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FindAStudy :: Human Studies @ UTHSCSA
289  Studies 131  Researchers 30  Categories
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  •   Cancers and Other Neoplasms

    •   Bones and joints

      •   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

         

      •   AOST1321 - Phase 2 Study of Denosumab (IND# 127430, NSC# 744010), a RANK...
        Protocol No.
        HSC20160209X
        Official Title
        AOST1321 - Phase 2 Study of Denosumab (IND# 127430, NSC# 744010), a RANK Ligand Antibody, for Recurrent or Refractory Osteosarcoma. An Intergroup NCTN Phase 2 Study
        Description
        Primary Aims 1.1.1 To determine whether denosumab therapy either increases the disease control rate at 4 months in patients with recurrent measurable osteosarcoma as compared to historical COG experience or denosumab therapy produces an objective response rate greater than 5% (Cohort 1). 1.1.2 To determine whether denosumab therapy increases the disease control rate at 12 months in patients with recurrent resected osteosarcoma as compared to historical COG experience (Cohort 2). Secondary Aims 1.2.1 To investigate the pharmacokinetics (PK) and pharmacodynamics (PD) of denosumab in subjects with recurrent osteosarcoma. 1.2.2 To describe the tolerability of denosumab in subjects with recurrent osteosarcoma. 1.2.3 To report the disease control rate and objective response rate for patients with recurrent osteosarcoma limited to bone. 1.2.4 To investigate biological markers potentially associated with response to denosumab in patients with recurrent osteosarcoma.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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    •   Bones and joints| Brain & Nervous System| Kidney| Melanoma, skin| Other Endocrine System | Soft Tissue

      •   GO29665, A PHASE I/II, MULTICENTER, OPEN-LABEL, DOSE-ESCALATION STUDY OF THE...
        Protocol No.
        HSC20160080H
        Official Title
        GO29665, A PHASE I/II, MULTICENTER, OPEN-LABEL, DOSE-ESCALATION STUDY OF THE SAFETY AND PHARMACOKINETICS OF COBIMETINIB IN PEDIATRIC AND YOUNG ADULT PATIENTS WITH PREVIOUSLY TREATED SOLID TUMORS
        Description
        CTRC#15-0005
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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    •   Bones and joints| Soft Tissue

      •   AEWS07B1, A COG Study for Collecting and Banking Ewing Sarcoma Specimens
        Protocol No.
        HSC20090244X
        Official Title
        AEWS07B1, A COG Study for Collecting and Banking Ewing Sarcoma Specimens
        Description
        This research study is collecting and storing samples of tumor tissue, bone marrow, and blood from patients with Ewing sarcoma. Collecting and storing samples of tumor tissue, bone marrow, and blood from patients with cancer to test in the laboratory may help the study of cancer in the future.
        Contact
        210-562-9149
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   AEWS1031 A Phase III Randomized Trial of Adding...
        Protocol No.
        HSC20110367X
        Official Title
        AEWS1031 A Phase III Randomized Trial of Adding Vincristine-topotecan-cyclophosphamide to Standard Chemotherapy in Initial Treatment of Non-metastatic Ewing Sarcoma
        Description
        This randomized phase III trial studies combination chemotherapy to see how well it works compared to combination chemotherapy with topotecan hydrochloride in treating patients with non-metastatic extracranial Ewing sarcoma. Drugs used in chemotherapy, such as vincristine sulfate, doxorubicin hydrochloride, cyclophosphamide, ifosfamide, etoposide, and topotecan hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. It is not yet known whether combination chemotherapy is more effective with topotecan hydrochloride in treating Ewing sarcoma.
        Contact
        210-562-9149
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        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
        To assess the safety, RP2D/MTD, and efficacy of LY500307 in combination with chemoradiation (Temozolomide + RT) for patients with newly diagnosed GBM To evaluate the progression-free survival (PFS) at 12 months for patients treated with LY500307 + chemoradiation (RT+ TMZ) and compare survival outcome with historical controls (TMZ + RT, based on the AVAglio study1)
        Contact
        210-450-5798
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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        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

         

      •   ACNS1221, A Phase II Study For The Treatment Of Non-Metastatic Nodular...
        Protocol No.
        HSC20160159X
        Official Title
        ACNS1221, A Phase II Study For The Treatment Of Non-Metastatic Nodular Desmoplastic Medulloblastoma In Children Less Than 4 Years Of Age
        Description
        1.1 Primary Aims Estimate of the PFS distribution for patients 0-
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   ALTE07C1 Neuropsychological, Social, Emotional, and Behavioral Outcomes in...
        Protocol No.
        HSC20090042X
        Official Title
        ALTE07C1 Neuropsychological, Social, Emotional, and Behavioral Outcomes in Children with Cancer
        Description
        This research trial studies neuropsychological (learning, remembering or thinking) and behavioral testing in younger patients with cancer. Collecting information over time from a series of tests may help doctors develop effective tests to measure neuropsychological and behavioral function of patients with cancer. Parent and child participants complete the COG Standard Neuropsychological and Behavioral Battery testing at 9, 30, and 60 months post-diagnosis in a 1-hour session conducted by a neuropsychologist or psychologist. The Battery consists of tests of intelligence, processing speed/attention, memory, language preference, general developmental progress, attention and behavior/social/emotional function, executive function, adoptive function, and quality of life. Additionally, parents complete a parent-report questionnaire to gather information about patient''s function in terms of attention, memory, executive abilities, and behavioral, social, and emotional adaption.
        Contact
        210-562-9149
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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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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      •   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

         

      •   STING (Study of Immunotherapy in Newly Diagnosed Glioblastoma): A Phase III...
        Protocol No.
        HSC20160158H
        Official Title
        STING (Study of Immunotherapy in Newly Diagnosed Glioblastoma): A Phase III Randomized Double-Blind, Controlled Study of ICT-107 with Maintenance Temozolomide (TMZ) in Newly Diagnosed Glioblastoma Following Resection and Concomitant TMZ Chemoradiotherapy (CTMS# 16-0008)
        Description
        Primary Objective ¿ To determine the OS of subjects treated with ICT-107 and standard of care (RT and TMZ) vs. placebo control and standard of care (RT and TMZ) : Secondary Objectives ¿ To determine the OS of subjects with unmethylated MGMT tumors treated with ICT-107 and standard of care vs. control and standard of care : ¿ To determine the OS of subjects with methylated MGMT tumors treated with ICT-107 and standard of care vs. control and standard of care. ¿ To evaluate progression-free survival (PFS) of subjects treated with ICT-107 and standard of care vs. control and standard of care ¿ To determine the overall safety of ICT-107 vs. control
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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    •   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 Fatty Acid Supplementation on Aromatase in Obese Subjects (CTMS# 15-2100)
        Description
        Primary Objectives Assess the impact of dietary (omega 3 FFA) or pharmacological (ASA) COX-2 inhibitors on: patient serum-induced expression of PGE2 and aromatase by neoplastic mammary epithelial cells circulating levels of pro-inflammatory cytokines (i.e. IL-6, TNF-¿, IGF-1), steroids (i.e. estrogen and testosterone) and lipids (omega-6 and omega-3 PUFAs) Secondary Objectives Correlation for body mass index impact on response to COX2 inhibition.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   A Phase 2 Study of Poziotinib in Patients with HER2-Positive Metastatic...
        Protocol No.
        HSC20160122H
        Official Title
        A Phase 2 Study of Poziotinib in Patients with HER2-Positive Metastatic Breast Cancer (MBC) Who Have Received Prior HER2 Regimens for MBC (CTMS# 16-0003)
        Description
        Primary Objective To evaluate the Objective Response Rate (ORR) of poziotinib in patients with HER2-positive metastatic breast cancer (MBC) Secondary Objectives To assess the safety and tolerability of poziotinib in patients with HER2-positive MBC To evaluate other efficacy variables of poziotinib in patients with HER2-positive MBC, including the following: Progression-Free Survival (PFS) Disease Control Rate (DCR) Overall Survival (OS) Time to Progression (TTP)
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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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 Postmenopausal Women with Advanced Estrogen Receptor Positive and HER2-Negative Breast Cancer (CTMS #15-2042)
        Description
        The primary objective is to determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of RAD1901 in patients with advanced ER+HER2- breast cancer The secondary objectives of this study are: To assess the safety and tolerability of RAD1901 To evaluate the pharmacokinetics (PK) of RAD1901 To evaluate the preliminary anti-tumor effect of RAD1901 The exploratory objectives of this study are: To explore the relationship between ER gene expression in circulating tumor cells (CTCs) and clinical response To explore the relationship between ER gene expression in tumor biopsies and clinical response (safety expansion cohort only)
        Contact
        210-450-5798
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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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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      •   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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        Learn More About This Study

         

