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FindAStudy :: Human Studies @ UTHSCSA
294  Studies 131  Researchers 29  Categories
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  •   Cancers and Other Neoplasms

    •   Bones and joints

      •   AAML1031, A Phase III Randomized Trial for Patients with de novo AML using...
        Protocol No.
        HSC20130256X
        Official Title
        AAML1031, A Phase III Randomized Trial for Patients with de novo AML using Bortezomib and Sorafenib (IND#114480; NSC# 681239, NSC# 724772) for Patients with High Allelic Ratio FLT3/ITD
        Description
        This randomized phase III trial studies how well bortezomib and sorafenib tosylate work in treating patients with newly diagnosed acute myeloid leukemia. Bortezomib and sorafenib tosylate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving bortezomib and sorafenib tosylate together with combination chemotherapy may be an effective treatment for acute myeloid leukemia.
        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

         

      •   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
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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
        Learn More About This Study

         

    •   Brain & Nervous System

      •   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 compund 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 radiaiton 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 portionms 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 evalaute 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 2, Investigator Initiated Study to Determine the Safety and Efficacy...
        Protocol No.
        HSC20130212H
        Official Title
        A Phase 2, Investigator Initiated Study to Determine the Safety and Efficacy of TH-302 in Combination with Bevacizumab for Glioblastoma Following Bevacizumab Failure (CTRC#12-0105)
        Description
        Dual center, single arm, two-stage, non-blinded, prospective study of combination therapy bevacizumab at 10mg/kg and TH-302 at 670mg/m2 every 2 weeks (6 week cycle) until disease progression.
        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 3, Randomized, Controlled, Double-Arm, Open-Label, Multi-Center...
        Protocol No.
        HSC20150548H
        Official Title
        A Phase 3, Randomized, Controlled, Double-Arm, Open-Label, Multi-Center Study of VB-111 Combined with Bevacizumab vs. Bevacizumab Monotherapy in Patients with Recurrent Glioblastoma (CTMS# 15-2078)
        Description
        This is a phase 3, randomized, multicenter study to compare VB-111 plus bevacizumab to bevacizumab in adult patients with recurrent Glioblastoma.
        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

         

      •   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

         

      •   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

         

      •   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
        Learn More About This Study

         

      •   ANBL0032, Phase III Randomized Study of Chimeric Antibody 14.18 (Ch14.18) in...
        Protocol No.
        HSC20090466H
        Official Title
        ANBL0032, Phase III Randomized Study of Chimeric Antibody 14.18 (Ch14.18) in High Risk Neuroblastoma Following Myeloablative Therapy and Autologous Stem Cell Rescue
        Description
        This partially randomized phase III trial studies isotretinoin with dinutuximab, aldesleukin, and sargramostim to see how well it works compared to isotretinoin alone following stem cell transplant in treating patients with neuroblastoma. Drugs used in chemotherapy, such as isotretinoin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as dinutuximab, may block tumor growth in different ways by targeting certain cells. Aldesleukin and sargramostim may stimulate a person''s white blood cells to kill cancer cells. It is not yet known if chemotherapy is more effective with or without dinutuximab, aldesleukin, and sargramostim following stem cell transplant in treating neuroblastoma.
        Contact
        210-562-9149
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   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

         

      •   NRG-BN001 Randomized Phase II Trial of Hypofractionated Dose-Escalated...
        Protocol No.
        HSC20150563X
        Official Title
        NRG-BN001 Randomized Phase II Trial of Hypofractionated Dose-Escalated Photon IMRT or Proton Beam Therapy Versus Conventional Photon Irradiation With Concomitant and Adjuvant Temozolomide in Patients With Newly Diagnosed Glioblastoma
        Description
        To determine if dose-escalated and -intensified photon IMRT or proton beam therapy (using a dose-per-fraction escalation with simultaneous integrated boost) with concomitant and adjuvant temozolomide improves overall survival, as compared to standard-dose photon irradiation with concomitant and adjuvant temozolomide.
        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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        Learn More About This Study

         

      •   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
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   Study of DCVax®-L to Treat Newly Diagnosed GBM Brain Cancer
        Protocol No.
        HSC20120273H
        Official Title
        A Phase III Clinical Trial Evaluating DCVax®-L, Autologous Dendritic Cells Pulsed with Tumor Lysate Antigen for the Treatment of Glioblastoma Multiforme (CTRC# 12-20)
        Description
        The primary purpose of the study is to determine the usefullness of new therapy called DCVax®-L in patients who have newly diagnosed GBM and surgery is planned. Patients must enter screening at a participating site prior to surgical resection of the tumor. Patients will receive the standard of care, including radiation and temozolomide (Temodar) therapy and two out of three will additionally receive DCVax-L, with the remaining one third receiving a placebo. Patients randomized to the placebo arm will have the option to receive DCVax-L in a crossover arm upon documented disease progression. The study will enroll approximately 300 patients from at least 50 cancer centers in the US and UK. In addition to other conditions for enrollment, eligible patients have newly diagnosed, unilateral GBM (grade IV). Participants must have sufficient tumor lysate protein that was generated from the surgically obtained tumor material. Patients must also have sufficient DCVax-L product available after manufacturing.
        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

         

    •   Breast

      •   A Phase 0, Investigator Initiated Study, Evaluating the Impact of Omega 3...
        Protocol No.
        HSC20150602H
        Official Title
        A Phase 0, Investigator Initiated Study, Evaluating the Impact of Omega 3 Free Fatty Acid Supplementation on Aromatase in Obese Postmenopausal Women with Estrogen Receptor Positive Breast Cancer (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 I, Multicenter, Open-Label, Two-Part, Dose-Escalation Study of...
        Protocol No.
        HSC20150372H
        Official Title
        A Phase I, Multicenter, Open-Label, Two-Part, Dose-Escalation Study of RAD1901 in Postmenopasual Women With Advanced Estrogen Receptor Positive and HER2-Negative Breast Cancer (CTMS# 15-2042)
        Description
        There are two parts to this Phase I study; the first part of the study (Dose Escalation, Part A) is designed to determine the MTD of RAD1901 in postmenopausal women with advanced breast cancer who are ER positive and HER2 negative. The second part of this study (Safety Expansion, Part B) is to evaluate the safety, tolerability and preliminary efficacy of therecommended Phase 2 dose (RP2D).RAD1901 will be administered orally on a continuous daily dosing schedule.  The study consists of a dose escalation (Part A) followed by a safety expansion (Part B), as described below.Part A, Dose Escalation:Patients will be assigned sequentially to escalating doses of RAD1901 using a standard 3+3 design. At each dose level, a cohort of at least 3 evaluable patients will typically be treated. The decision to dose escalate will be determined by the Study Committee (SC).  The starting dose will be 200 mg administered orally once daily. Dosing will be escalated inincrements of 200 mg for each new cohort of patients. It is estimated that 5 cohorts will be required to determine the MTD (i.e. 200 mg, 400 mg, 600 mg, 800 mg, 1000 mg). The MTD is defined as the highest dose at which 0/3, 0/6 or 1/6 patients experience a dose limiting toxicity (DLT) during the first 28 days of treatment. For the purposes of dose escalation decisions, the DLT evaluation period will be Day 1 through Day 28.Part B, Safety Expansion:Once the MTD has been identified and/or a RP2D has been selected in the dose escalation part of the study, additional patients will be enrolled to the safety expansion part in order to further evaluate the safety, tolerability and preliminary efficacy of the RP2D. 
        Contact
        210-450-5798
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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        Learn More About This Study

         

      •   A Phase II Randomized, Double-Blind Placebo Controlled, Study of Letrozole...
        Protocol No.
        HSC20150373H
        Official Title
        A Phase II Randomized, Double-Blind Placebo Controlled, Study of Letrozole With or Without BYL719 or Buparlisib, for the Neoadjuvant Treatment of Postmenopausal Women With Hormone Receptor-Positive HER2-Negative Breast Cancer (CTMS# 15-2039)
        Description
        The purpose of the study is to determine whether treatment with a PI3K inhibitor plus letrozole leads to an increase in pathologic response compared to treatment with placebo plus letrozole in patients with Breast cancer
        Contact
        210-450-5798
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   A Phase III Randomized, Double-Blind, Placebo-Controlled Study of LEE011 or...
        Protocol No.
        HSC20150291H
        Official Title
        A Phase III Randomized, Double-Blind, Placebo-Controlled Study of LEE011 or Placebo In Combination With Tamoxifen and Goserelin or a Non-Sterodial Aromatose Inhibitor (NSAI) and Goserelin for the Treatment of Premenopausal Women with Hormone Receptor Positive, HER2-Negative, Advanced Breast Cancer (CTMS# 14-2030)
        Description
        This is a multi-center, randomized, double-blinded, placebo controlled trial in pre-menopausal women with advanced breast cancer.
        Contact
        210-450-5798
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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        Learn More About This Study

         

      •   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
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      •   A Study of Neratinib Plus Capecitabine Versus Lapatinib Plus Capecitabine in...
        Protocol No.
        HSC20150443H
        Official Title
        A Study of Neratinib Plus Capecitabine Versus Lapatinib Plus Capecitabine in Patients with HER2+ Metastatic Breast Cancer Who Have Received Two or More Prior HER2- Directed Regimens in the Metastatic Setting (NALA) (CTMS# 15-2058)
        Description
        This is a randomized open-label study of the combinatoin of neratinib plus capecitabine versus the combination of lapatinib plus capecitabine in HER2+ metastatic breast cancer patients who have received two or more prior HER2 directed treatments.
        Contact
        210-450-5798
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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        Learn More About This Study

         

      •   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
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        Learn More About This Study

         

      •   Clinical trial to study the efficacy and safety of Eribulin Mesylate taken...
        Protocol No.
        HSC20150568H
        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
        This clinical trial will study the use of eribulin mesylate plus pembrolizumab in patients with triple-negative breast cancer that has spread after being previously treated with 0 to 2 chemotherapy regimens.  The first part of the study will include between 6 - 12 patients who will receive eribulin mesylate on Days 1 and 8 of a 21-day cycle andpembrolizumab on Day 1 of a 21-day cycle. The side effects will be assessed in the first cycle. The safest dose of eribulin mesylate + pembrolizumab will be determined for use in the second part of the study. About 83 patients may be enrolled in the second part of the study to receive the safest dose combination as idenfied in part 1.  Patients will be grouped into two groups:  The first group received no prior chemotherapy for metastatic disease and the second group was previously treated with 1 to 2 lines of chemotherapy for metastatic disease. The researchers will monitor the response rate after data is available for at least 38 subjects. The study could be stopped early if researches do not see enough benefit to continue.  Pharmacokinetic (PK) testing of eribulin mesylate will be performed in all subjects in part 1 of the study. Subjects in the part 2 part will have less frequent PK sampling where feasible.
        Contact
        410-450-5798
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   Doxorubicin Hydrochloride and Cyclophosphamide Followed by Paclitaxel With...
        Protocol No.
        HSC20150697X
        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
        This randomized trial studies how well doxorubicin hydrochloride and cyclophosphamide followed by paclitaxel with or without carboplatin work in treating patients with triple-negative breast cancer. Drugs used in chemotherapy, such as doxorubicin hydrochloride, cyclophosphamide, paclitaxel, and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether doxorubicin hydrochloride and cyclophosphamide is more effective when followed by paclitaxel alone or paclitaxel and carboplatin in treating triple-negative breast cancer.
        Contact
        410-450-5798
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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        Learn More About This Study

         

