety, tolerability and pharmacodynamics (PD) of PDR001 in combination with LCL161, everolimus (RAD001) or panobinostat (LBH589) (CTMS# 16-0058)
        Description
        Primary Objectives: To characterize the safety and tolerability of PDR001 in combination with LCL161, everolimus (RAD001) or panobinostat (LBH589) and to identify recommended doses and schedules for future studies Secondary Objectives: To characterize changes in the immune infiltrate in tumors To further characterize the safety of PDR001 in combination with LCL161, everolimus or panobinostat (LBH589) To estimate the anti-tumor activity of PDR001 in combination with LCL161, everolimus or panobinostat (LBH589) To characterize the pharmacokinetics of all study drugs in combination To assess immunogenicity of PDR001
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   Phase II Trial of Eribulin and Lenvatinib in Advanced Solid Tumors (CTMS#...
        Protocol No.
        HSC20150891HU
        Official Title
        Phase II Trial of Eribulin and Lenvatinib in Advanced Solid Tumors (CTMS# 15-2139)
        Description
        The overall purpose of this study is to determine the overall response rate, efficacy and safety of the combination of eribulin and Lenvatinib.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   Prognostic and predictive markers in patients with advanced metastatic tumors
        Protocol No.
        HSC20130219H
        Official Title
        Numeration and Single-Cell Molecular Profiling of Circulating Tumor Cells as Prognostic and Predictive Marker In Patients with Advanced Metastatic Tumors (CTRC#13-0001)
        Description
        This study will research possible associations between circulating tumor cells (CTC) quantities or gene profile characteristics and clinical outcomes. The primary objective is to obtain blood samples from participants over an 8-week period for research analysis.  The study will enroll approximately 200 patients at the CTRC. In addition to other conditions for enrollment, eligible patients have advanced metastatic cancer.
        Contact
        210-450-5798
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   Prospective Comparative Effectiveness Trial for Malignant Bowel Obstruction...
        Protocol No.
        HSC20170491HU
        Official Title
        Prospective Comparative Effectiveness Trial for Malignant Bowel Obstruction (CTMS# 17-0081)
        Description
        Number of days alive and outside the hospital
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
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      •   S1609, Dart: Dual Anti-CTLA-4 and Anti-PD-1 Blockage in Rare Tumors (CTMS#...
        Protocol No.
        HSC20170145HU
        Official Title
        S1609, Dart: Dual Anti-CTLA-4 and Anti-PD-1 Blockage in Rare Tumors (CTMS# 17-0013)
        Description
        Primary Objective To evaluate the RECIST 1.1 overall response rate (ORR) in subsets of patients with advanced rare cancers treated with ipilimumab plus nivolumab combination immunotherapy. Secondary Objectives To evaluate toxicities in each cohort. To estimate overall survival (OS), progression-free survival (PFS), clinical benefit rate; and to estimate immune-related ORR (irORR), and immune-related PFS (irPFS) by unidimensional immune-related response criteria. To collect specimens for banking for use in future correlative biomarker research studies.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   Safety, Tolerability & PK of KX2-361 in Subjects with advanced malignancies...
        Protocol No.
        HSC20150481HU
        Official Title
        A Phase 1 Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetics of KX2-361 in Subjects with Advanced Malignancies that are Refractory to Conventional Therapies (CTMS# 15-2063)
        Description
        Study Objectives: Primary Objective: To define the maximum tolerated dose (MTD) of KX2-361 in subjects with advanced refractory malignancies when administered as single and multiple oral doses. Secondary Objectives: To determine the safety and tolerability of KX2-361 after single and multiple oral doses, in subjects with advanced refractory malignancies. To characterize the pharmacokinetic profile of KX2-361 after single and multiple oral doses. To evaluate the activity of KX2-361 in both the Dose Escalation Cohort and the Expansion Cohort of subjects with high-grade glioma.
        Contact
        210-450-5798
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   Study of the Genetic Epidemiology of Childhood Cancer
        Protocol No.
        HSC20080057H
        Official Title
        Study of the Genetic Epidemiology of Childhood Cancer
        Description
        Study of the Genetic Epidemiology of Childhood Cancer
        Contact
        210-562-9123
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

    •   Colon

      •   A Dose Regimen-Finding Study to Evaluate the Safety, Tolerability,...
        Protocol No.
        HSC20170102HU
        Official Title
        A Dose Regimen-Finding Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Activity of Oradoxel Monotherapy in Subjects with Advanced Malignancies (CTMS# 16-0069)
        Description
        Primary Objective: To determine the maximum tolerated dose (MTD) of Oradoxel based on dose-limiting toxicity (DLT) in subjects with advanced malignancies Secondary Objectives To determine the safety and tolerability of docetaxel as Oradoxel To determine the incidence of unacceptable toxicity with Oradoxel To determine the recommended Phase 2 dose (RP2D) of docetaxel as Oradoxel To characterize the pharmacokinetic (PK) profile of docetaxel as Oradoxel To evaluate tumor response
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   A Dose Regimen-Finding Study to Evaluate the Safety, Tolerability,...
        Protocol No.
        HSC20160087HU
        Official Title
        A Dose Regimen-Finding Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Activity of Oraxol in Subjects with Advanced Malignancies (CTMS# 15-2137)
        Description
        Primary Objective To determine the maximum tolerated dose (MTD) and dosing regimen of Oraxol in subjects with advanced malignancies Secondary Objectives To determine the recommended Phase 2 dose of paclitaxel as Oraxol To determine the safety and tolerability of paclitaxel as Oraxol To characterize the pharmacokinetic (PK) profile of paclitaxel as Oraxol To evaluate the tumor response
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   A Phase 1 Dose Escalation and Cohort Expansion Study of TSR-042, an...
        Protocol No.
        HSC20170110HU
        Official Title
        A Phase 1 Dose Escalation and Cohort Expansion Study of TSR-042, an anti-PD-1 Monoclonal Antibody, in Patients with Advanced Solid Tumors (CTMS# 16-0091)
        Description
        Primary Objectives: Part 1 Dose Escalation Cohorts: To evaluate the safety and tolerability of TSR-042 using Common Terminology Criteria for Adverse Events (CTCAE v.4.03) in patients with advanced solid tumors Part 2 Expansion Cohorts: To evaluate the antitumor activity of TSR-042 in patients with advanced solid tumors, in terms of objective response rate (ORR) as assessed by the Investigators using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 Part 1 and Part 2: To define the recommended Phase 2 dose (RP2D) and schedule Secondary Objectives: Part 1 Dose Escalation Cohorts: To characterize the pharmacodynamic (PDy) profile of TSR-042 To evaluate ORR as assessed by the Investigators using RECIST v1.1 Part 2 Expansion Cohorts: To characterize the safety and tolerability of TSR-042 using CTCAE v.4.03 Part 1 and Part 2: To characterize the pharmacokinetic (PK) profile of TSR-042 To evaluate the immunogenicity of TSR-042 To evaluate additional measures of clinical benefit, including: ORR by immune-related RECIST (irRECIST) Duration of response (DOR) by RECIST v 1.1 Disease control rate (DCR) by RECIST v 1.1 and by irRECIST Progression-free survival (PFS) by RECIST v 1.1 and by irRECIST Overall survival (OS)
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   A Phase 1 Study of CBL0137 in Patients with Metastatic or Unresectable...
        Protocol No.
        HSC20130328H
        Official Title
        A Phase 1 Trial of CBL0137 In patients With Metastatic or Unresectable Advanced Solid Neoplasms or Refractory Lymphomas (CTRC# 13-0031)
        Description
        This Phase 1 study is designed to determine the best dose of CBL0137 to use when treating patients with metastatic or unresectable advanced solid tumors or lymphoma. The study will enroll up to 48 patients from at least 2 cancer centers in the US. In addition to other conditions for enrollment, eligible patients have cancer that has not improved or has come back after prior treatment and are otherwise in good health. Patients who have a history of active infection, cancer involving the central nervous system, a particular EKG abnormality or other serious medical conditions may not be eligible to enroll.
        Contact
        210-450-5798
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   A Phase 1/2A, Multicenter, Open-Label Study of LYC-55716 in Adult Subjects...
        Protocol No.
        HSC20160617HU
        Official Title
        A Phase 1/2A, Multicenter, Open-Label Study of LYC-55716 in Adult Subjects with Locally Advanced or Metastatic Cancer (CTMS# 16-0099)
        Description
        Primary Objectives Phase 1 Evaluate the safety and tolerability of LYC-55716 Determine the maximum tolerated dose (MTD) and the recommended Phase 2 dose (RP2D) Phase 2a Determine the objective response rate according to response evaluation criteria in solid tumors (RECIST) v1.1 Secondary Objectives Phase 1 Evaluate the activity of LYC-55716 by objective response according to RECIST v1.1 Determine the durability of any observed objective response Phase 2a Determine the duration of response Determine progression-free survival (PFS) and overall survival (OS) Determine suitability of the RP2D for further study Characterize the pharmacokinetics (PK) of LYC-55716 Exploratory Objectives Assess tumor activity in subjects with locally advanced or metastatic cancer according to immune-related response evaluation criteria in solid tumors (irRECIST) Exploratory analysis of metabolite in plasma Assess changes in circulating tumor markers (eg, cytokines/chemokines)
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
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      •   A Phase 1b Study of Oraxol in Combination with Ramucirumab in Patients with...
        Protocol No.
        HSC20170188HU
        Official Title
        A Phase 1b Study of Oraxol in Combination with Ramucirumab in Patients with Gastric, Gastro-esophageal, or Esophageal Cancers (CTMS# 16-0089)
        Description
        Primary Objective: To determine the maximum tolerated dose (MTD) of Oraxol in patients with advanced stage gastric, gastro-esophageal, or esophageal cancers who are being treated with Oraxol in combination with ramucirumab Secondary Objectives: To determine the safety and tolerability of Oraxol in combination with ramucirumab To determine the recommended Phase 2 dose of Oraxol in combination with ramucirumab To characterize the pharmacokinetic (PK) profile of Oraxol in combination with ramucirumab To characterize preliminary activity of Oraxol plus ramucirumab as determined by response rate, progression-free survival, and overall survival
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
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      •   A Phase 1b/2 Study of ARRY-382 in Combination with Pembrolizumab, a...
        Protocol No.
        HSC20170071HU
        Official Title
        A Phase 1b/2 Study of ARRY-382 in Combination with Pembrolizumab, a Programmed Cell Death Receptor 1 (PD-1) Antibody, for the Treatment of Patients with Advanced Solid Tumors (CTMS# 16-0084)
        Description
        Primary objective: To determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of ARRY-382 in combination with pembrolizumab in patients with selected solid tumors Secondary objectives:  To describe the preliminary antitumor activity of the combination based on the Response Criteria In Solid Tumors, version 1.1 (RECIST v1.1).  To describe the preliminary antitumor activity of the combination based on immune-related response criteria (irRC).  To characterize the safety and tolerability of the combination, including acute and chronic toxicities. To evaluate the pharmacokinetics of ARRY-382 in combination with pembrolizumab Exploratory objective: To explore the effect of the combination on circulating biomarkers of immune response. To describe the preliminary antitumor activity of the combination in patients with PD-L1 positive non-small cell lung cancer (NSCLC), as determined using a United States Food and Drug Administration (FDA)-approved test, using RECIST. To describe the preliminary antitumor activity of the combination in patients with PD-L1 positive non-small cell lung cancer (NSCLC), as determined using an FDA approved test, using irRC
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   A Phase I, First-in-human, Open-label, Dose-escalation, Safety,...
        Protocol No.
        HSC20160554HU
        Official Title
        A Phase I, First-in-human, Open-label, Dose-escalation, Safety, Pharmacokinetic, and Pharmacodynamic Study of Oral TP-0903 Administered Daily for 21 Days to Patients with Advanced Solid Tumors (CTMS# 16-0092)
        Description
        Primary Objective: To determine the maximum tolerated dose (MTD) and dose-limiting toxicities (DLTs) of oral TP-0903 administered daily for the first 21 days every 4 weeks, over a range of doses in patients with advanced solid tumors. Secondary Objectives: To establish the pharmacokinetics of orally administered TP-0903 To observe patients for any evidence of antitumor activity of TP-0903 by objective radiographic assessment To study the pharmacodynamics of TP-0903 therapy by: assessing biomarkers in tumor tissue assessing biomarkers in peripheral blood mononuclear cells (PBMCs) and serum To establish the Recommended Phase 2 Dose (RP2D) for future studies with TP-0903
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   A Phase I, Multicenter, Open-Label Dose Escalation and Expansion Study of...
        Protocol No.
        HSC20150289HU
        Official Title
        A Phase I, Multicenter, Open-Label Dose Escalation and Expansion Study of PCA062, Administered Intravenously In Adult Patients With pCAD-Positive Tumors (CTMS# 14-2019)
        Description
        Primary Objective To determine the MTD/RDE of PCA062 in patients with pCAD-positive tumors in the dose escalation part. Secondary Objectives To characterize the safety and tolerability of PCA062 To characterize the pharmacokinetic profile of PCA062 To assess emergence of anti-PCA062 antibodies following one or more intravenous infusions of PCA062 To assess the preliminary anti-tumor activity of PCA062 in patients with pCAD-positive triple negative breast cancer (TBNC), head and neck squamous cell carcinoma (HNSCC) or esophageal cancer (squamous and adenocarcinoma)
        Contact
        210-450-5798
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   A Phase I/II, open label, multicenter study of the safety and efficacy of...
        Protocol No.
        HSC20150421HU
        Official Title
        A Phase I/II, open label, multicenter study of the safety and efficacy of LAG525 single agent and in combination with PDR001 administered to patients with advanced malignancies (CTMS #15-2054)
        Description
        Primary Objectives Phase I part To estimate the RP2D or MTD for the single agent LAG525 and the combination of LAG525 and PDR001. Phase II part To estimate the overall response rate per RECIST V1.1 for single agent LAG525 as well as for the combination of LAG525 and PDR001 Secondary Objectives: To characterize the safety and tolerability of single agent LAG525 given alone and in combination with PDR001 To characterize the pharmacokinetic profile of single agent LAG525 given alone and in combination with PDR001 To assess emergence of anti-LAG525, and anti-PDR001 antibodies following one or more intravenous (i.v.) infusions of single agent LAG525 given alone or in combination with PDR001 To assess potential predictors of efficacy of single agent LAG525 and the combination of LAG525 and PDR001 To evaluate the preliminary antitumor activity of single agent LAG525 given alone or in combination of PDR001 To investigate patient selection and pharmacodynamic biomarkers in tumor tissue samples
        Contact
        210-450-5798
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   A Phase I/II, Open-Label, Multi-Center Study of the Safety and Efficacy of...
        Protocol No.
        HSC20160420HU
        Official Title
        A Phase I/II, Open-Label, Multi-Center Study of the Safety and Efficacy of BLZ945 as Single Agent and In Combination with PDR001 in Adult Patients with Advanced Solid Tumors (CTMS# 16-0071)
        Description
        Primary Objective: Phase I: To characterize the safety and tolerability of BLZ945 as a single agent and in combination with PDR001 and to identify the Maximum Tolerated Dose (MTD)/Recommended Phase 2 Dose (RP2D). Phase II: To assess the anti-tumor activity of BLZ945 in combination with PDR001 (and as single agent if appropriate) in patients with advanced solid tumors. Secondary Objective: Phase I: To characterize the pharmacodynamics effect of BLZ945 as a single agent and in combination with PDR001. To characterize PK of BLZ945 as a single agent and in combination with PDR001. To assess the preliminary anti-tumor activity of BLZ945 as single agent and in combination with PDR001. Phase I and II: To assess emergence of anti-PDR001 antibodies when BLZ945 is administered in combination with PDR001.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
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      •   A Phase Ib Trial of Pembrolizumab (MK-3475) in Combination with Dinaciclib...
        Protocol No.
        HSC20170106HU
        Official Title
        A Phase Ib Trial of Pembrolizumab (MK-3475) in Combination with Dinaciclib (MK-7965) in Subjects with Hematologic Malignancies (KEYNOTE-155) (CTMS# 16-0009)
        Description
        Primary Objective Objective: In both the Dose Evaluation and Signal Detection phases, evaluate the safety and tolerability of the treatment combination. Objective: Within each disease type of the Signal Detection phase, evaluate objective response rate (ORR) according to investigator assessment using the disease specific criteria. Secondary Objective: Objective: To evaluate the Objective Response Rate (ORR; complete response [CR] + partial response [PR]) of the combination of pembrolizumab and dinaciclib within each disease type, ie, CLL based on iwCLL guidelines (Hallek, 2008) [1], MM based on IMWG criteria (Durie, 2006) [2] and DLBCL based on the Revised Response Criteria for Malignant Lymphoma (Cheson, 2007) [3]. Objective: Within each disease type of the Signal Detection phase, evaluate Duration of Response (DOR), Progression-Free Survival (PFS) according to investigator assessment using the disease specific criteria; and Overall Survival (OS).
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
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      •   A pilot study to evaluate the chemopreventive effects of epigallocatechin...
        Protocol No.
        HSC20160446HU
        Official Title
        A pilot study to evaluate the chemopreventive effects of epigallocatechin gallate (EGCG) in colorectal cancer (CRC) patients with curative resections (CTMS# 16-0085)
        Description
        To evaluate the preventive effects of EGCG on colonic tissue in patients with resected colorectal cancer when compared to patients on observation.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
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      •   ABTR01B1, A Children''s Oncology Group Protocol for Collecting and Banking...
        Protocol No.
        HSC20040131H
        Official Title
        ABTR01B1, A Children''s Oncology Group Protocol for Collecting and Banking Pediatric Research Specimens Including Rare Pediatric Tumors
        Description
        This study is collecting and storing malignant, borderline malignant neoplasms, and related biological samples from young patients with cancer. Collecting and storing samples of tumor tissue, blood, and bone marrow from patients with cancer to study in the laboratory may help the study of cancer in the future.
        Contact
        210-562-9149
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
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      •   ACCL15N1CD Use of Evidence-Based Supportive Care Clinical Practice...
        Protocol No.
        HSC20160673X
        Official Title
        ACCL15N1CD Use of Evidence-Based Supportive Care Clinical Practice Guidelines in Pediatric
        Description
        Primary and Secondary Aims Aim 1: Chart Review To measure the rate of adherence to selected COG-endorsed supportive care CPG recommendations at NCORP sites Aim 1a To describe the possible influence of NCORP site size and the number of patients enrolled in COG studies per site on the delivery of CPG-consistent care. Aim 1b To describe the clinical outcome of episodes during which patients receive CPG-consistent or CPG-inconsistent care Aim 2: Focus Groups To describe facilitators of and barriers to the use of CPGs elicited via focus group interviews with a diverse set of potential users (physician, nurse, nurse practitioner and pharmacists) who provide pediatric cancer care at NCORP sites. Aim 3: Interviews To improve how well CPG recommendations are understood by health care providers by refining the CPG recommendation format based on an iterative process of cognitive interviewing and formatting revisions. Understanding is defined as the correct interpretation of the course of action recommended or suggested by a CPG.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   ACCRN07 Protocol for the Enrollment on the Official COG Registry, The...
        Protocol No.
        HSC20080271X
        Official Title
        ACCRN07 Protocol for the Enrollment on the Official COG Registry, The Childhood Cancer Research Network (CCRN)
        Description
        The Children s Oncology Group has established a research network, the Childhood Cancer Research Network (CCRN), to collect information about children with cancer and other conditions that are benign but involve abnormal cell growth in order to help doctors and scientists better understand childhood cancer. The CCRN''s goal is to collect clinical information about every child diagnosed with cancer and similar conditions in the United States and Canada, to allow researchers to study patterns, characteristics, and causes of childhood cancer. The information can also help researchers study the causes of childhood cancer. To expand the CCRN, parents of children who have been diagnosed with cancer will be asked to provide information about themselves and their child for research purposes.   Objectives: To obtain informed consent from parents (and the child, when appropriate) of infants, children, adolescents, and young adults newly diagnosed with cancer to enter their names and certain information concerning their child into the Childhood Cancer Research Network. To obtain informed consent from parents (and the child, when appropriate) of infants, children, adolescents, and young adults newly diagnosed with cancer for permission to be contacted in the future to consider participating in non-therapeutic and prevention research studies involving the parents and/or the child.
        Contact
        210-562-9149
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   Adolescent and Young Adult Childhood Cancer Survivorship (CTMS#17-0088)
        Protocol No.
        HSC20170474HU
        Official Title
        Adolescent and Young Adult Childhood Cancer Survivorship (CTMS#17-0088)
        Description
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   ALTE05N1, Umbrella Long-Term Follow-Up Protocol
        Protocol No.
        HSC20090478X
        Official Title
        ALTE05N1, Umbrella Long-Term Follow-Up Protocol
        Description
        Umbrella Long-Term Follow-Up Protocol
        Contact
        210-562-9149
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
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      •   ALTE1621 Pharmacologic Reversal of Ventricular Remodeling in Childhood...
        Protocol No.
        HSC20160394X
        Official Title
        ALTE1621 Pharmacologic Reversal of Ventricular Remodeling in Childhood Cancer Survivors at Risk for Heart Failure (PREVENT-HF): A Phase 2b Randomized Placebo-Controlled (Carvedilol) Trial
        Description
        1.1 Primary Aim To determine the impact of a two-year course of low-dose carvedilol on surrogate echocardiographic indices of heart failure (HF) risk, including Left Ventricular (LV) Posterior Wall Thickness-Dimension Ratio (LV T-D) a well-established index of early myocardial remodeling and subsequent HF risk (primary endpoint).  LV systolic and diastolic function and afterload established echocardiographic indices associated with HF risk.  Natriuretic peptides, troponins, and Galectin-3 - circulating biomarkers associated with myocardial injury, and HF risk. 1.2 Secondary Aims 1.2.1 To establish safety and tolerability of this two-year course of low-dose carvedilol, assessing both objective measures (hepatic function) and patient reported outcomes. 1.2.2 To examine the modifying effect of demographic, clinical, and molecular characteristics on the risk: benefit ratio from this two-year carvedilol intervention. 1.3 Exploratory Aim To evaluate the long-term efficacy of carvedilol in preventing cardiomyopathy and/or heart failure in high-risk childhood cancer survivors.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
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      •   AN EARLY-PHASE, MULTICENTER, OPEN-LABEL STUDY OF THE SAFETY AND...
        Protocol No.
        HSC20150549H
        Official Title
        AN EARLY-PHASE, MULTICENTER, OPEN-LABEL STUDY OF THE SAFETY AND PHARMACOKINETICS OF ATEZOLIZUMAB (MPDL3280A) IN PEDIATRIC AND YOUNG ADULT PATIENTS WITH PREVIOUSLY TREATED SOLID TUMORS
        Description
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
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      •   An Open-Label Rollover Study to Evaluate the Long-Term Safety, Tolerability,...
        Protocol No.
        HSC20170197XT
        Official Title
        An Open-Label Rollover Study to Evaluate the Long-Term Safety, Tolerability, Biological Activity of Oral TVB-2640 in Patients With Solid Tumors Previously Enrolled in 3V2640-CLIN-002 (CTMS# 17-0046)
        Description
        Primary: To continue to characterize the safety profile of TVB-2640. Secondary: To identify any early signs of anti-tumor activity, where possible.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   An Open-Label, Dose Escalation, Phase 1, First-In-Human Study of TAK-659 in...
        Protocol No.
        HSC20150255HU
        Official Title
        An Open-Label, Dose Escalation, Phase 1, First-In-Human Study of TAK-659 in Adult Patients with Advanced Solid Tumors and Lymphoma Malignancies (CTMS# 14-2013)
        Description
        To determine the safety, tolerability, maximum tolerated dose (MTD)/recommended phase 2 dose (RP2D) ofTAK-659 administered orally on a daily dosing schedule in patients with advanced solid tumor and lymphoma who do not have effective standard treatment available
        Contact
        210-450-5798
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
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      •   APEC14B1, THE PROJECT: EVERYCHILD PROTOCOL: A REGISTRY, ELIGIBILITY...
        Protocol No.
        HSC20150870XT
        Official Title
        APEC14B1, THE PROJECT: EVERYCHILD PROTOCOL: A REGISTRY, ELIGIBILITY SCREENING, BIOLOGY AND OUTCOME STUDY
        Description
        1.1 To maintain a Childhood Cancer Registry1 for infants, children, adolescents, and young adults with cancer. 1.2 To utilize clinical and biological data to help determine eligibility or stratification, based on childhood cancer disease classification schemas, for potential enrollment of research subjects onto COG therapeutic clinical trials. 1.3 To develop a well annotated childhood cancer biorepository for current and future research through the collection of biospecimens (at diagnosis, time of progression, time of recurrence and/or post-mortem), including tumor, host and when feasible parental germline DNA; and key clinical data, including presentation, diagnostic, staging, summary treatment, and outcome information, from every child diagnosed with cancer at COG institutions. 1.4 To allow use of registry data for permission to be contacted in the future to consider participating in non-therapeutic and prevention research studies involving the child or their parents.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   Cancer Therapy and Research Center''s Institute for Drug Development Solid...
        Protocol No.
        HSC20070684H
        Official Title
        Cancer Therapy and Research Center''s Institute for Drug Development Solid Tumors and Hematological Malignancies Biorepository for Biomarker Discovery
        Description
        Samples are collected for the Cancer Therapy and Research Center''s Solid Tumors and Hematological Malignancies Biorepository for Biomarker Discovery
        Contact
        210-450-5798
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   Caris Molecular Intelligence® and Caris Centers of Excellence for...
        Protocol No.
        HSC20170144HU
        Official Title
        Caris Molecular Intelligence® and Caris Centers of Excellence for Precision Medicine NetworkTM Retrospective Outcomes-Associated Database (CTMS# 16-0145)
        Description
        The objective of this project is the development of the Caris Molecular Intelligence® and Caris Centers of Excellence for Precision Medicine NetworkTM Outcomes Associated Repository, a disease research database (hereinafter referred to as the Database ) for the purpose of: 1. Effecting change in disease treatment processes by advancing precision medicine and improving care for cancer through acquiring and sharing valuable molecular tumor profiling information and clinical outcomes in a collaborative, secure environment. 2. Performing prospective research studies involving analyses of quality of life studies as well as subject medical records including clinical presentation and outcomes. This eligible cohort includes select subjects having undergone Caris Molecular Intelligence® evaluation for diagnosis and/or treatment management. 3. Evaluate the frequency of specific clinical events in relation to risk factors, diagnosis and treatments provided via the collection of outcomes data through automated data capture systems provided by a third-party data entity and manually-entered data when needed. 4. Provide information access that is vital to research collaborators, including potential researchers from pharmaceutical companies, governmental agencies, academia, healthcare providers, and payors, with catalogued subject outcome data for the use of drug development discoveries, clinically relevant research trials, publications and posters, the implementation of future healthcare policies, characterization of trends in practice patterns and their relation to subject outcomes and the economic impact of differing evaluation, treatment, and management paradigms. 5. Cultivate a repository for assay development and validation of emerging technologies to enhance clinical cancer care.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   Caris Molecular Intelligence® and Caris Centers of Excellence for Precision...
        Protocol No.
        HSC20170353HU
        Official Title
        Caris Molecular Intelligence® and Caris Centers of Excellence for Precision Medicine NetworkTM Outcomes Associated Repository (CTMS# 17-0023)
        Description
        The objective of this project is the development of the Caris Molecular Intelligence® and Caris Centers of Excellence for Precision Medicine NetworkTM Outcomes Associated Repository, a disease research database (hereinafter referred to as the Database) for the purpose of: 1. Effecting change in disease treatment processes by advancing precision medicine and improving care for cancer through acquiring and sharing valuable molecular tumor profiling information and clinical outcomes in a collaborative, secure environment. 2. Performing prospective research studies involving analyses of quality of life studies as well as subject medical records including clinical presentation and outcomes. This eligible cohort includes select subjects having undergone Caris Molecular Intelligence® evaluation for diagnosis and/or treatment management. 3. Evaluate the frequency of specific clinical events in relation to risk factors, diagnosis and treatments provided via the collection of outcomes data through automated data capture systems provided by a third-party data entity and manually-entered data when needed. 4. Provide information access that is vital to research collaborators, including potential researchers from pharmaceutical companies, governmental agencies, academia, healthcare providers, and payors, with catalogued subject outcome data for the use of drug development discoveries, clinically relevant research trials, publications and posters, the implementation of future healthcare policies, characterization of trends in practice patterns and their relation to subject outcomes and the economic impact of differing evaluation, treatment, and management paradigms. 5. Cultivate a repository for assay development and validation of emerging technologies to enhance clinical cancer care.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   Clinical Trial of Lurbinectedin (PM01183) in Selected Advanced Solid Tumors
        Protocol No.
        HSC20150542HU
        Official Title
        A Multicenter Phase II Clinical Trial of Lurbinectedin (PM01183) in Selected Advanced Solid Tumors (CTMS# 15-2071)
        Description
        Primary: To assess the antitumor activity of lurbinectedin (PM01183) in terms of overall response rate (ORR), according to the Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1, in the following advanced solid tumors: small cell lung cancer (SCLC), head and neck carcinoma (H&N), neuroendocrine tumors (NETs), biliary tract carcinoma, endometrial carcinoma, BRCA 1/2-associated metastatic breast carcinoma, carcinoma of unknown primary site, germ cell tumors (GCTs), and Ewing¿s family of tumors (EFTs). Secondary: To further characterize the antitumor activity of PM01183 in terms of duration of response (DR), clinical benefit [ORR or stable disease (SD) lasting over four months (SD ¿ 4 months)], progression-free survival (PFS), and one year overall survival (1y-OS) in each cohort of advanced solid tumors. Characterize the plasma pharmacokinetics (PK) of PM01183. To conduct an exploratory pharmacogenomic (PGx) and pharmacogenetic analysis. To evaluate the safety profile of PM01183 in this patient population.
        Contact
        410-450-5798
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   Clinical trial to study the safety and efficacy of MBG453 given alone and in...
        Protocol No.
        HSC20150730HU
        Official Title
        A Phase I-Ib/II, Open-Label, Multi-Center Study of the Safety and Efficacy of MBG453 as Single Agent and in Combination with PDR001 in Adult Patients with Advanced Malignancies (CTMS# 15-2114)
        Description
        Primary Objectives: Phase I-Ib: To characterize the safety and tolerability of MBG453 as a single agent and in combination with PDR001 and to identify recommended doses for future studies. Phase I-Ib dose ranging: To further investigate the safety and tolerability of different doses of MBG453 alone or in combination with PDR001. Phase II: To estimate the anti-tumor activity of MBG453 alone in patients with solid tumors, and in combination with PDR001 in selected disease indications (melanoma, non-small cell lung cancer (NSCLC), renal cell carcinoma (RCC)). Secondary Objectives Evaluate the preliminary anti-tumor activity of MBG453 alone and in combination with PDR001. Make an initial comparison of safety, PK and efficacy for MBG453 and PDR001 administered in combination on a every 2 weeks (Q2W) and every 4 weeks (Q4W) dosing schedules. Characterize the pharmacokinetic profile of MBG453 alone and in combination with PDR001. Assess emergence of anti-MBG453 and anti-PDR001 antibodies. Assess potential predictors of efficacy of MBG453 single agent and in combination with PDR001 in tumor samples. Assess the pharmacodynamic effect of MBG453 as single agent and in combination with PDR001 in tumor samples. Describe the survival distribution of patients treated with MBG453 as single agent and in combination with PDR001 for each disease group.
        Contact
        410-450-5798
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
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      •   DCP-001, Use of a Clinical Trial Screening Tool to Address Cancer Health...
        Protocol No.
        HSC20160342XT
        Official Title
        DCP-001, Use of a Clinical Trial Screening Tool to Address Cancer Health Disparities in the NCI Community Oncology Research Program (NCORP)
        Description
        Objectives 1) Implement a screening tool in NCORP to collect broader demographic and clinical data to generate hypothesis and research questions in the following areas of research: cancer screening, cancer prevention, symptom science, cancer care disparities, comparative effectiveness and cancer care delivery research. 2) Collect expanded demographic and clinical data (e.g., SES, co-morbidities, method of diagnosis) across the NCORP network to help identify and best characterize patients that are screened but not enrolled and for patients that participate in NCI trials, to understand how these variables may impact outcomes. 3) Enhance an understanding of site- specific and trial-specific accrual barriers that will inform the development of effective strategies to improve accrual, particularly for minority and underserved populations. 4) Provide data for internal and external evaluation of NCORP s first RFA cycle and reissuance.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   GO29665, A PHASE I/II, MULTICENTER, OPEN-LABEL, DOSE-ESCALATION STUDY OF THE...
        Protocol No.
        HSC20160080H
        Official Title
        GO29665, A PHASE I/II, MULTICENTER, OPEN-LABEL, DOSE-ESCALATION STUDY OF THE SAFETY AND PHARMACOKINETICS OF COBIMETINIB IN PEDIATRIC AND YOUNG ADULT PATIENTS WITH PREVIOUSLY TREATED SOLID TUMORS (CTRC# 15-0005)
        Description
        CTRC#15-0005
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   Head and Neck Cancer Repository
        Protocol No.
        HSC20170218HR
        Official Title
        Head and Neck Cancer Repository
        Description
        To establish a repository of head and neck cancers and PDX models from our south Texas patient population.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   Health Effects after Anthracycline and Radiation Therapy (HEART):...
        Protocol No.
        HSC20140058X
        Official Title
        Health Effects after Anthracycline and Radiation Therapy (HEART): Dexrazoxane and Prevention of Anthracycline-related Cardiomyopathy A Limited Institution Non-Therapeutic Study
        Description
        This clinical trial studies the effects of dexrazoxane hydrochloride on biomarkers associated with cardiomyopathy and heart failure after cancer treatment. Studying samples of blood in the laboratory from patients receiving dexrazoxane hydrochloride may help doctors learn more about the effects of dexrazoxane hydrochloride on cells. It may also help doctors understand how well patients respond to treatment.
        Contact
        210-562-9149
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   Incidence and Factors Associated with the Development and Severity of Oral...
        Protocol No.
        HSC20050218H
        Official Title
        Incidence and Factors Associated with the Development and Severity of Oral Mucositis in Patients Undergoing High Dose Chemotherapy and Peripheral Stem Cell Transplantation
        Description
        Our study intends to evaluate prospectively the incidence and severity of oral mucositis in patients undergoing high-dose chemotherapy and hematopoietic stem cell transplantation, as well as to evaluate the potential influence of nutritional-, physical-, and transplant-related factors associated with the development of this complication and its grade of involvement. Research plan: This is a prospective cohort study with an observational basis that involves all of the patients undergoing high-dose chemotherapy and peripheral blood stem cell transplantation at the Audie L. Murphy VA Hospital Bone Marrow Transplant Unit and at the University Hospital Bone Marrow Transplant Unit. We expect to enroll 400 patients during a 5-year period. Methods: In order to answer the study questions, subjects will be assessed several times during the study period. The study involves a multidisciplinary group that will be evaluating and following the subjects. A baseline will be established by a physician and a nutritionist before the subjects start the high-dose chemotherapy regimen. The subjects will be followed with oral evaluations 3 times per week, beginning on the day of the transplant and ending when mucositis resolves, or the patient is discharged home, or 30 days post-transplant, whichever occurs first. At day 15 post-transplant, patients will be evaluated for the second time by the nutritionist. Further information such as blood values, use of medications and treatment complications, will be obtained by daily chart review.  
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   MATCH Treatment Subprotocol B: Phase II Study of Afatinib in Patients with...
        Protocol No.
        HSC20150831HU
        Official Title
        MATCH Treatment Subprotocol B: Phase II Study of Afatinib in Patients with Tumors with HER2 Activating Mutations (CTMS# 15-2107)
        Description
        Primary Objective To evaluate the proportion of patients with objective response (OR) to targeted study agent(s) in patients with advanced refractory cancers/lymphomas. Secondary Objectives To evaluate the proportion of patients alive and progression free at 6 months of treatment with targeted study agent in patients with advanced refractory cancers/lymphomas. To evaluate time until death or disease progression. To identify potential predictive biomarkers beyond the genomic alteration by which treatment is assigned or resistance mechanisms using additional genomic, RNA and protein-based assessment platforms.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   MATCH Treatment Subprotocol C1: EAY131-C1: Crizotinib in Patients with...
        Protocol No.
        HSC20160463HU
        Official Title
        MATCH Treatment Subprotocol C1: EAY131-C1: Crizotinib in Patients with Tumors with MET Amplification (CTMS# 16-0064)
        Description
        The purpose of this study is to test any good and bad effects of the study drug called crizotinib in patients whose cancer has MET genetic changes.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   MATCH Treatment Subprotocol F: Crizotinib in Patients with Tumors (other...
        Protocol No.
        HSC20150750HU
        Official Title
        MATCH Treatment Subprotocol F: Crizotinib in Patients with Tumors (other than adenocarcinoma of lung or ALCL) with ALK Translocations (CTMS# 15-2081)
        Description
        Primary Objective To evaluate the proportion of patients with objective response (OR) to targeted study agent(s) in patients with advanced refractory cancers/lymphomas. Secondary Objectives To evaluate the proportion of patients alive and progression free at 6 months of treatment with targeted study agent in patients with advanced refractory cancers/lymphomas. To evaluate time until death or disease progression. To identify potential predictive biomarkers beyond the genomic alteration by which treatment is assigned or resistance mechanisms using additional genomic, RNA and protein-based assessment platforms.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   MATCH Treatment Subprotocol S1: Phase II Study of Trametinib in Patients...
        Protocol No.
        HSC20160260HU
        Official Title
        MATCH Treatment Subprotocol S1: Phase II Study of Trametinib in Patients with Tumors with NF1 Mutations (CTMS# 16-0028)
        Description
        PRIMARY OBJECTIVES: I. To evaluate the proportion of patients with objective response (OR) to targeted study agent(s) in patients with advanced refractory cancers/lymphomas. SECONDARY OBJECTIVES: I. To evaluate the proportion of patients alive and progression free at 6 months of treatment with targeted study agent in patients with advanced refractory cancers/lymphomas. II. To evaluate time until death or disease progression. III. To identify potential predictive biomarkers beyond the genomic alteration by which treatment is assigned or resistance mechanisms using additional genomic, ribonucleic acid (RNA) and protein-based assessment platforms.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   MATCH Treatment Subprotocol U: VS-6063 (defactinib) in Patients with Tumors...
        Protocol No.
        HSC20150839HU
        Official Title
        MATCH Treatment Subprotocol U: VS-6063 (defactinib) in Patients with Tumors with NF2 Loss (CTMS# 15-2110)
        Description
        Primary Objective To evaluate the proportion of patients with objective response (OR) to targeted study agent(s) in patients with advanced refractory cancers/lymphomas. Secondary Objectives To evaluate the proportion of patients alive and progression free at 6 months of treatment with targeted study agent in patients with advanced refractory cancers/lymphomas. To evaluate time until death or disease progression. To identify potential predictive biomarkers beyond the genomic alteration by which treatment is assigned or resistance mechanisms using additional genomic, RNA and protein-based assessment platforms.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   MATCH Treatment Subprotocol W: EAY131-W: Phase II Study of AZD4547 in...
        Protocol No.
        HSC20160541HU
        Official Title
        MATCH Treatment Subprotocol W: EAY131-W: Phase II Study of AZD4547 in Patients with Tumors with Aberrations in the FGFR Pathway (CTMS# 16-0065)
        Description
        The purpose of this study is to test any good and bad effects of the study drug, AZD4547, in patients whose cancer has genetic changes called FGFR gene alterations.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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        Learn More About This Study