      •   Aging mammary stem cells and breast cancer prevention (CTMS# 15-2096)
        Protocol No.
        HSC20150556H
        Official Title
        Aging mammary stem cells and breast cancer prevention (CTMS# 15-2096)
        Description
        To examine whether aging increases human mammary stem/progenitor cells (MaSC) with aberrant phenotypes and if rapamycin can reduce malignant markers and MaSC number in surgical specimens.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   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
        Primary Objectives For the Phase 1b part ¿ to determine safety and tolerability of eribulin mesylate in combination with pembrolizumab in subjects with metastatic triple-negative breast cancer previously treated with 0 to 2 lines of chemotherapy in the metastatic setting. For the Phase 2 part ¿ to evaluate objective response rate, based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, of eribulin mesylate in combination with pembrolizumab in subjects with metastatic triple-negative breast cancer previously treated with 0 to 2 lines of chemotherapy in the metastatic setting. Secondary Objectives To evaluate Progression-Free Survival (PFS) To evaluate Overall Survival (OS) To evaluate Duration of Response (DOR) To evaluate efficacy in a subset defined by PD-L1 (programmed death receptor-ligand 1) expression. To evaluate the safety and tolerability Exploratory Objectives To evaluate Clinical Benefit Rate (CBR) To evaluate exposure-response relationship To explore potential effects of pembrolizumab co-administration on the pharmacokinetics (PK) of eribulin mesylate To explore ORR, PFS, DOR, and CBR using the immune-related response criteria in solid tumors (irRECIST)
        Contact
        410-450-5798
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
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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
        Primary Objective To determine whether the addition of carboplatin to an adjuvant chemotherapy regimen of doxorubicin/cyclophosphamide followed by paclitaxel will improve the invasive disease-free survival (IDFS) compared to doxorubicin/cyclophosphamide followed by paclitaxel when administered to patients with operable node-positive or high-risk node-negative triple-negative breast cancer. Secondary Objectives To determine whether the addition of carboplatin to an adjuvant chemotherapy regimen of doxorubicin/cyclophosphamide followed by paclitaxel will improve the overall survival (OS) compared to doxorubicin/cyclophosphamide followed by paclitaxel when administered to patients with operable node-positive or high-risk node-negative triple-negative breast cancer. To determine whether the addition of carboplatin to an adjuvant chemotherapy regimen of doxorubicin/cyclophosphamide followed by paclitaxel will improve the breast cancer-free survival (BCFS) compared to doxorubicin/cyclophosphamide followed by paclitaxel when administered to patients with operable node-positive or high-risk node-negative triple-negative breast cancer. To determine whether the addition of carboplatin to an adjuvant chemotherapy regimen of doxorubicin/cyclophosphamide followed by paclitaxel will improve the recurrence-free interval (RFI) compared to doxorubicin/cyclophosphamide followed by paclitaxel when administered to patients with operable node-positive or high-risk node-negative triple-negative breast cancer. To determine whether the addition of carboplatin to an adjuvant chemotherapy regimen of doxorubicin/cyclophosphamide followed by paclitaxel will improve the distant recurrence-free interval (DRFI) compared to doxorubicin/cyclophosphamide followed by paclitaxel when administered to patients with operable node-positive or high-risk node-negative triple-negative breast cancer. To determine the toxicity of doxorubicin/cyclophosphamide followed by paclitaxel administered concurrently with carboplatin compared to the toxicity of doxorubicin/cyclophosphamide followed by paclitaxel alone. To determine if germline BRCA status is associated with benefit in IDFS or OS from the addition of carboplatin to an adjuvant chemotherapy regimen of doxorubicin/cyclophosphamide followed by paclitaxel in patients with operable node-positive or high-risk node-negative triple-negative breast cancer. To determine if the addition of carboplatin will improve the RFI among the homologous recombination (HR) deficient patients as determined by the homologous recombination deficiency (HRD) score. To determine whether the efficacy of carboplatin on RFI in HR-deficient patients differs from that in patients who are not HR-deficient. To collect tissue and blood samples at several occasions for future biomarkers development in predicting risk of breast cancer recurrence in patients with operable node-positive or high-risk node-negative triple-negative breast cancer treated with doxorubicin/cyclophosphamide followed by paclitaxel with or without carboplatin and predicting benefit from the addition of carboplatin among these patients.
        Contact
        410-450-5798
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   Evaluating the effectiveness of the medQuantive PBC Patient Education System...
        Protocol No.
        HSC20160390H
        Official Title
        Evaluating the effectiveness of the medQuantive PBC Patient Education System For the first time in breast cancer patients and their physicians (CTMS# 16-0077)
        Description
        This study will test the primary hypothesis that the medQuantive PBC Patient Education System (PES) can be successfully delivered to patients prior to their first breast cancer appointment in a tertiary care cancer clinic, increase patient satisfaction with their specialized cancer care, and improve their understanding of their breast cancer diagnosis. We will also test the secondary hypotheses that the PES will decrease patient anxiety and depression surrounding cancer diagnosis, and positively contribute to the time efficiency of the first appointment.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   NSABP B-51 A Randomized Phase III Clinical Trial Evaluating Post-Mastectomy...
        Protocol No.
        HSC20150021X
        Official Title
        NSABP B-51 A Randomized Phase III Clinical Trial Evaluating Post-Mastectomy Chestwall and Regional Nodal XRT and Post-Lumpectomy Regional Nodal XRT in Patients with Positive Axillary Nodes Before Neoadjuvant 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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      •   PUMA-NER-1301: A Study of Neratinib Plus Capecitabine Versus Lapatinib Plus...
        Protocol No.
        HSC20150443H
        Official Title
        PUMA-NER-1301: 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
        Primary: The co-primary objectives of this study are to compare independently adjudicated progression-free survival (PFS) following treatment with neratinib plus capecitabine versus lapatinib plus capecitabine in patients with HER2-positive (HER2+) MBC who have received two or more prior HER2-directed regimens in the metastatic setting. to compare overall survival (OS) following treatment with neratinib plus capecitabine versus lapatinib plus capecitabine in this population. Secondary: The secondary objectives of this study are to compare between the two treatment groups: Investigator-assessed PFS. Objective response rate (ORR), duration of response (DOR) and clinical benefit (CBR) (complete response [CR] or partial response [PR] or stable disease [SD] ¿24 weeks). Time to intervention for symptomatic metastatic central nervous system (CNS) disease. Safety (adverse events [AEs], serious adverse events [SAEs]). Health outcomes assessments. Exploratory: The exploratory objective of this study is: To assess the population pharmacokinetics (PK) of neratinib when administered in combination with capecitabine.
        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

         

      •   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
        Efficacy Objectives The primary efficacy objective for this study is to evaluate the safety and tolerability of the following combination treatments administered q3w to patients with HER2-positive MBC or operable LABC or inflammatory EBC: ¿ Atezolizumab in combination with trastuzumab and pertuzumab ¿ Atezolizumab in combination with trastuzumab emtansine Pharmacokinetic Objectives The pharmacokinetic (PK) objectives for this study are as follows: ¿ To characterize the pharmacokinetics of atezolizumab, trastuzumab, and pertuzumab when administered concurrently in treatment-naive patients with both metastatic and operable LABC or inflammatory EBC ¿ To characterize the pharmacokinetics of atezolizumab and trastuzumab emtansine when administered concurrently in treatment-naive patients with both metastatic and operable LABC or inflammatory EBC Exploratory Clinical Activity Objectives The exploratory clinical activity objectives of this study for patients in the safety-evaluation cohorts are as follows: ¿ To assess the clinical activity of atezolizumab when administered with either trastuzumab and pertuzumab or trastuzumab emtansine in patients with MBC, as measured by PFS, ORR, and duration of objective response (DOR) among patients with an OR per investigator assessment using RECIST v1.1 ¿ To assess the clinical activity of atezolizumab when administered with either trastuzumab and pertuzumab or trastuzumab emtansine in patients with MBC, as measured by PFS, ORR, and DOR per immune-modified RECIST To assess the clinical activity of atezolizumab when administered with either trastuzumab and pertuzumab or trastuzumab emtansine in patients with operable LABC or inflammatory EBC as measured by the rate of pathologic complete response (pCR; i.e., ypT0/Tis ypN0 in the current AJCC staging system) at breast surgery following completion of neoadjuvant systemic therapy. Exploratory Biomarker Objectives The exploratory objectives for this study are as follows: ¿ To identify candidate biomarkers that correlate with safety signals ¿ To assess changes in expression levels of biomarker or biomarker panels during and after investigational treatment with atezolizumab, trastuzumab, and pertuzumab, and atezolizumab plus trastuzumab emtansine
        Contact
        210-450-5798
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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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
        Primary Objectives: The primary objective is to determine whether treatment with alpelisib in combination with fulvestrant prolongs PFS compared to treatment with placebo in combination with fulvestrant based on local radiological assessment for each of the following cohorts i) patients with PIK3CA mutant status ii) patients with PIK3CA non-mutant status The key secondary objective is to determine whether treatment with alpelisib in combination with fulvestrant prolongs overall survival (OS) compared to treatment with placebo in combination with fulvestrant for each of the following cohorts i) patients with PIK3CA mutant status ii) patients with PIK3CA non-mutant status Secondary Objectives The primary objective is to determine whether treatment with alpelisib in combination with fulvestrant prolongs PFS compared to treatment with placebo in combination with fulvestrant based on local radiological assessment for each of the following cohorts i) patients with PIK3CA mutant status ii) patients with PIK3CA non-mutant status The key secondary objective is to determine whether treatment with alpelisib in combination with fulvestrant prolongs overall survival (OS) compared to treatment with placebo in combination with fulvestrant for each of the following cohorts i) patients with PIK3CA mutant status ii) patients with PIK3CA non-mutant status Secondary Objectives To evaluate the two treatment arms and cohorts of interest with respect to centrally assessed PFS To evaluate the two treatment arms and cohorts of interest with respect to overall response rate (ORR), clinical benefit rate. To evaluate the two treatment arms and cohorts of interest with respect to time to deterioration of Eastern Cooperative Oncology Group (ECOG) performance status To evaluate the safety and tolerability of alpelisib in combination with fulvestrant To evaluate change in global health status/Quality of Life (QOL) in the two treatment arms and cohorts of interest To characterize the pharmacokinetics (PK) of fulvestrant and alpelisib when given in combination with fulvestrant. To evaluate the association between PIK3CA mutation status as measured in ctDNA at baseline with PFS upon treatment with alpelisib.
        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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    •   Colon