      •   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 ChemotherapyWho 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
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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
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   Safety and Pharmacokinetics of Atezolizumab in Combination With Trastuzumab...
        Protocol No.
        HSC20150769H
        Official Title
        A Phase Ib, Open-Label, Two-Arm Study Evaluating the Safety and Pharmacokinetics of Atezolizumab (anti-PD-L1 Antibody) in Combination with Trastuzumab Emtansine or With Trastuzumab and Pertuzumab in Patients with HER2-Positive Breast Cancer (CTMS# 15-2125)
        Description
        This is a Phase Ib, open-label study with two active regimens in each stage designed to evaluate the safety and tolerability of combination treatment with atezolizumab, trastuzumab, and pertuzumab or atezolizumab and trastuzumab emtansine in human epidermal growth factor receptor 2 (HER2) positive metastatic breast cancer (MBC) and locally advanced early breast cancer (EBC).
        Contact
        210-450-5798
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   Study looking at how safe and efficetive Alpelisib Plus Fulvestrant is in...
        Protocol No.
        HSC20150533H
        Official Title
        SOLAR-1: A Phase III Randomized Double-Blind, Placebo Controlled Study of Alpelisib in Combination with Fulvestrant for Men and Postmenopausal Women with Hormone Receptor Positive, HER2-Negative Advanced Breast Cancer Which Progressed On or After Aromatase Inhibitor Treatment (CTMS# 15-2073)
        Description
        To see if treatment with alpelisib plus fulvestrant prolongs progression-free survival compared to fulvestrant and placebo in men and postmenopausal women with hormone receptor positive (HR+), HER2-negative breast cancer, after being treated with an Aromatase Inhibitor.
        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

         

      •   Understanding Health Care Interactions
        Protocol No.
        HSC20150023H
        Official Title
        Understanding Health Care Interactions
        Description
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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    •   Cervix

    •   Colon

      •   A Phase II, Multicenter, Randomized, Double-Blind Study to Evaluate the...
        Protocol No.
        HSC20140356H
        Official Title
        A Phase II, Multicenter, Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of RO5520985 Plus Folfox Versus Bevacizumab Plus Folfox in Patients with Previously Untreated Metastatic Colorectal Cancer
        Description
        This is a Phase II multicenter, randomized, parallel arms, double-blind study of RO5520985 to evaluate the efficacy and safety of RO5520985 in combination with oxaliplatin, folinic acid, and 5-fluorouracil (mFOLFOX-6) versus bevacizumab (Avastin) plus mFOLFOX-6 in patients previously untreated metastatic colorectal cancer. The study consists of an safety run-in open-label, single-arm part (Part I) and a randomized, parallel-arms, double-blind part (Part II). During Part I at least 6 eligible patients will be exposed to 2000 mg Q2W RO5520985 + mFOLFOX-6 in order to confirm the dose and schedule that will be used in Part II. All patients in Part I will receive induction and maintenance therapy as described for patients in the experimental arm of Part II. Upon completion of Part I, eligible patients will be randomized in a ratio of 1:1 to receive either mFOLFOX-6 +RO5520985 or mFOLFOX-6 + Avastin. Study treatment, induction and maintenance, will be given on Day 1 of each 14-day cycle. Induction therapy will consist of up to 8 cycles of mFOLFOX-6 plus either Avastin or RO5520985. During maintenance therapy, patients will receive 5-FU and folinic acid plus either RO5520985 or Avastin for up to 24 months or until disease progession, unacceptable toxicity, Investigator decision or consent withdrawal.
        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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      •   Hydroxychloroquine + Vorinostat in Advanced Solid Tumors
        Protocol No.
        HSC20080462H
        Official Title
        Inhibition of Autophagy in Solid Tumors: A Phase I Pharmacokinetic and Pharmacodynamic Study of Hydroxychloroquine in Combination with the HDAC Inhibitor SAHA for the Treatment of Patients with Advanced Solid Tumors with an expansion study in advanced Renal and Colorectal Cancer (CTRC# 08-52)
        Description
        This trial will study hydroxychloroquine (HCQ) and Vorinostat in patients with advanced solid tumors to determine the maximum tolerated dose (MTD) and to evaluate the safety and antitumor activity of this drug combination.  The study is listed on clinicaltrials.gov, NCT01023737. 
        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

         

      •   Modulation of Autophagy: A Clinical Study of Vorinostat Plus...
        Protocol No.
        HSC20150178H
        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
        The investigators will give VOR 400 mg PO daily and HCQ 600 mg PO daily in 4-week cycles. Patients will require imaging up to 6 weeks prior to enrollment and will be assessed for measureable evidence of mCRC. This will be a randomized, controlled phase II clinical trial of patients with histological documentation of metastatic colorectal cancer, who have received locally and currently approved standard therapies, excluding RGF. Patients will be randomized 1:1 to RGF or VOR/HCQ (see schema below). Also, crossover is optional after first progression on the initial therapy, and based on physician discretion and in the best interest of the patient. If crossover is not done, then the patient will be off study and can go on to receive other treatments.
        Contact
        210-450-5798
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   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
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      •   This clinical trial will study BAX69 and 5-FU/Leucovorin or Panitumumab...
        Protocol No.
        HSC20150474H
        Official Title
        A Phase 2a Randomized, Open-Label Study to Assess the Safety, Tolerability, and Efficacy of BAX69 in Combination with 5-FU/Leucovorin or Panitumumab Versus Standard of Care in Subjects with Metastatic Colorectal Cancer (CTMS# 15-2051)
        Description
        This study will evaluate the safety and tolerability of BAX69 combined with 5-fluorouracil (5-FU)/leucovorin (LV) or panitumumab to determine the recommended dose for phase II study of each combination; and to compare the efficacy between BAX69 combined with 5-FU/LV or panitumumab compared to standard treatment in metastatic colorectal cancer.  This study is listed on clinicaltrials.gov, NCT02448810.
        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

         

    •   Esophagus

      •   A Four Part, Phase 1, Multi-center, Open-label Study of DKN-01 in...
        Protocol No.
        HSC20140189H
        Official Title
        A Four 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 (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

         

    •   Hodgkin's Lymphoma

      •   AHOD1331 - A Randomized Phase III Study of Brentuximab Vedotin (SGN-35, IND...
        Protocol No.
        HSC20150884X
        Official Title
        AHOD1331 - A Randomized Phase III Study of Brentuximab Vedotin (SGN-35, IND #117117) for Newly Diagnosed High-Risk Classical Hodgkin Lymphoma (cHL) in Children and Adolescents
        Description
        Primary Aims 1.1.1 To assess the event free survival (EFS) of a novel regimen incorporating brentuximab vedotin (Bv; AdcetrisTM) in the chemotherapy backbone of doxorubicin (Adriamycin), vincristine, etoposide, prednisone and cyclophosphamide (Bv-AVEPC) in newly diagnosed high-risk cHL compared to those treated with ABVE-PC. Secondary Aims 1.2.1 To determine whether children/adolescents with high-risk cHL treated with Bv-AVEPC have a higher rate of early response (determined by FDG-PET) and a reduction in response-directed radiation therapy (RT) compared to those treated with ABVE-PC. 1.2.2 To compare the rate of neuropathy (> Grade 3) among patients treated on the Bv-AVEPC (experimental arm) to patients treated on the ABVE-PC (standard arm). Exploratory Aims Childhood International Prognostic Score (CHIPS) 1.3.1 To validate and compare the Childhood Hodgkin International Prognostic Score (CHIPS) to conventional Ann Arbor Stage (Stages II B with bulk, III B, IV A or B) in predicting outcome in high-risk childhood cHL. Biology 1.3.2 To determine the incidence of preferentially expressed antigen in melanoma (PRAME) and testis-specific antigens in EBV- cHL tumors and the incidence of EBV antigens (EBNA1, LMP1, LMP2) in EBV+ cHL tumors, with the goal of developing strategies to integrate cellular therapy into treatment for newly diagnosed high-risk cHL. Imaging 1.3.3 To incorporate qualitative visual FDG-PET into response-directed treatment algorithms and explore quantitative FDG-PET and CT definitions of tumor burden and response for incorporation into next generation pediatric cHL risk-stratification schemes. Radiation Therapy 1.3.4 To evaluate the reduction in normal tissue irradiation associated with the current treatment approach compared to the volume of historic IFRT fields. 1.3.5 To evaluate EFS and patterns of relapse following protocol-specified RT utilization and treatment volumes. Patient Reported Outcomes (PRO) of Peripheral Neuropathy and Health-Related Quality of Life 1.3.6 To characterize the extent of chemotherapy induced peripheral neuropathy (CIPN), as reported by patients and parent proxies, through serial administration of the FACT-GOG-NTX. 1.3.7 To describe the Health-Related Quality of Life (HRQL) consequences of peripheral neuropathy over time by correlating total neuropathy scale scores with the individual items with the CHRIs-Global scale (e.g., physical health, pain, emotional functioning). 1.3.8 To perform a cross validation of the FACT-GOG-NTX with the TNS-PV to determine the performance of both measures with the use of brentuximab vedotin in a limited institutional approach in children and adolescents with cHL (See Appendix VII). Economic (For US Institutions Only) 1.3.9 To assess the resource use and cost implications of Bv in combination with chemotherapy and radiotherapy (RT) for newly diagnosed high-risk cHL in children and adolescents (See Appendix VIII).
        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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        Learn More About This Study

         

      •   Longitudinal Assessment of Ovarian Reserve in Adolescents with Lymphoma A...
        Protocol No.
        HSC20140059X
        Official Title
        Longitudinal Assessment of Ovarian Reserve in Adolescents with Lymphoma A Groupwide Non-Therapeutic Protocol
        Description
        This clinical trial studies blood sample markers of reproductive hormones in assessing ovarian reserve in younger patients with newly diagnosed lymphomas. Studying samples of blood from patients with cancer in the laboratory may help measure the effect of curative therapy for lymphoma on ovarian failure.
        Contact
        210-562-9149
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   SCUSF1202 [prev. ACCL1032], A Randomized Controlled Trial of Acupressure to...
        Protocol No.
        HSC20130271H
        Official Title
        SCUSF1202 [prev. ACCL1032], A Randomized Controlled Trial of Acupressure to Control Chemotherapy-Induced Nausea in Children Receiving Highly Emetogenic Chemotherapy (previously ACCL1032)
        Description
        RATIONALE: Acupressure wristbands may prevent or reduce nausea and caused by chemotherapy. It is not yet known whether standard care is more effective with or without acupressure wristbands in controlling acute and delayed nausea. PURPOSE: This randomized phase III trial is studying how well acupressure wristbands work with or without standard care in controlling nausea in young patients receiving highly emetogenic chemotherapy.
        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

         

    •   Hodgkin's Lymphoma| Non-Hodgkin's Lymphoma

      •   A Phase 1 Adaptive Dose-Escalation Study to Evaluate the Tolerability,...
        Protocol No.
        HSC20150395H
        Official Title
        A Phase 1 Adaptive Dose-Escalation Study to Evaluate the Tolerability, Safety, Pharmacokinetics, and Antitumor Activity of ADCT-301 in Patients with Relapsed or Refractory Hodgkin Lymphoma and Non-Hodgkin Lymphoma (CTMS# 15-2052)
        Description
        This study evaluates ADCT-301 in patients with relapsed/refractory Non-Hodgkin or Hodgkin lymphoma. Patients will participate in a dose-escalation phase (Part 1) and receive escalating doses of ADCT-301 every 3 weeks. In Part 2 of the study, patients will receive a recommended dose of ADCT-301 every 3 weeks
        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

         