         

      •   MATCH Treatment Subprotocol X: Phase II Study of Dasatinib in Patients with...
        Protocol No.
        HSC20160282HU
        Official Title
        MATCH Treatment Subprotocol X: Phase II Study of Dasatinib in Patients with Tumors with DDR2 Mutations (CTMS# 16-0032)
        Description
        PRIMARY OBJECTIVES: I. To evaluate the proportion of patients with objective response (OR) to targeted study agent(s) in patients with advanced refractory cancers/lymphomas. SECONDARY OBJECTIVES: I. To evaluate the proportion of patients alive and progression free at 6 months of treatment with targeted study agent in patients with advanced refractory cancers/lymphomas. II. To evaluate time until death or disease progression. III. To identify potential predictive biomarkers beyond the genomic alteration by which treatment is assigned or resistance mechanisms using additional genomic, ribonucleic acid (RNA) and protein-based assessment platforms.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   MATCH Treatment Subprotocol Z1A: EAY131-Z1A: Binimetinib in Patients with...
        Protocol No.
        HSC20160499HU
        Official Title
        MATCH Treatment Subprotocol Z1A: EAY131-Z1A: Binimetinib in Patients with Tumors (Other Than Melanoma) with NRAS Mutations (CTMS# 16-0066)
        Description
        The purpose of this study is to test any good and bad effects of the experimental study drug binimetinib in patients whose cancer has NRAS mutations.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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        Learn More About This Study

         

      •   MATCH Treatment Subprotocol Z1B: EAY131-Z1B: Phase II Study of Palbociclib...
        Protocol No.
        HSC20160491HU
        Official Title
        MATCH Treatment Subprotocol Z1B: EAY131-Z1B: Phase II Study of Palbociclib (PD-0332991) in Patients with Tumors with CCND1, 2, 3 Amplification and Rb Protein Expression by IHC (CTMS# 16-0067)
        Description
        The purpose of this study is to test any good and bad effects of the study drug, palbociclib, in patients whose cancer has CCND1, 2 or 3 amplification and tested positive for a protein called Rb protein.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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        Learn More About This Study

         

      •   Modulation of Autophagy: A Clinical Study of Vorinostat plus...
        Protocol No.
        HSC20150178HU
        Official Title
        Modulation of Autophagy: A Clinical Study of Vorinostat plus Hydroxychloroquine versus Regorafenib in Refractory Metastatic Colorectal Cancer (mCRC) Patients (CTMS# 14-2015)
        Description
        To determine the clinical efficacy with progression-free survival (PFS-1) of the combination of VOR plus HCQ when compared to RGF in treatment-refractory mCRC.
        Contact
        210-450-5798
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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        Learn More About This Study

         

      •   Molecular Analysis for Therapy Choice (MATCH) / MATCH Treatment Subprotocol...
        Protocol No.
        HSC20170176HU
        Official Title
        Molecular Analysis for Therapy Choice (MATCH) / MATCH Treatment Subprotocol H: EAY131-H: Phase II Study of Dabrafenib and Trametinib in Patients with Tumors with BRAF V600E or V600K Mutations (Excluding Melanoma, Thyroid Cancer, and Colorectal Adenocarcinoma) (CTMS# 15-2083)
        Description
        Primary Objective To evaluate the proportion of patients with objective response (OR) to targeted study agent(s) in patients with advanced refractory cancers/lymphomas. Secondary Objectives To evaluate the proportion of patients alive and progression free at 6 months of treatment with targeted study agent in patients with advanced refractory cancers/lymphomas. To evaluate time until death or disease progression. To identify potential predictive biomarkers beyond the genomic alteration by which treatment is assigned or resistance mechanisms using additional genomic, RNA and protein-based assessment platforms.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   Molecular Analysis for Therapy Choice (NCI-MATCH)
        Protocol No.
        HSC20150719XT
        Official Title
        EAY131, Molecular Analysis for Therapy Choice (MATCH) (CTMS# 15-2080)
        Description
        Primary Objective To evaluate the proportion of patients with objective response (OR) to targeted study agent(s) in patients with advanced refractory cancers/lymphomas. Secondary Objectives To evaluate the proportion of patients alive and progression free at 6 months of treatment with targeted study agent in patients with advanced refractory cancers/lymphomas. To evaluate time until death or disease progression. To identify potential predictive biomarkers beyond the genomic alteration by which treatment is assigned or resistance mechanisms using additional genomic, RNA and protein-based assessment platforms.
        Contact
        410-450-5798
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   Novel Listeria Vectors Secreting Gut Flora-Altering Agents to Prevent Colon...
        Protocol No.
        HSC20160555HU
        Official Title
        Novel Listeria Vectors Secreting Gut Flora-Altering Agents to Prevent Colon Cancer and Treat Colitis (CTMS#16-0101)
        Description
        This study will evaluate the expression of B7-H1 in human colon tissue, define B7-H1 signaling pathways in colon cells and test the ability of recombinant Listeria to modulate B7-H1 in human colonic tissues in vitro.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   NRG-HN003, A PHASE I AND EXPANSION COHORT STUDY OF ADJUVANT CISPLATIN,...
        Protocol No.
        HSC20170206HU
        Official Title
        NRG-HN003, A PHASE I AND EXPANSION COHORT STUDY OF ADJUVANT CISPLATIN, INTENSITY-MODULATED RADIOTHERAPY, AND MK-3475 (PEMBROLIZUMAB) IN HIGH-RISK HEAD AND NECK SQUAMOUS CELL CARCINOMA (HNSCC) (CTMS# 17-0022)
        Description
        Primary Outcome Measures: DLT in patients with high-risk head and neck squamous cell carcinoma treated with adjuvant cisplatin, IMRT, and pembrolizumab [ Time Frame: Up to 4 weeks post IMRT ] Will be summarized using proportions for binary outcome per cohort.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   Phase I Clinical Trial of Camptothecin-20-O-Propionate hydrate (CZ48) (CTMS#...
        Protocol No.
        HSC20150748HU
        Official Title
        Phase I Clinical Trial of Camptothecin-20-O-Propionate hydrate (CZ48) (CTMS# 15-2103)
        Description
        PRIMARY: To describe the dose limiting toxicities and adverse event profile of Camptothecin-20-O-Propionate hydrate (CZ48) administered orally every day. To determine Phase II recommended dose of Camptothecin-20-O-Propionate hydrate (CZ48) administered orally every day. SECONDARY: To perform a pharmacokinetic study of orally administered CZ48. To assess responses by RECIST criteria when applicable. To follow patients for survival.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   Phase I study of carfilzomib in combination with cyclophosphamide and...
        Protocol No.
        HSC20160206HU
        Official Title
        Phase I study of carfilzomib in combination with cyclophosphamide and etoposide for children with relapsed and refractory solid tumors and leukemias (CTMS# 15-2097)
        Description
        Primary Objective: To determine the DLTs and MTD of carfilzomib given in combination with cyclophosphamide and etoposide in pediatric patients with relapsed/refractory leukemias and solid tumors Secondary Objectives: 1. To evaluate toxicities of carfilzomib in the pediatric population when combined with conventional chemotherapy 2. To gather preliminary efficacy data on the drug combination 3. To measure if circulating plasma proteasome (cProt) levels post treatment correlate with response to therapy and overall survival 4. To measure if the levels of proteasome activity and resistance to carfilzomib correlates with toxicity and/or response to treatment. 5. To measure if inhibition of proteasome activity by carfilzomib results in alteration in a number of autophagy and apoptosis related proteins, providing means to evaluate correlates of activity of carfilzomib. 6. To measure the level of proteasome inhibition in patient PBMCs before and during treatment by determination of the level of protein ubiquitination. 7. To determine in vitro sensitivity of patient leukemias and solid tumors to carfilzomib alone and in combination with study chemotherapeutic agents in order to generate a predictive model of drug sensitivity. 8. To expand patient leukemia and solid tumor samples in order to save tissue for future studies but also to serve as a pre-clinical in vivo model to be included in the generation and testing of a drug sensitivity predictive model. 9. To perform whole exome sequencing (WES) and RNA seq on patient leukemia and solid tumor samples and WES on germ line DNA in order to determine potential mechanisms of drug sensitivity or resistance as well as contribute to testing a computer `learning engine (Bionet) for predicting clinical responses from genomic and drug sensitivity data.
        Contact
        210-562-9149
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   Phase Ib, open-label, multi-center study to characterize the safety,...
        Protocol No.
        HSC20160552HU
        Official Title
        Phase Ib, open-label, multi-center study to characterize the safety, tolerability and pharmacodynamics (PD) of PDR001 in combination with LCL161, everolimus (RAD001) or panobinostat (LBH589) (CTMS# 16-0058)
        Description
        Primary Objectives: To characterize the safety and tolerability of PDR001 in combination with LCL161, everolimus (RAD001) or panobinostat (LBH589) and to identify recommended doses and schedules for future studies Secondary Objectives: To characterize changes in the immune infiltrate in tumors To further characterize the safety of PDR001 in combination with LCL161, everolimus or panobinostat (LBH589) To estimate the anti-tumor activity of PDR001 in combination with LCL161, everolimus or panobinostat (LBH589) To characterize the pharmacokinetics of all study drugs in combination To assess immunogenicity of PDR001
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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        Learn More About This Study