      •   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 #2015)
        Description
        To determine the clinical efficacy with progression-free survival (PFS-1) of the combination of VOR plus HCQ when compared to RGF in treatment-refractory mCRC.
        Contact
        210-450-5798
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
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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
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   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
        Primary Objectives 1. To determine the RP2D of BAX69 in combination with 5-FU/LV or panitumumab (Part 1) 2. To compare progression-free survival (PFS) between BAX69 in combination with 5-FU/LV for subjects with KRAS or NRAS mut or in combination with panitumumab for subjects with KRAS and NRAS wt tumor versus SoC (Investigator choice) as third or fourth treatment line (Part 2) Secondary Objectives 1. To assess the safety and tolerability of BAX69 in combination with 5-FU/LV or panitumumab 2. To compare overall response rate (ORR) and clinical benefit rate (CBR) in subjects treated at RP2D with BAX69 in combination with 5-FU/LV or panitumumab versus SoC (investigator choice) as third or fourth treatment line 3. To compare OS of subjects who received BAX69 in combination with 5-FU/LV or panitumumab versus SoC (investigator choice) as third or fourth treatment line 4. To characterize the PK of BAX69 in combination with 5-FU/LV or panitumumab 5. To compare Quality of Life (QoL) of subjects who received BAX69 in combination with 5-FU/LV or panitumumab versus SoC (investigator choice) as third or fourth treatment line
        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

      •   A Phase 1 Pharmacokinetic - Pharmacodynamic Study of Avelumab (MSB00100718C)...
        Protocol No.
        HSC20160061H
        Official Title
        A Phase 1 Pharmacokinetic - Pharmacodynamic Study of Avelumab (MSB00100718C) in Patients with Previously Treated Advanced Stage Classical Hodgkins Lymphoma (CTMS# 15-2149)
        Description
        Primary Objective To characterize the pharmacokinetics (PK) of different dosing regimens of avelumab and its relation to target occupancy (TO) in peripheral blood of patients with classical Hodgkin¿s Lymphoma (cHL). Secondary Objectives To evaluate the overall safety and tolerability of different dosing regimens of avelumab. To assess the immunogenicity of different dosing regimens of avelumab. To evaluate the effect of different dosing regimens of avelumab on pharmacodynamic biomarkers of tumor immunophenotype and anti-tumor immune response. To evaluate the anti-tumor activity of avelumab in patients with cHL. Exploratory Objectives To characterize the association of TO and tumor immunophenotype with tumor responses. To explore the effects of different dosing regimens of avelumab on the abundance of T cell clones and the diversity of the T cell repertoire in tumor biopsy tissue and peripheral blood. To explore the effects of different dosing regimens of avelumab on the prevalence and diversity of tumor antigenic epitopes in tumor biopsy tissue. To measure the expression of PD-L1/PD-L2 in tumor biopsy tissue and in tumor infiltrating macrophages. Measure time course of potential plasma biomarkers. ¿ To collect exploratory biomarker/genomics samples for biobanking.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   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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    •   Hodgkin's Lymphoma| Multiple sites| Non-Hodgkin's Lymphoma

      •   AN EARLY-PHASE, MULTICENTER, OPEN-LABEL STUDY OF THE SAFETY AND...
        Protocol No.
        HSC20150549H
        Official Title
        AN EARLY-PHASE, MULTICENTER, OPEN-LABEL STUDY OF THE SAFETY AND PHARMACOKINETICS OF ATEZOLIZUMAB (MPDL3280A) IN PEDIATRIC AND YOUNG ADULT PATIENTS WITH PREVIOUSLY TREATED SOLID TUMORS
        Description
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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    •   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 (CTRC# 15-2052
        Description
        Primary objectives: Evaluate the safety and tolerability and determine the maximum tolerated dose (MTD) of ADCT-301 in patients with relapsed/refractory lymphoma Determine the recommended dose of ADCT-301 for Part 2 (expansion). Secondary objectives: Evaluate the activity of ADCT-301 measured by overall response rate, duration of response, progression-free survival, and overall survival. Characterize the pharmacokinetic (PK) profile of HuMax-TAC (total antibody; drug-to-antibody ratio [DAR] ¿0), PBD-conjugated HuMax-TAC (DAR ¿1), and free warhead SG3199. Evaluate anti-drug antibodies (ADAs) in blood before, during, and after treatment with ADCT-301. Exploratory objectives: Evaluate the pharmacodynamic (PD) profile of ADCT-301 as measured by correlation between clinical activity and CD25 expression level in tumor tissue, soluble CD25, and DNA cross-links in blood. Evaluate the PK and PD relationship of ADCT-301. Evaluate the change in white blood cell populations (such as activated T -cells) before, during, and after treatment with ADCT-301 (Part 2 only). Explore the ADCT-301 and free warhead SG3199 concentration-QTc interval relationship.
        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

         

      •   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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    •   Kidney

      •   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
        View all Cancer Therapy & Research Center clinical trials
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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

      •   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
        View all Cancer Therapy & Research Center clinical trials
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      •   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
        View all Cancer Therapy & Research Center clinical trials
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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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      •   Hepatocellular Carcinoma Tissue Acquisition
        Protocol No.
        HSC20150834H
        Official Title
        Hepatocellular Carcinoma Tissue Acquisition
        Description
        Obtain biopsy specimens from Hispanic patients with liver cancer when they come to Radiology clinic for ablation therapy
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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    •   Lung

      •   A Phase III, Open-Label, Randomized Study of Atezolizumab (Anti-PD-L1...
        Protocol No.
        HSC20150706H
        Official Title
        A Phase III, Open-Label, Randomized Study of Atezolizumab (Anti-PD-L1 Antibody) in Combination with Carboplatin + Paclitaxel with or without Bevacizumab Compared with Carboplatin + Paclitaxel + Bevacizumab in Chemotherapy-Naive Patients with Stage IV Non-Squamous Non-Small Cell Lung Cancer (CTMS# 15-2113)
        Description
        Primary Efficacy Objectives The co-primary objectives of this study are: ¿ To evaluate the efficacy of MPDL3280A in the ITT population as measured by investigator-assessed PFS according to RECIST v1.1 in each of the following two treatment comparisons: MPDL3280A + carboplatin + paclitaxel vs. carboplatin + paclitaxel + bevacizumab MPDL3280A + carboplatin + paclitaxel + bevacizumab vs. carboplatin + paclitaxel + bevacizumab To evaluate the efficacy of MPDL3280A in the PD-L1¿selected population as measured by investigator-assessed PFS according to RECIST v1.1 in each of the two treatment comparisons described above
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   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
        Primary objective: To demonstrate the antitumor activity of INC280, as measured by overall response rate (ORR) by Blinded Independent Review Committee (BIRC) assessment, by cohort Key secondary objective: To evaluate duration of response (DOR) as assessed by BIRC, by cohort Secondary Objectives Objective 1: To evaluate ORR and DOR by investigator assessment, by cohort Objective 2: To evaluate time to response (TTR), disease control rate (DCR) and progression-free survival (PFS) by investigator and by BIRC assessment, by cohort Objective 3: To evaluate overall survival (OS), by cohort Objective 4: To evaluate INC280 safety profile as monotherapy in NSCLC patients who have received one or two prior lines of systemic therapy in advanced/metastatic setting Objective 5: To characterize the 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

         