    •   Kidney

      •   An Open-Label, Non-Randomized, Multicentre, Comparative, Phase I Study to...
        Protocol No.
        HSC20150093H
        Official Title
        An Open-Label, Non-Randomized, Multicentre, Comparative, Phase I Study to Determine the Pharmacokinetics, Safety and Tolerability of AZD9291 Following A Single Oral Dose to Patients with Advanced Solid Tumours and Normal Hepatic Function or Mild or Moderate Hepatic Impairment
        Description
        This is a 2-part study in patients with advanced solid tumours. Part A will investigate the pharmacokinetics (PK) of AZD9291 in patients with mild or moderate hepatic impairment compared to patients with normal hepatic function; Part B will allow any patient with mild or moderate hepatic impairment or normal hepatic function, who completes Part A, continued access to AZD9291 after the PK phase and will provide additional safety data.
        Contact
        210-450-5798
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   AREN03B2 Renal Tumors Classification, Biology and Banking Study
        Protocol No.
        HSC20070394X
        Official Title
        AREN03B2 Renal Tumors Classification, Biology and Banking Study
        Description
        This research trial studies kidney tumors in younger patients. Collecting and storing samples of tumor tissue, blood, and urine from patients with cancer to study in the laboratory may help doctors learn more about changes that occur in deoxyribonucleic acid (DNA) and identify biomarkers related to cancer.
        Contact
        210-562-9149
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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        Learn More About This Study

         

      •   Everolimus vs Nothing as Treatment for Kidney Cancer After Kidney Surgery
        Protocol No.
        HSC20110362H
        Official Title
        S0931 - EVEREST: EVErolimus for Renal Cancer Ensuing Surgical Therapy, A Phase III Study
        Description
        The purpose of this study is to see how well everolimus works as a prevention treatment for kidney cancer patients who have undergone surgery to remove all or part of a kidney. The primary objective is to determine if everolimus works better than taking nothing for preventing kidney cancer from coming back after surgery. The study will enroll 1170 participants from many cancer centers in the US. In addition to other conditions for enrollment, patients have a diagnosis of renal cell or clear cell kidney cancer but no evidence of cancer in other parts of the body.  Eligible patients have recovered from the kidney surgery and have not received any other treatment for their cancer.  Eligible patients are able to take oral medications and do not have any digestive problem that would affect how well a drug is digested.  Patients are not eligible if they have uncontrolled diabetes, impaired liver function, or impaired breathing function.
        Contact
        210-450-5798
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   Viral Reporters to Determine Circulating Tumor Cells Level and Viability in...
        Protocol No.
        HSC20140294H
        Official Title
        Viral Reporters to Determine Circulating Tumor Cells Level and Viability in Patients with Kidney Cancer: A Pilot Study
        Description
        Primary objective: Determine if our novel ex-vivo diagnostic assays, Circulating Tumor Cells Reporter Vector (CTC-RV) is capable of detecting a reporter signal from the collected blood and urine samples of patients with kidney cancer.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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    •   Kidney| Other Male Genital| Prostate| Urinary Bladder

    •   Leukemia, other

      •   AALL1131, A Phase III Randomized Trial for Newly Diagnosed High Risk...
        Protocol No.
        HSC20120250X
        Official Title
        AALL1131, A Phase III Randomized Trial for Newly Diagnosed High Risk B-precursor Acute Lymphoblastic Leukemia (ALL) Testing Clofarabine (IND# 73789, NSC# 606869) in the Very High Risk Stratum
        Description
        This randomized phase III trial is studying how well combination chemotherapy works in treating young patients with newly diagnosed high-risk acute lymphoblastic leukemia. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) and giving the drugs in different doses and in different combinations may kill more cancer cells.
        Contact
        210-562-9149
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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        Learn More About This Study

         

      •   ACCL0934, A Randomized Trial of Levofloxacin to Prevent Bacteremia in...
        Protocol No.
        HSC20110480X
        Official Title
        ACCL0934, A Randomized Trial of Levofloxacin to Prevent Bacteremia in Children Being Treated for Acute Leukemia (AL) or Undergoing Hematopoietic Stem Cell Transplantation (HSCT)
        Description
        This randomized phase III trial studies how well levofloxacin works in preventing infection in young patients with acute leukemia receiving chemotherapy or undergoing stem cell transplant. Giving antibiotics may be effective in preventing or controlling early infection in patients receiving chemotherapy or undergoing stem cell transplant for acute leukemia. It is not yet known whether levofloxacin is effective in preventing infection.
        Contact
        210-562-9149
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   ACCL1033, A Comprehensive Approach to Improve Medication Adherence in...
        Protocol No.
        HSC20130254X
        Official Title
        ACCL1033, A Comprehensive Approach to Improve Medication Adherence in Pediatric ALL
        Description
        This randomized phase III trial studies compliance to a mercaptopurine treatment intervention compared to standard of care in younger patients with acute lymphoblastic leukemia in remission. Assessing ways to help patients who have acute lymphoblastic leukemia to take their medications as prescribed may help them in taking their medications more consistently and may improve treatment outcomes.
        Contact
        210-562-9149
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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        Learn More About This Study

         

      •   COG AALL05B1, A Children''s Oncology Group Protocol for Collecting and...
        Protocol No.
        HSC20070100X
        Official Title
        COG AALL05B1, A Children''s Oncology Group Protocol for Collecting and Banking Relapsed Acute Lymphoblastic Leukemia Research Specimens
        Description
        RATIONALE: Collecting and storing samples of bone marrow and blood from patients with cancer to study in the laboratory may help doctors learn more about cancer and help predict the recurrence of cancer. PURPOSE: This research study is collecting and storing samples of bone marrow and blood from patients with relapsed acute lymphoblastic leukemia or relapsed non-Hodgkin lymphoma.
        Contact
        210-562-9149
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   Study of moxetumomab pasudotox in patients with relapsed or refractory hairy...
        Protocol No.
        HSC20150442H
        Official Title
        A Pivotal Multicenter Trial of Moxetumomab Pasudotox in Relapsed/Refractory Hairy Cell Leukemia (CTMS# 14-2022)
        Description
        Moxetumomab pasudotox is an experimental cancer treatment drug. It looks for a marker on the surface of almost all hairy cell leukemia cells. Moxetumomab pasudotox binds to that marker and then goes into the cell releasing a toxin which kills the cell. In a previous trial it showed activity in relapsed/refractory hairy cell leukemia.  This is a phase III multicenter trial designed to confirm these results.
        Contact
        210-450-5798
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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    •   Lip, Oral Cavity and Pharynx

      •   Cardiorespiratory Fitness and Cancer Treatment Toxicities (CTMS# 14-2027)
        Protocol No.
        HSC20150329H
        Official Title
        Cardiorespiratory Fitness and Cancer Treatment Toxicities (CTMS# 14-2027)
        Description
        Purpose/Aims: To determine if a patient''s cardiorespiratory fitness score (CSF), as determined without formal testing using a questionnaire and clinical data[1] has a direct correlation with grade of toxicities due to concurrent chemoradiation (CRT) treatment [2] has a direct correlation with the frequency of toxicities due to concurrent chemoradiation treatment[3] has a direct correlation with performance status (PS) by the Eastern Cooperative Oncology Group (ECOG) scale or Karnofsky score (KS)
        Contact
        210-450-5798
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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    •   Liver

      •   A Randomized, Multi-center Phase III Study of Nivolumab versus Sorafenib as...
        Protocol No.
        HSC20150713H
        Official Title
        A Randomized, Multi-center Phase III Study of Nivolumab versus Sorafenib as First-Line Treatment in Patients with Advanced Hepatocellular Carcinoma (CTMS# 15-2119)
        Description
        Primary Objectives To compare the overall survival (OS) and time to progression (TTP) of nivolumab to sorafenib in subjects with advanced HCC who have not received prior systemic therapy. TTP will be determined from assessments by a blinded independent central review (BICR) based on RECIST 1.1. Secondary Objectives To compare overall response rate (ORR) of nivolumab and sorafenib. ORR will be determined from assessments by a blinded independent central review (BICR) based on RECIST 1.1 To evaluate progression free survival (PFS) rates of nivolumab and sorafenib. PFS will be determined from assessments by a blinded independent central review (BICR) based on RECIST 1.1 To evaluate the relationship between tumor PD-L1 expression and efficacy
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   AHEP0731 Treatment of Children with all Stages of Hepatoblastoma
        Protocol No.
        HSC20100158X
        Official Title
        AHEP0731 Treatment of Children with all Stages of Hepatoblastoma
        Description
        This phase III trial studies the side effects and how well risk-based therapy works in treating younger patients with newly diagnosed liver cancer. Surgery, chemotherapy drugs (cancer fighting medicines), and when necessary liver transplant are the main current treatments for hepatoblastoma. The stage of the cancer is one factor used to decide the best treatment. Treating patients according to the risk group they are in may help get rid of the cancer, keep it from coming back, and decrease the side effects of chemotherapy.
        Contact
        210-562-9149
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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        Learn More About This Study

         

      •   HepaSphere/Quadrasphere Microspheres for Delivery of Doxorubicin for the...
        Protocol No.
        HSC20120330H
        Official Title
        Phase 3 Prospective, Randomized, Blinded and Controlled Investigation of Hepasphere/Quadrasphere Microspheres for Delivery of Doxorubicin for the Treatment of Hepatocellular Cancer
        Description
        The purpose of this study is to evaluate overall survival in patients treated with HepaSphere/Quadrasphere compared to conventional transarterial chemoembolization with particle PVA. Eligible adult patients have a diagnosis of hepatocellular cancer and are not currently or previously treated with chemo- or radiation therapy or sorafenib. Estimated Enrollment: 520 from multiple cancer centers in the US and Europe.
        Contact
        210-567-5564
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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        Learn More About This Study

         

      •   Pharmacokinetics of Oral Alisertib (MLN8237) in Adult Patients With Advanced...
        Protocol No.
        HSC20140397H
        Official Title
        Pharmacokinetics of Oral Alisertib (MLN8237) in Adult Patients With Advanced Solid Tumors or Relapsed/Refractory Lymphoma With Varying Degrees of Hepatic Function
        Description
        The drug being tested in this study is called alisertib. Alisertib is being tested to assess how it is processed by the body in participants with advanced solid tumors or relapsed/refractory lymphoma with varying degrees of liver function. This study will also assess laboratory results and safety. The study will enroll approximately 48 participants. Participants will be assigned to 1 of the 3 treatment groups based on the status of their liver function: Normal hepatic function (Total bilirubin ≤ upper limit of the normal range [ULN] and alanine aminotransferase [ALT] level ≤ ULN), moderate hepatic impairment (Total bilirubin > 1.5-3 x ULN and ALT level = Any), or severe hepatic impairment (Total bilirubin > 3 x ULN and ALT level = Any). All participants will be administered one 50 mg dose of alisertib on Day 1, Cycle 1. Alisertib will be administered again on Days 8 through 14 of Cycle 1, followed by a 14-day rest period. Doses administered on Days 8-14 will be 50, 30, or 20 mg of alisertib, depending on hepatic function. Alisertib may then be continued at the same dose as in Cycle 1, Days 8-14 in 21-day cycles (7 days of alisertib followed by a 14-day rest period) for up to 1 year (approximately 16 cycles). This multicenter trial will be conducted in USA only. The overall time to participate in this study is up to 13 months unless it is determined by the investigator, with agreement by the sponsor, that a participant would derive clinical benefit from continued treatment beyond 12 months. Participants will make up to 51 visits to the clinic including an end-of-study visit 30 days after the last dose of study drug for a follow-up assessment.
        Contact
        210-450-5798
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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    •   Lung