         

      •   Phase II Trial of Eribulin and Lenvatinib in Advanced Solid Tumors (CTMS#...
        Protocol No.
        HSC20150891HU
        Official Title
        Phase II Trial of Eribulin and Lenvatinib in Advanced Solid Tumors (CTMS# 15-2139)
        Description
        The overall purpose of this study is to determine the overall response rate, efficacy and safety of the combination of eribulin and Lenvatinib.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
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      •   Prognostic and predictive markers in patients with advanced metastatic tumors
        Protocol No.
        HSC20130219H
        Official Title
        Numeration and Single-Cell Molecular Profiling of Circulating Tumor Cells as Prognostic and Predictive Marker In Patients with Advanced Metastatic Tumors (CTRC#13-0001)
        Description
        This study will research possible associations between circulating tumor cells (CTC) quantities or gene profile characteristics and clinical outcomes. The primary objective is to obtain blood samples from participants over an 8-week period for research analysis.  The study will enroll approximately 200 patients at the CTRC. In addition to other conditions for enrollment, eligible patients have advanced metastatic cancer.
        Contact
        210-450-5798
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   Prospective Comparative Effectiveness Trial for Malignant Bowel Obstruction...
        Protocol No.
        HSC20170491HU
        Official Title
        Prospective Comparative Effectiveness Trial for Malignant Bowel Obstruction (CTMS# 17-0081)
        Description
        Number of days alive and outside the hospital
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   S1609, Dart: Dual Anti-CTLA-4 and Anti-PD-1 Blockage in Rare Tumors (CTMS#...
        Protocol No.
        HSC20170145HU
        Official Title
        S1609, Dart: Dual Anti-CTLA-4 and Anti-PD-1 Blockage in Rare Tumors (CTMS# 17-0013)
        Description
        Primary Objective To evaluate the RECIST 1.1 overall response rate (ORR) in subsets of patients with advanced rare cancers treated with ipilimumab plus nivolumab combination immunotherapy. Secondary Objectives To evaluate toxicities in each cohort. To estimate overall survival (OS), progression-free survival (PFS), clinical benefit rate; and to estimate immune-related ORR (irORR), and immune-related PFS (irPFS) by unidimensional immune-related response criteria. To collect specimens for banking for use in future correlative biomarker research studies.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   Safety, Tolerability & PK of KX2-361 in Subjects with advanced malignancies...
        Protocol No.
        HSC20150481HU
        Official Title
        A Phase 1 Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetics of KX2-361 in Subjects with Advanced Malignancies that are Refractory to Conventional Therapies (CTMS# 15-2063)
        Description
        Study Objectives: Primary Objective: To define the maximum tolerated dose (MTD) of KX2-361 in subjects with advanced refractory malignancies when administered as single and multiple oral doses. Secondary Objectives: To determine the safety and tolerability of KX2-361 after single and multiple oral doses, in subjects with advanced refractory malignancies. To characterize the pharmacokinetic profile of KX2-361 after single and multiple oral doses. To evaluate the activity of KX2-361 in both the Dose Escalation Cohort and the Expansion Cohort of subjects with high-grade glioma.
        Contact
        210-450-5798
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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        Learn More About This Study

         

      •   Study of the Genetic Epidemiology of Childhood Cancer
        Protocol No.
        HSC20080057H
        Official Title
        Study of the Genetic Epidemiology of Childhood Cancer
        Description
        Study of the Genetic Epidemiology of Childhood Cancer
        Contact
        210-562-9123
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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        Learn More About This Study

         

      •   SWOG S0820, Adenoma and Second Primary Colorectal Cancer Prevention Trial...
        Protocol No.
        HSC20130412H
        Official Title
        S0820 - A Double Blind Placebo-Controlled Trial of Eflornithine and Sulindac to Prevent Recurrence of High Risk Adenomas and Second Primary Colorectal Cancers in Patients with Stage 0-III Colon Cancer, Phase III - Preventing Adenomas of the Colon with Eflornithine and Sulindac (PACES) (CTRC#13-0036)
        Description
        The study is designed to investigate whether eflornithine, sulindac or both are effective in preventing or delaying adenomas and second primary colorectal cancers in patients previously treated for Stages 0 through III colon cancer. The primary objective is to assess whether eflornithine and/or sulindac are effective in reducing the recurrence rate at 3 years. The study will enroll approximately 1340 participants from hundreds of cancer centers in the US. In addition to other conditions for enrollment, eligible patients have a history of stage 0-III colon cancer that was surgically removed up to 1 year previously; rectosigmoid cancers are eligible if no prior radiation therapy, no evidence of cancer by colonoscopy exam at time of study entry, and able to take oral medications. Patients who have a history of uncontrolled hypertension or gastric/duodenal ulcer within past year or other medical conditions may not be eligible to enroll.
        Contact
        210-450-5798
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
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    •   Corpus Uteri