      •   S1400, Phase II/III Biomarker-Driven Master Protocol for Second Line Therapy...
        Protocol No.
        HSC20150302X
        Official Title
        S1400, Phase II/III Biomarker-Driven Master Protocol for Second Line Therapy of Squamous Cell Lung Cancer (Screening Step) Lung-MAP Sub-Study (CTRC #14-0036)
        Description
        The overarching goal for this protocol is to establish a National Clinical Trials Network (NCTN) mechanism for genomically screening large but homogeneous cancer populations and subsequently assigning and accruing simultaneously to a multi-sub­ study Master Protocol. Biomarker-driven sub-studies in this protocol will compare new targeted therapy (TT) or targeted therapy combinations (TTC) to standard of care (SoC) therapy based on designated therapeutic biomarker-drug combinations, with the ultimate goal being approval of 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 (NMT) to SoC also with the goal of approval. We hypothesize that this Master Protocol mechanism will yield definable and measurable efficiencies in terms of improving genomic screening of cancer patients for clinical trial entry, and improved time lines for drug-biomarker testing allowing for inclusion of the maximum numbers of otherwise eligible patients in comparison with currently employed single screen-single trial approaches.
        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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      •   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-Naive Patients with Advanced, EGFR Mutation Positive Non-Small Cell Lung Cancer (NSCLC) (CTMS #15-2060)
        Description
        Objective: The purpose of this study is to compare the effects, good and/or bad, of using afatinib along with cetuximab to using afatinib alone in participants with non-small cell lung cancer which has an EGFR positive genetic mutation. The addition of cetuximab to the usual afatinib could shrink the cancer, but it could also cause side effects. The study will be considered positive if the study approach increases life by eight months or more compared to the usual approach.
        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

      •   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
        Learn More About This Study

         

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

         

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

         

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

         

    •   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
        Phase 1a Objectives: Primary: The primary phase 1a objective is to determine the dose-limiting toxicities (DLTs) and the maximum tolerated dose (MTD), if present, for oral administration of ACY-241 as monotherapy in the patient population. Secondary: The secondary phase 1a objectives are to: Characterize the safety of ACY-241 mono therapy administered once daily (qd) or twice daily (bid) for 21 consecutive days in a single 4-week treatment cycle in the patient population. Determine the single- and multiple-dose pharmacokinetics (PK) of ACY-241 monotherapy in the patient population. Characterize metabolites of ACY-241 in blood samples from the patient population. Evaluate the pharmacodynamics of ACY-241 mono therapy in the patient population specifically, the levels of acetylated tubulin and acetylated histones. Assess the exposure-response relationship of ACY-241monotherapy and potential biomarkers of response in the patient population. Exploratory: The exploratory objective is to evaluate an additional pharmacodynamic measurement of histone deacetylase (HDAC) 1 and 2 inhibition. Phase 1b Objectives: Primary: The primary phase 1b objective is to evaluate the DLT and MTD, if present, and to determine recommended phase 2 dose and schedule of ACY-241 for oral administration in combination therapy with pomalidomide and low-dose dexamethasone for further clinical investigation in the patient population. Secondary: The secondary phase 1b objectives are to: Characterize the safety of ACY-241 administered in combination therapy with pomalidomide and low-dose dexamethasone in the patient population. Determine the preliminary antitumor activity of ACY-241 administered in combination therapy with pomalidomide and low-dose dexamethasone in the patient population. Determine the single- and multiple-dose PK of ACY-241 administered in combination therapy with pomalidomide and low-dose dexamethasone in the patient population. Determine the single- and multiple-dose PK of pomalidomide administered in combination therapy with ACY-241 and low-dose dexamethasone in the patient population. Determine the single- and multiple-dose PK of low-dose dexamethasone administered in combination therapy with ACY-241 and pomalidomide in the patient population. Evaluate the pharmacodynamics of ACY-241 administered in combination with pomalidomide and low-dose dexamethasone in the patient population. Assess the exposure-response relationship of ACY-241 administered in combination therapy with pomalidomide and low-dose dexamethasone and potential biomarkers of response in the patient population.
        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 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
        Primary Objective The primary objective is to compare the efficacy of daratumumab when combined with lenalidomide and dexamethasone (DRd) to that of lenalidomide and dexamethasone (Rd), in terms of progression-free survival (PFS) in subjects with newly diagnosed myeloma who are not candidates for high dose chemotherapy and autologous stem cell transplant. Secondary Objectives The secondary objectives are: To evaluate clinical outcomes including: Time to disease progression (TTP) Stringent CR (sCR) rate CR rate PFS2 (defined as time from randomization to progression on the next line of therapy or death, whichever comes first) Time to next treatment Overall response rate (CR + partial response [PR] rate) Proportion of subjects who achieve very good partial response (VGPR) or better Duration of response Overall survival To assess the safety and tolerability of daratumumab when administered in combination with Rd. To assess the pharmacokinetics of daratumumab in combination with Rd. To assess the immunogenicity of daratumumab. To evaluate treatment effects on patient reported outcomes and heath economic/resource utilization To assess the minimal residual disease (MRD) negative rate after treatment To evaluate the clinical efficacy of daratumumab combination with Rd in high-risk molecular subgroups Exploratory Objectives To explore biomarkers predictive of response or resistance to therapy
        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

         

      •   Bortezomib or Carfilzomib with Lenalidomide & Dexamethasone in patients with...
        Protocol No.
        HSC20150407X
        Official Title
        E1A11, Randomized Phase III Trial of Bortezomib, 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
        Primary Objective To compare the overall survival between two strategies of lenalidomide maintenance following induction with a proteasome inhibitor¿IMiD combination: limited duration of maintenance (24 months) versus indefinite maintenance therapy until disease progression. Secondary Objectives To compare the progression-free survival between two strategies of lenalidomide maintenance following induction with a proteasome inhibitor¿IMiD combination: limited duration of maintenance (24 months) or indefinite maintenance therapy until disease progression. To compare the progression-free survival between VRd and CRd induction followed by lenalidomide maintenance in patients with newly diagnosed symptomatic multiple myeloma. To compare induction rates of response between VRd and CRd arms. To evaluate the time to progression, duration of response and overall survival between VRd and CRd induction therapy. To compare induction rates of toxicity between VRd and CRd arms. To evaluate toxicity during lenalidomide maintenance. Quality of Life Objectives To compare the short and long-term health-related quality of life impact between two strategies of lenalidomide maintenance following induction with a proteasome inhibitor¿IMiD combination: limited duration of maintenance (24 months) versus indefinite maintenance therapy until disease progression. To compare the impact on health-related quality of life between VRd and CRd induction therapy. To evaluate the association between early induction response and change in health-related quality of life. To describe changes in health-related quality of life during the induction, active maintenance and observation phases. To evaluate correlation between treatment adherence during maintenance and health-related quality of life. Correlative Laboratory Study Objectives To compare induction minimal residual disease negativity rates between VRd and CRd arms. To compare minimal residual disease negativity rates between two strategies of lenalidomide maintenance following induction with a proteasome inhibitor¿IMiD combination: limited duration of maintenance (24 months) versus indefinite maintenance therapy until disease progression. To describe changes in minimal residual disease during the induction and active maintenance phases and explore association with response.
        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

         

      •   MATCH Treatment Subprotocol G: Phase II Study of Crizotinib in Patients with...
        Protocol No.
        HSC20150751X
        Official Title
        MATCH Treatment Subprotocol G: Phase II Study of Crizotinib in Patients with ROS1 Translocations (other than patients with nonsmall cell lung cancer) (CTMS# 15-2082)
        Description
        Primary Objective To evaluate the proportion of patients with objective response (OR) to targeted study agent(s) in patients with advanced refractory cancers/lymphomas. Secondary Objectives To evaluate the proportion of patients alive and progression free at 6 months of treatment with targeted study agent in patients with advanced refractory cancers/lymphomas. To evaluate time until death or disease progression. To identify potential predictive biomarkers beyond the genomic alteration by which treatment is assigned or resistance mechanisms using additional genomic, RNA and protein-based assessment platforms.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

    •   Myeloid and Monocytic Leukemia

      •   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

         

    •   Non-Hodgkin's Lymphoma

      •   A PHASE 3, RANDOMIZED, DOUBLE-BLIND STUDY OF PF-05280586 VERSUS RITUXIMAB...
        Protocol No.
        HSC20160185H
        Official Title
        A PHASE 3, RANDOMIZED, DOUBLE-BLIND STUDY OF PF-05280586 VERSUS RITUXIMAB FOR THE FIRST-LINE TREATMENT OF PATIENTS WITH CD20-POSITIVE, LOW TUMOR BURDEN, FOLLICULAR LYMPHOMA
        Description
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