      •   A Phase 1 Study to Evaluate MEDI4736 at Treatment for Advanced Malignant...
        Protocol No.
        HSC20120299H
        Official Title
        A Phase 1/2 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MEDI4736 in Subjects with Advanced Solid Tumors (CTRC#12-0061)
        Description
        This Phase I study is designed to evaluate MEDI4736 in advanced cancer patients. The primary objective is to determine the best dose of MEDI4736 to use when treating patients with metastatic or unresectable advanced solid tumors. The study will enroll approximately 90 patients from at least 5 cancer centers in the US. In addition to other conditions for enrollment, eligible patients have advanced malignant melanoma, renal cell carcinoma, non-small cell lung cancer, or colorectal cancer that has not responded to standard therapy and for which no standard therapy exists. Patients who have a history of treatment with an anti-PD-1 agent/antibody, tuberculosis, hepatitis A, B, or C infection, symptomatic or untreated central nervous system disease or other severe medical conditions may not be eligible to enroll.  
        Contact
        210-450-5798
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   A Randomized, Open-Label, Multicenter, Phase 3 Trial Comparing Veliparib...
        Protocol No.
        HSC20150133H
        Official Title
        A Randomized, Open-Label, Multicenter, Phase 3 Trial Comparing Veliparib Plus Carboplatin and Paclitaxel Versus Investigator''s Choice of Standard Chemotherapy in Subjects Receiving First Cytotoxic Chemotherapy for Metastatic or Advanced Non-Squamous Non-Small Cell Lung Cancer (NSCLC) and Who Are Current or Former Smokers (CTMS# 14-2012)
        Description
        This is a 2-arm, Phase 3 study to evaluate the safety and efficacy of veliparib plus carboplatin and paclitaxel versus the Investigator''s choice of standard chemotherapy in current or former smokers who are receiving their first cytotoxic therapy for metastatic or advanced non-squamous non-small cell lung 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

         

      •   Clinical Study of Oral cMET Inhibitor INC280 in Adult Patients With Advanced...
        Protocol No.
        HSC20150625H
        Official Title
        A Phase II, Multicenter, Three-Cohort Study of Oral cMET Inhibitor INC280 in Adult Patients with EGFR Wild-Type (wt), Advanced Non-Small Cell Lung Cancer (NSCLC) Who Have Received One or Two Prior Lines of Systemic Therapy for Advanced/Metastatic Disease (CTMS# 15-2074)
        Description
        A phase II study to evaluate antitumor activity of oral cMET inhibitor INC280 in adult patients with EGFR wild-type, advanced non-small cell lung cancer (NSCLC) after one or two prior lines of systemic therapy for advanced/metastatic disease as measured by overall response rate (ORR). The study will also evaluate safety and pharmacokinetics of INC280.
        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

         

      •   Dose Escalating Study of IMGN853 for Patients with Cancer
        Protocol No.
        HSC20120333H
        Official Title
        A Phase 1, First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of IMGN853 in Adults with Ovarian Cancer and other FOLR1- Positive Solid Tumors (CTRC# 12-0064)
        Description
        The purpose of this study is to determine the best dose of IMGN853 to use when treating people with cancer, in particular, ovarian cancer, that has spread to other areas in the body and/or cannot be removed surgically. The primary objective is to identify the side effects and right dose of IMGN853 and to find out if IMGN853 works as a treatment for patients with specific types of cancer. The study will enroll approximately 64 participants from no more than 6 cancer centers in the US. In addition to other conditions for enrollment, eligible adult patients are those whose tumors have become worse in spite of treatment and who otherwise are in good health.  The tumors of all potential participants will be tested for the presence of a specific protein and results of the test will help determine if the patient is a candidate for treatment with IMGN853. Likely tumors are those that began in the ovary or fallopian tube, but some types of lung cancer and kidney cancer might also have this protein present. Participants cannot have a history of bone marrow transplant, cornea (eye) problems, active infection, significant heart history, multiple sclerosis or nerve damage.
        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

         

      •   Hypofractionated Image-Guided Radiation Therapy (IGRT) for patients with...
        Protocol No.
        HSC20120093H
        Official Title
        Phase III Randomized Study of Standard versus Accelerated Hypofractionated Image-Guided Radiation Therapy (IGRT) in the Definitive Setting for Patients with Stage II-III or Recurrent Non-Small Cell Lung Cancer and Poor Performance Status
        Description
        The study is designed to determine whether an accelerated course of hypofractionated radiation therapy with daily image guidance and motion assessment/control will allow more effective treatment of poor performance status patients with stage II-III non-small cell lung cancer (NSCLC), who would benefit from local therapy compared to standard radiation therapy (60 Gy in 2 Gy per fraction). The primary objective is to compare one type of radiation therapy with another type in order to determine if one is better than the other.    The study will enroll approximately 226 patients from 5 cancer centers in Texas. In addition to other conditions for enrollment, eligible patients have state II or III NSCLC and are otherwise in good health. Patients who have a history of radiotherapy to the area that overlaps the area to be treated may not be eligible to enroll.
        Contact
        210-450-5924
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
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      •   Open-Label, Multicenter Phase 1 Study of Mogamulizumab (KW-0761) in...
        Protocol No.
        HSC20150316H
        Official Title
        Open-Label, Multicenter Phase 1 Study of Mogamulizumab (KW-0761) in Combination with Docetaxel as Second-Line Treatment in Subjects with Non-Small Cell Lung Cancer (NSCLC) (CTMS# 14-2020)
        Description
        The purpose of this study is to evaluate the safety of mogamulizumab in combination with docetaxel in adult subjects with locally advanced or metastatic non-small cell lung 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

         

      •   S1400 - A Biomarker-Driven Master Protocol for Previously Treated Squamous...
        Protocol No.
        HSC20150302X
        Official Title
        S1400 - A Biomarker-Driven Master Protocol for Previously Treated Squamous Cell Lung Cancer (Lung-Map)
        Description
        This screening and multi-sub-study randomized phase II/III trial will establish a method for genomic screening of similar large cancer populations followed by assigning and accruing simultaneously to a multi-sub-study "Master Protocol". The type of cancer trait (biomarker) will determine to which sub-study, within this protocol, a participant will be assigned to compare new targeted cancer therapy, designed to block the growth and spread of cancer, or combinations to standard of care therapy with the ultimate goal of being able to approve new targeted therapies in this setting. In addition, the protocol includes a "non-match" sub-study which will include all screened patients not eligible for any of the biomarker-driven sub-studies. This sub-study will compare a non-match therapy to standard of care also with the goal of approval.
        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

         

      •   S1403, A Randomized Phase II/III Trial of Afatinib Plus Cetuximab Versus...
        Protocol No.
        HSC20150454X
        Official Title
        S1403, A Randomized Phase II/III Trial of Afatinib Plus Cetuximab Versus Afatinib Alone in Treatment-Niave Patients with Advanced, EGFR Mutation Positive Non-Small Cell Lung Cancer (NSCLC) (CTMS# 15-2060)
        Description
        This randomized phase II/III trial studies how well afatinib dimaleate with cetuximab works and compares it with afatinib dimaleate alone in treating patients with newly diagnosed stage IV or recurrent (has come back), epidermal growth factor receptor (EGFR) mutation positive non-small cell lung cancer. Afatinib dimaleate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as cetuximab, may block tumor growth in different ways by targeting certain cells. It is not yet known whether afatinib dimaleate is more effective when given alone or with cetuximab in treating patients with non-small cell lung 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

         

    •   Lymphoid Leukemia

      •   A Phase I Trial of SGN-CD70A In Patients with CD70-Positive Malignancies
        Protocol No.
        HSC20140423H
        Official Title
        A Phase I Trial of SGN-CD70A In Patients with CD70-Positive Malignancies
        Description
        This study will examine the safety profile of SGN-CD70A. The study will test increasing doses of SGN-CD70A given every 3 weeks to small groups of patients. The goal is to find the highest dose of SGN-CD70A that can be given to patients without causing unacceptable side effects. The pharmacokinetics and antitumor activity of SGN-CD70A will also be evaluated.
        Contact
        210-450-5798
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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        Learn More About This Study

         

      •   AALL08B1, Classification of Newly Diagnosed Acute Lymphoblastic Leukemia (ALL)
        Protocol No.
        HSC20110017X
        Official Title
        AALL08B1, Classification of Newly Diagnosed Acute Lymphoblastic Leukemia (ALL)
        Description
        This research trial studies a risk-based classification system for patients with newly diagnosed acute lymphoblastic leukemia. Gathering health information about patients with acute lymphoblastic leukemia may help doctors learn more about the disease and plan the best 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

         

      •   AALL0932, Treatment of Patients with Newly Diagnosed Standard Risk...
        Protocol No.
        HSC20110028X
        Official Title
        AALL0932, Treatment of Patients with Newly Diagnosed Standard Risk B-Precursor Acute Lymphoblastic Leukemia (ALL)
        Description
        This partially randomized phase III clinical trial is studying different combinations of risk-adapted chemotherapy regimens and their side effects and comparing how well they work in treating younger patients with newly diagnosed standard-risk acute lymphoblastic leukemia. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy), giving the drugs in different doses, and giving the drugs in different combinations may kill more cancer cells.
        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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      •   AALL1231 - A Phase III Randomized Trial Investigating Bortezomib (NSC#...
        Protocol No.
        HSC20150314X
        Official Title
        AALL1231 - A Phase III Randomized Trial Investigating Bortezomib (NSC# 681239; IND# 58443) on a Modified Augmented BFM (ABFM) Backbone in Newly Diagnosed T- Lymphoblastic Leukemia (T-ALL)and T- Lymphoblastic Lymphoma (T-LLy)A Groupwide Phase III Study
        Description
        Primary Aims: To compare EFS in patients with newly diagnosed T-ALL and T-LLy who are randomized to a modified ABFM backbone versus bortezomib plus the modified ABFM backbone. Secondary Aims: 1)To determine the safety and feasibility of modifying standard therapy for T-ALL and T-LLy based on the results of UKALL 2003, which includes a dexamethasone-based Induction, additional doses of pegaspargase (PEG-ASP) during Induction and Delayed Intensification (DI), and dexamethasone pulses during Maintenance therapy 2)To determine if prophylactic (presymptomatic) cranial radiation therapy (CRT) can be safely and effectively eliminated in the 85-90% of T-ALL patients classified as standard or intermediate risk. 3)To determine the proportion of EOC MRD ¿ 0.1% T-ALL patients who become MRD negative (undetectable by flow cytometry) after intensification of chemotherapy, using three high risk (HR) BFM blocks, and to compare EFS between the patients who become MRD negative after the three HR BFM blocks and continue on chemotherapy with those who continue to have detectable MRD and are eligible for other treatment strategies, including hematopoietic stem cell transplant (HSCT). Similarly, to compare the EFS between very high risk (Induction failure) T-LLy patients treated with HR BFM intensification blocks who have partial or complete response (PR or CR) with those who do not respond (NR). Correlative Aims: 1)To investigate the prognostic significance of Day 29 BM MRD in T-LLy patients. 2)To determine if protein expression patterns can predict bortezomib response and drug resistance in T-ALL 3)To analyze and target relevant signaling pathways in T-ALL blasts, focusing on Early T cell Precursor (ETP) ALL
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   E1912: A Randomized Phase III Study of Ibrutinib (PCI-32736)-Based Therapy...
        Protocol No.
        HSC20140340X
        Official Title
        E1912: A Randomized Phase III Study of Ibrutinib (PCI-32736)-Based Therapy vs Standard Fludarabine, Cyclophosphamide, and Rituximab (FCR) Chemoimmunotherapy in Untreated Younger Patients with Chronic Lymphocytic Leukemia (CLL)
        Description
        PRIMARY OBJECTIVES: I. To evaluate the ability of Ibrutinib-based induction therapy to prolong progression free survival (PFS) compared to standard fludarabine phosphate, cyclophosphamide, and rituximab (FCR) chemoimmunotherapy for younger patients with chronic lymphocytic leukemia (CLL). SECONDARY OBJECTIVES: I. Evaluate overall survival (OS) of patients based on treatment arm. II. Monitor and assess toxicity of treatment with Ibrutinib-based induction relative to standard FCR chemotherapy. III. To compare quality of life (QOL) in CLL patients during the first 6 months of treatment among patients receiving Ibrutinib-based induction therapy relative to standard FCR chemoimmunotherapy. IV. To compare QOL over the long-term in CLL patients receiving continuous therapy using Ibrutinib to that of CLL patients who completed FCR therapy. V. Determine the effect of pretreatment clinical and biological characteristics (e.g. disease stage, immunoglobulin heavy chain variable region gene [IGHV] mutation status, fluorescent in situ hybridization [FISH]) on clinical outcomes (e.g. complete response, PFS) of the different arms. VI. Determine if the minimal residual disease (MRD) status as assessed by flow cytometry at different time points during and after treatment is an effective surrogate marker for prolonged PFS and overall survival. VII. Compare the genetic abnormalities and dynamics of intra-clonal architecture of CLL patients before and after treatment with chemoimmunotherapy (CIT) and non-CIT approaches and explore relationships with treatment resistance. VIII. Explore the effects of FCR and Ibrutinib-based therapy on T-cell immune function. IX. Conduct confirmatory validation genotyping of single nucleotide polymorphisms (SNPs) associated with the efficacy and toxicity of fludarabine-based therapy as in a prior Eastern Cooperative Oncology Group (ECOG) genome-wide association study (GWAS) analysis in the E2997 trial. X. Evaluate the ability of prognostic model that incorporates clinical and biologic characters to predict a response to therapy and clinical outcome (PFS, OS). XI. Evaluate signaling networks downstream of the B-cell receptor in patients receiving Ibrutinib-based therapy. XII. Collect relapse samples to study mechanisms of resistance to both FCR and Ibrutinib-based therapy. OUTLINE: Patients are randomized to 1 of 2 treatment arms.
        Contact
        210-450-5798
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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    •   Multiple Myeloma