      •   A Dose Regimen-Finding Study to Evaluate the Safety, Tolerability,...
        Protocol No.
        HSC20170102HU
        Official Title
        A Dose Regimen-Finding Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Activity of Oradoxel Monotherapy in Subjects with Advanced Malignancies (CTMS# 16-0069)
        Description
        Primary Objective: To determine the maximum tolerated dose (MTD) of Oradoxel based on dose-limiting toxicity (DLT) in subjects with advanced malignancies Secondary Objectives To determine the safety and tolerability of docetaxel as Oradoxel To determine the incidence of unacceptable toxicity with Oradoxel To determine the recommended Phase 2 dose (RP2D) of docetaxel as Oradoxel To characterize the pharmacokinetic (PK) profile of docetaxel as Oradoxel To evaluate tumor response
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   A Dose Regimen-Finding Study to Evaluate the Safety, Tolerability,...
        Protocol No.
        HSC20160087HU
        Official Title
        A Dose Regimen-Finding Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Activity of Oraxol in Subjects with Advanced Malignancies (CTMS# 15-2137)
        Description
        Primary Objective To determine the maximum tolerated dose (MTD) and dosing regimen of Oraxol in subjects with advanced malignancies Secondary Objectives To determine the recommended Phase 2 dose of paclitaxel as Oraxol To determine the safety and tolerability of paclitaxel as Oraxol To characterize the pharmacokinetic (PK) profile of paclitaxel as Oraxol To evaluate the tumor response
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   A Phase 1 Dose Escalation and Cohort Expansion Study of TSR-042, an...
        Protocol No.
        HSC20170110HU
        Official Title
        A Phase 1 Dose Escalation and Cohort Expansion Study of TSR-042, an anti-PD-1 Monoclonal Antibody, in Patients with Advanced Solid Tumors (CTMS# 16-0091)
        Description
        Primary Objectives: Part 1 Dose Escalation Cohorts: To evaluate the safety and tolerability of TSR-042 using Common Terminology Criteria for Adverse Events (CTCAE v.4.03) in patients with advanced solid tumors Part 2 Expansion Cohorts: To evaluate the antitumor activity of TSR-042 in patients with advanced solid tumors, in terms of objective response rate (ORR) as assessed by the Investigators using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 Part 1 and Part 2: To define the recommended Phase 2 dose (RP2D) and schedule Secondary Objectives: Part 1 Dose Escalation Cohorts: To characterize the pharmacodynamic (PDy) profile of TSR-042 To evaluate ORR as assessed by the Investigators using RECIST v1.1 Part 2 Expansion Cohorts: To characterize the safety and tolerability of TSR-042 using CTCAE v.4.03 Part 1 and Part 2: To characterize the pharmacokinetic (PK) profile of TSR-042 To evaluate the immunogenicity of TSR-042 To evaluate additional measures of clinical benefit, including: ORR by immune-related RECIST (irRECIST) Duration of response (DOR) by RECIST v 1.1 Disease control rate (DCR) by RECIST v 1.1 and by irRECIST Progression-free survival (PFS) by RECIST v 1.1 and by irRECIST Overall survival (OS)
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   A Phase 1 Study of CBL0137 in Patients with Metastatic or Unresectable...
        Protocol No.
        HSC20130328H
        Official Title
        A Phase 1 Trial of CBL0137 In patients With Metastatic or Unresectable Advanced Solid Neoplasms or Refractory Lymphomas (CTRC# 13-0031)
        Description
        This Phase 1 study is designed to determine the best dose of CBL0137 to use when treating patients with metastatic or unresectable advanced solid tumors or lymphoma. The study will enroll up to 48 patients from at least 2 cancer centers in the US. In addition to other conditions for enrollment, eligible patients have cancer that has not improved or has come back after prior treatment and are otherwise in good health. Patients who have a history of active infection, cancer involving the central nervous system, a particular EKG abnormality or other serious medical conditions may not be eligible to enroll.
        Contact
        210-450-5798
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   A Phase 1/2A, Multicenter, Open-Label Study of LYC-55716 in Adult Subjects...
        Protocol No.
        HSC20160617HU
        Official Title
        A Phase 1/2A, Multicenter, Open-Label Study of LYC-55716 in Adult Subjects with Locally Advanced or Metastatic Cancer (CTMS# 16-0099)
        Description
        Primary Objectives Phase 1 Evaluate the safety and tolerability of LYC-55716 Determine the maximum tolerated dose (MTD) and the recommended Phase 2 dose (RP2D) Phase 2a Determine the objective response rate according to response evaluation criteria in solid tumors (RECIST) v1.1 Secondary Objectives Phase 1 Evaluate the activity of LYC-55716 by objective response according to RECIST v1.1 Determine the durability of any observed objective response Phase 2a Determine the duration of response Determine progression-free survival (PFS) and overall survival (OS) Determine suitability of the RP2D for further study Characterize the pharmacokinetics (PK) of LYC-55716 Exploratory Objectives Assess tumor activity in subjects with locally advanced or metastatic cancer according to immune-related response evaluation criteria in solid tumors (irRECIST) Exploratory analysis of metabolite in plasma Assess changes in circulating tumor markers (eg, cytokines/chemokines)
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
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      •   A Phase 1b Study of Oraxol in Combination with Ramucirumab in Patients with...
        Protocol No.
        HSC20170188HU
        Official Title
        A Phase 1b Study of Oraxol in Combination with Ramucirumab in Patients with Gastric, Gastro-esophageal, or Esophageal Cancers (CTMS# 16-0089)
        Description
        Primary Objective: To determine the maximum tolerated dose (MTD) of Oraxol in patients with advanced stage gastric, gastro-esophageal, or esophageal cancers who are being treated with Oraxol in combination with ramucirumab Secondary Objectives: To determine the safety and tolerability of Oraxol in combination with ramucirumab To determine the recommended Phase 2 dose of Oraxol in combination with ramucirumab To characterize the pharmacokinetic (PK) profile of Oraxol in combination with ramucirumab To characterize preliminary activity of Oraxol plus ramucirumab as determined by response rate, progression-free survival, and overall survival
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   A Phase 1b/2 Study of ARRY-382 in Combination with Pembrolizumab, a...
        Protocol No.
        HSC20170071HU
        Official Title
        A Phase 1b/2 Study of ARRY-382 in Combination with Pembrolizumab, a Programmed Cell Death Receptor 1 (PD-1) Antibody, for the Treatment of Patients with Advanced Solid Tumors (CTMS# 16-0084)
        Description
        Primary objective: To determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of ARRY-382 in combination with pembrolizumab in patients with selected solid tumors Secondary objectives:  To describe the preliminary antitumor activity of the combination based on the Response Criteria In Solid Tumors, version 1.1 (RECIST v1.1).  To describe the preliminary antitumor activity of the combination based on immune-related response criteria (irRC).  To characterize the safety and tolerability of the combination, including acute and chronic toxicities. To evaluate the pharmacokinetics of ARRY-382 in combination with pembrolizumab Exploratory objective: To explore the effect of the combination on circulating biomarkers of immune response. To describe the preliminary antitumor activity of the combination in patients with PD-L1 positive non-small cell lung cancer (NSCLC), as determined using a United States Food and Drug Administration (FDA)-approved test, using RECIST. To describe the preliminary antitumor activity of the combination in patients with PD-L1 positive non-small cell lung cancer (NSCLC), as determined using an FDA approved test, using irRC
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   A Phase I, First-in-human, Open-label, Dose-escalation, Safety,...
        Protocol No.
        HSC20160554HU
        Official Title
        A Phase I, First-in-human, Open-label, Dose-escalation, Safety, Pharmacokinetic, and Pharmacodynamic Study of Oral TP-0903 Administered Daily for 21 Days to Patients with Advanced Solid Tumors (CTMS# 16-0092)
        Description
        Primary Objective: To determine the maximum tolerated dose (MTD) and dose-limiting toxicities (DLTs) of oral TP-0903 administered daily for the first 21 days every 4 weeks, over a range of doses in patients with advanced solid tumors. Secondary Objectives: To establish the pharmacokinetics of orally administered TP-0903 To observe patients for any evidence of antitumor activity of TP-0903 by objective radiographic assessment To study the pharmacodynamics of TP-0903 therapy by: assessing biomarkers in tumor tissue assessing biomarkers in peripheral blood mononuclear cells (PBMCs) and serum To establish the Recommended Phase 2 Dose (RP2D) for future studies with TP-0903
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   A Phase I, Multicenter, Open-Label Dose Escalation and Expansion Study of...
        Protocol No.
        HSC20150289HU
        Official Title
        A Phase I, Multicenter, Open-Label Dose Escalation and Expansion Study of PCA062, Administered Intravenously In Adult Patients With pCAD-Positive Tumors (CTMS# 14-2019)
        Description
        Primary Objective To determine the MTD/RDE of PCA062 in patients with pCAD-positive tumors in the dose escalation part. Secondary Objectives To characterize the safety and tolerability of PCA062 To characterize the pharmacokinetic profile of PCA062 To assess emergence of anti-PCA062 antibodies following one or more intravenous infusions of PCA062 To assess the preliminary anti-tumor activity of PCA062 in patients with pCAD-positive triple negative breast cancer (TBNC), head and neck squamous cell carcinoma (HNSCC) or esophageal cancer (squamous and adenocarcinoma)
        Contact
        210-450-5798
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   A Phase I/II, open label, multicenter study of the safety and efficacy of...
        Protocol No.
        HSC20150421HU
        Official Title
        A Phase I/II, open label, multicenter study of the safety and efficacy of LAG525 single agent and in combination with PDR001 administered to patients with advanced malignancies (CTMS #15-2054)
        Description
        Primary Objectives Phase I part To estimate the RP2D or MTD for the single agent LAG525 and the combination of LAG525 and PDR001. Phase II part To estimate the overall response rate per RECIST V1.1 for single agent LAG525 as well as for the combination of LAG525 and PDR001 Secondary Objectives: To characterize the safety and tolerability of single agent LAG525 given alone and in combination with PDR001 To characterize the pharmacokinetic profile of single agent LAG525 given alone and in combination with PDR001 To assess emergence of anti-LAG525, and anti-PDR001 antibodies following one or more intravenous (i.v.) infusions of single agent LAG525 given alone or in combination with PDR001 To assess potential predictors of efficacy of single agent LAG525 and the combination of LAG525 and PDR001 To evaluate the preliminary antitumor activity of single agent LAG525 given alone or in combination of PDR001 To investigate patient selection and pharmacodynamic biomarkers in tumor tissue samples
        Contact
        210-450-5798
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
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      •   A Phase I/II, Open-Label, Multi-Center Study of the Safety and Efficacy of...
        Protocol No.
        HSC20160420HU
        Official Title
        A Phase I/II, Open-Label, Multi-Center Study of the Safety and Efficacy of BLZ945 as Single Agent and In Combination with PDR001 in Adult Patients with Advanced Solid Tumors (CTMS# 16-0071)
        Description
        Primary Objective: Phase I: To characterize the safety and tolerability of BLZ945 as a single agent and in combination with PDR001 and to identify the Maximum Tolerated Dose (MTD)/Recommended Phase 2 Dose (RP2D). Phase II: To assess the anti-tumor activity of BLZ945 in combination with PDR001 (and as single agent if appropriate) in patients with advanced solid tumors. Secondary Objective: Phase I: To characterize the pharmacodynamics effect of BLZ945 as a single agent and in combination with PDR001. To characterize PK of BLZ945 as a single agent and in combination with PDR001. To assess the preliminary anti-tumor activity of BLZ945 as single agent and in combination with PDR001. Phase I and II: To assess emergence of anti-PDR001 antibodies when BLZ945 is administered in combination with PDR001.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   A Phase Ib Trial of Pembrolizumab (MK-3475) in Combination with Dinaciclib...
        Protocol No.
        HSC20170106HU
        Official Title
        A Phase Ib Trial of Pembrolizumab (MK-3475) in Combination with Dinaciclib (MK-7965) in Subjects with Hematologic Malignancies (KEYNOTE-155) (CTMS# 16-0009)
        Description
        Primary Objective Objective: In both the Dose Evaluation and Signal Detection phases, evaluate the safety and tolerability of the treatment combination. Objective: Within each disease type of the Signal Detection phase, evaluate objective response rate (ORR) according to investigator assessment using the disease specific criteria. Secondary Objective: Objective: To evaluate the Objective Response Rate (ORR; complete response [CR] + partial response [PR]) of the combination of pembrolizumab and dinaciclib within each disease type, ie, CLL based on iwCLL guidelines (Hallek, 2008) [1], MM based on IMWG criteria (Durie, 2006) [2] and DLBCL based on the Revised Response Criteria for Malignant Lymphoma (Cheson, 2007) [3]. Objective: Within each disease type of the Signal Detection phase, evaluate Duration of Response (DOR), Progression-Free Survival (PFS) according to investigator assessment using the disease specific criteria; and Overall Survival (OS).
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   ABTR01B1, A Children''s Oncology Group Protocol for Collecting and Banking...
        Protocol No.
        HSC20040131H
        Official Title
        ABTR01B1, A Children''s Oncology Group Protocol for Collecting and Banking Pediatric Research Specimens Including Rare Pediatric Tumors
        Description
        This study is collecting and storing malignant, borderline malignant neoplasms, and related biological samples from young patients with cancer. Collecting and storing samples of tumor tissue, blood, and bone marrow from patients with cancer to study in the laboratory may help the study of cancer in the future.
        Contact
        210-562-9149
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   ACCL15N1CD Use of Evidence-Based Supportive Care Clinical Practice...
        Protocol No.
        HSC20160673X
        Official Title
        ACCL15N1CD Use of Evidence-Based Supportive Care Clinical Practice Guidelines in Pediatric
        Description
        Primary and Secondary Aims Aim 1: Chart Review To measure the rate of adherence to selected COG-endorsed supportive care CPG recommendations at NCORP sites Aim 1a To describe the possible influence of NCORP site size and the number of patients enrolled in COG studies per site on the delivery of CPG-consistent care. Aim 1b To describe the clinical outcome of episodes during which patients receive CPG-consistent or CPG-inconsistent care Aim 2: Focus Groups To describe facilitators of and barriers to the use of CPGs elicited via focus group interviews with a diverse set of potential users (physician, nurse, nurse practitioner and pharmacists) who provide pediatric cancer care at NCORP sites. Aim 3: Interviews To improve how well CPG recommendations are understood by health care providers by refining the CPG recommendation format based on an iterative process of cognitive interviewing and formatting revisions. Understanding is defined as the correct interpretation of the course of action recommended or suggested by a CPG.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   ACCRN07 Protocol for the Enrollment on the Official COG Registry, The...
        Protocol No.
        HSC20080271X
        Official Title
        ACCRN07 Protocol for the Enrollment on the Official COG Registry, The Childhood Cancer Research Network (CCRN)
        Description
        The Children s Oncology Group has established a research network, the Childhood Cancer Research Network (CCRN), to collect information about children with cancer and other conditions that are benign but involve abnormal cell growth in order to help doctors and scientists better understand childhood cancer. The CCRN''s goal is to collect clinical information about every child diagnosed with cancer and similar conditions in the United States and Canada, to allow researchers to study patterns, characteristics, and causes of childhood cancer. The information can also help researchers study the causes of childhood cancer. To expand the CCRN, parents of children who have been diagnosed with cancer will be asked to provide information about themselves and their child for research purposes.   Objectives: To obtain informed consent from parents (and the child, when appropriate) of infants, children, adolescents, and young adults newly diagnosed with cancer to enter their names and certain information concerning their child into the Childhood Cancer Research Network. To obtain informed consent from parents (and the child, when appropriate) of infants, children, adolescents, and young adults newly diagnosed with cancer for permission to be contacted in the future to consider participating in non-therapeutic and prevention research studies involving the parents and/or the child.
        Contact
        210-562-9149
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   Adolescent and Young Adult Childhood Cancer Survivorship (CTMS#17-0088)
        Protocol No.
        HSC20170474HU
        Official Title
        Adolescent and Young Adult Childhood Cancer Survivorship (CTMS#17-0088)
        Description
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   ALTE05N1, Umbrella Long-Term Follow-Up Protocol
        Protocol No.
        HSC20090478X
        Official Title
        ALTE05N1, Umbrella Long-Term Follow-Up Protocol
        Description
        Umbrella Long-Term Follow-Up Protocol
        Contact
        210-562-9149
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   ALTE1621 Pharmacologic Reversal of Ventricular Remodeling in Childhood...
        Protocol No.
        HSC20160394X
        Official Title
        ALTE1621 Pharmacologic Reversal of Ventricular Remodeling in Childhood Cancer Survivors at Risk for Heart Failure (PREVENT-HF): A Phase 2b Randomized Placebo-Controlled (Carvedilol) Trial
        Description
        1.1 Primary Aim To determine the impact of a two-year course of low-dose carvedilol on surrogate echocardiographic indices of heart failure (HF) risk, including Left Ventricular (LV) Posterior Wall Thickness-Dimension Ratio (LV T-D) a well-established index of early myocardial remodeling and subsequent HF risk (primary endpoint).  LV systolic and diastolic function and afterload established echocardiographic indices associated with HF risk.  Natriuretic peptides, troponins, and Galectin-3 - circulating biomarkers associated with myocardial injury, and HF risk. 1.2 Secondary Aims 1.2.1 To establish safety and tolerability of this two-year course of low-dose carvedilol, assessing both objective measures (hepatic function) and patient reported outcomes. 1.2.2 To examine the modifying effect of demographic, clinical, and molecular characteristics on the risk: benefit ratio from this two-year carvedilol intervention. 1.3 Exploratory Aim To evaluate the long-term efficacy of carvedilol in preventing cardiomyopathy and/or heart failure in high-risk childhood cancer survivors.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   AN EARLY-PHASE, MULTICENTER, OPEN-LABEL STUDY OF THE SAFETY AND...
        Protocol No.
        HSC20150549H
        Official Title
        AN EARLY-PHASE, MULTICENTER, OPEN-LABEL STUDY OF THE SAFETY AND PHARMACOKINETICS OF ATEZOLIZUMAB (MPDL3280A) IN PEDIATRIC AND YOUNG ADULT PATIENTS WITH PREVIOUSLY TREATED SOLID TUMORS
        Description
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   An Open-Label Rollover Study to Evaluate the Long-Term Safety, Tolerability,...
        Protocol No.
        HSC20170197XT
        Official Title
        An Open-Label Rollover Study to Evaluate the Long-Term Safety, Tolerability, Biological Activity of Oral TVB-2640 in Patients With Solid Tumors Previously Enrolled in 3V2640-CLIN-002 (CTMS# 17-0046)
        Description
        Primary: To continue to characterize the safety profile of TVB-2640. Secondary: To identify any early signs of anti-tumor activity, where possible.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   An Open-Label, Dose Escalation, Phase 1, First-In-Human Study of TAK-659 in...
        Protocol No.
        HSC20150255HU
        Official Title
        An Open-Label, Dose Escalation, Phase 1, First-In-Human Study of TAK-659 in Adult Patients with Advanced Solid Tumors and Lymphoma Malignancies (CTMS# 14-2013)
        Description
        To determine the safety, tolerability, maximum tolerated dose (MTD)/recommended phase 2 dose (RP2D) ofTAK-659 administered orally on a daily dosing schedule in patients with advanced solid tumor and lymphoma who do not have effective standard treatment available
        Contact
        210-450-5798
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   APEC14B1, THE PROJECT: EVERYCHILD PROTOCOL: A REGISTRY, ELIGIBILITY...
        Protocol No.
        HSC20150870XT
        Official Title
        APEC14B1, THE PROJECT: EVERYCHILD PROTOCOL: A REGISTRY, ELIGIBILITY SCREENING, BIOLOGY AND OUTCOME STUDY
        Description
        1.1 To maintain a Childhood Cancer Registry1 for infants, children, adolescents, and young adults with cancer. 1.2 To utilize clinical and biological data to help determine eligibility or stratification, based on childhood cancer disease classification schemas, for potential enrollment of research subjects onto COG therapeutic clinical trials. 1.3 To develop a well annotated childhood cancer biorepository for current and future research through the collection of biospecimens (at diagnosis, time of progression, time of recurrence and/or post-mortem), including tumor, host and when feasible parental germline DNA; and key clinical data, including presentation, diagnostic, staging, summary treatment, and outcome information, from every child diagnosed with cancer at COG institutions. 1.4 To allow use of registry data for permission to be contacted in the future to consider participating in non-therapeutic and prevention research studies involving the child or their parents.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   Cancer Therapy and Research Center''s Institute for Drug Development Solid...
        Protocol No.
        HSC20070684H
        Official Title
        Cancer Therapy and Research Center''s Institute for Drug Development Solid Tumors and Hematological Malignancies Biorepository for Biomarker Discovery
        Description
        Samples are collected for the Cancer Therapy and Research Center''s Solid Tumors and Hematological Malignancies Biorepository for Biomarker Discovery
        Contact
        210-450-5798
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   Caris Molecular Intelligence® and Caris Centers of Excellence for...
        Protocol No.
        HSC20170144HU
        Official Title
        Caris Molecular Intelligence® and Caris Centers of Excellence for Precision Medicine NetworkTM Retrospective Outcomes-Associated Database (CTMS# 16-0145)
        Description
        The objective of this project is the development of the Caris Molecular Intelligence® and Caris Centers of Excellence for Precision Medicine NetworkTM Outcomes Associated Repository, a disease research database (hereinafter referred to as the Database ) for the purpose of: 1. Effecting change in disease treatment processes by advancing precision medicine and improving care for cancer through acquiring and sharing valuable molecular tumor profiling information and clinical outcomes in a collaborative, secure environment. 2. Performing prospective research studies involving analyses of quality of life studies as well as subject medical records including clinical presentation and outcomes. This eligible cohort includes select subjects having undergone Caris Molecular Intelligence® evaluation for diagnosis and/or treatment management. 3. Evaluate the frequency of specific clinical events in relation to risk factors, diagnosis and treatments provided via the collection of outcomes data through automated data capture systems provided by a third-party data entity and manually-entered data when needed. 4. Provide information access that is vital to research collaborators, including potential researchers from pharmaceutical companies, governmental agencies, academia, healthcare providers, and payors, with catalogued subject outcome data for the use of drug development discoveries, clinically relevant research trials, publications and posters, the implementation of future healthcare policies, characterization of trends in practice patterns and their relation to subject outcomes and the economic impact of differing evaluation, treatment, and management paradigms. 5. Cultivate a repository for assay development and validation of emerging technologies to enhance clinical cancer care.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
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      •   Caris Molecular Intelligence® and Caris Centers of Excellence for Precision...
        Protocol No.
        HSC20170353HU
        Official Title
        Caris Molecular Intelligence® and Caris Centers of Excellence for Precision Medicine NetworkTM Outcomes Associated Repository (CTMS# 17-0023)
        Description
        The objective of this project is the development of the Caris Molecular Intelligence® and Caris Centers of Excellence for Precision Medicine NetworkTM Outcomes Associated Repository, a disease research database (hereinafter referred to as the Database) for the purpose of: 1. Effecting change in disease treatment processes by advancing precision medicine and improving care for cancer through acquiring and sharing valuable molecular tumor profiling information and clinical outcomes in a collaborative, secure environment. 2. Performing prospective research studies involving analyses of quality of life studies as well as subject medical records including clinical presentation and outcomes. This eligible cohort includes select subjects having undergone Caris Molecular Intelligence® evaluation for diagnosis and/or treatment management. 3. Evaluate the frequency of specific clinical events in relation to risk factors, diagnosis and treatments provided via the collection of outcomes data through automated data capture systems provided by a third-party data entity and manually-entered data when needed. 4. Provide information access that is vital to research collaborators, including potential researchers from pharmaceutical companies, governmental agencies, academia, healthcare providers, and payors, with catalogued subject outcome data for the use of drug development discoveries, clinically relevant research trials, publications and posters, the implementation of future healthcare policies, characterization of trends in practice patterns and their relation to subject outcomes and the economic impact of differing evaluation, treatment, and management paradigms. 5. Cultivate a repository for assay development and validation of emerging technologies to enhance clinical cancer care.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
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      •   Clinical Trial of Lurbinectedin (PM01183) in Selected Advanced Solid Tumors
        Protocol No.
        HSC20150542HU
        Official Title
        A Multicenter Phase II Clinical Trial of Lurbinectedin (PM01183) in Selected Advanced Solid Tumors (CTMS# 15-2071)
        Description
        Primary: To assess the antitumor activity of lurbinectedin (PM01183) in terms of overall response rate (ORR), according to the Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1, in the following advanced solid tumors: small cell lung cancer (SCLC), head and neck carcinoma (H&N), neuroendocrine tumors (NETs), biliary tract carcinoma, endometrial carcinoma, BRCA 1/2-associated metastatic breast carcinoma, carcinoma of unknown primary site, germ cell tumors (GCTs), and Ewing¿s family of tumors (EFTs). Secondary: To further characterize the antitumor activity of PM01183 in terms of duration of response (DR), clinical benefit [ORR or stable disease (SD) lasting over four months (SD ¿ 4 months)], progression-free survival (PFS), and one year overall survival (1y-OS) in each cohort of advanced solid tumors. Characterize the plasma pharmacokinetics (PK) of PM01183. To conduct an exploratory pharmacogenomic (PGx) and pharmacogenetic analysis. To evaluate the safety profile of PM01183 in this patient population.
        Contact
        410-450-5798
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   Clinical trial to study the safety and efficacy of MBG453 given alone and in...
        Protocol No.
        HSC20150730HU
        Official Title
        A Phase I-Ib/II, Open-Label, Multi-Center Study of the Safety and Efficacy of MBG453 as Single Agent and in Combination with PDR001 in Adult Patients with Advanced Malignancies (CTMS# 15-2114)
        Description
        Primary Objectives: Phase I-Ib: To characterize the safety and tolerability of MBG453 as a single agent and in combination with PDR001 and to identify recommended doses for future studies. Phase I-Ib dose ranging: To further investigate the safety and tolerability of different doses of MBG453 alone or in combination with PDR001. Phase II: To estimate the anti-tumor activity of MBG453 alone in patients with solid tumors, and in combination with PDR001 in selected disease indications (melanoma, non-small cell lung cancer (NSCLC), renal cell carcinoma (RCC)). Secondary Objectives Evaluate the preliminary anti-tumor activity of MBG453 alone and in combination with PDR001. Make an initial comparison of safety, PK and efficacy for MBG453 and PDR001 administered in combination on a every 2 weeks (Q2W) and every 4 weeks (Q4W) dosing schedules. Characterize the pharmacokinetic profile of MBG453 alone and in combination with PDR001. Assess emergence of anti-MBG453 and anti-PDR001 antibodies. Assess potential predictors of efficacy of MBG453 single agent and in combination with PDR001 in tumor samples. Assess the pharmacodynamic effect of MBG453 as single agent and in combination with PDR001 in tumor samples. Describe the survival distribution of patients treated with MBG453 as single agent and in combination with PDR001 for each disease group.
        Contact
        410-450-5798
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   DCP-001, Use of a Clinical Trial Screening Tool to Address Cancer Health...
        Protocol No.
        HSC20160342XT
        Official Title
        DCP-001, Use of a Clinical Trial Screening Tool to Address Cancer Health Disparities in the NCI Community Oncology Research Program (NCORP)
        Description
        Objectives 1) Implement a screening tool in NCORP to collect broader demographic and clinical data to generate hypothesis and research questions in the following areas of research: cancer screening, cancer prevention, symptom science, cancer care disparities, comparative effectiveness and cancer care delivery research. 2) Collect expanded demographic and clinical data (e.g., SES, co-morbidities, method of diagnosis) across the NCORP network to help identify and best characterize patients that are screened but not enrolled and for patients that participate in NCI trials, to understand how these variables may impact outcomes. 3) Enhance an understanding of site- specific and trial-specific accrual barriers that will inform the development of effective strategies to improve accrual, particularly for minority and underserved populations. 4) Provide data for internal and external evaluation of NCORP s first RFA cycle and reissuance.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   GO29665, A PHASE I/II, MULTICENTER, OPEN-LABEL, DOSE-ESCALATION STUDY OF THE...
        Protocol No.
        HSC20160080H
        Official Title
        GO29665, A PHASE I/II, MULTICENTER, OPEN-LABEL, DOSE-ESCALATION STUDY OF THE SAFETY AND PHARMACOKINETICS OF COBIMETINIB IN PEDIATRIC AND YOUNG ADULT PATIENTS WITH PREVIOUSLY TREATED SOLID TUMORS (CTRC# 15-0005)
        Description
        CTRC#15-0005
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   Head and Neck Cancer Repository
        Protocol No.
        HSC20170218HR
        Official Title
        Head and Neck Cancer Repository
        Description
        To establish a repository of head and neck cancers and PDX models from our south Texas patient population.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   Health Effects after Anthracycline and Radiation Therapy (HEART):...
        Protocol No.
        HSC20140058X
        Official Title
        Health Effects after Anthracycline and Radiation Therapy (HEART): Dexrazoxane and Prevention of Anthracycline-related Cardiomyopathy A Limited Institution Non-Therapeutic Study
        Description
        This clinical trial studies the effects of dexrazoxane hydrochloride on biomarkers associated with cardiomyopathy and heart failure after cancer treatment. Studying samples of blood in the laboratory from patients receiving dexrazoxane hydrochloride may help doctors learn more about the effects of dexrazoxane hydrochloride on cells. It may also help doctors understand how well patients respond to treatment.
        Contact
        210-562-9149
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   Incidence and Factors Associated with the Development and Severity of Oral...
        Protocol No.
        HSC20050218H
        Official Title
        Incidence and Factors Associated with the Development and Severity of Oral Mucositis in Patients Undergoing High Dose Chemotherapy and Peripheral Stem Cell Transplantation
        Description
        Our study intends to evaluate prospectively the incidence and severity of oral mucositis in patients undergoing high-dose chemotherapy and hematopoietic stem cell transplantation, as well as to evaluate the potential influence of nutritional-, physical-, and transplant-related factors associated with the development of this complication and its grade of involvement. Research plan: This is a prospective cohort study with an observational basis that involves all of the patients undergoing high-dose chemotherapy and peripheral blood stem cell transplantation at the Audie L. Murphy VA Hospital Bone Marrow Transplant Unit and at the University Hospital Bone Marrow Transplant Unit. We expect to enroll 400 patients during a 5-year period. Methods: In order to answer the study questions, subjects will be assessed several times during the study period. The study involves a multidisciplinary group that will be evaluating and following the subjects. A baseline will be established by a physician and a nutritionist before the subjects start the high-dose chemotherapy regimen. The subjects will be followed with oral evaluations 3 times per week, beginning on the day of the transplant and ending when mucositis resolves, or the patient is discharged home, or 30 days post-transplant, whichever occurs first. At day 15 post-transplant, patients will be evaluated for the second time by the nutritionist. Further information such as blood values, use of medications and treatment complications, will be obtained by daily chart review.  
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   MATCH Treatment Subprotocol B: Phase II Study of Afatinib in Patients with...
        Protocol No.
        HSC20150831HU
        Official Title
        MATCH Treatment Subprotocol B: Phase II Study of Afatinib in Patients with Tumors with HER2 Activating Mutations (CTMS# 15-2107)
        Description
        Primary Objective To evaluate the proportion of patients with objective response (OR) to targeted study agent(s) in patients with advanced refractory cancers/lymphomas. Secondary Objectives To evaluate the proportion of patients alive and progression free at 6 months of treatment with targeted study agent in patients with advanced refractory cancers/lymphomas. To evaluate time until death or disease progression. To identify potential predictive biomarkers beyond the genomic alteration by which treatment is assigned or resistance mechanisms using additional genomic, RNA and protein-based assessment platforms.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
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      •   MATCH Treatment Subprotocol C1: EAY131-C1: Crizotinib in Patients with...
        Protocol No.
        HSC20160463HU
        Official Title
        MATCH Treatment Subprotocol C1: EAY131-C1: Crizotinib in Patients with Tumors with MET Amplification (CTMS# 16-0064)
        Description
        The purpose of this study is to test any good and bad effects of the study drug called crizotinib in patients whose cancer has MET genetic changes.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
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      •   MATCH Treatment Subprotocol F: Crizotinib in Patients with Tumors (other...
        Protocol No.
        HSC20150750HU
        Official Title
        MATCH Treatment Subprotocol F: Crizotinib in Patients with Tumors (other than adenocarcinoma of lung or ALCL) with ALK Translocations (CTMS# 15-2081)
        Description
        Primary Objective To evaluate the proportion of patients with objective response (OR) to targeted study agent(s) in patients with advanced refractory cancers/lymphomas. Secondary Objectives To evaluate the proportion of patients alive and progression free at 6 months of treatment with targeted study agent in patients with advanced refractory cancers/lymphomas. To evaluate time until death or disease progression. To identify potential predictive biomarkers beyond the genomic alteration by which treatment is assigned or resistance mechanisms using additional genomic, RNA and protein-based assessment platforms.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   MATCH Treatment Subprotocol S1: Phase II Study of Trametinib in Patients...
        Protocol No.
        HSC20160260HU
        Official Title
        MATCH Treatment Subprotocol S1: Phase II Study of Trametinib in Patients with Tumors with NF1 Mutations (CTMS# 16-0028)
        Description
        PRIMARY OBJECTIVES: I. To evaluate the proportion of patients with objective response (OR) to targeted study agent(s) in patients with advanced refractory cancers/lymphomas. SECONDARY OBJECTIVES: I. To evaluate the proportion of patients alive and progression free at 6 months of treatment with targeted study agent in patients with advanced refractory cancers/lymphomas. II. To evaluate time until death or disease progression. III. To identify potential predictive biomarkers beyond the genomic alteration by which treatment is assigned or resistance mechanisms using additional genomic, ribonucleic acid (RNA) and protein-based assessment platforms.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   MATCH Treatment Subprotocol U: VS-6063 (defactinib) in Patients with Tumors...
        Protocol No.
        HSC20150839HU
        Official Title
        MATCH Treatment Subprotocol U: VS-6063 (defactinib) in Patients with Tumors with NF2 Loss (CTMS# 15-2110)
        Description
        Primary Objective To evaluate the proportion of patients with objective response (OR) to targeted study agent(s) in patients with advanced refractory cancers/lymphomas. Secondary Objectives To evaluate the proportion of patients alive and progression free at 6 months of treatment with targeted study agent in patients with advanced refractory cancers/lymphomas. To evaluate time until death or disease progression. To identify potential predictive biomarkers beyond the genomic alteration by which treatment is assigned or resistance mechanisms using additional genomic, RNA and protein-based assessment platforms.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   MATCH Treatment Subprotocol W: EAY131-W: Phase II Study of AZD4547 in...
        Protocol No.
        HSC20160541HU
        Official Title
        MATCH Treatment Subprotocol W: EAY131-W: Phase II Study of AZD4547 in Patients with Tumors with Aberrations in the FGFR Pathway (CTMS# 16-0065)
        Description
        The purpose of this study is to test any good and bad effects of the study drug, AZD4547, in patients whose cancer has genetic changes called FGFR gene alterations.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   MATCH Treatment Subprotocol X: Phase II Study of Dasatinib in Patients with...
        Protocol No.
        HSC20160282HU
        Official Title
        MATCH Treatment Subprotocol X: Phase II Study of Dasatinib in Patients with Tumors with DDR2 Mutations (CTMS# 16-0032)
        Description
        PRIMARY OBJECTIVES: I. To evaluate the proportion of patients with objective response (OR) to targeted study agent(s) in patients with advanced refractory cancers/lymphomas. SECONDARY OBJECTIVES: I. To evaluate the proportion of patients alive and progression free at 6 months of treatment with targeted study agent in patients with advanced refractory cancers/lymphomas. II. To evaluate time until death or disease progression. III. To identify potential predictive biomarkers beyond the genomic alteration by which treatment is assigned or resistance mechanisms using additional genomic, ribonucleic acid (RNA) and protein-based assessment platforms.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   MATCH Treatment Subprotocol Z1A: EAY131-Z1A: Binimetinib in Patients with...
        Protocol No.
        HSC20160499HU
        Official Title
        MATCH Treatment Subprotocol Z1A: EAY131-Z1A: Binimetinib in Patients with Tumors (Other Than Melanoma) with NRAS Mutations (CTMS# 16-0066)
        Description
        The purpose of this study is to test any good and bad effects of the experimental study drug binimetinib in patients whose cancer has NRAS mutations.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   MATCH Treatment Subprotocol Z1B: EAY131-Z1B: Phase II Study of Palbociclib...
        Protocol No.
        HSC20160491HU
        Official Title
        MATCH Treatment Subprotocol Z1B: EAY131-Z1B: Phase II Study of Palbociclib (PD-0332991) in Patients with Tumors with CCND1, 2, 3 Amplification and Rb Protein Expression by IHC (CTMS# 16-0067)
        Description
        The purpose of this study is to test any good and bad effects of the study drug, palbociclib, in patients whose cancer has CCND1, 2 or 3 amplification and tested positive for a protein called Rb protein.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   Molecular Analysis for Therapy Choice (MATCH) / MATCH Treatment Subprotocol...
        Protocol No.
        HSC20170176HU
        Official Title
        Molecular Analysis for Therapy Choice (MATCH) / MATCH Treatment Subprotocol H: EAY131-H: Phase II Study of Dabrafenib and Trametinib in Patients with Tumors with BRAF V600E or V600K Mutations (Excluding Melanoma, Thyroid Cancer, and Colorectal Adenocarcinoma) (CTMS# 15-2083)
        Description
        Primary Objective To evaluate the proportion of patients with objective response (OR) to targeted study agent(s) in patients with advanced refractory cancers/lymphomas. Secondary Objectives To evaluate the proportion of patients alive and progression free at 6 months of treatment with targeted study agent in patients with advanced refractory cancers/lymphomas. To evaluate time until death or disease progression. To identify potential predictive biomarkers beyond the genomic alteration by which treatment is assigned or resistance mechanisms using additional genomic, RNA and protein-based assessment platforms.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   Molecular Analysis for Therapy Choice (NCI-MATCH)
        Protocol No.
        HSC20150719XT
        Official Title
        EAY131, Molecular Analysis for Therapy Choice (MATCH) (CTMS# 15-2080)
        Description
        Primary Objective To evaluate the proportion of patients with objective response (OR) to targeted study agent(s) in patients with advanced refractory cancers/lymphomas. Secondary Objectives To evaluate the proportion of patients alive and progression free at 6 months of treatment with targeted study agent in patients with advanced refractory cancers/lymphomas. To evaluate time until death or disease progression. To identify potential predictive biomarkers beyond the genomic alteration by which treatment is assigned or resistance mechanisms using additional genomic, RNA and protein-based assessment platforms.
        Contact
        410-450-5798
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   NRG-HN003, A PHASE I AND EXPANSION COHORT STUDY OF ADJUVANT CISPLATIN,...
        Protocol No.
        HSC20170206HU
        Official Title
        NRG-HN003, A PHASE I AND EXPANSION COHORT STUDY OF ADJUVANT CISPLATIN, INTENSITY-MODULATED RADIOTHERAPY, AND MK-3475 (PEMBROLIZUMAB) IN HIGH-RISK HEAD AND NECK SQUAMOUS CELL CARCINOMA (HNSCC) (CTMS# 17-0022)
        Description
        Primary Outcome Measures: DLT in patients with high-risk head and neck squamous cell carcinoma treated with adjuvant cisplatin, IMRT, and pembrolizumab [ Time Frame: Up to 4 weeks post IMRT ] Will be summarized using proportions for binary outcome per cohort.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
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      •   Phase I Clinical Trial of Camptothecin-20-O-Propionate hydrate (CZ48) (CTMS#...
        Protocol No.
        HSC20150748HU
        Official Title
        Phase I Clinical Trial of Camptothecin-20-O-Propionate hydrate (CZ48) (CTMS# 15-2103)
        Description
        PRIMARY: To describe the dose limiting toxicities and adverse event profile of Camptothecin-20-O-Propionate hydrate (CZ48) administered orally every day. To determine Phase II recommended dose of Camptothecin-20-O-Propionate hydrate (CZ48) administered orally every day. SECONDARY: To perform a pharmacokinetic study of orally administered CZ48. To assess responses by RECIST criteria when applicable. To follow patients for survival.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
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      •   Phase I study of carfilzomib in combination with cyclophosphamide and...
        Protocol No.
        HSC20160206HU
        Official Title
        Phase I study of carfilzomib in combination with cyclophosphamide and etoposide for children with relapsed and refractory solid tumors and leukemias (CTMS# 15-2097)
        Description
        Primary Objective: To determine the DLTs and MTD of carfilzomib given in combination with cyclophosphamide and etoposide in pediatric patients with relapsed/refractory leukemias and solid tumors Secondary Objectives: 1. To evaluate toxicities of carfilzomib in the pediatric population when combined with conventional chemotherapy 2. To gather preliminary efficacy data on the drug combination 3. To measure if circulating plasma proteasome (cProt) levels post treatment correlate with response to therapy and overall survival 4. To measure if the levels of proteasome activity and resistance to carfilzomib correlates with toxicity and/or response to treatment. 5. To measure if inhibition of proteasome activity by carfilzomib results in alteration in a number of autophagy and apoptosis related proteins, providing means to evaluate correlates of activity of carfilzomib. 6. To measure the level of proteasome inhibition in patient PBMCs before and during treatment by determination of the level of protein ubiquitination. 7. To determine in vitro sensitivity of patient leukemias and solid tumors to carfilzomib alone and in combination with study chemotherapeutic agents in order to generate a predictive model of drug sensitivity. 8. To expand patient leukemia and solid tumor samples in order to save tissue for future studies but also to serve as a pre-clinical in vivo model to be included in the generation and testing of a drug sensitivity predictive model. 9. To perform whole exome sequencing (WES) and RNA seq on patient leukemia and solid tumor samples and WES on germ line DNA in order to determine potential mechanisms of drug sensitivity or resistance as well as contribute to testing a computer `learning engine (Bionet) for predicting clinical responses from genomic and drug sensitivity data.
        Contact
        210-562-9149
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
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      •   Phase Ib, open-label, multi-center study to characterize the safety,...
        Protocol No.
        HSC20160552HU
        Official Title
        Phase Ib, open-label, multi-center study to characterize the safety, tolerability and pharmacodynamics (PD) of PDR001 in combination with LCL161, everolimus (RAD001) or panobinostat (LBH589) (CTMS# 16-0058)
        Description
        Primary Objectives: To characterize the safety and tolerability of PDR001 in combination with LCL161, everolimus (RAD001) or panobinostat (LBH589) and to identify recommended doses and schedules for future studies Secondary Objectives: To characterize changes in the immune infiltrate in tumors To further characterize the safety of PDR001 in combination with LCL161, everolimus or panobinostat (LBH589) To estimate the anti-tumor activity of PDR001 in combination with LCL161, everolimus or panobinostat (LBH589) To characterize the pharmacokinetics of all study drugs in combination To assess immunogenicity of PDR001
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   Phase II Trial of Eribulin and Lenvatinib in Advanced Solid Tumors (CTMS#...
        Protocol No.
        HSC20150891HU
        Official Title
        Phase II Trial of Eribulin and Lenvatinib in Advanced Solid Tumors (CTMS# 15-2139)
        Description
        The overall purpose of this study is to determine the overall response rate, efficacy and safety of the combination of eribulin and Lenvatinib.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
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      •   Prognostic and predictive markers in patients with advanced metastatic tumors
        Protocol No.
        HSC20130219H
        Official Title
        Numeration and Single-Cell Molecular Profiling of Circulating Tumor Cells as Prognostic and Predictive Marker In Patients with Advanced Metastatic Tumors (CTRC#13-0001)
        Description
        This study will research possible associations between circulating tumor cells (CTC) quantities or gene profile characteristics and clinical outcomes. The primary objective is to obtain blood samples from participants over an 8-week period for research analysis.  The study will enroll approximately 200 patients at the CTRC. In addition to other conditions for enrollment, eligible patients have advanced metastatic cancer.
        Contact
        210-450-5798
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   Prospective Comparative Effectiveness Trial for Malignant Bowel Obstruction...
        Protocol No.
        HSC20170491HU
        Official Title
        Prospective Comparative Effectiveness Trial for Malignant Bowel Obstruction (CTMS# 17-0081)
        Description
        Number of days alive and outside the hospital
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
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      •   S1609, Dart: Dual Anti-CTLA-4 and Anti-PD-1 Blockage in Rare Tumors (CTMS#...
        Protocol No.
        HSC20170145HU
        Official Title
        S1609, Dart: Dual Anti-CTLA-4 and Anti-PD-1 Blockage in Rare Tumors (CTMS# 17-0013)
        Description
        Primary Objective To evaluate the RECIST 1.1 overall response rate (ORR) in subsets of patients with advanced rare cancers treated with ipilimumab plus nivolumab combination immunotherapy. Secondary Objectives To evaluate toxicities in each cohort. To estimate overall survival (OS), progression-free survival (PFS), clinical benefit rate; and to estimate immune-related ORR (irORR), and immune-related PFS (irPFS) by unidimensional immune-related response criteria. To collect specimens for banking for use in future correlative biomarker research studies.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   Safety, Tolerability & PK of KX2-361 in Subjects with advanced malignancies...
        Protocol No.
        HSC20150481HU
        Official Title
        A Phase 1 Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetics of KX2-361 in Subjects with Advanced Malignancies that are Refractory to Conventional Therapies (CTMS# 15-2063)
        Description
        Study Objectives: Primary Objective: To define the maximum tolerated dose (MTD) of KX2-361 in subjects with advanced refractory malignancies when administered as single and multiple oral doses. Secondary Objectives: To determine the safety and tolerability of KX2-361 after single and multiple oral doses, in subjects with advanced refractory malignancies. To characterize the pharmacokinetic profile of KX2-361 after single and multiple oral doses. To evaluate the activity of KX2-361 in both the Dose Escalation Cohort and the Expansion Cohort of subjects with high-grade glioma.
        Contact
        210-450-5798
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   Study of the Genetic Epidemiology of Childhood Cancer
        Protocol No.
        HSC20080057H
        Official Title
        Study of the Genetic Epidemiology of Childhood Cancer
        Description
        Study of the Genetic Epidemiology of Childhood Cancer
        Contact
        210-562-9123
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