    •   Other Digestive Organ| Stomach

      •   A Phase III open-label, multicenter trial of maintenance therapy with...
        Protocol No.
        HSC20160157H
        Official Title
        A Phase III open-label, multicenter trial of maintenance therapy with avelumab (MSB0010718C) versus continuation of first-line chemotherapy in subjects with unresectable, locally advanced or metastatic, adenocarcinoma of the stomach, or of the gastro-esophageal junction (CTMS# 16-0005)
        Description
        Primary objective: The primary objective of this trial is to demonstrate superiority of maintenance therapy with avelumab versus continuation of first-line chemotherapy with regard to Overall Survival (OS) in subjects who have not progressed on first-line chemotherapy Secondary objectives: To demonstrate superiority of maintenance therapy with avelumab versus continuation of first-line chemotherapy with regard to Progression-free Survival (PFS) as per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1). To demonstrate superiority of maintenance therapy with avelumab versus continuation of first-line chemotherapy with regard to objective response rate (ORR) as per RECIST v1.1. To compare the subject-reported outcomes / quality of life of subjects when treated with avelumab versus continuation of first-line chemotherapy as assessed by the European Quality of Life (EuroQOL) 5-dimensions and 5-levels questionnaire (EQ-5D-5L), and the European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 and module QLQ-STO22 To determine the safety and tolerability of avelumab Exploratory objectives To evaluate tumor shrinkage in target lesions at each time point from baseline To evaluate PD-L1 expression levels in tumor cells and cells of the tumor microenvironment (for example, infiltrating lymphocytes) as candidate predictive biomarker with their relation to selected clinical response parameters To determine duration of response To determine time to response To characterize population pharmacokinetics (PK) of avelumab and individual drug exposures based on sparse PK sampling To characterize exposure response (exposure safety and exposure efficacy) for avelumab with respect to selected safety and efficacy endpoints To explore molecular, cellular, and soluble markers (for example, but not limited to changes in gene expression profiles, microsatellite instability status, tumor-infiltrating lymphocytes and cytokine levels) in peripheral blood and/or tumor tissue that may be relevant to the mechanism of action of, or response/resistance to avelumab To characterize the immunogenicity of avelumab.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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    •   Other Endocrine System

    •   Other Hematopoietic

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

         

    •   Pancreas

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

         

      •   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
        1. To determine the safety and Dose-limiting toxicities (DLTs) of Reolysin and chemotherapy (gemcitabine or irinotecan or 5FU) in combination with pembrolizumab in patients with advanced pancreatic adenocarcinoma who have progressed after ( or did not tolerate) first line treatment. 2.To determine the overall response rate (ORR), and progression-free survival (PFS) by immune-related response criteria [4], as well as overall survival (OS). 3. To determine the effects of Reolysin and pembrolizumab when administered in combination as determined by analysis of pre- and post-treatment biopsies and blood-based immune markers.
        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

      •   An Interventional Study to Reduce Folate Levels in Men on Active...
        Protocol No.
        HSC20160340H
        Official Title
        An Interventional Study to Reduce Folate Levels in Men on Active Surveillance for Prostate Cancer
        Description
        Ascertain the impact of a low folate (folic acid) enriched diet- a reverse dietary intervention- on prostate cancer prevention and progression.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   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
        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
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   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
        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
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   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
        Learn More About This Study

         

      •   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
        Learn More About This Study

         

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

         

      •   Improving the Detection of Prostate Cancer in Men with Low Serum PSA
        Protocol No.
        HSC20160310H
        Official Title
        Improving the Detection of Prostate Cancer in Men with Low Serum PSA
        Description
        Utilize biomarkers and imaging to identify men who have prostate cancer but low PSA levels.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

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

         

      •   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
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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
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      •   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
        CTRC Clinical Trials Website
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      •   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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      •   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
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    •   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
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    •   Thyroid