      •   A Phase 1a/1b Multicenter, Single-Arm, Open-Label, Dose-Escalation Study to...
        Protocol No.
        HSC20150341H
        Official Title
        A Phase 1a/1b Multicenter, Single-Arm, Open-Label, Dose-Escalation Study to Determine the Maximum Tolerated Dose, Safety, and Preliminary Activity of Oral ACY-241 Alone and in Combination With Pomalidomide and Low-Dose Dexamethasone in Patients With Relapsed or Relapsed-and-Refractory Multiple Myeloma (CTMS# 15-2041)
        Description
        This is a phase 1a/1b, multicenter, single-arm, open-label, dose escalation study to determine the maximum tolerated dose (MTD) and evaluate the safety and preliminary antitumor activity of ACY-241 for oral administration as monotherapy and in combination therapy with orally administered pomalidomide and low-dose dexamethasone in eligible patients with relapsed or relapsed-and-refractory multiple myeloma (MM).
        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 3 Study Comparing Daratumumab, Lenalidomide, and Dexamethasone (DRd)...
        Protocol No.
        HSC20150503H
        Official Title
        A Phase 3 Study Comparing Daratumumab, Lenalidomide, and Dexamethasone (DRd) vs Lenalidomide and Dexamethasone (Rd) in Subjects with Previously Untreated Multiple Myeloma who are Ineligible for High Dose Therapy (CTMS# 15-2065)
        Description
        This study will compare the efficacy of daratumumab combined with lenalidomide and dexamethasone to that of lenalidomide and dexamethasone in terms of progression-free survival (PFS) in adult patients with newly diagnosed multiple myeloma who are not candidates for high dose chemotherapy and autologous stem cell transplant.
        Contact
        210-450-5798
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   Bortezomib or Carfilzomib with Lenalidomide & Dexamethasone in patients with...
        Protocol No.
        HSC20150407X
        Official Title
        E1A11, Randomized Phase III Trial of Borezomib, LENalidomide and Dexamethasone (VRd) Versus Carfilzomib, Lenalidomide and Dexamethasone (CRd) Followed by Limited or Indefinite DURation Lenalidomide MaintenANCE in Patients with Newly Diagnosed Symptomatic Multiple Myeloma (ENDURANCE) (CTMS# 15-2043)
        Description
        This clinical trial studies the combination of bortezomib, lenalidomide and dexamethasone to see how well it works compared to the combination of carfilzomib, lenalidomide and dexamethasone in patients with newly diagnosed multiple myeloma.  The study is listed on clinicaltrials.gov, NCT01863550.
        Contact
        210-450-5798
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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    •   Multiple sites

      •   A Phase Ib Study of the Safety, Pharmacokinetics, and Preliminary Antitumor...
        Protocol No.
        HSC20150849H
        Official Title
        A Phase Ib Study of the Safety, Pharmacokinetics, and Preliminary Antitumor Activity of ACY-241 in Combination with Paclitaxel in Patients with Advanced Solid Tumors (CTMS# 15-2115)
        Description
        Primary Objectives: Evaluate the dose-limiting toxicities (DLTs) and maximum tolerated dose (MTD), if present. Determine the recommended phase 2 dose and schedule of ACY-241 in combination with paclitaxel on a weekly schedule. Secondary Objectives: Evaluate the safety of ACY-241 administered in combination with paclitaxel. Determine the preliminary antitumor activity of ACY-241 administered in combination with paclitaxel in the patient population. Determine the single- and multiple-dose pharmacokinetics (PK) of ACY-241 administered in combination with paclitaxel in the patient population. Determine the single- and multiple-dose PK of paclitaxel administered in combination with ACY-241 in the patient population. Evaluate the pharmacodynamics of ACY-241 administered in combination with paclitaxel in the patient population. Assess the exposure-response relationship of ACY-241 administered in combination with paclitaxel and potential biomarkers of response in the patient population. Exploratory Objectives: To assess the potential of ACY-241 to have a peripheral neuropathy-attenuating effect, the Total Neuropathy Score ¿ nurse (TNSn) will be implemented at discrete time points during the study.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   A Single-Center, Open-Label, Proof of Concept Trial to Evaluate the...
        Protocol No.
        HSC20150252H
        Official Title
        A Single-Center, Open-Label, Proof of Concept Trial to Evaluate the Efficacy, Safety and Tolerability Trial of a New Botanical Drug Product Containing East Indian Sandalwood Oil (EISO) for the Prevention and Treatment of Oral Mucositis Induced by Radiation Therapy with or without Concurrent Chemotherapy
        Description
        Sandalwood Oil
        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
        Learn More About This Study

         

      •   An Open-Label Phase I Study to Determine the Effect of Lenvatinib (E7080) on...
        Protocol No.
        HSC20160033H
        Official Title
        An Open-Label Phase I Study to Determine the Effect of Lenvatinib (E7080) on the Pharmacokinetics of Midazolam, a CYP3A4 Substrate, in Subjects with Advanced Solid Tumors (CTMS# 15-2130)
        Description
        Primary Objective To determine the effect of lenvatinib on cytochrome P450 3A4 (CYP3A4) activity by using midazolam as a probe Secondary Objective To assess the safety of lenvatinib in subjects with advanced solid tumors Exploratory Objective To explore the efficacy of lenvatinib in subjects with advanced solid tumors
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   APEC14B1 THE PROJECT:EVERYCHILD PROTOCOL: A REGISTRY, ELIGIBILITY SCREENING,...
        Protocol No.
        HSC20150870X
        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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      •   Circulating Tumor Cells in Pediatric Solid Tumors
        Protocol No.
        HSC20150037H
        Official Title
        Circulating Tumor Cells in Pediatric Solid Tumors
        Description
        Circulating Tumor Cells in Pediatric Solid Tumors
        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.
        HSC20150748H
        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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      •   S1204, A Sero-Epidemiologic Survey and Cost-Effectiveness Study of Screening...
        Protocol No.
        HSC20150515H
        Official Title
        S1204, A Sero-Epidemiologic Survey and Cost-Effectiveness Study of Screening for Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV) and Hepatitis C Virus (HCV) Among Newly Diagnosed Cancer Patients (CTMS# 15-2070)
        Description
        Primary Objective Among newly diagnosed cancer patients presenting to SWOG-affiliated community and academic oncology clinics, estimate the prevalence of human immunodeficiency virus (HIV), hepatitis B (HBV), and hepatitis C (HCV) infection. Prevalence estimates will be further stratified: by whether infection with the virus(es) is known, as reported by patients and/or their physician prior to study testing, vs. unknown; by presenting cancer type, and by self-reported risk factors for each virus. Secondary Objectives a. Evaluate known sociodemographic, clinical, and behavioral factors that are significantly associated with previously undiagnosed HIV, HBV, and/or HCV infection in a population of people with newly diagnosed cancer. b. Among patients who are identified as having HIV, HBV, and/or HCV, evaluate the timing and type of treatments received, both for the viral infections and the cancers. c. Evaluate type and rate of cancer treatment-related adverse events in patients with HIV, HBV, and/or HCV infection. d. Using simulation modeling that is directly informed by the data obtained from this study, determine the cost-effectiveness (expressed as cost per infection detected and cost per year of life gained) of (1) routine, universal screening and (2) risk factor-directed screening of newly diagnosed cancer patients for HIV, HBV, and/or HCV vs. current care. Tertiary Objective Create a biorepository of stored serum for future translational medicine studies that may include identifying genomic and viral factors that increase the risk of serious adverse effects among participants infected with HIV, HBV, and/or HCV being treated for invasive cancers.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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    •   Myeloid and Monocytic Leukemia

      •   AAML08B1 Biology Study of Transient Myeloproliferative Disorder (TMD) in...
        Protocol No.
        HSC20110348X
        Official Title
        AAML08B1 Biology Study of Transient Myeloproliferative Disorder (TMD) in Children with Down Syndrome (DS)
        Description
        RATIONALE: Studying the genes expressed in samples of blood from patients with Down syndrome may help doctors identify biomarkers related to cancer. PURPOSE: This research study is looking at blood samples from newborns with Down syndrome.
        Contact
        210-562-9149
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   MRX34 as treatment for patients with unresectable liver cancer or metastatic...
        Protocol No.
        HSC20130176H
        Official Title
        A Multicenter Phase I Study of MRX34, MicroRNA miR-RX34 Liposomal Injection (CTRC# 12-0110)
        Description
        This Phase I study is designed to evaluate the safety of MRX34 in patients with primary liver cancer or those with liver metastasis from other cancers. The primary objective is to identify the side effects of MRX34. The study will enroll approximately 48 patients at two cancer centers in Texas. In addition to other conditions for enrollment, eligible patients have liver cancer or advanced metastatic cancer with liver metastasis that cannot be removed surgically and are otherwise in good health. Patients who have a history of infection including hepatitis, bleeding problems, central nervous system involvement, or require anticoagulant therapy may not be eligible to enroll.
        Contact
        210-450-5798
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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    •   Non-Hodgkin's Lymphoma

      •   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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      •   Rituximab and Combination Chemotherapy With or Without Lenalidomide in...
        Protocol No.
        HSC20150288H
        Official Title
        E1412, Randomized Phase II Open Label Study of Lenalidomide R-CHOP (R2CHOP) vs RCHOP (Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone) in Patients with Newly Diagnosed Diffuse Large B Cell Lymphoma (CTMS# 15-2037)
        Description
        This trial looks at how well rituximab and combination chemotherapy with or without lenalidomide work to treat newly diagnosed stage II-IV diffuse large B cell lymphoma. Monoclonal antibodies, like rituximab, may interfere with the ability of cancer cells to grow and spread. Chemotherapy drugs like cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, and prednisone, work in different ways to keep cancer cells from growing and spreading. Lenalidomide may work with the immune system to stop cancer cells from growing.
        Contact
        210-450-5798
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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        Learn More About This Study

         