    •   Esophagus

      •   A Dose Regimen-Finding Study to Evaluate the Safety, Tolerability,...
        Protocol No.
        HSC20170102HU
        Official Title
        A Dose Regimen-Finding Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Activity of Oradoxel Monotherapy in Subjects with Advanced Malignancies (CTMS# 16-0069)
        Description
        Primary Objective: To determine the maximum tolerated dose (MTD) of Oradoxel based on dose-limiting toxicity (DLT) in subjects with advanced malignancies Secondary Objectives To determine the safety and tolerability of docetaxel as Oradoxel To determine the incidence of unacceptable toxicity with Oradoxel To determine the recommended Phase 2 dose (RP2D) of docetaxel as Oradoxel To characterize the pharmacokinetic (PK) profile of docetaxel as Oradoxel To evaluate tumor response
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   A Dose Regimen-Finding Study to Evaluate the Safety, Tolerability,...
        Protocol No.
        HSC20160087HU
        Official Title
        A Dose Regimen-Finding Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Activity of Oraxol in Subjects with Advanced Malignancies (CTMS# 15-2137)
        Description
        Primary Objective To determine the maximum tolerated dose (MTD) and dosing regimen of Oraxol in subjects with advanced malignancies Secondary Objectives To determine the recommended Phase 2 dose of paclitaxel as Oraxol To determine the safety and tolerability of paclitaxel as Oraxol To characterize the pharmacokinetic (PK) profile of paclitaxel as Oraxol To evaluate the tumor response
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   A Five Part, Phase 1, Multi-center, Open-label Study of DKN-01 in...
        Protocol No.
        HSC20140189H
        Official Title
        A Five Part, Phase 1, Multi-center, Open-label Study of DKN-01 in Combination with Weekly Paclitaxel; Part A: A Dose-Escalation Study in Patients with Relapsed or Refractory Esophageal Cancer or Gastro-esophageal Junction Tumors; Part B: An Expansion Cohort in Patients with Relapsed or Refractory Esophageal Cancer or Gastro-esophageal Junction Tumors; Part C: An Expansion Cohort in Patients with Relapsed or Refractory Esophageal or Gastro-esophageal Junction Adenocarcinoma; Part D: An Expansion Cohort in Patients with Relapsed or Refractory Esophageal Squamous Cell Cancer; Part E: An Expansion Cohort in Patients with Relapsed or Refractory Gastric Adenocarcinoma with Wnt Signaling Alterations (CTRC# 14-0002)
        Description
        A study to evaluate the safety and tolerability of DKN-01 in combination with weekly paclitaxel in participants with refractory/recurrent esophageal or gastro-esophageal junction cancer Part A is a Dose-Escalation Study in Participants with Relapsed or Refractory Esophageal Cancer or Gastro-Esophageal Junction Tumors. Part B is an Expansion Cohort in Participants with Relapsed or Refractory Esophageal Cancer or Gastro-Esophageal Junction Tumors
        Contact
        210-450-5798
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   A Phase 1 Dose Escalation and Cohort Expansion Study of TSR-042, an...
        Protocol No.
        HSC20170110HU
        Official Title
        A Phase 1 Dose Escalation and Cohort Expansion Study of TSR-042, an anti-PD-1 Monoclonal Antibody, in Patients with Advanced Solid Tumors (CTMS# 16-0091)
        Description
        Primary Objectives: Part 1 Dose Escalation Cohorts: To evaluate the safety and tolerability of TSR-042 using Common Terminology Criteria for Adverse Events (CTCAE v.4.03) in patients with advanced solid tumors Part 2 Expansion Cohorts: To evaluate the antitumor activity of TSR-042 in patients with advanced solid tumors, in terms of objective response rate (ORR) as assessed by the Investigators using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 Part 1 and Part 2: To define the recommended Phase 2 dose (RP2D) and schedule Secondary Objectives: Part 1 Dose Escalation Cohorts: To characterize the pharmacodynamic (PDy) profile of TSR-042 To evaluate ORR as assessed by the Investigators using RECIST v1.1 Part 2 Expansion Cohorts: To characterize the safety and tolerability of TSR-042 using CTCAE v.4.03 Part 1 and Part 2: To characterize the pharmacokinetic (PK) profile of TSR-042 To evaluate the immunogenicity of TSR-042 To evaluate additional measures of clinical benefit, including: ORR by immune-related RECIST (irRECIST) Duration of response (DOR) by RECIST v 1.1 Disease control rate (DCR) by RECIST v 1.1 and by irRECIST Progression-free survival (PFS) by RECIST v 1.1 and by irRECIST Overall survival (OS)
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   A Phase 1 Study of CBL0137 in Patients with Metastatic or Unresectable...
        Protocol No.
        HSC20130328H
        Official Title
        A Phase 1 Trial of CBL0137 In patients With Metastatic or Unresectable Advanced Solid Neoplasms or Refractory Lymphomas (CTRC# 13-0031)
        Description
        This Phase 1 study is designed to determine the best dose of CBL0137 to use when treating patients with metastatic or unresectable advanced solid tumors or lymphoma. The study will enroll up to 48 patients from at least 2 cancer centers in the US. In addition to other conditions for enrollment, eligible patients have cancer that has not improved or has come back after prior treatment and are otherwise in good health. Patients who have a history of active infection, cancer involving the central nervous system, a particular EKG abnormality or other serious medical conditions may not be eligible to enroll.
        Contact
        210-450-5798
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   A Phase 1/2A, Multicenter, Open-Label Study of LYC-55716 in Adult Subjects...
        Protocol No.
        HSC20160617HU
        Official Title
        A Phase 1/2A, Multicenter, Open-Label Study of LYC-55716 in Adult Subjects with Locally Advanced or Metastatic Cancer (CTMS# 16-0099)
        Description
        Primary Objectives Phase 1 Evaluate the safety and tolerability of LYC-55716 Determine the maximum tolerated dose (MTD) and the recommended Phase 2 dose (RP2D) Phase 2a Determine the objective response rate according to response evaluation criteria in solid tumors (RECIST) v1.1 Secondary Objectives Phase 1 Evaluate the activity of LYC-55716 by objective response according to RECIST v1.1 Determine the durability of any observed objective response Phase 2a Determine the duration of response Determine progression-free survival (PFS) and overall survival (OS) Determine suitability of the RP2D for further study Characterize the pharmacokinetics (PK) of LYC-55716 Exploratory Objectives Assess tumor activity in subjects with locally advanced or metastatic cancer according to immune-related response evaluation criteria in solid tumors (irRECIST) Exploratory analysis of metabolite in plasma Assess changes in circulating tumor markers (eg, cytokines/chemokines)
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   A Phase 1b Study of Oraxol in Combination with Ramucirumab in Patients with...
        Protocol No.
        HSC20170188HU
        Official Title
        A Phase 1b Study of Oraxol in Combination with Ramucirumab in Patients with Gastric, Gastro-esophageal, or Esophageal Cancers (CTMS# 16-0089)
        Description
        Primary Objective: To determine the maximum tolerated dose (MTD) of Oraxol in patients with advanced stage gastric, gastro-esophageal, or esophageal cancers who are being treated with Oraxol in combination with ramucirumab Secondary Objectives: To determine the safety and tolerability of Oraxol in combination with ramucirumab To determine the recommended Phase 2 dose of Oraxol in combination with ramucirumab To characterize the pharmacokinetic (PK) profile of Oraxol in combination with ramucirumab To characterize preliminary activity of Oraxol plus ramucirumab as determined by response rate, progression-free survival, and overall survival
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   A Phase 1b/2 Study of ARRY-382 in Combination with Pembrolizumab, a...
        Protocol No.
        HSC20170071HU
        Official Title
        A Phase 1b/2 Study of ARRY-382 in Combination with Pembrolizumab, a Programmed Cell Death Receptor 1 (PD-1) Antibody, for the Treatment of Patients with Advanced Solid Tumors (CTMS# 16-0084)
        Description
        Primary objective: To determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of ARRY-382 in combination with pembrolizumab in patients with selected solid tumors Secondary objectives:  To describe the preliminary antitumor activity of the combination based on the Response Criteria In Solid Tumors, version 1.1 (RECIST v1.1).  To describe the preliminary antitumor activity of the combination based on immune-related response criteria (irRC).  To characterize the safety and tolerability of the combination, including acute and chronic toxicities. To evaluate the pharmacokinetics of ARRY-382 in combination with pembrolizumab Exploratory objective: To explore the effect of the combination on circulating biomarkers of immune response. To describe the preliminary antitumor activity of the combination in patients with PD-L1 positive non-small cell lung cancer (NSCLC), as determined using a United States Food and Drug Administration (FDA)-approved test, using RECIST. To describe the preliminary antitumor activity of the combination in patients with PD-L1 positive non-small cell lung cancer (NSCLC), as determined using an FDA approved test, using irRC
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   A Phase I, First-in-human, Open-label, Dose-escalation, Safety,...
        Protocol No.
        HSC20160554HU
        Official Title
        A Phase I, First-in-human, Open-label, Dose-escalation, Safety, Pharmacokinetic, and Pharmacodynamic Study of Oral TP-0903 Administered Daily for 21 Days to Patients with Advanced Solid Tumors (CTMS# 16-0092)
        Description
        Primary Objective: To determine the maximum tolerated dose (MTD) and dose-limiting toxicities (DLTs) of oral TP-0903 administered daily for the first 21 days every 4 weeks, over a range of doses in patients with advanced solid tumors. Secondary Objectives: To establish the pharmacokinetics of orally administered TP-0903 To observe patients for any evidence of antitumor activity of TP-0903 by objective radiographic assessment To study the pharmacodynamics of TP-0903 therapy by: assessing biomarkers in tumor tissue assessing biomarkers in peripheral blood mononuclear cells (PBMCs) and serum To establish the Recommended Phase 2 Dose (RP2D) for future studies with TP-0903
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   A Phase I, Multicenter, Open-Label Dose Escalation and Expansion Study of...
        Protocol No.
        HSC20150289HU
        Official Title
        A Phase I, Multicenter, Open-Label Dose Escalation and Expansion Study of PCA062, Administered Intravenously In Adult Patients With pCAD-Positive Tumors (CTMS# 14-2019)
        Description
        Primary Objective To determine the MTD/RDE of PCA062 in patients with pCAD-positive tumors in the dose escalation part. Secondary Objectives To characterize the safety and tolerability of PCA062 To characterize the pharmacokinetic profile of PCA062 To assess emergence of anti-PCA062 antibodies following one or more intravenous infusions of PCA062 To assess the preliminary anti-tumor activity of PCA062 in patients with pCAD-positive triple negative breast cancer (TBNC), head and neck squamous cell carcinoma (HNSCC) or esophageal cancer (squamous and adenocarcinoma)
        Contact
        210-450-5798
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   A Phase I/II, open label, multicenter study of the safety and efficacy of...
        Protocol No.
        HSC20150421HU
        Official Title
        A Phase I/II, open label, multicenter study of the safety and efficacy of LAG525 single agent and in combination with PDR001 administered to patients with advanced malignancies (CTMS #15-2054)
        Description
        Primary Objectives Phase I part To estimate the RP2D or MTD for the single agent LAG525 and the combination of LAG525 and PDR001. Phase II part To estimate the overall response rate per RECIST V1.1 for single agent LAG525 as well as for the combination of LAG525 and PDR001 Secondary Objectives: To characterize the safety and tolerability of single agent LAG525 given alone and in combination with PDR001 To characterize the pharmacokinetic profile of single agent LAG525 given alone and in combination with PDR001 To assess emergence of anti-LAG525, and anti-PDR001 antibodies following one or more intravenous (i.v.) infusions of single agent LAG525 given alone or in combination with PDR001 To assess potential predictors of efficacy of single agent LAG525 and the combination of LAG525 and PDR001 To evaluate the preliminary antitumor activity of single agent LAG525 given alone or in combination of PDR001 To investigate patient selection and pharmacodynamic biomarkers in tumor tissue samples
        Contact
        210-450-5798
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   A Phase I/II, Open-Label, Multi-Center Study of the Safety and Efficacy of...
        Protocol No.
        HSC20160420HU
        Official Title
        A Phase I/II, Open-Label, Multi-Center Study of the Safety and Efficacy of BLZ945 as Single Agent and In Combination with PDR001 in Adult Patients with Advanced Solid Tumors (CTMS# 16-0071)
        Description
        Primary Objective: Phase I: To characterize the safety and tolerability of BLZ945 as a single agent and in combination with PDR001 and to identify the Maximum Tolerated Dose (MTD)/Recommended Phase 2 Dose (RP2D). Phase II: To assess the anti-tumor activity of BLZ945 in combination with PDR001 (and as single agent if appropriate) in patients with advanced solid tumors. Secondary Objective: Phase I: To characterize the pharmacodynamics effect of BLZ945 as a single agent and in combination with PDR001. To characterize PK of BLZ945 as a single agent and in combination with PDR001. To assess the preliminary anti-tumor activity of BLZ945 as single agent and in combination with PDR001. Phase I and II: To assess emergence of anti-PDR001 antibodies when BLZ945 is administered in combination with PDR001.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
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      •   A Phase Ib Trial of Pembrolizumab (MK-3475) in Combination with Dinaciclib...
        Protocol No.
        HSC20170106HU
        Official Title
        A Phase Ib Trial of Pembrolizumab (MK-3475) in Combination with Dinaciclib (MK-7965) in Subjects with Hematologic Malignancies (KEYNOTE-155) (CTMS# 16-0009)
        Description
        Primary Objective Objective: In both the Dose Evaluation and Signal Detection phases, evaluate the safety and tolerability of the treatment combination. Objective: Within each disease type of the Signal Detection phase, evaluate objective response rate (ORR) according to investigator assessment using the disease specific criteria. Secondary Objective: Objective: To evaluate the Objective Response Rate (ORR; complete response [CR] + partial response [PR]) of the combination of pembrolizumab and dinaciclib within each disease type, ie, CLL based on iwCLL guidelines (Hallek, 2008) [1], MM based on IMWG criteria (Durie, 2006) [2] and DLBCL based on the Revised Response Criteria for Malignant Lymphoma (Cheson, 2007) [3]. Objective: Within each disease type of the Signal Detection phase, evaluate Duration of Response (DOR), Progression-Free Survival (PFS) according to investigator assessment using the disease specific criteria; and Overall Survival (OS).
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   ABTR01B1, A Children''s Oncology Group Protocol for Collecting and Banking...
        Protocol No.
        HSC20040131H
        Official Title
        ABTR01B1, A Children''s Oncology Group Protocol for Collecting and Banking Pediatric Research Specimens Including Rare Pediatric Tumors
        Description
        This study is collecting and storing malignant, borderline malignant neoplasms, and related biological samples from young patients with cancer. Collecting and storing samples of tumor tissue, blood, and bone marrow from patients with cancer to study in the laboratory may help the study of cancer in the future.
        Contact
        210-562-9149
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   ACCL15N1CD Use of Evidence-Based Supportive Care Clinical Practice...
        Protocol No.
        HSC20160673X
        Official Title
        ACCL15N1CD Use of Evidence-Based Supportive Care Clinical Practice Guidelines in Pediatric
        Description
        Primary and Secondary Aims Aim 1: Chart Review To measure the rate of adherence to selected COG-endorsed supportive care CPG recommendations at NCORP sites Aim 1a To describe the possible influence of NCORP site size and the number of patients enrolled in COG studies per site on the delivery of CPG-consistent care. Aim 1b To describe the clinical outcome of episodes during which patients receive CPG-consistent or CPG-inconsistent care Aim 2: Focus Groups To describe facilitators of and barriers to the use of CPGs elicited via focus group interviews with a diverse set of potential users (physician, nurse, nurse practitioner and pharmacists) who provide pediatric cancer care at NCORP sites. Aim 3: Interviews To improve how well CPG recommendations are understood by health care providers by refining the CPG recommendation format based on an iterative process of cognitive interviewing and formatting revisions. Understanding is defined as the correct interpretation of the course of action recommended or suggested by a CPG.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   ACCRN07 Protocol for the Enrollment on the Official COG Registry, The...
        Protocol No.
        HSC20080271X
        Official Title
        ACCRN07 Protocol for the Enrollment on the Official COG Registry, The Childhood Cancer Research Network (CCRN)
        Description
        The Children s Oncology Group has established a research network, the Childhood Cancer Research Network (CCRN), to collect information about children with cancer and other conditions that are benign but involve abnormal cell growth in order to help doctors and scientists better understand childhood cancer. The CCRN''s goal is to collect clinical information about every child diagnosed with cancer and similar conditions in the United States and Canada, to allow researchers to study patterns, characteristics, and causes of childhood cancer. The information can also help researchers study the causes of childhood cancer. To expand the CCRN, parents of children who have been diagnosed with cancer will be asked to provide information about themselves and their child for research purposes.   Objectives: To obtain informed consent from parents (and the child, when appropriate) of infants, children, adolescents, and young adults newly diagnosed with cancer to enter their names and certain information concerning their child into the Childhood Cancer Research Network. To obtain informed consent from parents (and the child, when appropriate) of infants, children, adolescents, and young adults newly diagnosed with cancer for permission to be contacted in the future to consider participating in non-therapeutic and prevention research studies involving the parents and/or the child.
        Contact
        210-562-9149
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
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      •   Acetic Acid Chromoendoscopy in Barrett''s esophagus surveillance is superior...
        Protocol No.
        HSC20160676HU
        Official Title
        Acetic Acid Chromoendoscopy in Barrett''s esophagus surveillance is superior to the standardized random biopsy protocol in detecting neoplasia: A Prospective Randomized Trial
        Description
        To compare neoplasia yield when using acetic acid chromoendoscopy versus the neoplasia yield from standardized random biopsy protocol in Barretts esophagus surveillance population at DHR
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
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      •   Adolescent and Young Adult Childhood Cancer Survivorship (CTMS#17-0088)
        Protocol No.
        HSC20170474HU
        Official Title
        Adolescent and Young Adult Childhood Cancer Survivorship (CTMS#17-0088)
        Description
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   ALTE05N1, Umbrella Long-Term Follow-Up Protocol
        Protocol No.
        HSC20090478X
        Official Title
        ALTE05N1, Umbrella Long-Term Follow-Up Protocol
        Description
        Umbrella Long-Term Follow-Up Protocol
        Contact
        210-562-9149
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
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      •   ALTE1621 Pharmacologic Reversal of Ventricular Remodeling in Childhood...
        Protocol No.
        HSC20160394X
        Official Title
        ALTE1621 Pharmacologic Reversal of Ventricular Remodeling in Childhood Cancer Survivors at Risk for Heart Failure (PREVENT-HF): A Phase 2b Randomized Placebo-Controlled (Carvedilol) Trial
        Description
        1.1 Primary Aim To determine the impact of a two-year course of low-dose carvedilol on surrogate echocardiographic indices of heart failure (HF) risk, including Left Ventricular (LV) Posterior Wall Thickness-Dimension Ratio (LV T-D) a well-established index of early myocardial remodeling and subsequent HF risk (primary endpoint).  LV systolic and diastolic function and afterload established echocardiographic indices associated with HF risk.  Natriuretic peptides, troponins, and Galectin-3 - circulating biomarkers associated with myocardial injury, and HF risk. 1.2 Secondary Aims 1.2.1 To establish safety and tolerability of this two-year course of low-dose carvedilol, assessing both objective measures (hepatic function) and patient reported outcomes. 1.2.2 To examine the modifying effect of demographic, clinical, and molecular characteristics on the risk: benefit ratio from this two-year carvedilol intervention. 1.3 Exploratory Aim To evaluate the long-term efficacy of carvedilol in preventing cardiomyopathy and/or heart failure in high-risk childhood cancer survivors.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   AN EARLY-PHASE, MULTICENTER, OPEN-LABEL STUDY OF THE SAFETY AND...
        Protocol No.
        HSC20150549H
        Official Title
        AN EARLY-PHASE, MULTICENTER, OPEN-LABEL STUDY OF THE SAFETY AND PHARMACOKINETICS OF ATEZOLIZUMAB (MPDL3280A) IN PEDIATRIC AND YOUNG ADULT PATIENTS WITH PREVIOUSLY TREATED SOLID TUMORS
        Description
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
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      •   An Open-Label Rollover Study to Evaluate the Long-Term Safety, Tolerability,...
        Protocol No.
        HSC20170197XT
        Official Title
        An Open-Label Rollover Study to Evaluate the Long-Term Safety, Tolerability, Biological Activity of Oral TVB-2640 in Patients With Solid Tumors Previously Enrolled in 3V2640-CLIN-002 (CTMS# 17-0046)
        Description
        Primary: To continue to characterize the safety profile of TVB-2640. Secondary: To identify any early signs of anti-tumor activity, where possible.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   An Open-Label, Dose Escalation, Phase 1, First-In-Human Study of TAK-659 in...
        Protocol No.
        HSC20150255HU
        Official Title
        An Open-Label, Dose Escalation, Phase 1, First-In-Human Study of TAK-659 in Adult Patients with Advanced Solid Tumors and Lymphoma Malignancies (CTMS# 14-2013)
        Description
        To determine the safety, tolerability, maximum tolerated dose (MTD)/recommended phase 2 dose (RP2D) ofTAK-659 administered orally on a daily dosing schedule in patients with advanced solid tumor and lymphoma who do not have effective standard treatment available
        Contact
        210-450-5798
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
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      •   APEC14B1, THE PROJECT: EVERYCHILD PROTOCOL: A REGISTRY, ELIGIBILITY...
        Protocol No.
        HSC20150870XT
        Official Title
        APEC14B1, THE PROJECT: EVERYCHILD PROTOCOL: A REGISTRY, ELIGIBILITY SCREENING, BIOLOGY AND OUTCOME STUDY
        Description
        1.1 To maintain a Childhood Cancer Registry1 for infants, children, adolescents, and young adults with cancer. 1.2 To utilize clinical and biological data to help determine eligibility or stratification, based on childhood cancer disease classification schemas, for potential enrollment of research subjects onto COG therapeutic clinical trials. 1.3 To develop a well annotated childhood cancer biorepository for current and future research through the collection of biospecimens (at diagnosis, time of progression, time of recurrence and/or post-mortem), including tumor, host and when feasible parental germline DNA; and key clinical data, including presentation, diagnostic, staging, summary treatment, and outcome information, from every child diagnosed with cancer at COG institutions. 1.4 To allow use of registry data for permission to be contacted in the future to consider participating in non-therapeutic and prevention research studies involving the child or their parents.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
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      •   Cancer Therapy and Research Center''s Institute for Drug Development Solid...
        Protocol No.
        HSC20070684H
        Official Title
        Cancer Therapy and Research Center''s Institute for Drug Development Solid Tumors and Hematological Malignancies Biorepository for Biomarker Discovery
        Description
        Samples are collected for the Cancer Therapy and Research Center''s Solid Tumors and Hematological Malignancies Biorepository for Biomarker Discovery
        Contact
        210-450-5798
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
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      •   Caris Molecular Intelligence® and Caris Centers of Excellence for...
        Protocol No.
        HSC20170144HU
        Official Title
        Caris Molecular Intelligence® and Caris Centers of Excellence for Precision Medicine NetworkTM Retrospective Outcomes-Associated Database (CTMS# 16-0145)
        Description
        The objective of this project is the development of the Caris Molecular Intelligence® and Caris Centers of Excellence for Precision Medicine NetworkTM Outcomes Associated Repository, a disease research database (hereinafter referred to as the Database ) for the purpose of: 1. Effecting change in disease treatment processes by advancing precision medicine and improving care for cancer through acquiring and sharing valuable molecular tumor profiling information and clinical outcomes in a collaborative, secure environment. 2. Performing prospective research studies involving analyses of quality of life studies as well as subject medical records including clinical presentation and outcomes. This eligible cohort includes select subjects having undergone Caris Molecular Intelligence® evaluation for diagnosis and/or treatment management. 3. Evaluate the frequency of specific clinical events in relation to risk factors, diagnosis and treatments provided via the collection of outcomes data through automated data capture systems provided by a third-party data entity and manually-entered data when needed. 4. Provide information access that is vital to research collaborators, including potential researchers from pharmaceutical companies, governmental agencies, academia, healthcare providers, and payors, with catalogued subject outcome data for the use of drug development discoveries, clinically relevant research trials, publications and posters, the implementation of future healthcare policies, characterization of trends in practice patterns and their relation to subject outcomes and the economic impact of differing evaluation, treatment, and management paradigms. 5. Cultivate a repository for assay development and validation of emerging technologies to enhance clinical cancer care.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   Caris Molecular Intelligence® and Caris Centers of Excellence for Precision...
        Protocol No.
        HSC20170353HU
        Official Title