      •   A Dose Regimen-Finding Study to Evaluate the Safety, Tolerability,...
        Protocol No.
        HSC20160087H
        Official Title
        A Dose Regimen-Finding Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Activity of Oraxol in Subjects with Advanced Malignancies (CTMS# 15-2137)
        Description
        Primary Objective To determine the maximum tolerated dose (MTD) and dosing regimen of Oraxol in subjects with advanced malignancies Secondary Objectives To determine the recommended Phase 2 dose of paclitaxel as Oraxol To determine the safety and tolerability of paclitaxel as Oraxol To characterize the pharmacokinetic (PK) profile of paclitaxel as Oraxol To evaluate the tumor response
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   A 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
        Primary Objective To evaluate the inhibitory effect of ceritinib on the pharmacokinetics of a drug cocktail containing midazolam and warfarin in patients with ALK-positive advanced tumors including NSCLC. Secondary Objectives To assess the PK, safety and tolerability of ceritinib in patients with ALK-positive advanced tumors including NSCLC. To evaluate preliminary evidence of antitumor activity of ceritinib in patients with ALK-positive advanced tumors including NSCLC.
        Contact
        210-450-5798
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   A Phase 1 Study of CBL0137 in Patients with Metastatic or Unresectable...
        Protocol No.
        HSC20130328H
        Official Title
        A Phase 1 Trial of CBL0137 In patients With Metastatic or Unresectable Advanced Solid Neoplasms or Refractory Lymphomas (CTRC# 13-0031)
        Description
        This Phase 1 study is designed to determine the best dose of CBL0137 to use when treating patients with metastatic or unresectable advanced solid tumors or lymphoma. The study will enroll up to 48 patients from at least 2 cancer centers in the US. In addition to other conditions for enrollment, eligible patients have cancer that has not improved or has come back after prior treatment and are otherwise in good health. Patients who have a history of active infection, cancer involving the central nervous system, a particular EKG abnormality or other serious medical conditions may not be eligible to enroll.
        Contact
        210-450-5798
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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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
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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
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      •   A Phase 1a/1b Study of FPA008 in Combination with Nivolumab in Patients with...
        Protocol No.
        HSC20150835H
        Official Title
        A Phase 1a/1b Study of FPA008 in Combination with Nivolumab in Patients with Selected Advanced Cancers (CTMS# 15-2117)
        Description
        Phase 1a Objectives Primary ¿ To assess the safety and tolerability of FPA008 as monotherapy ¿ To assess the safety and tolerability of FPA008 in combination with nivolumab ¿ To determine the recommended dose (RD) of FPA008 in combination with a fixed dose of nivolumab Secondary ¿ To characterize the PK profile of FPA008 ¿ To characterize the PK profile of nivolumab when administered in combination with FPA008 ¿ To characterize the immunogenicity of FPA008 and nivolumab ¿ To characterize the PD profile of FPA008 and nivolumab by analyses of tumor biopsies (including IHC analyses of CD8, CD68, and other selected biomarkers) Exploratory ¿ To further characterize the PD profile of FPA008 and nivolumab (may include analyses of peripheral T-cells, MDSC, and selected serum markers) Phase 1b Objectives Primary ¿ To evaluate the clinical benefit of FPA008 in combination with nivolumab in patients with selected advanced cancers through the analysis of objective response rate (ORR) ¿ To evaluate the safety and tolerability of FPA008 in combination with nivolumab in patients with selected advanced cancers treated at the RD Secondary ¿ To evaluate the clinical benefit of FPA008 in combination with nivolumab in patients with selected advanced cancers through the analysis of overall survival (OS), duration of response (DOR), and progression free survival (PFS) ¿ To characterize the PK profile of FPA008 when administered in combination with nivolumab ¿ To characterize the PK profile of nivolumab when administered in combination with FPA008
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   A Phase 2, Open-Label, Single-Arm Study to Evaluate the Safety and Efficacy...
        Protocol No.
        HSC20160220H
        Official Title
        A Phase 2, Open-Label, Single-Arm Study to Evaluate the Safety and Efficacy of Niraparib in Patients with Advanced, Relapsed, High-Grade Serous Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Who Have Received Three or Four Previous Chemotherapy Regimens (CTMS# 16-0035)
        Description
        Primary Objective: ¿ To evaluate the antitumor activity of niraparib in patients with advanced, relapsed, high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer as assessed by overall response rate (ORR) Secondary Objectives: ¿ To evaluate the durability of the antitumor activity of niraparib ¿ To evaluate antitumor activity of niraparib in homologous recombination deficiency (HRD)-positive patients and in patients with germline breast cancer gene mutation (gBRCAmut) ¿ To evaluate the following additional measures of clinical benefit of niraparib: ¿ Disease control rate (DCR) ¿ Progression-free survival (PFS) ¿ Overall survival (OS) ¿ To evaluate the safety and tolerability of niraparib Exploratory Objectives: ¿ To evaluate QTc in a subset of niraparib-treated ovarian cancer patients ¿ To assess population pharmacokinetics (PK) and estimate PK parameters for niraparib and its major metabolite ¿ To explore potential biomarkers of poly(ADP-ribose) polymerase (PARP) inhibitor sensitivity and tolerability
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   A Phase 3 Clinical Trial of Pembrolizumab (MK-3475) in First Line Treatment...
        Protocol No.
        HSC20160062H
        Official Title
        A Phase 3 Clinical Trial of Pembrolizumab (MK-3475) in First Line Treatment of Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma (CTMS# 15-2148)
        Description
        All subjects: (1) Objective: To compare the Progression Free Survival (PFS) per RECIST 1.1 as assessed by central radiologists¿ review in subjects with first line R/M HNSCC treated with pembrolizumab monotherapy or a combination of pembrolizumab with chemotherapy versus standard treatment cetuximab with chemotherapy. Hypothesis (H1): Pembrolizumab prolongs PFS by RECIST 1.1 (central radiologists¿ review) in subjects with R/M HNSCC compared to standard treatment. Hypothesis (H2): Pembrolizumab in combination with chemotherapy prolongs PFS by RECIST 1.1 (central radiologists¿ review) in subjects with R/M HNSCC compared to standard treatment. Subjects with strongly positive PD-L1 expression: Objective: To compare the Progression Free Survival (PFS) per RECIST 1.1 as assessed by central radiologists¿ review in a subgroup of first line recurrent/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC) subjects with strongly positive PD-L1 expression, treated with pembrolizumab monotherapy or a combination of pembrolizumab with chemotherapy versus standard treatment cetuximab with chemotherapy. Hypothesis (H3): Pembrolizumab prolongs PFS by RECIST 1.1 (central radiologists¿ review) in a subgroup of R/M HNSCC subjects with strongly positive PD-L1 expression compared to standard treatment. Hypothesis (H4): Pembrolizumab in combination with chemotherapy prolongs PFS by RECIST 1.1 (central radiologists¿ review) in a subgroup of R/M HNSCC subjects with strongly positive PD-L1 expression compared to standard treatment.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   A Phase I, First in Human, Dose Escalation Trial of MSC2363318A, a Dual...
        Protocol No.
        HSC20150877H
        Official Title
        A Phase I, First in Human, Dose Escalation Trial of MSC2363318A, a Dual p70S6K/Akt Inhibitor, in Subjects with Advanced Malignancies (CTMS# 15-2123)
        Description
        Part 1 and Part 2, Cohort 1: MSC2363318A as Monotherapy Primary: To determine the maximum tolerated dose (MTD), characterize dose limiting toxicities (DLTs), and select the recommended phase 2 dose (RP2D) of MSC2363318A. Secondary: To assess safety and tolerability and characterize pharmacokinetics (PK) (including the food effect on PK) and antitumor activity during treatment with MSC2363318A. Exploratory: To characterize pharmacodynamics (PD) during treatment with MSC2363318A and, for Cohort 1 only, explore the antitumor activity of MSC2363318A in subjects with no confounding mutations. Part 2: Cohort 2: MSC2363318A in Combination with Trastuzumab Primary: To select the RP2D of MSC2363318A in combination with trastuzumab. Secondary: To assess the safety and tolerability and characterize PK and antitumor activity of MSC2363318A during treatment with MSC2363318A in combination with trastuzumab. Exploratory: To characterize PD of MSC2363318A during treatment with MSC2363318A in combination with trastuzumab. Cohort 3: MSC2363318A in Combination with Tamoxifen Primary: To select the RP2D of MSC2363318A in combination with tamoxifen. Secondary: To assess the safety and tolerability and characterize PK and antitumor activity of MSC2363318A during treatment with MSC2363318A in combination with tamoxifen. Exploratory: To characterize PD of MSC2363318A during treatment with MSC2363318A in combination with tamoxifen.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   A Phase I, Multicenter, Open-Label Dose Escalation and Expansion Study of...
        Protocol No.
        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
        Primary Objective To determine the MTD/RDE of PCA062 in patients with pCAD-positive tumors in the dose escalation part. Secondary Objectives To characterize the safety and tolerability of PCA062 To characterize the pharmacokinetic profile of PCA062 To assess emergence of anti-PCA062 antibodies following one or more intravenous infusions of PCA062 To assess the preliminary anti-tumor activity of PCA062 in patients with pCAD-positive triple negative breast cancer (TBNC), head and neck squamous cell carcinoma (HNSCC) or esophageal cancer (squamous and adenocarcinoma)
        Contact
        210-450-5798
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   A Phase I, Multicenter, Open-Label, Single-Sequence Drug-Drug Interaction...
        Protocol No.
        HSC20160205H
        Official Title
        A Phase I, Multicenter, Open-Label, Single-Sequence Drug-Drug Interaction Study to Assess the Effect of INC280 on the Pharmacokinetics of Midazolam and Caffeine in Patients with cMET-Dysregulated Advanced Solid Tumors (CTMS# 15-2098)
        Description
        Primary objective: To evaluate the effect of multiple doses of INC280 on the pharmacokinetics of a single oral dose of midazolam and caffeine in patients with cMET-dysregulated advanced solid tumors Key secondary objective: To assess safety and tolerability of INC280 in patients with cMET-dysregulated advanced solid tumors Secondary Objectives: To evaluate the preliminary evidence of anti-tumor activity of INC280 in patients with cMET-dysregulated advanced solid tumors
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   A Phase I/II, open label, multicenter study of the safety and efficacy of...
        Protocol No.
        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
        Primary Objectives Phase I part To estimate the RP2D or MTD for the single agent LAG525 and the combination of LAG525 and PDR001. Phase II part To estimate the overall response rate per RECIST V1.1 for single agent LAG525 as well as for the combination of LAG525 and PDR001 Secondary Objectives: To characterize the safety and tolerability of single agent LAG525 given alone and in combination with PDR001 To characterize the pharmacokinetic profile of single agent LAG525 given alone and in combination with PDR001 To assess emergence of anti-LAG525, and anti-PDR001 antibodies following one or more intravenous (i.v.) infusions of single agent LAG525 given alone or in combination with PDR001 To assess potential predictors of efficacy of single agent LAG525 and the combination of LAG525 and PDR001 To evaluate the preliminary antitumor activity of single agent LAG525 given alone or in combination of PDR001 To investigate patient selection and pharmacodynamic biomarkers in tumor tissue samples