    •   Other Digestive Organ

      •   Prospective Randomized Phase II Trial of Pazopanib (NSC# 737754, IND 75648)...
        Protocol No.
        HSC20150052H
        Official Title
        A021202 - Prospective Randomized Phase II Trial of Pazopanib (NSC# 737754, IND 75648) Versus Placebo in Patients with Progressive Carcinoid Tumors (CTRC 14-0046)
        Description
        This randomized phase II trial studies how well pazopanib hydrochloride works in treating patients with carcinoid tumors that are growing, spreading, or getting worse. Pazopanib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth   PRIMARY OBJECTIVES: I. For patients with progressive carcinoid tumors, progression-free survival (progression-free survival [PFS] defined by central review according to Response Evaluation Criteria in Solid Tumors [RECIST] 1.1) will be compared between patients randomized to treatment with pazopanib versus placebo. SECONDARY OBJECTIVES: I. Overall survival will be compared between treatment arms. II. Objective response rate, duration of response, and time to treatment failure will be compared between treatment arms.   III. Progression free survival as assessed by central radiology review and local radiology review will be compared overall and within treatment arms.    IV. PFS at 6 months and 12 months will be estimated within each treatment arm. V. Safety and tolerability of treatment with pazopanib/placebo will be evaluated within each treatment arm. VI. Biochemical response (for chromogranin A, defined as a decrease of 50% or more in chromogranin A levels from baseline and for 5-hydroxyindoleacetic acid [5-HIAA], defined as a decrease of 50% or more in urinary 5-HIAA levels from baseline) will be compared between treatment arms among patients with elevated baseline levels of chromogranin A (CGA) and 5-HIAA.   VII. PFS and other indicators of efficacy will be estimated in patients who crossover to pazopanib from placebo. OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM I: Patients receive pazopanib hydrochloride orally (PO) once daily (QD) on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. ARM II: Patients receive placebo PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. At the time of progressive disease, patients may cross-over to Arm I. After completion of study treatment, patients are followed up every 3-6 months for 5 years.
        Contact
        210-450-5798
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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        Learn More About This Study

         

    •   Other Endocrine System

      •   Clinical Trial of Lurbinectedin (PM01183) in Selected Advanced Solid Tumors
        Protocol No.
        HSC20150542H
        Official Title
        A Multicenter Phase II Clinical Trial of Lurbinectedin (PM01183) in Selected Advanced Solid Tumors (CTMS# 15-2071)
        Description
        A Trial of Lurbinectedin (PM01183) in selected advanced cancers to assess how well lurbinectedin (PM01183) works in terms of overall response rate (ORR).
        Contact
        410-450-5798
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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        Learn More About This Study

         

      •   Genetic Analysis of Pheochromocytomas and Paragangliomas
        Protocol No.
        HSC20060069H
        Official Title
        Genetic Analysis of Pheochromocytomas and Paragangliomas
        Description
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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        Learn More About This Study

         

    •   Other Hematopoietic

      •   An Open-Label, Dose Escalation, Phase 1, First-In-Human Study of TAK-659 in...
        Protocol No.
        HSC20150255H
        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
        his study is an open-label, multicenter, phase 1, dose escalation study of TAK-659 in adult patients with advanced solid tumor and lymphoma malignancies. This study will be the first to administer TAK-659 to humans. The patient population during dose escalation (Part A) will consist of adults previously diagnosed with any form of a solid tumor or lymphoma for which standard, curative, or life-prolonging treatment does not exist or is no longer effective. This first-in-human (FIH) study will include 2 dose expansion cohorts in refractory and/or relapsed CLL and DLBCL (Part B) following completion of dose escalation (Part A).
        Contact
        210-450-5798
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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    •   Pancreas

      •   M402 combined with Nab-Paclitaxel and gemcitabine in metastatic pancreatic...
        Protocol No.
        HSC20120151H
        Official Title
        A Phase I/II, Two-Part, Multicenter Study to Evaluate the Safety and Efficacy of M402 in Combination with nab-Paclitaxel and Gemcitabine in Patients with Metastatic Pancreatic Cancer (CTRC# 12-11)
        Description
        Patients with metastatic pancreatic cancer will be treated with nab-paclitaxel and gemcitabine in combination with an investigational agent called necuparanib (M402). It is made from heparin, which is a well known blood thinner. Blood thinners have been shown in prior animal and human studies to have anti-cancer effects. Necuparanib has been re-engineered from heparin to have much lower blood thinning activity while keeping the anti-tumor activity. The investigators are testing whether necuparanib administered in combination with nab-paclitaxel and gemcitabine may be more effective than nab-paclitaxel and gemcitabine.  This study is listed on clinicaltrials.gov, NCT01621243.
        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

         

      •   S1505, A Randomized Phase II Study of Perioperative mFolfirinox Versus...
        Protocol No.
        HSC20160013H
        Official Title
        S1505, A Randomized Phase II Study of Perioperative mFolfirinox Versus Gemcitabine/Nab-Paclitaxel as Therapy for Resectable Pancreatic Adenocarcinoma (CTMS# 15-2140)
        Description
        Primary Objectives a. To assess 2-year overall survival in each treatment arm (mFOLFIRINOX and gemcitabine/nab-paclitaxel) in patients with resectable pancreatic cancer. b. If the stated threshold is met in one or both arms: to choose the better regimen with respect to 2-year overall survival. Secondary Objectives To estimate, for all patients and within treatment arms: a. Frequency and severity of adverse events associated with chemotherapy in the perioperative setting. b. Proportion of patients going to surgery for resection after preoperative chemotherapy. c. Proportion of patients achieving R0 resection after preoperative chemotherapy. d. Overall response rate following preoperative chemotherapy, including confirmed and unconfirmed, complete and partial response, per RECIST 1.1. e. Pathologic response rates after R0 or R1 resection. f. Patterns of recurrence (loco-regional, distant) after R0 or R1 resection. g. Disease-free survival from the time of R0 or R1 resection.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   This is a study of pembrolizumab (KEYTRUDA) in combination of REOLYSIN...
        Protocol No.
        HSC20150813H
        Official Title
        A Phase 1b study of pembrolizumab (KEYTRUDA) in combination of REOLYSIN (pelareorep) and chemotherapy in patients with advances pancreatic adenocarcinoma CTMS# 15-2127
        Description
        This study will evaluate the combination of REOLYSIN, chemotherapy and pembrolizumab. This study is intended to find the best dose to use in further studies.
        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

         

    •   Prostate

      •   Biomarkers and clinical parameters associated with Gleason score upgrading
        Protocol No.
        HSC20140367H
        Official Title
        Biomarkers and clinical parameters associated with Gleason score upgrading
        Description
        This study involves the collection of blood samples by finger stick, heel stick, ear stick, or venipuncture from unhealthy adults, pregnant adults or children.  Considering the person’s age, weight, and health, the collection procedure, the amount of blood to be collected, and the frequency with which it will be collected the blood samples intended for this study are minimal risk.
        Contact
        210-567-0178
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
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      •   Dynamic Multi-Cohort Prediction Modeling of Prostate Biopsy Outcome
        Protocol No.
        HSC20150050H
        Official Title
        Dynamic Multi-Cohort Prediction Modeling of Prostate Biopsy Outcome
        Description
        Dynamic Multi-Cohort Prediction Modeling of Prostate Biopsy Outcome
        Contact
        210-450-0754
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
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      •   Enzalutamide With or Without Abiraterone and Prednisone in Treating Patients...
        Protocol No.
        HSC20150788X
        Official Title
        A031201, Phase III Trial of Enzulutamide (NSC# 766085) Versus Enzalutamide, Abiraterone and Prednisone for Castration Resistant Metastatic Prostate Cancer (CTMS# 15-2099)
        Description
        This randomized phase III trial studies enzalutamide to see how well it works compared to enzalutamide, abiraterone, and prednisone in treating patients with castration-resistant metastatic prostate cancer. Androgens can cause the growth of prostate cancer cells. Drugs, such as enzalutamide, abiraterone acetate, and prednisone, may lessen the amount of androgens made by the body.
        Contact
        210-450-5798
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   Hormonal Therapy plus Radiation Therapy as Treatment for Prostate Cancer
        Protocol No.
        HSC20130062H
        Official Title
        RTOG 0924 Androgen Deprivation Therapy and High Dose Radiotherapy With or Without Whole-Pelvic Radiotherapy in Unfavorable Intermediate or Favorable High Risk Prostate Cancer: A Phase III Randomized Trial
        Description
        The purpose of this study is determine which type of anti-hormonal therapy and radiation therapy will result in an improvement in survival in patients with “unfavorable” intermediate risk or “favorable” high risk prostate cancer.  The risk is the possibility or chances of the prostate cancer coming back after being treated. The primary objective is to see which treatment improves the duration of survival. The study will enroll 2,580 participants from many cancer centers in the US. In addition to other conditions for enrollment, men who were diagnosed with prostate cancer within the past 180 days and have no evidence of lymph node involvement by CT scan or MRI within the past 90 days may be enrolled. Men are not eligible for this study if the prostate or testes have been surgically removed. Men who have already been treated with brachytherapy or radiation to the pelvis or hormonal therapy are not enrolled. Patients with a history of other cancers may not be eligible.
        Contact
        210-450-5924
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
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      •   Identification of Protein and Genetic Biomarkers of Prostate Cancer and Risk...
        Protocol No.
        HSC20020380H
        Official Title
        Identification of Protein and Genetic Biomarkers of Prostate Cancer and Risk Factors for Progression of Disease
        Description
        The purpose of this study is to identify genetic variants that predict progression of prostate cancer.
        Contact
        210-567-0178
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
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      •   Impact of Yoga as Complementary Therapy on Quality of Live, Pro-Inflammatory...
        Protocol No.
        HSC20150406H
        Official Title
        Impact of Yoga as Complementary Therapy on Quality of Live, Pro-Inflammatory and Cellular Immune Biomarkers in Patients Undergoing Radical Prostatectomy: A Pilot Randomized Controlled Trial
        Description
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   Prostate MRI as a Screening Tool to Detect Prostate Cancer (Novel Prostate...
        Protocol No.
        HSC20150160H
        Official Title
        Prostate MRI as a Screening Tool to Detect Prostate Cancer (Novel Prostate MRI Technique as a Prostate Cancer Biomarker)
        Description
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   Prostate Wash Epithelial Cell Repository (PWER) (CTRC#12-0070)
        Protocol No.
        HSC20120262H
        Official Title
        Prostate Wash Epithelial Cell Repository (PWER) (CTRC#12-0070)
        Description
        This tissue bank will store epithelial cell samples from prostate biopsies and measure Prostate Specific Antigen (PSA) and Prostate Specific Membrane Antigen (PSMA) in the urine specimens for future scientific research studies.  The stored specimens will be used for research investigating the causes of prostate diseases, the methods for improving diagnosis, and highly aggressive forms from less aggressive forms of prostate cancers.
        Contact
        210-450-0754
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   REASSURE-Radium-223 alpha Emitter Agent in Safety Study in mCRPC popUlation...
        Protocol No.
        HSC20150164H
        Official Title
        REASSURE-Radium-223 alpha Emitter Agent in Safety Study in mCRPC popUlation for long-teRm Evaluation
        Description
        Observational study in the routine clinical practice setting to evaluate the short and long term safety profile of Radium-223 in metastatic castration resistant prostate cancer patients and to evaluate the risk of developing second primary cancers.
        Contact
        210-450-5924
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
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      •   San Antonio Center of Biomarkers of Risk for Prostate Cancer (SABOR)
        Protocol No.
        HSC20000030H
        Official Title
        San Antonio Center of Biomarkers of Risk for Prostate Cancer (SABOR)
        Description
        The San Antonio Center of Biomarkers of Risk for Prostate Cancer (SABOR), is a long-term research study of a large group of men that will help researchers improve the detection of prostate cancer.  The program provides annual PSA (Prostate Specific Antigen) screening at no cost.  Subjects participating in this study will be asked to attend one visit per year for PSA screening and complete annual follow-up phone interviews. Written PSA results will be provided to you, and if you request, to your provider
        Contact
        210-567-0178
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   Texas Cancer Diagnostics Pipeline Consortium, Lab on a Chip
        Protocol No.
        HSC20110483H
        Official Title
        Texas Cancer Diagnostics Pipeline Consortium, Lab on a Chip
        Description
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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        Learn More About This Study