        Caris Molecular Intelligence® and Caris Centers of Excellence for Precision Medicine NetworkTM Outcomes Associated Repository (CTMS# 17-0023)
        Description
        The objective of this project is the development of the Caris Molecular Intelligence® and Caris Centers of Excellence for Precision Medicine NetworkTM Outcomes Associated Repository, a disease research database (hereinafter referred to as the Database) for the purpose of: 1. Effecting change in disease treatment processes by advancing precision medicine and improving care for cancer through acquiring and sharing valuable molecular tumor profiling information and clinical outcomes in a collaborative, secure environment. 2. Performing prospective research studies involving analyses of quality of life studies as well as subject medical records including clinical presentation and outcomes. This eligible cohort includes select subjects having undergone Caris Molecular Intelligence® evaluation for diagnosis and/or treatment management. 3. Evaluate the frequency of specific clinical events in relation to risk factors, diagnosis and treatments provided via the collection of outcomes data through automated data capture systems provided by a third-party data entity and manually-entered data when needed. 4. Provide information access that is vital to research collaborators, including potential researchers from pharmaceutical companies, governmental agencies, academia, healthcare providers, and payors, with catalogued subject outcome data for the use of drug development discoveries, clinically relevant research trials, publications and posters, the implementation of future healthcare policies, characterization of trends in practice patterns and their relation to subject outcomes and the economic impact of differing evaluation, treatment, and management paradigms. 5. Cultivate a repository for assay development and validation of emerging technologies to enhance clinical cancer care.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   Clinical Trial of Lurbinectedin (PM01183) in Selected Advanced Solid Tumors
        Protocol No.
        HSC20150542HU
        Official Title
        A Multicenter Phase II Clinical Trial of Lurbinectedin (PM01183) in Selected Advanced Solid Tumors (CTMS# 15-2071)
        Description
        Primary: To assess the antitumor activity of lurbinectedin (PM01183) in terms of overall response rate (ORR), according to the Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1, in the following advanced solid tumors: small cell lung cancer (SCLC), head and neck carcinoma (H&N), neuroendocrine tumors (NETs), biliary tract carcinoma, endometrial carcinoma, BRCA 1/2-associated metastatic breast carcinoma, carcinoma of unknown primary site, germ cell tumors (GCTs), and Ewing¿s family of tumors (EFTs). Secondary: To further characterize the antitumor activity of PM01183 in terms of duration of response (DR), clinical benefit [ORR or stable disease (SD) lasting over four months (SD ¿ 4 months)], progression-free survival (PFS), and one year overall survival (1y-OS) in each cohort of advanced solid tumors. Characterize the plasma pharmacokinetics (PK) of PM01183. To conduct an exploratory pharmacogenomic (PGx) and pharmacogenetic analysis. To evaluate the safety profile of PM01183 in this patient population.
        Contact
        410-450-5798
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
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      •   Clinical trial to study the safety and efficacy of MBG453 given alone and in...
        Protocol No.
        HSC20150730HU
        Official Title
        A Phase I-Ib/II, Open-Label, Multi-Center Study of the Safety and Efficacy of MBG453 as Single Agent and in Combination with PDR001 in Adult Patients with Advanced Malignancies (CTMS# 15-2114)
        Description
        Primary Objectives: Phase I-Ib: To characterize the safety and tolerability of MBG453 as a single agent and in combination with PDR001 and to identify recommended doses for future studies. Phase I-Ib dose ranging: To further investigate the safety and tolerability of different doses of MBG453 alone or in combination with PDR001. Phase II: To estimate the anti-tumor activity of MBG453 alone in patients with solid tumors, and in combination with PDR001 in selected disease indications (melanoma, non-small cell lung cancer (NSCLC), renal cell carcinoma (RCC)). Secondary Objectives Evaluate the preliminary anti-tumor activity of MBG453 alone and in combination with PDR001. Make an initial comparison of safety, PK and efficacy for MBG453 and PDR001 administered in combination on a every 2 weeks (Q2W) and every 4 weeks (Q4W) dosing schedules. Characterize the pharmacokinetic profile of MBG453 alone and in combination with PDR001. Assess emergence of anti-MBG453 and anti-PDR001 antibodies. Assess potential predictors of efficacy of MBG453 single agent and in combination with PDR001 in tumor samples. Assess the pharmacodynamic effect of MBG453 as single agent and in combination with PDR001 in tumor samples. Describe the survival distribution of patients treated with MBG453 as single agent and in combination with PDR001 for each disease group.
        Contact
        410-450-5798
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
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      •   DCP-001, Use of a Clinical Trial Screening Tool to Address Cancer Health...
        Protocol No.
        HSC20160342XT
        Official Title
        DCP-001, Use of a Clinical Trial Screening Tool to Address Cancer Health Disparities in the NCI Community Oncology Research Program (NCORP)
        Description
        Objectives 1) Implement a screening tool in NCORP to collect broader demographic and clinical data to generate hypothesis and research questions in the following areas of research: cancer screening, cancer prevention, symptom science, cancer care disparities, comparative effectiveness and cancer care delivery research. 2) Collect expanded demographic and clinical data (e.g., SES, co-morbidities, method of diagnosis) across the NCORP network to help identify and best characterize patients that are screened but not enrolled and for patients that participate in NCI trials, to understand how these variables may impact outcomes. 3) Enhance an understanding of site- specific and trial-specific accrual barriers that will inform the development of effective strategies to improve accrual, particularly for minority and underserved populations. 4) Provide data for internal and external evaluation of NCORP s first RFA cycle and reissuance.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   GO29665, A PHASE I/II, MULTICENTER, OPEN-LABEL, DOSE-ESCALATION STUDY OF THE...
        Protocol No.
        HSC20160080H
        Official Title
        GO29665, A PHASE I/II, MULTICENTER, OPEN-LABEL, DOSE-ESCALATION STUDY OF THE SAFETY AND PHARMACOKINETICS OF COBIMETINIB IN PEDIATRIC AND YOUNG ADULT PATIENTS WITH PREVIOUSLY TREATED SOLID TUMORS (CTRC# 15-0005)
        Description
        CTRC#15-0005
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
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      •   Head and Neck Cancer Repository
        Protocol No.
        HSC20170218HR
        Official Title
        Head and Neck Cancer Repository
        Description
        To establish a repository of head and neck cancers and PDX models from our south Texas patient population.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
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      •   Health Effects after Anthracycline and Radiation Therapy (HEART):...
        Protocol No.
        HSC20140058X
        Official Title
        Health Effects after Anthracycline and Radiation Therapy (HEART): Dexrazoxane and Prevention of Anthracycline-related Cardiomyopathy A Limited Institution Non-Therapeutic Study
        Description
        This clinical trial studies the effects of dexrazoxane hydrochloride on biomarkers associated with cardiomyopathy and heart failure after cancer treatment. Studying samples of blood in the laboratory from patients receiving dexrazoxane hydrochloride may help doctors learn more about the effects of dexrazoxane hydrochloride on cells. It may also help doctors understand how well patients respond to treatment.
        Contact
        210-562-9149
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
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      •   Incidence and Factors Associated with the Development and Severity of Oral...
        Protocol No.
        HSC20050218H
        Official Title
        Incidence and Factors Associated with the Development and Severity of Oral Mucositis in Patients Undergoing High Dose Chemotherapy and Peripheral Stem Cell Transplantation
        Description
        Our study intends to evaluate prospectively the incidence and severity of oral mucositis in patients undergoing high-dose chemotherapy and hematopoietic stem cell transplantation, as well as to evaluate the potential influence of nutritional-, physical-, and transplant-related factors associated with the development of this complication and its grade of involvement. Research plan: This is a prospective cohort study with an observational basis that involves all of the patients undergoing high-dose chemotherapy and peripheral blood stem cell transplantation at the Audie L. Murphy VA Hospital Bone Marrow Transplant Unit and at the University Hospital Bone Marrow Transplant Unit. We expect to enroll 400 patients during a 5-year period. Methods: In order to answer the study questions, subjects will be assessed several times during the study period. The study involves a multidisciplinary group that will be evaluating and following the subjects. A baseline will be established by a physician and a nutritionist before the subjects start the high-dose chemotherapy regimen. The subjects will be followed with oral evaluations 3 times per week, beginning on the day of the transplant and ending when mucositis resolves, or the patient is discharged home, or 30 days post-transplant, whichever occurs first. At day 15 post-transplant, patients will be evaluated for the second time by the nutritionist. Further information such as blood values, use of medications and treatment complications, will be obtained by daily chart review.  
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   MATCH Treatment Subprotocol B: Phase II Study of Afatinib in Patients with...
        Protocol No.
        HSC20150831HU
        Official Title
        MATCH Treatment Subprotocol B: Phase II Study of Afatinib in Patients with Tumors with HER2 Activating Mutations (CTMS# 15-2107)
        Description
        Primary Objective To evaluate the proportion of patients with objective response (OR) to targeted study agent(s) in patients with advanced refractory cancers/lymphomas. Secondary Objectives To evaluate the proportion of patients alive and progression free at 6 months of treatment with targeted study agent in patients with advanced refractory cancers/lymphomas. To evaluate time until death or disease progression. To identify potential predictive biomarkers beyond the genomic alteration by which treatment is assigned or resistance mechanisms using additional genomic, RNA and protein-based assessment platforms.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
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      •   MATCH Treatment Subprotocol C1: EAY131-C1: Crizotinib in Patients with...
        Protocol No.
        HSC20160463HU
        Official Title
        MATCH Treatment Subprotocol C1: EAY131-C1: Crizotinib in Patients with Tumors with MET Amplification (CTMS# 16-0064)
        Description
        The purpose of this study is to test any good and bad effects of the study drug called crizotinib in patients whose cancer has MET genetic changes.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
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      •   MATCH Treatment Subprotocol F: Crizotinib in Patients with Tumors (other...
        Protocol No.
        HSC20150750HU
        Official Title
        MATCH Treatment Subprotocol F: Crizotinib in Patients with Tumors (other than adenocarcinoma of lung or ALCL) with ALK Translocations (CTMS# 15-2081)
        Description
        Primary Objective To evaluate the proportion of patients with objective response (OR) to targeted study agent(s) in patients with advanced refractory cancers/lymphomas. Secondary Objectives To evaluate the proportion of patients alive and progression free at 6 months of treatment with targeted study agent in patients with advanced refractory cancers/lymphomas. To evaluate time until death or disease progression. To identify potential predictive biomarkers beyond the genomic alteration by which treatment is assigned or resistance mechanisms using additional genomic, RNA and protein-based assessment platforms.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
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      •   MATCH Treatment Subprotocol S1: Phase II Study of Trametinib in Patients...
        Protocol No.
        HSC20160260HU
        Official Title
        MATCH Treatment Subprotocol S1: Phase II Study of Trametinib in Patients with Tumors with NF1 Mutations (CTMS# 16-0028)
        Description
        PRIMARY OBJECTIVES: I. To evaluate the proportion of patients with objective response (OR) to targeted study agent(s) in patients with advanced refractory cancers/lymphomas. SECONDARY OBJECTIVES: I. To evaluate the proportion of patients alive and progression free at 6 months of treatment with targeted study agent in patients with advanced refractory cancers/lymphomas. II. To evaluate time until death or disease progression. III. To identify potential predictive biomarkers beyond the genomic alteration by which treatment is assigned or resistance mechanisms using additional genomic, ribonucleic acid (RNA) and protein-based assessment platforms.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   MATCH Treatment Subprotocol U: VS-6063 (defactinib) in Patients with Tumors...
        Protocol No.
        HSC20150839HU
        Official Title
        MATCH Treatment Subprotocol U: VS-6063 (defactinib) in Patients with Tumors with NF2 Loss (CTMS# 15-2110)
        Description
        Primary Objective To evaluate the proportion of patients with objective response (OR) to targeted study agent(s) in patients with advanced refractory cancers/lymphomas. Secondary Objectives To evaluate the proportion of patients alive and progression free at 6 months of treatment with targeted study agent in patients with advanced refractory cancers/lymphomas. To evaluate time until death or disease progression. To identify potential predictive biomarkers beyond the genomic alteration by which treatment is assigned or resistance mechanisms using additional genomic, RNA and protein-based assessment platforms.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   MATCH Treatment Subprotocol W: EAY131-W: Phase II Study of AZD4547 in...
        Protocol No.
        HSC20160541HU
        Official Title
        MATCH Treatment Subprotocol W: EAY131-W: Phase II Study of AZD4547 in Patients with Tumors with Aberrations in the FGFR Pathway (CTMS# 16-0065)
        Description
        The purpose of this study is to test any good and bad effects of the study drug, AZD4547, in patients whose cancer has genetic changes called FGFR gene alterations.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   MATCH Treatment Subprotocol X: Phase II Study of Dasatinib in Patients with...
        Protocol No.
        HSC20160282HU
        Official Title
        MATCH Treatment Subprotocol X: Phase II Study of Dasatinib in Patients with Tumors with DDR2 Mutations (CTMS# 16-0032)
        Description
        PRIMARY OBJECTIVES: I. To evaluate the proportion of patients with objective response (OR) to targeted study agent(s) in patients with advanced refractory cancers/lymphomas. SECONDARY OBJECTIVES: I. To evaluate the proportion of patients alive and progression free at 6 months of treatment with targeted study agent in patients with advanced refractory cancers/lymphomas. II. To evaluate time until death or disease progression. III. To identify potential predictive biomarkers beyond the genomic alteration by which treatment is assigned or resistance mechanisms using additional genomic, ribonucleic acid (RNA) and protein-based assessment platforms.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   MATCH Treatment Subprotocol Z1A: EAY131-Z1A: Binimetinib in Patients with...
        Protocol No.
        HSC20160499HU
        Official Title
        MATCH Treatment Subprotocol Z1A: EAY131-Z1A: Binimetinib in Patients with Tumors (Other Than Melanoma) with NRAS Mutations (CTMS# 16-0066)
        Description
        The purpose of this study is to test any good and bad effects of the experimental study drug binimetinib in patients whose cancer has NRAS mutations.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   MATCH Treatment Subprotocol Z1B: EAY131-Z1B: Phase II Study of Palbociclib...
        Protocol No.
        HSC20160491HU
        Official Title
        MATCH Treatment Subprotocol Z1B: EAY131-Z1B: Phase II Study of Palbociclib (PD-0332991) in Patients with Tumors with CCND1, 2, 3 Amplification and Rb Protein Expression by IHC (CTMS# 16-0067)
        Description
        The purpose of this study is to test any good and bad effects of the study drug, palbociclib, in patients whose cancer has CCND1, 2 or 3 amplification and tested positive for a protein called Rb protein.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
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      •   Molecular Analysis for Therapy Choice (MATCH) / MATCH Treatment Subprotocol...
        Protocol No.
        HSC20170176HU
        Official Title
        Molecular Analysis for Therapy Choice (MATCH) / MATCH Treatment Subprotocol H: EAY131-H: Phase II Study of Dabrafenib and Trametinib in Patients with Tumors with BRAF V600E or V600K Mutations (Excluding Melanoma, Thyroid Cancer, and Colorectal Adenocarcinoma) (CTMS# 15-2083)
        Description
        Primary Objective To evaluate the proportion of patients with objective response (OR) to targeted study agent(s) in patients with advanced refractory cancers/lymphomas. Secondary Objectives To evaluate the proportion of patients alive and progression free at 6 months of treatment with targeted study agent in patients with advanced refractory cancers/lymphomas. To evaluate time until death or disease progression. To identify potential predictive biomarkers beyond the genomic alteration by which treatment is assigned or resistance mechanisms using additional genomic, RNA and protein-based assessment platforms.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   Molecular Analysis for Therapy Choice (NCI-MATCH)
        Protocol No.
        HSC20150719XT
        Official Title
        EAY131, Molecular Analysis for Therapy Choice (MATCH) (CTMS# 15-2080)
        Description
        Primary Objective To evaluate the proportion of patients with objective response (OR) to targeted study agent(s) in patients with advanced refractory cancers/lymphomas. Secondary Objectives To evaluate the proportion of patients alive and progression free at 6 months of treatment with targeted study agent in patients with advanced refractory cancers/lymphomas. To evaluate time until death or disease progression. To identify potential predictive biomarkers beyond the genomic alteration by which treatment is assigned or resistance mechanisms using additional genomic, RNA and protein-based assessment platforms.
        Contact
        410-450-5798
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   NRG-HN003, A PHASE I AND EXPANSION COHORT STUDY OF ADJUVANT CISPLATIN,...
        Protocol No.
        HSC20170206HU
        Official Title
        NRG-HN003, A PHASE I AND EXPANSION COHORT STUDY OF ADJUVANT CISPLATIN, INTENSITY-MODULATED RADIOTHERAPY, AND MK-3475 (PEMBROLIZUMAB) IN HIGH-RISK HEAD AND NECK SQUAMOUS CELL CARCINOMA (HNSCC) (CTMS# 17-0022)
        Description
        Primary Outcome Measures: DLT in patients with high-risk head and neck squamous cell carcinoma treated with adjuvant cisplatin, IMRT, and pembrolizumab [ Time Frame: Up to 4 weeks post IMRT ] Will be summarized using proportions for binary outcome per cohort.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   Phase I Clinical Trial of Camptothecin-20-O-Propionate hydrate (CZ48) (CTMS#...
        Protocol No.
        HSC20150748HU
        Official Title
        Phase I Clinical Trial of Camptothecin-20-O-Propionate hydrate (CZ48) (CTMS# 15-2103)
        Description
        PRIMARY: To describe the dose limiting toxicities and adverse event profile of Camptothecin-20-O-Propionate hydrate (CZ48) administered orally every day. To determine Phase II recommended dose of Camptothecin-20-O-Propionate hydrate (CZ48) administered orally every day. SECONDARY: To perform a pharmacokinetic study of orally administered CZ48. To assess responses by RECIST criteria when applicable. To follow patients for survival.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
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      •   Phase I study of carfilzomib in combination with cyclophosphamide and...
        Protocol No.
        HSC20160206HU
        Official Title
        Phase I study of carfilzomib in combination with cyclophosphamide and etoposide for children with relapsed and refractory solid tumors and leukemias (CTMS# 15-2097)
        Description
        Primary Objective: To determine the DLTs and MTD of carfilzomib given in combination with cyclophosphamide and etoposide in pediatric patients with relapsed/refractory leukemias and solid tumors Secondary Objectives: 1. To evaluate toxicities of carfilzomib in the pediatric population when combined with conventional chemotherapy 2. To gather preliminary efficacy data on the drug combination 3. To measure if circulating plasma proteasome (cProt) levels post treatment correlate with response to therapy and overall survival 4. To measure if the levels of proteasome activity and resistance to carfilzomib correlates with toxicity and/or response to treatment. 5. To measure if inhibition of proteasome activity by carfilzomib results in alteration in a number of autophagy and apoptosis related proteins, providing means to evaluate correlates of activity of carfilzomib. 6. To measure the level of proteasome inhibition in patient PBMCs before and during treatment by determination of the level of protein ubiquitination. 7. To determine in vitro sensitivity of patient leukemias and solid tumors to carfilzomib alone and in combination with study chemotherapeutic agents in order to generate a predictive model of drug sensitivity. 8. To expand patient leukemia and solid tumor samples in order to save tissue for future studies but also to serve as a pre-clinical in vivo model to be included in the generation and testing of a drug sensitivity predictive model. 9. To perform whole exome sequencing (WES) and RNA seq on patient leukemia and solid tumor samples and WES on germ line DNA in order to determine potential mechanisms of drug sensitivity or resistance as well as contribute to testing a computer `learning engine (Bionet) for predicting clinical responses from genomic and drug sensitivity data.
        Contact
        210-562-9149
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   Phase Ib, open-label, multi-center study to characterize the safety,...
        Protocol No.
        HSC20160552HU
        Official Title
        Phase Ib, open-label, multi-center study to characterize the safety, tolerability and pharmacodynamics (PD) of PDR001 in combination with LCL161, everolimus (RAD001) or panobinostat (LBH589) (CTMS# 16-0058)
        Description
        Primary Objectives: To characterize the safety and tolerability of PDR001 in combination with LCL161, everolimus (RAD001) or panobinostat (LBH589) and to identify recommended doses and schedules for future studies Secondary Objectives: To characterize changes in the immune infiltrate in tumors To further characterize the safety of PDR001 in combination with LCL161, everolimus or panobinostat (LBH589) To estimate the anti-tumor activity of PDR001 in combination with LCL161, everolimus or panobinostat (LBH589) To characterize the pharmacokinetics of all study drugs in combination To assess immunogenicity of PDR001
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   Phase II Trial of Eribulin and Lenvatinib in Advanced Solid Tumors (CTMS#...
        Protocol No.
        HSC20150891HU
        Official Title
        Phase II Trial of Eribulin and Lenvatinib in Advanced Solid Tumors (CTMS# 15-2139)
        Description
        The overall purpose of this study is to determine the overall response rate, efficacy and safety of the combination of eribulin and Lenvatinib.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
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      •   Prognostic and predictive markers in patients with advanced metastatic tumors
        Protocol No.
        HSC20130219H
        Official Title
        Numeration and Single-Cell Molecular Profiling of Circulating Tumor Cells as Prognostic and Predictive Marker In Patients with Advanced Metastatic Tumors (CTRC#13-0001)
        Description
        This study will research possible associations between circulating tumor cells (CTC) quantities or gene profile characteristics and clinical outcomes. The primary objective is to obtain blood samples from participants over an 8-week period for research analysis.  The study will enroll approximately 200 patients at the CTRC. In addition to other conditions for enrollment, eligible patients have advanced metastatic cancer.
        Contact
        210-450-5798
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   Prospective Comparative Effectiveness Trial for Malignant Bowel Obstruction...
        Protocol No.
        HSC20170491HU
        Official Title
        Prospective Comparative Effectiveness Trial for Malignant Bowel Obstruction (CTMS# 17-0081)
        Description
        Number of days alive and outside the hospital
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
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      •   S1609, Dart: Dual Anti-CTLA-4 and Anti-PD-1 Blockage in Rare Tumors (CTMS#...
        Protocol No.
        HSC20170145HU
        Official Title
        S1609, Dart: Dual Anti-CTLA-4 and Anti-PD-1 Blockage in Rare Tumors (CTMS# 17-0013)
        Description
        Primary Objective To evaluate the RECIST 1.1 overall response rate (ORR) in subsets of patients with advanced rare cancers treated with ipilimumab plus nivolumab combination immunotherapy. Secondary Objectives To evaluate toxicities in each cohort. To estimate overall survival (OS), progression-free survival (PFS), clinical benefit rate; and to estimate immune-related ORR (irORR), and immune-related PFS (irPFS) by unidimensional immune-related response criteria. To collect specimens for banking for use in future correlative biomarker research studies.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   Safety, Tolerability & PK of KX2-361 in Subjects with advanced malignancies...
        Protocol No.
        HSC20150481HU
        Official Title
        A Phase 1 Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetics of KX2-361 in Subjects with Advanced Malignancies that are Refractory to Conventional Therapies (CTMS# 15-2063)
        Description
        Study Objectives: Primary Objective: To define the maximum tolerated dose (MTD) of KX2-361 in subjects with advanced refractory malignancies when administered as single and multiple oral doses. Secondary Objectives: To determine the safety and tolerability of KX2-361 after single and multiple oral doses, in subjects with advanced refractory malignancies. To characterize the pharmacokinetic profile of KX2-361 after single and multiple oral doses. To evaluate the activity of KX2-361 in both the Dose Escalation Cohort and the Expansion Cohort of subjects with high-grade glioma.
        Contact
        210-450-5798
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   Study of the Genetic Epidemiology of Childhood Cancer
        Protocol No.
        HSC20080057H
        Official Title
        Study of the Genetic Epidemiology of Childhood Cancer
        Description
        Study of the Genetic Epidemiology of Childhood Cancer
        Contact
        210-562-9123
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