        Contact
        210-450-5798
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   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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      •   ABTR01B1, A Children''s Oncology Group Protocol for Collecting and Banking...
        Protocol No.
        HSC20040131H
        Official Title
        ABTR01B1, A Children''s Oncology Group Protocol for Collecting and Banking Pediatric Research Specimens Including Rare Pediatric Tumors
        Description
        This study is collecting and storing malignant, borderline malignant neoplasms, and related biological samples from young patients with cancer. Collecting and storing samples of tumor tissue, blood, and bone marrow from patients with cancer to study in the laboratory may help the study of cancer in the future.
        Contact
        210-562-9149
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   ACCRN07 Protocol for the Enrollment on the Official COG Registry, The...
        Protocol No.
        HSC20080271X
        Official Title
        ACCRN07 Protocol for the Enrollment on the Official COG Registry, The Childhood Cancer Research Network (CCRN)
        Description
        The Children s Oncology Group has established a research network, the Childhood Cancer Research Network (CCRN), to collect information about children with cancer and other conditions that are benign but involve abnormal cell growth in order to help doctors and scientists better understand childhood cancer. The CCRN''s goal is to collect clinical information about every child diagnosed with cancer and similar conditions in the United States and Canada, to allow researchers to study patterns, characteristics, and causes of childhood cancer. The information can also help researchers study the causes of childhood cancer. To expand the CCRN, parents of children who have been diagnosed with cancer will be asked to provide information about themselves and their child for research purposes.   Objectives: To obtain informed consent from parents (and the child, when appropriate) of infants, children, adolescents, and young adults newly diagnosed with cancer to enter their names and certain information concerning their child into the Childhood Cancer Research Network. To obtain informed consent from parents (and the child, when appropriate) of infants, children, adolescents, and young adults newly diagnosed with cancer for permission to be contacted in the future to consider participating in non-therapeutic and prevention research studies involving the parents and/or the child.
        Contact
        210-562-9149
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   ALTE05N1, Umbrella Long-Term Follow-Up Protocol
        Protocol No.
        HSC20090478X
        Official Title
        ALTE05N1, Umbrella Long-Term Follow-Up Protocol
        Description
        Umbrella Long-Term Follow-Up Protocol
        Contact
        210-562-9149
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   ALTE1621 Pharmacologic Reversal of Ventricular Remodeling in Childhood...
        Protocol No.
        HSC20160394X
        Official Title
        ALTE1621 Pharmacologic Reversal of Ventricular Remodeling in Childhood Cancer Survivors at Risk for Heart Failure (PREVENT-HF): A Phase 2b Randomized Placebo-Controlled (Carvedilol) Trial
        Description
        1.1 Primary Aim To determine the impact of a two-year course of low-dose carvedilol on surrogate echocardiographic indices of heart failure (HF) risk, including: ¿ Left Ventricular (LV) Posterior Wall Thickness-Dimension Ratio (LV T-D) a wellestablished index of early myocardial remodeling and subsequent HF risk (primary endpoint). ¿ LV systolic and diastolic function, and afterload ¿ established echocardiographic indices associated with HF risk. ¿ Natriuretic peptides, troponins, and Galectin-3 - circulating biomarkers associated with myocardial injury, and HF risk. 1.2 Secondary Aims 1.2.1 To establish safety and tolerability of this two-year course of low-dose carvedilol, assessing both objective measures (hepatic function) and patient reported outcomes. 1.2.2 To examine the modifying effect of demographic, clinical, and molecular characteristics on the risk: benefit ratio from this two-year carvedilol intervention. 1.3 Exploratory Aim To evaluate the long-term efficacy of carvedilol in preventing cardiomyopathy and/or heart failure in high-risk childhood cancer survivors.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   An 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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      •   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
        To determine the safety, tolerability, maximum tolerated dose (MTD)/recommended phase 2 dose (RP2D) ofTAK-659 administered orally on a daily dosing schedule in patients with advanced solid tumor and lymphoma who do not have effective standard treatment available
        Contact
        210-450-5798
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   An Open-label, Non-randomised, Multicentre, Comparative, Phase I Study to...
        Protocol No.
        HSC20150093H
        Official Title
        An Open-label, Non-randomised, 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 AZD9291 D5160C00008 D5A (CTMS# 14-2003)
        Description
        Primary Objective: To characterise the effect of hepatic impainnent on the PK of AZD9291 after a single oral dose of 80 mg to patients with advanced solid tumours and mild or moderate hepatic impainnent or nonnal hepatic function. Secondary Objectives: To characterise the effect of hepatic impainnent on the PK of AZD9291 metabolites AZ5104 and AZ7550 after a single oral dose of 80 mg to patients with advanced solid tumours and mild or moderate hepatic impainnent or nonnal hepatic function. To investigate the safety and tolerability of single and multiple oral doses of AZD9291 in advanced solid tumour patients with mild or moderate hepatic impainnent and in those with normal hepatic function. Exploratory objectives: To explore changes in the protein binding of AZD9291 (and of metabolites AZ5104 and AZ7550) and the subsequent effects on its PK, in patients with varying degrees of hepatic function. To provide data to allow analysis using population PK approaches. To collect and store a phannacogenetic blood sample for future exploratory research into genes/genetic variation that may influence response (ie, distribution, safety, tolerability and efficacy) to AZD9291.
        Contact
        210-450-5798
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   APEC14B1, THE PROJECT: EVERYCHILD PROTOCOL: A REGISTRY, ELIGIBILITY...
        Protocol No.
        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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      •   Cancer Therapy and Research Center''s Institute for Drug Development Solid...
        Protocol No.
        HSC20070684H
        Official Title
        Cancer Therapy and Research Center''s Institute for Drug Development Solid Tumors and Hematological Malignancies Biorepository for Biomarker Discovery
        Description
        Samples are collected for the Cancer Therapy and Research Center''s Solid Tumors and Hematological Malignancies Biorepository for Biomarker Discovery
        Contact
        210-450-5798
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   Cardiorespiratory Fitness and Cancer Treatment Toxicities (CTMS# 14-2027)
        Protocol No.
        HSC20150329H
        Official Title
        Cardiorespiratory Fitness and Cancer Treatment Toxicities (CTMS# 14-2027)
        Description
        Objectives: 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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      •   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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      •   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
        Primary: To assess the antitumor activity of lurbinectedin (PM01183) in terms of overall response rate (ORR), according to the Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1, in the following advanced solid tumors: small cell lung cancer (SCLC), head and neck carcinoma (H&N), neuroendocrine tumors (NETs), biliary tract carcinoma, endometrial carcinoma, BRCA 1/2-associated metastatic breast carcinoma, carcinoma of unknown primary site, germ cell tumors (GCTs), and Ewing¿s family of tumors (EFTs). Secondary: To further characterize the antitumor activity of PM01183 in terms of duration of response (DR), clinical benefit [ORR or stable disease (SD) lasting over four months (SD ¿ 4 months)], progression-free survival (PFS), and oneyear overall survival (1y-OS) in each cohort of advanced solid tumors. Characterize the plasma pharmacokinetics (PK) of PM01183. To conduct an exploratory pharmacogenomic (PGx) and pharmacogenetic analysis. To evaluate the safety profile of PM01183 in this patient population.
        Contact
        410-450-5798
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   Clinical trial to study the safety and efficacy of MBG453 given alone and in...
        Protocol No.
        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
        Primary Objectives: Phase I-Ib: To characterize the safety and tolerability of MBG453 as a single agent and in combination with PDR001 and to identify recommended doses for future studies. Phase I-Ib dose ranging: To further investigate the safety and tolerability of different doses of MBG453 alone or in combination with PDR001. Phase II: To estimate the anti-tumor activity of MBG453 alone in patients with solid tumors, and in combination with PDR001 in selected disease indications (melanoma, non-small cell lung cancer (NSCLC), renal cell carcinoma (RCC)). Secondary Objectives Evaluate the preliminary anti-tumor activity of MBG453 alone and in combination with PDR001. Make an initial comparison of safety, PK and efficacy for MBG453 and PDR001 administered in combination on a every 2 weeks (Q2W) and every 4 weeks (Q4W) dosing schedules. Characterize the pharmacokinetic profile of MBG453 alone and in combination with PDR001. Assess emergence of anti-MBG453 and anti-PDR001 antibodies. Assess potential predictors of efficacy of MBG453 single agent and in combination with PDR001 in tumor samples. Assess the pharmacodynamic effect of MBG453 as single agent and in combination with PDR001 in tumor samples. Describe the survival distribution of patients treated with MBG453 as single agent and in combination with PDR001 for each disease group.
        Contact
        410-450-5798
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   DCP-001, Use of a Clinical Trial Screening Tool to Address Cancer Health...
        Protocol No.
        HSC20160342X
        Official Title
        DCP-001, Use of a Clinical Trial Screening Tool to Address Cancer Health Disparities in the NCI Community Oncology Research Program (NCORP)
        Description
        Objectives 1) Implement a screening tool in NCORP to collect broader demographic and clinical data to generate hypothesis and research questions in the following areas of research: cancer screening, cancer prevention, symptom science, cancer care disparities, comparative effectiveness and cancer care delivery research. 2) Collect expanded demographic and clinical data (e.g., SES, co-morbidities, method of diagnosis) across the NCORP network to help identify and best characterize patients that are screened but not enrolled and for patients that participate in NCI trials, to understand how these variables may impact outcomes. 3) Enhance an understanding of site- specific and trial-specific accrual barriers that will inform the development of effective strategies to improve accrual, particularly for minority and underserved populations. 4) Provide data for internal and external evaluation of NCORP¿s first RFA cycle and reissuance.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   Efficacy and Safety of Rivaroxaban Prophylaxis Compared with Placebo in...
        Protocol No.
        HSC20160228H
        Official Title
        Efficacy and Safety of Rivaroxaban Prophylaxis Compared with Placebo in Ambulatory Cancer Patients Initiating Systemic Cancer Therapy and at High Risk for Venous Thromboembolism (CTMS# 15-2145)
        Description