         

      •   Tissue Bank and Data Base for Urologic Diseases
        Protocol No.
        HSC20050234H
        Official Title
        Tissue Bank and Data Base for Urologic Diseases
        Description
        The purpose of this project is to establish a high-quality repository of male and female genitourinary tissue specimens with an associated database of relevant clinical, follow-up and outcome data.  Development and maintenance of a high-quality repository is essential to the conduct of translational research for genitourinary cancer. When possible, specimens will be accrued by freezing fresh excess tissue removed at surgery or biopsy. No extra tissue will be removed during surgery expressly for the repository. Specimens will also be obtained from archival paraffin-embedded tissue. Clinical data will be obtained from tumor registry files, from subjects, or review of medical records.
        Contact
        210-567-0178
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

    •   Soft Tissue

      •   A COG Soft Tissue Sarcoma Diagnosis, Biology and Banking Protocol
        Protocol No.
        HSC19990345X
        Official Title
        A COG Soft Tissue Sarcoma Diagnosis, Biology and Banking Protocol
        Description
        The purpose of this study is to collect and store tumor tissue, blood, and bone marrow samples from patients with soft tissue sarcoma that will be tested in the laboratory. Collecting and storing samples of tumor tissue, blood, and bone marrow from patients to test in the laboratory may help the study of 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

         

      •   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
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    •   Thyroid

      •   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, First-In-Human Study of Escalating Doses of Oral TVB-2640 In...
        Protocol No.
        HSC20140398H
        Official Title
        A Phase 1, First-In-Human Study of Escalating Doses of Oral TVB-2640 In Patient With Solid Tumors
        Description
        This first in human phase 1 study of TVB-2640 is being conducted in patients with advanced stage solid malignant tumors. This research is being done to find out how safe and useful TVB-2640 is for patients who have received previous cancer therapy, and for whom no therapy exists that would be curative or might provide significant benefit. TVB-2640 belongs to a class of drugs called fatty acid synthase inhibitors (FASN inhibitors). This means that they interfere with the body''s (and the tumor''s) ability to use a substance called fatty acid synthase (FASN). Research has shown that some tumors appear to need FASN to keep growing.
        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, Open-Label, Dose Escalation, Multi-Center Study of ACT-PFK-158,...
        Protocol No.
        HSC20150170H
        Official Title
        A Phase 1, Open-Label, Dose Escalation, Multi-Center Study of ACT-PFK-158, 2HCl in Patients with Advanced Solid Tumors (CTMS# 14-2014)
        Description
        ACT-PFK-158 is a novel anti-cancer agent that inhibits glucose uptake in cancer cells. The primary objective of the study will be to determine the maximum tolerated dose (MTD) and to describe any dose limiting toxicity. The secondary objectives of the study will be to determine the safety profile of the drug, to determine the pharmacokinetic profile, to identify any anti-tumor activity, and to determine the pharmacodynamic profile of ACT-PFK-158.
        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, Multicenter, Open-Label Dose Escalation and Expansion Study of...
        Protocol No.
        HSC20150289H
        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
        A first-in-human study using PCA062 in patients with p-CAD positive solid 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 I/II, Open Label, Multicenter Study of the Safety and Efficacy of...
        Protocol No.
        HSC20150421H
        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
        This study is to characterize the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and anti-tumor activity of LAG525 as a single agent and in combination with PDR001 to adult patients with solid tumors. The study consists of a dose escalation phase (Ib) to determine the maximum tolerated dose (MTD) or recommended Phase 2 dose (RP2D) for LAG525 as a single agent and in combination with PDR001, and a dose expansion phase (II) which will characterize treatment of LAG525 as a single agent and in combination with PDR001 at the MTD or RP2D.
        Contact
        210-450-5798
        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

         

      •   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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      •   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

         

      •   Clinical trial to study the safety and efficacy of MBG453 given alone and in...
        Protocol No.
        HSC20150730H
        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
        This is the first study done in humans for a new drug called MBG453.  The purpose of the study is to learn about the safety, tolerability and antitumor activity of MBG453, when it is given IV either alone or in combination with PDR001 in adult patients with advanced cancers.  In addition, blood tests will be done for pharmacokinetics (PK) to see how the body breaks down the drug.
        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

         

      •   Evaluation of the effect of lurbinectedin (PM01183) on electrocardiogram...
        Protocol No.
        HSC20150544H
        Official Title
        Evaluation of the Effect of Lurbinectedin (PM01183) on Cardiac Repolarization (QTc Duration) in Patients with Selected Solid Tumors (CTMS# 15-2072)
        Description
        Study to assess the potential effects of lurbinectedin (PM01183) at a therapeutic dose on the duration of the QTc interval, measured by electrocardiograms (ECGs), to characterize the plasma concentration/QTc relationship, and to explore related ECG parameters in patients with selected cancers.
        Contact
        410-450-5798
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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        Learn More About This Study

         

      •   Exceptional Responders Pilot study: Molecular profiling of tumors from...
        Protocol No.
        HSC20150477X
        Official Title
        NCI 9671, Exceptional Responders Pilot study: Molecular profiling of tumors from cancer patients who are exceptional responders (CTMS# 15-2062)
        Description
        This study looks at the molecular profile of tissue samples from cancer patients who got better with treatment that didn''t work for most other patients with the same disease.
        Contact
        210-450-5798
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   Molecular Analysis for Therapy Choice (NCI-MATCH)
        Protocol No.
        HSC20150719X
        Official Title
        EAY131, Molecular Analysis for Therapy Choice (MATCH) (CTMS# 15-2080)
        Description
        This trial studies how well treatment that is directed by genetic testing works against certain cancers that have gotten worse after at least one standard treatment, or for which no standard treatment exists. Genetic tests look at the unique genes of the tumor cells. Patients with certain genetic abnormalities may benefit more from treatment which targets their tumor''s particular genetic abnormality. Identifying these genetic abnormalities first may help doctors plan better treatment for patients with cancer.
        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

         

      •   Phase I Study to Evaluate the Effect of LDE225 on the Pharmacokinetics of...
        Protocol No.
        HSC20130180H
        Official Title
        A Phase Ib, Multi-Center, Two Parallel Group, Open-Label, Drug-Drug Interaction Study to Assess the Effect of LDE225 on the Pharmacokinetics of Bupropion and Warfarin in Patients with Advanced Solid Tumors (CTRC# 12-0111)
        Description
        This Phase I study is designed to evaluate a possible drug-drug interaction between LDE225 on warfarin and bupropion in patients with advanced cancer.   The primary objective is to determine if LDE225 has a drug interaction with bupropion and warfarin.    The study will enroll approximately 60 patients at several cancer centers in the US. In addition to other conditions for enrollment, eligible patients have advanced cancer that has become worse in spite of therapy and are otherwise in good health. Patients who have a history of brain metastases, bleeding disorders, neuromuscular disorders, infection including hepatitis, or are already on bupropion (Wellbutrin), warfarin (Coumadin), or vitamin K therapy may not be eligible to enroll.
        Contact
        210-450-5798
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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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
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      •   Safety, Tolerability & PK of KX2-361 in Subjects with advanced malignancies...
        Protocol No.
        HSC20150481H
        Official Title
        A Phase I 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
        The purpose of this study is to determine the safety and tolerability of the study drug and to see how much of the study drug enters the bloodstream in patients with advanced cancers that have not responded to conventional therapies. The study is listed on clinicaltrials.gov as NCT02326441.
        Contact
        210-450-5798
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   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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    •   Unknown sites

      •   A Drug-drug Interaction Study to Assess the Effect of Ceritinib on the...
        Protocol No.
        HSC20150693H
        Official Title
        A Phase I, Multi-Center, Open Label, Drug-Drug Interaction Study to Assess the Effect of Ceritinib on the Pharmacokinetics of Warfarin and Midazolam Administered as a Two-Drug Cocktail in Patients with ALK-Positive Advanced Tumors Including Non-Small Cell Lung Cancer (NSCLC) (CTMS# 15-2056)
        Description
        The purpose of this study is to evaluate the potential inhibitory effects of ceritinib on the CYP3A4- and CYP2C9-mediated metabolism of the probe drugs midazolam and warfarin, respectively, when administered simultaneously as a cocktail. The results obtained from this drug interaction study will provide guidance that will enable an update to the ceritinib labeling and will help guide recommendations for administration of co-medications in future clinical trials.
        Contact
        210-450-5798
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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    •   Urinary Bladder

      •   A Phase III, Open-Label, Multicenter, Randomized Study of Atezolizumab...
        Protocol No.
        HSC20150561H
        Official Title
        A Phase III, Open-Label, Multicenter, Randomized Study of Atezolizumab (Anti-PD-L1 Antibody) Versus Observation as Adjuvant Therapy in Patients with PD-L1-Selected, High-Risk Muscle-Invasive Bladder Cancer After Cystectomy (CTMS# 15-2067)
        Description
        Efficacy Objectives The primary efficacy objective for this study is as follows: ¿ To evaluate the efficacy of adjuvant MPDL3280A treatment in patients with PD- L1¿selected muscle invasive bladder cancer (MIBC), as measured by disease-free survival (DFS) The secondary efficacy objectives for this study are as follows: ¿ To evaluate the efficacy of adjuvant MPDL3280A treatment, as measured by overall survival (OS) ¿ To evaluate the efficacy of adjuvant MPDL3280A treatment, as measured by disease-specific survival (DSS) ¿ To evaluate the efficacy of adjuvant MPDL3280A treatment, as measured by distant metastasis-free survival (DMFS) Safety Objectives The safety objectives for this study are as follows: ¿ To evaluate the safety and tolerability of MPDL3280A in the adjuvant setting ¿ To evaluate the incidence of anti-therapeutic antibodies (ATAs) against MPDL3280A and to explore the potential relationship of the immunogenicity response with pharmacokinetics, safety, and efficacy Pharmacokinetic Objective The pharmacokinetic (PK) objective for this study is as follows: ¿ To characterize the pharmacokinetics of MPDL32820A Patient-Reported Outcome Objective The patient-reported outcome (PRO) objective for this study is as follows: ¿ To assess health status as measured by the EuroQol 5-dimension, 5-level version (EQ-5D-5L) questionnaire Exploratory Objective The exploratory objective for this study is as follows: ¿ To assess predictive, prognostic, and pharmacodynamic exploratory biomarkers in archival and/or fresh tumor tissue and blood and their association with disease recurrence Country-Specific Objectives The primary country-specific objective is to evaluate the efficacy of MPDL3280A adjuvant treatment in patients who are residents of China, with PD-L1-selected MIBC after cystectomy, as measured by DFS. There are no country-specific secondary objectives for the population of Chinese patients. Country¿specific exploratory objectives for the Chinese patient population are identical to the secondary efficacy, safety, PK, and PRO objectives specified above.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   Evaluating responses to intravesical BCG administration to patients with...
        Protocol No.
        HSC20140002H
        Official Title
        Evaluating responses to intravesical BCG administration to patients with invasive bladder cancer: Defining mechanisms of mTOR inhibition to boost immunotherapy in bladder cancer and Improving immunotherapy in bladder cancer by targeting immune dysfunction
        Description
        Patients with muscle invasive (≥T1) bladder cancer will be given 3-6 treatments (based on treatment response) intravesically TICE® BCG for intravesical use, is an attenuated, live culture preparation of the Bacillus of Calmette and Guerin (BCG) strain of Mycobacterium bovis. After completion of BCG treatments the patient will undergo a cystectomy. A portion of bladder tumor tissue and lymph nodes will be collected for research purposes during the cystectomy.
        Contact
        210-450-0507
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   Providing access to MPDL3280A for Patients with certain advanced or...
        Protocol No.
        HSC20150570H
        Official Title
        An Open-Label, Multicenter, Expanded Access Program for MPDL3280A in Patients with PD-L1-Positive Locally Advanced or Metastatic Urothelial Bladder Cancer After Failure with Platinum-Containing Chemotherapy (CTMS# 15-2068)
        Description
        This is an expanded access program (EAP) designed to provide MPDL3280A to patients with PD-L1-positive locally advanced or metastatic UBC that has progressed during or following a platinum-containing regimen.
        Contact
        410-450-5798
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   Repository for Bladder and Genitourinary Cancer
        Protocol No.
        HSC20120159H
        Official Title
        Repository for Bladder and Genitourinary Cancer
        Description
        The primary objective of this repository is to collect and store specimens from patients with suspicion of or diagnosed with bladder cancer.  These specimens will be used to determine the local and systemic immune profiles of patients with bladder cancer.
        Contact
        210-450-0507
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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        Learn More About This Study