    •   Eye and Orbit

      •   A Dose Regimen-Finding Study to Evaluate the Safety, Tolerability,...
        Protocol No.
        HSC20170102HU
        Official Title
        A Dose Regimen-Finding Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Activity of Oradoxel Monotherapy in Subjects with Advanced Malignancies (CTMS# 16-0069)
        Description
        Primary Objective: To determine the maximum tolerated dose (MTD) of Oradoxel based on dose-limiting toxicity (DLT) in subjects with advanced malignancies Secondary Objectives To determine the safety and tolerability of docetaxel as Oradoxel To determine the incidence of unacceptable toxicity with Oradoxel To determine the recommended Phase 2 dose (RP2D) of docetaxel as Oradoxel To characterize the pharmacokinetic (PK) profile of docetaxel as Oradoxel To evaluate tumor response
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   A Dose Regimen-Finding Study to Evaluate the Safety, Tolerability,...
        Protocol No.
        HSC20160087HU
        Official Title
        A Dose Regimen-Finding Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Activity of Oraxol in Subjects with Advanced Malignancies (CTMS# 15-2137)
        Description
        Primary Objective To determine the maximum tolerated dose (MTD) and dosing regimen of Oraxol in subjects with advanced malignancies Secondary Objectives To determine the recommended Phase 2 dose of paclitaxel as Oraxol To determine the safety and tolerability of paclitaxel as Oraxol To characterize the pharmacokinetic (PK) profile of paclitaxel as Oraxol To evaluate the tumor response
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   A Phase 1 Dose Escalation and Cohort Expansion Study of TSR-042, an...
        Protocol No.
        HSC20170110HU
        Official Title
        A Phase 1 Dose Escalation and Cohort Expansion Study of TSR-042, an anti-PD-1 Monoclonal Antibody, in Patients with Advanced Solid Tumors (CTMS# 16-0091)
        Description
        Primary Objectives: Part 1 Dose Escalation Cohorts: To evaluate the safety and tolerability of TSR-042 using Common Terminology Criteria for Adverse Events (CTCAE v.4.03) in patients with advanced solid tumors Part 2 Expansion Cohorts: To evaluate the antitumor activity of TSR-042 in patients with advanced solid tumors, in terms of objective response rate (ORR) as assessed by the Investigators using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 Part 1 and Part 2: To define the recommended Phase 2 dose (RP2D) and schedule Secondary Objectives: Part 1 Dose Escalation Cohorts: To characterize the pharmacodynamic (PDy) profile of TSR-042 To evaluate ORR as assessed by the Investigators using RECIST v1.1 Part 2 Expansion Cohorts: To characterize the safety and tolerability of TSR-042 using CTCAE v.4.03 Part 1 and Part 2: To characterize the pharmacokinetic (PK) profile of TSR-042 To evaluate the immunogenicity of TSR-042 To evaluate additional measures of clinical benefit, including: ORR by immune-related RECIST (irRECIST) Duration of response (DOR) by RECIST v 1.1 Disease control rate (DCR) by RECIST v 1.1 and by irRECIST Progression-free survival (PFS) by RECIST v 1.1 and by irRECIST Overall survival (OS)
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   A Phase 1 Study of CBL0137 in Patients with Metastatic or Unresectable...
        Protocol No.
        HSC20130328H
        Official Title
        A Phase 1 Trial of CBL0137 In patients With Metastatic or Unresectable Advanced Solid Neoplasms or Refractory Lymphomas (CTRC# 13-0031)
        Description
        This Phase 1 study is designed to determine the best dose of CBL0137 to use when treating patients with metastatic or unresectable advanced solid tumors or lymphoma. The study will enroll up to 48 patients from at least 2 cancer centers in the US. In addition to other conditions for enrollment, eligible patients have cancer that has not improved or has come back after prior treatment and are otherwise in good health. Patients who have a history of active infection, cancer involving the central nervous system, a particular EKG abnormality or other serious medical conditions may not be eligible to enroll.
        Contact
        210-450-5798
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   A Phase 1/2A, Multicenter, Open-Label Study of LYC-55716 in Adult Subjects...
        Protocol No.
        HSC20160617HU
        Official Title
        A Phase 1/2A, Multicenter, Open-Label Study of LYC-55716 in Adult Subjects with Locally Advanced or Metastatic Cancer (CTMS# 16-0099)
        Description
        Primary Objectives Phase 1 Evaluate the safety and tolerability of LYC-55716 Determine the maximum tolerated dose (MTD) and the recommended Phase 2 dose (RP2D) Phase 2a Determine the objective response rate according to response evaluation criteria in solid tumors (RECIST) v1.1 Secondary Objectives Phase 1 Evaluate the activity of LYC-55716 by objective response according to RECIST v1.1 Determine the durability of any observed objective response Phase 2a Determine the duration of response Determine progression-free survival (PFS) and overall survival (OS) Determine suitability of the RP2D for further study Characterize the pharmacokinetics (PK) of LYC-55716 Exploratory Objectives Assess tumor activity in subjects with locally advanced or metastatic cancer according to immune-related response evaluation criteria in solid tumors (irRECIST) Exploratory analysis of metabolite in plasma Assess changes in circulating tumor markers (eg, cytokines/chemokines)
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   A Phase 1b Study of Oraxol in Combination with Ramucirumab in Patients with...
        Protocol No.
        HSC20170188HU
        Official Title
        A Phase 1b Study of Oraxol in Combination with Ramucirumab in Patients with Gastric, Gastro-esophageal, or Esophageal Cancers (CTMS# 16-0089)
        Description
        Primary Objective: To determine the maximum tolerated dose (MTD) of Oraxol in patients with advanced stage gastric, gastro-esophageal, or esophageal cancers who are being treated with Oraxol in combination with ramucirumab Secondary Objectives: To determine the safety and tolerability of Oraxol in combination with ramucirumab To determine the recommended Phase 2 dose of Oraxol in combination with ramucirumab To characterize the pharmacokinetic (PK) profile of Oraxol in combination with ramucirumab To characterize preliminary activity of Oraxol plus ramucirumab as determined by response rate, progression-free survival, and overall survival
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   A Phase 1b/2 Study of ARRY-382 in Combination with Pembrolizumab, a...
        Protocol No.
        HSC20170071HU
        Official Title
        A Phase 1b/2 Study of ARRY-382 in Combination with Pembrolizumab, a Programmed Cell Death Receptor 1 (PD-1) Antibody, for the Treatment of Patients with Advanced Solid Tumors (CTMS# 16-0084)
        Description
        Primary objective: To determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of ARRY-382 in combination with pembrolizumab in patients with selected solid tumors Secondary objectives:  To describe the preliminary antitumor activity of the combination based on the Response Criteria In Solid Tumors, version 1.1 (RECIST v1.1).  To describe the preliminary antitumor activity of the combination based on immune-related response criteria (irRC).  To characterize the safety and tolerability of the combination, including acute and chronic toxicities. To evaluate the pharmacokinetics of ARRY-382 in combination with pembrolizumab Exploratory objective: To explore the effect of the combination on circulating biomarkers of immune response. To describe the preliminary antitumor activity of the combination in patients with PD-L1 positive non-small cell lung cancer (NSCLC), as determined using a United States Food and Drug Administration (FDA)-approved test, using RECIST. To describe the preliminary antitumor activity of the combination in patients with PD-L1 positive non-small cell lung cancer (NSCLC), as determined using an FDA approved test, using irRC
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
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      •   A Phase I, First-in-human, Open-label, Dose-escalation, Safety,...
        Protocol No.
        HSC20160554HU
        Official Title
        A Phase I, First-in-human, Open-label, Dose-escalation, Safety, Pharmacokinetic, and Pharmacodynamic Study of Oral TP-0903 Administered Daily for 21 Days to Patients with Advanced Solid Tumors (CTMS# 16-0092)
        Description
        Primary Objective: To determine the maximum tolerated dose (MTD) and dose-limiting toxicities (DLTs) of oral TP-0903 administered daily for the first 21 days every 4 weeks, over a range of doses in patients with advanced solid tumors. Secondary Objectives: To establish the pharmacokinetics of orally administered TP-0903 To observe patients for any evidence of antitumor activity of TP-0903 by objective radiographic assessment To study the pharmacodynamics of TP-0903 therapy by: assessing biomarkers in tumor tissue assessing biomarkers in peripheral blood mononuclear cells (PBMCs) and serum To establish the Recommended Phase 2 Dose (RP2D) for future studies with TP-0903
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   A Phase I, Multicenter, Open-Label Dose Escalation and Expansion Study of...
        Protocol No.
        HSC20150289HU
        Official Title
        A Phase I, Multicenter, Open-Label Dose Escalation and Expansion Study of PCA062, Administered Intravenously In Adult Patients With pCAD-Positive Tumors (CTMS# 14-2019)
        Description
        Primary Objective To determine the MTD/RDE of PCA062 in patients with pCAD-positive tumors in the dose escalation part. Secondary Objectives To characterize the safety and tolerability of PCA062 To characterize the pharmacokinetic profile of PCA062 To assess emergence of anti-PCA062 antibodies following one or more intravenous infusions of PCA062 To assess the preliminary anti-tumor activity of PCA062 in patients with pCAD-positive triple negative breast cancer (TBNC), head and neck squamous cell carcinoma (HNSCC) or esophageal cancer (squamous and adenocarcinoma)
        Contact
        210-450-5798
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   A Phase I/II, open label, multicenter study of the safety and efficacy of...
        Protocol No.
        HSC20150421HU
        Official Title
        A Phase I/II, open label, multicenter study of the safety and efficacy of LAG525 single agent and in combination with PDR001 administered to patients with advanced malignancies (CTMS #15-2054)
        Description
        Primary Objectives Phase I part To estimate the RP2D or MTD for the single agent LAG525 and the combination of LAG525 and PDR001. Phase II part To estimate the overall response rate per RECIST V1.1 for single agent LAG525 as well as for the combination of LAG525 and PDR001 Secondary Objectives: To characterize the safety and tolerability of single agent LAG525 given alone and in combination with PDR001 To characterize the pharmacokinetic profile of single agent LAG525 given alone and in combination with PDR001 To assess emergence of anti-LAG525, and anti-PDR001 antibodies following one or more intravenous (i.v.) infusions of single agent LAG525 given alone or in combination with PDR001 To assess potential predictors of efficacy of single agent LAG525 and the combination of LAG525 and PDR001 To evaluate the preliminary antitumor activity of single agent LAG525 given alone or in combination of PDR001 To investigate patient selection and pharmacodynamic biomarkers in tumor tissue samples
        Contact
        210-450-5798
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   A Phase I/II, Open-Label, Multi-Center Study of the Safety and Efficacy of...
        Protocol No.
        HSC20160420HU
        Official Title
        A Phase I/II, Open-Label, Multi-Center Study of the Safety and Efficacy of BLZ945 as Single Agent and In Combination with PDR001 in Adult Patients with Advanced Solid Tumors (CTMS# 16-0071)
        Description
        Primary Objective: Phase I: To characterize the safety and tolerability of BLZ945 as a single agent and in combination with PDR001 and to identify the Maximum Tolerated Dose (MTD)/Recommended Phase 2 Dose (RP2D). Phase II: To assess the anti-tumor activity of BLZ945 in combination with PDR001 (and as single agent if appropriate) in patients with advanced solid tumors. Secondary Objective: Phase I: To characterize the pharmacodynamics effect of BLZ945 as a single agent and in combination with PDR001. To characterize PK of BLZ945 as a single agent and in combination with PDR001. To assess the preliminary anti-tumor activity of BLZ945 as single agent and in combination with PDR001. Phase I and II: To assess emergence of anti-PDR001 antibodies when BLZ945 is administered in combination with PDR001.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
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      •   A Phase Ib Trial of Pembrolizumab (MK-3475) in Combination with Dinaciclib...
        Protocol No.
        HSC20170106HU
        Official Title
        A Phase Ib Trial of Pembrolizumab (MK-3475) in Combination with Dinaciclib (MK-7965) in Subjects with Hematologic Malignancies (KEYNOTE-155) (CTMS# 16-0009)
        Description
        Primary Objective Objective: In both the Dose Evaluation and Signal Detection phases, evaluate the safety and tolerability of the treatment combination. Objective: Within each disease type of the Signal Detection phase, evaluate objective response rate (ORR) according to investigator assessment using the disease specific criteria. Secondary Objective: Objective: To evaluate the Objective Response Rate (ORR; complete response [CR] + partial response [PR]) of the combination of pembrolizumab and dinaciclib within each disease type, ie, CLL based on iwCLL guidelines (Hallek, 2008) [1], MM based on IMWG criteria (Durie, 2006) [2] and DLBCL based on the Revised Response Criteria for Malignant Lymphoma (Cheson, 2007) [3]. Objective: Within each disease type of the Signal Detection phase, evaluate Duration of Response (DOR), Progression-Free Survival (PFS) according to investigator assessment using the disease specific criteria; and Overall Survival (OS).
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   ABTR01B1, A Children''s Oncology Group Protocol for Collecting and Banking...
        Protocol No.
        HSC20040131H
        Official Title
        ABTR01B1, A Children''s Oncology Group Protocol for Collecting and Banking Pediatric Research Specimens Including Rare Pediatric Tumors
        Description
        This study is collecting and storing malignant, borderline malignant neoplasms, and related biological samples from young patients with cancer. Collecting and storing samples of tumor tissue, blood, and bone marrow from patients with cancer to study in the laboratory may help the study of cancer in the future.
        Contact
        210-562-9149
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   ACCL15N1CD Use of Evidence-Based Supportive Care Clinical Practice...
        Protocol No.
        HSC20160673X
        Official Title
        ACCL15N1CD Use of Evidence-Based Supportive Care Clinical Practice Guidelines in Pediatric
        Description
        Primary and Secondary Aims Aim 1: Chart Review To measure the rate of adherence to selected COG-endorsed supportive care CPG recommendations at NCORP sites Aim 1a To describe the possible influence of NCORP site size and the number of patients enrolled in COG studies per site on the delivery of CPG-consistent care. Aim 1b To describe the clinical outcome of episodes during which patients receive CPG-consistent or CPG-inconsistent care Aim 2: Focus Groups To describe facilitators of and barriers to the use of CPGs elicited via focus group interviews with a diverse set of potential users (physician, nurse, nurse practitioner and pharmacists) who provide pediatric cancer care at NCORP sites. Aim 3: Interviews To improve how well CPG recommendations are understood by health care providers by refining the CPG recommendation format based on an iterative process of cognitive interviewing and formatting revisions. Understanding is defined as the correct interpretation of the course of action recommended or suggested by a CPG.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   ACCRN07 Protocol for the Enrollment on the Official COG Registry, The...
        Protocol No.
        HSC20080271X
        Official Title
        ACCRN07 Protocol for the Enrollment on the Official COG Registry, The Childhood Cancer Research Network (CCRN)
        Description
        The Children s Oncology Group has established a research network, the Childhood Cancer Research Network (CCRN), to collect information about children with cancer and other conditions that are benign but involve abnormal cell growth in order to help doctors and scientists better understand childhood cancer. The CCRN''s goal is to collect clinical information about every child diagnosed with cancer and similar conditions in the United States and Canada, to allow researchers to study patterns, characteristics, and causes of childhood cancer. The information can also help researchers study the causes of childhood cancer. To expand the CCRN, parents of children who have been diagnosed with cancer will be asked to provide information about themselves and their child for research purposes.   Objectives: To obtain informed consent from parents (and the child, when appropriate) of infants, children, adolescents, and young adults newly diagnosed with cancer to enter their names and certain information concerning their child into the Childhood Cancer Research Network. To obtain informed consent from parents (and the child, when appropriate) of infants, children, adolescents, and young adults newly diagnosed with cancer for permission to be contacted in the future to consider participating in non-therapeutic and prevention research studies involving the parents and/or the child.
        Contact
        210-562-9149
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   Adolescent and Young Adult Childhood Cancer Survivorship (CTMS#17-0088)
        Protocol No.
        HSC20170474HU
        Official Title
        Adolescent and Young Adult Childhood Cancer Survivorship (CTMS#17-0088)
        Description
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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        Learn More About This Study

         