         

      •   S1314, A Randomized Phase II Study of Co-Expression Extrapolation (COXEN)...
        Protocol No.
        HSC20150027X
        Official Title
        S1314, A Randomized Phase II Study of Co-Expression Extrapolation (COXEN) with Neoadjuvant Chemotherapy for Localized, Muscle-Invasive Bladder Cancer (CTMS# 14-2007)
        Description
        The primary focus of this study is to see if looking at tumor biomarkers using a program called coexpression extrapolation or "COXEN" may predict a patient''s response to chemotherapy before surgery.   The COXEN program will not select a patient''s therapy, but the type of chemotherapy that he/she will receive will be randomly decided. The patient''s response to chemotherapy will be used to test the usefulness of the COXEN program, which is the main goal of this trial. Other potential tests to predict a patient''s response to chemotherapy will also be evaluated. In this study, the patient may receive the treatment in Arm 1 (gemcitabine and cisplatin) or the treatment in Arm 2 [methotrexate, vinblastine, doxorubicin, cisplatin, and filgrastim (or pegfilgrastim)]. There will be about 184 people taking part in this study (92 in each arm).
        Contact
        210-450-5798
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   Standard or Extended Pelvic Lymph Node Surgery as Part of Treatment for...
        Protocol No.
        HSC20110462H
        Official Title
        S1011: A Phase III Surgical Trial to Evaluate the Benefit of a Standard Versus an Extended Pelvic Lymphadenectomy Performed at Time of Radial Cystectomy for Muscle Invasive Urothelial Cancer (IDD# 11-46)
        Description
        This purpose of this study is to determine whether standard surgery to remove the pelvic lymph nodes works the same, better, or worse than extended pelvic lymph node removal when treating patients with surgery for invasive bladder cancer. The primary objective is to compare the difference, if there is any, in the length of time it takes bladder cancer to come back and/or spread to other parts of the body in patients who have been diagnosed with muscle-invasive bladder cancer who are undergoing surgery to remove the entire bladder.  Study participants will have either extended pelvic lymph node removal or standard pelvic lymph node removal. The study will enroll 620 participants from many cancer centers in the US. In addition to other conditions for enrollment, patients have urothelial cancer of the bladder and require surgery for definitive treatment.  Eligible patients have not had prior surgery to remove part of the bladder or any pelvic lymph node s. Eligible patients have not had prior pelvic radiation therapy.
        Contact
        210-567-1995
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   Surveillance for low and low-intermediate-risk non-muscle invasive bladder...
        Protocol No.
        HSC20130177H
        Official Title
        Surveillance for low and low-intermediate-risk non-muscle invasive bladder cancer: A Pilot Study (CTRC#12-0108)
        Description
        This is a two-arm, randomized-controlled pilot study with 2 year duration. The "intervention" refers to surveillance based on the EAU guidelines and the "control" refers to surveillance based on the AUA guidelines. Research methods: Participants who presents with non-muscle invasive bladder cancer and meets the inclusion/exclusion criteria will be given an option to participate in the study. Participants will be enrolled at the Urology Clinics at the University of Texas Health Science Center San Antonio (UTHSCSA) Medical Arts and Research Center (MARC) and South Texas Veterans Health Care System (STVHCS). Non-local site include the University of Texas Southwestern Medical Center (UTSW). The research procedures consist of urine collection, cystoscopy, and patient satisfaction and cost questionnaires. The evaluation will be done by the tumor recurrence and progression of the disease. At various time points throughout the study, urine may be obtained from the patient and banked in the Genitourinary (GU) Tissue Bank. Subjects asked to provide a urine sample(s) will be asked to sign a separate informed consent. The urine is de-identified in the lab per the Health Insurance Portability and Accountability Act (HIPAA) protocol GU Tissue Bank Institutional Review Board (IRB) # 20050234H). Patients will undergo cystoscopy in clinic (standard of care). In the intervention arm, patient surveillance cystoscopy will be performed at 3, 12 months and again at 24 months following the diagnosis of bladder cancer. Patients randomized to the control arm, will undergo surveillance cystoscopy every 3 months for 2 years following the diagnosis of bladder cancer. Because use of cytology is variable among the participating urologist, the utilization of cytology will be at the treating urologist''s discretion as per usual standard care. Study duration will be 2 years from most recent biopsy. Patients will be placed on the surveillance schedule based on the length of time from their last tumor.
        Contact
        210-450-0507
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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  •   Diagnostic

    •   New Cancer Diagnosis Costs and Follow up Patterns for Uninsured vs Insured...
      Protocol No.
      HSC20140018H
      Official Title
      New Cancer Diagnosis Costs and Follow up Patterns for Uninsured vs Insured Patients: A Quality Improvement Project (CTRC#13-0038)
      Description
      The financial cost of cancer is a large burden to the patient and their family, as well as the US Economy. National cancer care expenditures have been rising substantially in the US over the last several years, and accounted for $124.6 billion in medical care expenditures in 2010 [1].  Expenditures associated with cancer can be divided into the initial phase after diagnosis, the continuing phase or monitoring phase, and the last year of life.  Cancers with the largest expenditures in the initial phase of care are female breast, colorectal, lung and prostate [1].  We hope to examine these costs during the initial phase, based on cancer type, insurance status of patient, and further subdivide this category to see where costs are being allocated (i.e. surgery, biopsy, hospital complications, etc.). With this study we also hope to examine the follow up patterns of these patients at University Hospital with newly diagnosed cancer. Several studies have showed differences in timeliness of follow up after abnormal screening mammography, specifically in breast cancer [2-4].  It will be helpful for us to see the follow up rates with the Oncologist based on the various cancer types, as well as the insurance status of the patient.  It has been shown that patient navigator intervention, or phone calls after hospital discharge have improved follow up rates. By collecting patient information at time of admission and following up with for up to four months post discharge, we hope to also improve the time to cancer treatment as well as the rate of follow up with an Oncologist for future patients by identifying patients at higher risk for not following up with recommended providers after discharge from University Hospital.
      Contact
      210-450-5798
      Locations
      UT Health Science Center
      Learn More About This Study

       

  •   Healthy Subjects Needed

    •   Immune Tests in Blood to Study Estrogens and Immune Co-Signal Effects on...
      Protocol No.
      HSC20110472H
      Official Title
      Immune Tests in Blood to Study Estrogens and Immune Co-Signal Effects on Immune Function in Age
      Description
      This study will help understand why immunity differs between men and women and how differences change over time. These data will help understand why women are more prone to autoimmunity, and how to use immune therapy effectively in different age groups and sexes. We will also test specific immune defects seen in mouse models of autoimmunity and cancer to determine if these defects also occur in humans.
      Contact
      450-1439
      Locations
      UT Health Science Center
      Learn More About This Study

       

    •   Canary Prostate Active Surveillance Study (PASS)
      Protocol No.
      HSC20080303H
      Official Title
      Canary Prostate Active Surveillance Study (PASS)
      Description
      All care participants receive is Standard of Care for Active Surveillance.  Research procedures include blood draw every 6 months for serum and plasma, urine collections, prostate tissue collection, Food & Supplement Use Questionnaire and the Health-Related Quality of Life Questionnaire.  Purpose of the PASS is to understand how prostate cancer behaves and to find unique biomarkers (substances in blood, urine or tissue which can indicate the presence of cancer) associated with prostate cancer
      Contact
      210-450-0705
      Locations
      UT Health Science Center
      Learn More About This Study

       

    •   Establishing Community-Based Normal Distributions of Selected Urinary Biomarkers
      Protocol No.
      HSC20110312H
      Official Title
      Establishing Community-Based Normal Distributions of Selected Urinary Biomarkers
      Description
      This research study has been ongoing for 10 years and originally funded by the American Cancer Society.  For the past 3 years it has been funded by the National Cancer institute but with a different focus.  The three goals of this study are: To improve the accuracy of screening tests for the diagnosis of prostate cancer. Identify biomarkers that will predict how aggressive prostate cancer will be.  The tests currently in use for screening for prostate cancer are the PSA blood test and digital rectal examination (DRE) of the prostate.  When either or both of these tests are positive, a tissue biopsy of the prostate is recommended. The third goal is to provide accurate information about how rapidly prostate cancers will become worse.  To accomplish this we will study tissue and blood to identify proteins and genes that are present at high or low levels in prostate cancers that progress slowly versus those that progress more rapidly.
      Contact
      210-567-0178
      Locations
      UT Health Science Center
      Learn More About This Study

       

    •   Symptom Management in Prostate Cancer Survivors: Cancer-Related Fatigue,...
      Protocol No.
      HSC20130013H
      Official Title
      Symptom Management in Prostate Cancer Survivors: Cancer-Related Fatigue, Quality Of Life and Physical Function in Prostate Cancer Survivors
      Description
      This study is designed as a cross sectional, exploratory pilot study to examine the onset and progression of cancer-related fatigue in prostate cancer patients. The goal of this project is to report the effect of fatigue on quality of life and pilot a novel salivary biomarker to measure fatigue. One hundred men,diagnosed with prostate cancer and 200 men without prostate cancer  will be recruited to participate in this study. Detailed medical and medication history will be reviewed to determine if subjects are eligible to participate in this study.All eligible participants will be recruited to participate in this study. All activities will be done during the patients regularly schedule visit with their oncologist at the CTRC. Each subject will sign an informed consent form indicating their willingness to participate afterwhich they will complete a battery of survey instruments and provide a 4 mL saliva sample. Saliva will be used to assess concentrations of a fatigue biomarkers in this study and banked for future research studies. Total length of time for study participation for each subject should be less than 1 hour.
      Contact
      210-567-0362
      Locations
      UT Health Science Center
      Learn More About This Study

       

    •   Viral Reporters to Determine Circulating Tumor Cells Level and Viability in...
      Protocol No.
      HSC20140107H
      Official Title
      Viral Reporters to Determine Circulating Tumor Cells Level and Viability in Patients with Bladder Cancer: A Pilot Study
      Description
      Locations
      UT Health Science Center
      Learn More About This Study

       

  •   Heart, Vascular and Blood

    •   Air Force Villages Aging Study
      Protocol No.
      HSC20080234H
      Official Title
      Air Force Villages Aging Study
      Description
      The purpose of this study is to study protein changes and other biomarkers in the blood that occur with aging. Over the past decade, advances in biomedical science and technology have led to the development of state-of-the-art laboratory techniques for studying proteins in a blood sample. This is called comparative proteomics, where researchers compare hundreds, even thousands, of proteins in the blood for people with different diseases. For example, it has been used to identify cancer in people without having to have a biopsy, which is a needle that is used to get tissue from the inside of the body. Until now, comparative proteomics has only been used in animals to study changes in proteins with aging. We believe that by applying these methods in humans, we can better understand what happens inside the body as a person ages. We believe this information (how the proteins from a blood sample change with age) can help us to find ways in which we can help people age successfully and remain independent into late life.
      Contact
      210-617-5197
      Locations
      UT Health Science Center
      Learn More About This Study