      •   ALTE05N1, Umbrella Long-Term Follow-Up Protocol
        Protocol No.
        HSC20090478X
        Official Title
        ALTE05N1, Umbrella Long-Term Follow-Up Protocol
        Description
        Umbrella Long-Term Follow-Up Protocol
        Contact
        210-562-9149
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   ALTE1621 Pharmacologic Reversal of Ventricular Remodeling in Childhood...
        Protocol No.
        HSC20160394X
        Official Title
        ALTE1621 Pharmacologic Reversal of Ventricular Remodeling in Childhood Cancer Survivors at Risk for Heart Failure (PREVENT-HF): A Phase 2b Randomized Placebo-Controlled (Carvedilol) Trial
        Description
        1.1 Primary Aim To determine the impact of a two-year course of low-dose carvedilol on surrogate echocardiographic indices of heart failure (HF) risk, including Left Ventricular (LV) Posterior Wall Thickness-Dimension Ratio (LV T-D) a well-established index of early myocardial remodeling and subsequent HF risk (primary endpoint).  LV systolic and diastolic function and afterload established echocardiographic indices associated with HF risk.  Natriuretic peptides, troponins, and Galectin-3 - circulating biomarkers associated with myocardial injury, and HF risk. 1.2 Secondary Aims 1.2.1 To establish safety and tolerability of this two-year course of low-dose carvedilol, assessing both objective measures (hepatic function) and patient reported outcomes. 1.2.2 To examine the modifying effect of demographic, clinical, and molecular characteristics on the risk: benefit ratio from this two-year carvedilol intervention. 1.3 Exploratory Aim To evaluate the long-term efficacy of carvedilol in preventing cardiomyopathy and/or heart failure in high-risk childhood cancer survivors.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   AN EARLY-PHASE, MULTICENTER, OPEN-LABEL STUDY OF THE SAFETY AND...
        Protocol No.
        HSC20150549H
        Official Title
        AN EARLY-PHASE, MULTICENTER, OPEN-LABEL STUDY OF THE SAFETY AND PHARMACOKINETICS OF ATEZOLIZUMAB (MPDL3280A) IN PEDIATRIC AND YOUNG ADULT PATIENTS WITH PREVIOUSLY TREATED SOLID TUMORS
        Description
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   An Open-Label Rollover Study to Evaluate the Long-Term Safety, Tolerability,...
        Protocol No.
        HSC20170197XT
        Official Title
        An Open-Label Rollover Study to Evaluate the Long-Term Safety, Tolerability, Biological Activity of Oral TVB-2640 in Patients With Solid Tumors Previously Enrolled in 3V2640-CLIN-002 (CTMS# 17-0046)
        Description
        Primary: To continue to characterize the safety profile of TVB-2640. Secondary: To identify any early signs of anti-tumor activity, where possible.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   An Open-Label, Dose Escalation, Phase 1, First-In-Human Study of TAK-659 in...
        Protocol No.
        HSC20150255HU
        Official Title
        An Open-Label, Dose Escalation, Phase 1, First-In-Human Study of TAK-659 in Adult Patients with Advanced Solid Tumors and Lymphoma Malignancies (CTMS# 14-2013)
        Description
        To determine the safety, tolerability, maximum tolerated dose (MTD)/recommended phase 2 dose (RP2D) ofTAK-659 administered orally on a daily dosing schedule in patients with advanced solid tumor and lymphoma who do not have effective standard treatment available
        Contact
        210-450-5798
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   APEC14B1, THE PROJECT: EVERYCHILD PROTOCOL: A REGISTRY, ELIGIBILITY...
        Protocol No.
        HSC20150870XT
        Official Title
        APEC14B1, THE PROJECT: EVERYCHILD PROTOCOL: A REGISTRY, ELIGIBILITY SCREENING, BIOLOGY AND OUTCOME STUDY
        Description
        1.1 To maintain a Childhood Cancer Registry1 for infants, children, adolescents, and young adults with cancer. 1.2 To utilize clinical and biological data to help determine eligibility or stratification, based on childhood cancer disease classification schemas, for potential enrollment of research subjects onto COG therapeutic clinical trials. 1.3 To develop a well annotated childhood cancer biorepository for current and future research through the collection of biospecimens (at diagnosis, time of progression, time of recurrence and/or post-mortem), including tumor, host and when feasible parental germline DNA; and key clinical data, including presentation, diagnostic, staging, summary treatment, and outcome information, from every child diagnosed with cancer at COG institutions. 1.4 To allow use of registry data for permission to be contacted in the future to consider participating in non-therapeutic and prevention research studies involving the child or their parents.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   Cancer Therapy and Research Center''s Institute for Drug Development Solid...
        Protocol No.
        HSC20070684H
        Official Title
        Cancer Therapy and Research Center''s Institute for Drug Development Solid Tumors and Hematological Malignancies Biorepository for Biomarker Discovery
        Description
        Samples are collected for the Cancer Therapy and Research Center''s Solid Tumors and Hematological Malignancies Biorepository for Biomarker Discovery
        Contact
        210-450-5798
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   Caris Molecular Intelligence® and Caris Centers of Excellence for...
        Protocol No.
        HSC20170144HU
        Official Title
        Caris Molecular Intelligence® and Caris Centers of Excellence for Precision Medicine NetworkTM Retrospective Outcomes-Associated Database (CTMS# 16-0145)
        Description
        The objective of this project is the development of the Caris Molecular Intelligence® and Caris Centers of Excellence for Precision Medicine NetworkTM Outcomes Associated Repository, a disease research database (hereinafter referred to as the Database ) for the purpose of: 1. Effecting change in disease treatment processes by advancing precision medicine and improving care for cancer through acquiring and sharing valuable molecular tumor profiling information and clinical outcomes in a collaborative, secure environment. 2. Performing prospective research studies involving analyses of quality of life studies as well as subject medical records including clinical presentation and outcomes. This eligible cohort includes select subjects having undergone Caris Molecular Intelligence® evaluation for diagnosis and/or treatment management. 3. Evaluate the frequency of specific clinical events in relation to risk factors, diagnosis and treatments provided via the collection of outcomes data through automated data capture systems provided by a third-party data entity and manually-entered data when needed. 4. Provide information access that is vital to research collaborators, including potential researchers from pharmaceutical companies, governmental agencies, academia, healthcare providers, and payors, with catalogued subject outcome data for the use of drug development discoveries, clinically relevant research trials, publications and posters, the implementation of future healthcare policies, characterization of trends in practice patterns and their relation to subject outcomes and the economic impact of differing evaluation, treatment, and management paradigms. 5. Cultivate a repository for assay development and validation of emerging technologies to enhance clinical cancer care.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
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      •   Caris Molecular Intelligence® and Caris Centers of Excellence for Precision...
        Protocol No.
        HSC20170353HU
        Official Title
        Caris Molecular Intelligence® and Caris Centers of Excellence for Precision Medicine NetworkTM Outcomes Associated Repository (CTMS# 17-0023)
        Description
        The objective of this project is the development of the Caris Molecular Intelligence® and Caris Centers of Excellence for Precision Medicine NetworkTM Outcomes Associated Repository, a disease research database (hereinafter referred to as the Database) for the purpose of: 1. Effecting change in disease treatment processes by advancing precision medicine and improving care for cancer through acquiring and sharing valuable molecular tumor profiling information and clinical outcomes in a collaborative, secure environment. 2. Performing prospective research studies involving analyses of quality of life studies as well as subject medical records including clinical presentation and outcomes. This eligible cohort includes select subjects having undergone Caris Molecular Intelligence® evaluation for diagnosis and/or treatment management. 3. Evaluate the frequency of specific clinical events in relation to risk factors, diagnosis and treatments provided via the collection of outcomes data through automated data capture systems provided by a third-party data entity and manually-entered data when needed. 4. Provide information access that is vital to research collaborators, including potential researchers from pharmaceutical companies, governmental agencies, academia, healthcare providers, and payors, with catalogued subject outcome data for the use of drug development discoveries, clinically relevant research trials, publications and posters, the implementation of future healthcare policies, characterization of trends in practice patterns and their relation to subject outcomes and the economic impact of differing evaluation, treatment, and management paradigms. 5. Cultivate a repository for assay development and validation of emerging technologies to enhance clinical cancer care.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
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      •   Clinical Trial of Lurbinectedin (PM01183) in Selected Advanced Solid Tumors
        Protocol No.
        HSC20150542HU
        Official Title
        A Multicenter Phase II Clinical Trial of Lurbinectedin (PM01183) in Selected Advanced Solid Tumors (CTMS# 15-2071)
        Description
        Primary: To assess the antitumor activity of lurbinectedin (PM01183) in terms of overall response rate (ORR), according to the Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1, in the following advanced solid tumors: small cell lung cancer (SCLC), head and neck carcinoma (H&N), neuroendocrine tumors (NETs), biliary tract carcinoma, endometrial carcinoma, BRCA 1/2-associated metastatic breast carcinoma, carcinoma of unknown primary site, germ cell tumors (GCTs), and Ewing¿s family of tumors (EFTs). Secondary: To further characterize the antitumor activity of PM01183 in terms of duration of response (DR), clinical benefit [ORR or stable disease (SD) lasting over four months (SD ¿ 4 months)], progression-free survival (PFS), and one year overall survival (1y-OS) in each cohort of advanced solid tumors. Characterize the plasma pharmacokinetics (PK) of PM01183. To conduct an exploratory pharmacogenomic (PGx) and pharmacogenetic analysis. To evaluate the safety profile of PM01183 in this patient population.
        Contact
        410-450-5798
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   Clinical trial to study the safety and efficacy of MBG453 given alone and in...
        Protocol No.
        HSC20150730HU
        Official Title
        A Phase I-Ib/II, Open-Label, Multi-Center Study of the Safety and Efficacy of MBG453 as Single Agent and in Combination with PDR001 in Adult Patients with Advanced Malignancies (CTMS# 15-2114)
        Description
        Primary Objectives: Phase I-Ib: To characterize the safety and tolerability of MBG453 as a single agent and in combination with PDR001 and to identify recommended doses for future studies. Phase I-Ib dose ranging: To further investigate the safety and tolerability of different doses of MBG453 alone or in combination with PDR001. Phase II: To estimate the anti-tumor activity of MBG453 alone in patients with solid tumors, and in combination with PDR001 in selected disease indications (melanoma, non-small cell lung cancer (NSCLC), renal cell carcinoma (RCC)). Secondary Objectives Evaluate the preliminary anti-tumor activity of MBG453 alone and in combination with PDR001. Make an initial comparison of safety, PK and efficacy for MBG453 and PDR001 administered in combination on a every 2 weeks (Q2W) and every 4 weeks (Q4W) dosing schedules. Characterize the pharmacokinetic profile of MBG453 alone and in combination with PDR001. Assess emergence of anti-MBG453 and anti-PDR001 antibodies. Assess potential predictors of efficacy of MBG453 single agent and in combination with PDR001 in tumor samples. Assess the pharmacodynamic effect of MBG453 as single agent and in combination with PDR001 in tumor samples. Describe the survival distribution of patients treated with MBG453 as single agent and in combination with PDR001 for each disease group.
        Contact
        410-450-5798
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   DCP-001, Use of a Clinical Trial Screening Tool to Address Cancer Health...
        Protocol No.
        HSC20160342XT
        Official Title
        DCP-001, Use of a Clinical Trial Screening Tool to Address Cancer Health Disparities in the NCI Community Oncology Research Program (NCORP)
        Description
        Objectives 1) Implement a screening tool in NCORP to collect broader demographic and clinical data to generate hypothesis and research questions in the following areas of research: cancer screening, cancer prevention, symptom science, cancer care disparities, comparative effectiveness and cancer care delivery research. 2) Collect expanded demographic and clinical data (e.g., SES, co-morbidities, method of diagnosis) across the NCORP network to help identify and best characterize patients that are screened but not enrolled and for patients that participate in NCI trials, to understand how these variables may impact outcomes. 3) Enhance an understanding of site- specific and trial-specific accrual barriers that will inform the development of effective strategies to improve accrual, particularly for minority and underserved populations. 4) Provide data for internal and external evaluation of NCORP s first RFA cycle and reissuance.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   GO29665, A PHASE I/II, MULTICENTER, OPEN-LABEL, DOSE-ESCALATION STUDY OF THE...
        Protocol No.
        HSC20160080H
        Official Title
        GO29665, A PHASE I/II, MULTICENTER, OPEN-LABEL, DOSE-ESCALATION STUDY OF THE SAFETY AND PHARMACOKINETICS OF COBIMETINIB IN PEDIATRIC AND YOUNG ADULT PATIENTS WITH PREVIOUSLY TREATED SOLID TUMORS (CTRC# 15-0005)
        Description
        CTRC#15-0005
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   Head and Neck Cancer Repository
        Protocol No.
        HSC20170218HR
        Official Title
        Head and Neck Cancer Repository
        Description
        To establish a repository of head and neck cancers and PDX models from our south Texas patient population.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   Health Effects after Anthracycline and Radiation Therapy (HEART):...
        Protocol No.
        HSC20140058X
        Official Title
        Health Effects after Anthracycline and Radiation Therapy (HEART): Dexrazoxane and Prevention of Anthracycline-related Cardiomyopathy A Limited Institution Non-Therapeutic Study
        Description
        This clinical trial studies the effects of dexrazoxane hydrochloride on biomarkers associated with cardiomyopathy and heart failure after cancer treatment. Studying samples of blood in the laboratory from patients receiving dexrazoxane hydrochloride may help doctors learn more about the effects of dexrazoxane hydrochloride on cells. It may also help doctors understand how well patients respond to treatment.
        Contact
        210-562-9149
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   Incidence and Factors Associated with the Development and Severity of Oral...
        Protocol No.
        HSC20050218H
        Official Title
        Incidence and Factors Associated with the Development and Severity of Oral Mucositis in Patients Undergoing High Dose Chemotherapy and Peripheral Stem Cell Transplantation
        Description
        Our study intends to evaluate prospectively the incidence and severity of oral mucositis in patients undergoing high-dose chemotherapy and hematopoietic stem cell transplantation, as well as to evaluate the potential influence of nutritional-, physical-, and transplant-related factors associated with the development of this complication and its grade of involvement. Research plan: This is a prospective cohort study with an observational basis that involves all of the patients undergoing high-dose chemotherapy and peripheral blood stem cell transplantation at the Audie L. Murphy VA Hospital Bone Marrow Transplant Unit and at the University Hospital Bone Marrow Transplant Unit. We expect to enroll 400 patients during a 5-year period. Methods: In order to answer the study questions, subjects will be assessed several times during the study period. The study involves a multidisciplinary group that will be evaluating and following the subjects. A baseline will be established by a physician and a nutritionist before the subjects start the high-dose chemotherapy regimen. The subjects will be followed with oral evaluations 3 times per week, beginning on the day of the transplant and ending when mucositis resolves, or the patient is discharged home, or 30 days post-transplant, whichever occurs first. At day 15 post-transplant, patients will be evaluated for the second time by the nutritionist. Further information such as blood values, use of medications and treatment complications, will be obtained by daily chart review.  
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   MATCH Treatment Subprotocol B: Phase II Study of Afatinib in Patients with...
        Protocol No.
        HSC20150831HU
        Official Title
        MATCH Treatment Subprotocol B: Phase II Study of Afatinib in Patients with Tumors with HER2 Activating Mutations (CTMS# 15-2107)
        Description
        Primary Objective To evaluate the proportion of patients with objective response (OR) to targeted study agent(s) in patients with advanced refractory cancers/lymphomas. Secondary Objectives To evaluate the proportion of patients alive and progression free at 6 months of treatment with targeted study agent in patients with advanced refractory cancers/lymphomas. To evaluate time until death or disease progression. To identify potential predictive biomarkers beyond the genomic alteration by which treatment is assigned or resistance mechanisms using additional genomic, RNA and protein-based assessment platforms.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
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      •   MATCH Treatment Subprotocol C1: EAY131-C1: Crizotinib in Patients with...
        Protocol No.
        HSC20160463HU
        Official Title
        MATCH Treatment Subprotocol C1: EAY131-C1: Crizotinib in Patients with Tumors with MET Amplification (CTMS# 16-0064)
        Description
        The purpose of this study is to test any good and bad effects of the study drug called crizotinib in patients whose cancer has MET genetic changes.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   MATCH Treatment Subprotocol F: Crizotinib in Patients with Tumors (other...
        Protocol No.
        HSC20150750HU
        Official Title
        MATCH Treatment Subprotocol F: Crizotinib in Patients with Tumors (other than adenocarcinoma of lung or ALCL) with ALK Translocations (CTMS# 15-2081)
        Description
        Primary Objective To evaluate the proportion of patients with objective response (OR) to targeted study agent(s) in patients with advanced refractory cancers/lymphomas. Secondary Objectives To evaluate the proportion of patients alive and progression free at 6 months of treatment with targeted study agent in patients with advanced refractory cancers/lymphomas. To evaluate time until death or disease progression. To identify potential predictive biomarkers beyond the genomic alteration by which treatment is assigned or resistance mechanisms using additional genomic, RNA and protein-based assessment platforms.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
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      •   MATCH Treatment Subprotocol S1: Phase II Study of Trametinib in Patients...
        Protocol No.
        HSC20160260HU
        Official Title
        MATCH Treatment Subprotocol S1: Phase II Study of Trametinib in Patients with Tumors with NF1 Mutations (CTMS# 16-0028)
        Description
        PRIMARY OBJECTIVES: I. To evaluate the proportion of patients with objective response (OR) to targeted study agent(s) in patients with advanced refractory cancers/lymphomas. SECONDARY OBJECTIVES: I. To evaluate the proportion of patients alive and progression free at 6 months of treatment with targeted study agent in patients with advanced refractory cancers/lymphomas. II. To evaluate time until death or disease progression. III. To identify potential predictive biomarkers beyond the genomic alteration by which treatment is assigned or resistance mechanisms using additional genomic, ribonucleic acid (RNA) and protein-based assessment platforms.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
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      •   MATCH Treatment Subprotocol U: VS-6063 (defactinib) in Patients with Tumors...
        Protocol No.
        HSC20150839HU
        Official Title
        MATCH Treatment Subprotocol U: VS-6063 (defactinib) in Patients with Tumors with NF2 Loss (CTMS# 15-2110)
        Description
        Primary Objective To evaluate the proportion of patients with objective response (OR) to targeted study agent(s) in patients with advanced refractory cancers/lymphomas. Secondary Objectives To evaluate the proportion of patients alive and progression free at 6 months of treatment with targeted study agent in patients with advanced refractory cancers/lymphomas. To evaluate time until death or disease progression. To identify potential predictive biomarkers beyond the genomic alteration by which treatment is assigned or resistance mechanisms using additional genomic, RNA and protein-based assessment platforms.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
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      •   MATCH Treatment Subprotocol W: EAY131-W: Phase II Study of AZD4547 in...
        Protocol No.
        HSC20160541HU
        Official Title
        MATCH Treatment Subprotocol W: EAY131-W: Phase II Study of AZD4547 in Patients with Tumors with Aberrations in the FGFR Pathway (CTMS# 16-0065)
        Description
        The purpose of this study is to test any good and bad effects of the study drug, AZD4547, in patients whose cancer has genetic changes called FGFR gene alterations.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   MATCH Treatment Subprotocol X: Phase II Study of Dasatinib in Patients with...
        Protocol No.
        HSC20160282HU
        Official Title
        MATCH Treatment Subprotocol X: Phase II Study of Dasatinib in Patients with Tumors with DDR2 Mutations (CTMS# 16-0032)
        Description
        PRIMARY OBJECTIVES: I. To evaluate the proportion of patients with objective response (OR) to targeted study agent(s) in patients with advanced refractory cancers/lymphomas. SECONDARY OBJECTIVES: I. To evaluate the proportion of patients alive and progression free at 6 months of treatment with targeted study agent in patients with advanced refractory cancers/lymphomas. II. To evaluate time until death or disease progression. III. To identify potential predictive biomarkers beyond the genomic alteration by which treatment is assigned or resistance mechanisms using additional genomic, ribonucleic acid (RNA) and protein-based assessment platforms.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
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      •   MATCH Treatment Subprotocol Z1A: EAY131-Z1A: Binimetinib in Patients with...
        Protocol No.
        HSC20160499HU
        Official Title
        MATCH Treatment Subprotocol Z1A: EAY131-Z1A: Binimetinib in Patients with Tumors (Other Than Melanoma) with NRAS Mutations (CTMS# 16-0066)
        Description
        The purpose of this study is to test any good and bad effects of the experimental study drug binimetinib in patients whose cancer has NRAS mutations.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
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      •   MATCH Treatment Subprotocol Z1B: EAY131-Z1B: Phase II Study of Palbociclib...
        Protocol No.
        HSC20160491HU
        Official Title
        MATCH Treatment Subprotocol Z1B: EAY131-Z1B: Phase II Study of Palbociclib (PD-0332991) in Patients with Tumors with CCND1, 2, 3 Amplification and Rb Protein Expression by IHC (CTMS# 16-0067)
        Description
        The purpose of this study is to test any good and bad effects of the study drug, palbociclib, in patients whose cancer has CCND1, 2 or 3 amplification and tested positive for a protein called Rb protein.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   Molecular Analysis for Therapy Choice (MATCH) / MATCH Treatment Subprotocol...
        Protocol No.
        HSC20170176HU
        Official Title
        Molecular Analysis for Therapy Choice (MATCH) / MATCH Treatment Subprotocol H: EAY131-H: Phase II Study of Dabrafenib and Trametinib in Patients with Tumors with BRAF V600E or V600K Mutations (Excluding Melanoma, Thyroid Cancer, and Colorectal Adenocarcinoma) (CTMS# 15-2083)
        Description
        Primary Objective To evaluate the proportion of patients with objective response (OR) to targeted study agent(s) in patients with advanced refractory cancers/lymphomas. Secondary Objectives To evaluate the proportion of patients alive and progression free at 6 months of treatment with targeted study agent in patients with advanced refractory cancers/lymphomas. To evaluate time until death or disease progression. To identify potential predictive biomarkers beyond the genomic alteration by which treatment is assigned or resistance mechanisms using additional genomic, RNA and protein-based assessment platforms.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
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      •   Molecular Analysis for Therapy Choice (NCI-MATCH)
        Protocol No.
        HSC20150719XT
        Official Title
        EAY131, Molecular Analysis for Therapy Choice (MATCH) (CTMS# 15-2080)
        Description
        Primary Objective To evaluate the proportion of patients with objective response (OR) to targeted study agent(s) in patients with advanced refractory cancers/lymphomas. Secondary Objectives To evaluate the proportion of patients alive and progression free at 6 months of treatment with targeted study agent in patients with advanced refractory cancers/lymphomas. To evaluate time until death or disease progression. To identify potential predictive biomarkers beyond the genomic alteration by which treatment is assigned or resistance mechanisms using additional genomic, RNA and protein-based assessment platforms.
        Contact
        410-450-5798
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   NRG-HN003, A PHASE I AND EXPANSION COHORT STUDY OF ADJUVANT CISPLATIN,...
        Protocol No.
        HSC20170206HU
        Official Title
        NRG-HN003, A PHASE I AND EXPANSION COHORT STUDY OF ADJUVANT CISPLATIN, INTENSITY-MODULATED RADIOTHERAPY, AND MK-3475 (PEMBROLIZUMAB) IN HIGH-RISK HEAD AND NECK SQUAMOUS CELL CARCINOMA (HNSCC) (CTMS# 17-0022)
        Description
        Primary Outcome Measures: DLT in patients with high-risk head and neck squamous cell carcinoma treated with adjuvant cisplatin, IMRT, and pembrolizumab [ Time Frame: Up to 4 weeks post IMRT ] Will be summarized using proportions for binary outcome per cohort.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   Phase I Clinical Trial of Camptothecin-20-O-Propionate hydrate (CZ48) (CTMS#...
        Protocol No.
        HSC20150748HU
        Official Title
        Phase I Clinical Trial of Camptothecin-20-O-Propionate hydrate (CZ48) (CTMS# 1