        Primary Objectives The primary efficacy objective is to demonstrate that rivaroxaban is superior to placebo for reducing the risk of the primary composite outcome as defined by objectively confirmed symptomatic lower extremity proximal DVT, asymptomatic lower extremity proximal DVT, symptomatic upper extremity DVT, symptomatic non-fatal PE, incidental PE, and VTE-related death in ambulatory adult subjects with various cancer types receiving systemic cancer therapy who are at high risk of developing a VTE. Secondary Objectives The key secondary efficacy objectives of this study are to compare the efficacy of rivaroxaban with placebo for reducing the risk of symptomatic VTE events and VTE-related deaths and all-cause mortality in ambulatory adult subjects with various cancer types receiving systemic cancer therapy who are at high risk of developing a VTE. Other secondary efficacy objectives include the evaluation of the individual components of the primary efficacy composite variable analyzed separately, a composite of confirmed fatal/non-fatal arterial thromboembolism (ATE) events, a composite of confirmed fatal/non-fatal visceral VTE events, and a composite of symptomatic lower extremity proximal DVT, asymptomatic lower extremity proximal DVT, symptomatic upper extremity DVT, non-fatal PE, incidental PE and all-cause mortality. Safety Objectives The safety objective of this study is to assess major bleeding events (as defined by the International Society of Thrombosis and Haemsotasis [ISTH]). In addition, clinically relevant non-major bleeding, minor bleeding, and any bleeding (defined as major, clinically relevant non-major, and minor bleeding) will be assessed as measured by ISTH definition. Exploratory Objectives The exploratory objectives of this study are: To assess inflammation- and hypercoagulability-related biomarkers including d-dimer, p-selectin, and Tissue Factor To analyze the steady state pharmacokinetics (PK) and exposure response of rivaroxaban To collect health care resource utilization (HCRU) data that may be used in future economic modeling (the construction and reporting of the economic model will be conducted separately from this study)
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   Exceptional Responders Pilot study: Molecular profiling of tumors from...
        Protocol No.
        HSC20150477X
        Official Title
        NCI Protocol #9671, Exceptional Responders Pilot study: Molecular profiling of tumors from cancer patients who are Exceptional Responders (CTMS #15-2062)
        Description
        PRIMARY OBJECTIVES: I. To identify molecular indicators in malignant tissues from patients who were exceptional responders on clinical trials or treatments using whole exome and/or targeted deep sequencing as well as potentially other sequencing, and other molecular characterization methods (if adequate tissue exists). II. To explore associations between the identified molecular indicators and the putative mechanism of action of the treatment received by the patient. III. To test the feasibility of identifying exceptional responders, obtaining the relevant tumor and normal tissue and clinical data, and performing whole exome and/or targeted deep sequencing on these samples.
        Contact
        210-450-5798
        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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      •   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
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      •   Incidence and Factors Associated with the Development and Severity of Oral...
        Protocol No.
        HSC20050218H
        Official Title
        Incidence and Factors Associated with the Development and Severity of Oral Mucositis in Patients Undergoing High Dose Chemotherapy and Peripheral Stem Cell Transplantation
        Description
        Our study intends to evaluate prospectively the incidence and severity of oral mucositis in patients undergoing high-dose chemotherapy and hematopoietic stem cell transplantation, as well as to evaluate the potential influence of nutritional-, physical-, and transplant-related factors associated with the development of this complication and its grade of involvement. Research plan: This is a prospective cohort study with an observational basis that involves all of the patients undergoing high-dose chemotherapy and peripheral blood stem cell transplantation at the Audie L. Murphy VA Hospital Bone Marrow Transplant Unit and at the University Hospital Bone Marrow Transplant Unit. We expect to enroll 400 patients during a 5-year period. Methods: In order to answer the study questions, subjects will be assessed several times during the study period. The study involves a multidisciplinary group that will be evaluating and following the subjects. A baseline will be established by a physician and a nutritionist before the subjects start the high-dose chemotherapy regimen. The subjects will be followed with oral evaluations 3 times per week, beginning on the day of the transplant and ending when mucositis resolves, or the patient is discharged home, or 30 days post-transplant, whichever occurs first. At day 15 post-transplant, patients will be evaluated for the second time by the nutritionist. Further information such as blood values, use of medications and treatment complications, will be obtained by daily chart review.  
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   MATCH Treatment Subprotocol B: Phase II Study of Afatinib in Patients with...
        Protocol No.
        HSC20150831X
        Official Title
        MATCH Treatment Subprotocol B: Phase II Study of Afatinib in Patients with Tumors with HER2 Activating Mutations (CTMS# 15-2107)
        Description
        Primary Objective To evaluate the proportion of patients with objective response (OR) to targeted study agent(s) in patients with advanced refractory cancers/lymphomas. Secondary Objectives To evaluate the proportion of patients alive and progression free at 6 months of treatment with targeted study agent in patients with advanced refractory cancers/lymphomas. To evaluate time until death or disease progression. To identify potential predictive biomarkers beyond the genomic alteration by which treatment is assigned or resistance mechanisms using additional genomic, RNA and protein-based assessment platforms.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   MATCH Treatment Subprotocol F: Crizotinib in Patients with Tumors (other...
        Protocol No.
        HSC20150750X
        Official Title
        MATCH Treatment Subprotocol F: Crizotinib in Patients with Tumors (other than adenocarcinoma of lung or ALCL) with ALK Translocations (CTMS# 15-2081)
        Description
        Primary Objective To evaluate the proportion of patients with objective response (OR) to targeted study agent(s) in patients with advanced refractory cancers/lymphomas. Secondary Objectives To evaluate the proportion of patients alive and progression free at 6 months of treatment with targeted study agent in patients with advanced refractory cancers/lymphomas. To evaluate time until death or disease progression. To identify potential predictive biomarkers beyond the genomic alteration by which treatment is assigned or resistance mechanisms using additional genomic, RNA and protein-based assessment platforms.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   MATCH Treatment Subprotocol I: GDC-0032 (taselisib) in Patients with Tumors...
        Protocol No.
        HSC20160259X
        Official Title
        MATCH Treatment Subprotocol I: GDC-0032 (taselisib) in Patients with Tumors (other than breast cancer) with PIK3CA Mutation but without KRAS Mutation or PTEN Loss (CTMS# 16-0023)
        Description
        PRIMARY OBJECTIVES: I. To evaluate the proportion of patients with objective response (OR) to targeted study agent(s) in patients with advanced refractory cancers/lymphomas. SECONDARY OBJECTIVES: I. To evaluate the proportion of patients alive and progression free at 6 months of treatment with targeted study agent in patients with advanced refractory cancers/lymphomas. II. To evaluate time until death or disease progression. III. To identify potential predictive biomarkers beyond the genomic alteration by which treatment is assigned or resistance mechanisms using additional genomic, ribonucleic acid (RNA) and protein-based assessment platforms.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   MATCH Treatment Subprotocol S1: Phase II Study of Trametinib in Patients...
        Protocol No.
        HSC20160260X
        Official Title
        MATCH Treatment Subprotocol S1: Phase II Study of Trametinib in Patients with Tumors with NF1 Mutations (CTMS# 16-0028)
        Description
        PRIMARY OBJECTIVES: I. To evaluate the proportion of patients with objective response (OR) to targeted study agent(s) in patients with advanced refractory cancers/lymphomas. SECONDARY OBJECTIVES: I. To evaluate the proportion of patients alive and progression free at 6 months of treatment with targeted study agent in patients with advanced refractory cancers/lymphomas. II. To evaluate time until death or disease progression. III. To identify potential predictive biomarkers beyond the genomic alteration by which treatment is assigned or resistance mechanisms using additional genomic, ribonucleic acid (RNA) and protein-based assessment platforms.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   MATCH Treatment Subprotocol U: VS-6063 (defactinib) in Patients with Tumors...
        Protocol No.
        HSC20150839X
        Official Title
        MATCH Treatment Subprotocol U: VS-6063 (defactinib) in Patients with Tumors with NF2 Loss (CTMS# 15-2110)
        Description
        Primary Objective To evaluate the proportion of patients with objective response (OR) to targeted study agent(s) in patients with advanced refractory cancers/lymphomas. Secondary Objectives To evaluate the proportion of patients alive and progression free at 6 months of treatment with targeted study agent in patients with advanced refractory cancers/lymphomas. To evaluate time until death or disease progression. To identify potential predictive biomarkers beyond the genomic alteration by which treatment is assigned or resistance mechanisms using additional genomic, RNA and protein-based assessment platforms.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   MATCH Treatment Subprotocol X: Phase II Study of Dasatinib in Patients with...
        Protocol No.
        HSC20160282X
        Official Title
        MATCH Treatment Subprotocol X: Phase II Study of Dasatinib in Patients with Tumors with DDR2 Mutations (CTMS# 16-0032)
        Description
        PRIMARY OBJECTIVES: I. To evaluate the proportion of patients with objective response (OR) to targeted study agent(s) in patients with advanced refractory cancers/lymphomas. SECONDARY OBJECTIVES: I. To evaluate the proportion of patients alive and progression free at 6 months of treatment with targeted study agent in patients with advanced refractory cancers/lymphomas. II. To evaluate time until death or disease progression. III. To identify potential predictive biomarkers beyond the genomic alteration by which treatment is assigned or resistance mechanisms using additional genomic, ribonucleic acid (RNA) and protein-based assessment platforms.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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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
        Primary Objective To evaluate the proportion of patients with objective response (OR) to targeted study agent(s) in patients with advanced refractory cancers/lymphomas. Secondary Objectives To evaluate the proportion of patients alive and progression free at 6 months of treatment with targeted study agent in patients with advanced refractory cancers/lymphomas. To evaluate time until death or disease progression. To identify potential predictive biomarkers beyond the genomic alteration by which treatment is assigned or resistance mechanisms using additional genomic, RNA and protein-based assessment platforms.
        Contact
        410-450-5798
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
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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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      •   Phase I study of carfilzomib in combination with cyclophosphamide and...
        Protocol No.
        HSC20160206H
        Official Title
        Phase I study of carfilzomib in combination with cyclophosphamide and etoposide for children with relapsed and refractory solid tumors and leukemias
        Description
        Primary Objective: To determine the DLTs and MTD of carfilzomib given in combination with cyclophosphamide and etoposide in pediatric patients with relapsed/refractory leukemias and solid tumors Secondary Objectives: 1. To evaluate toxicities of carfilzomib in the pediatric population when combined with conventional chemotherapy 2. To gather preliminary efficacy data on the drug combination 3. To measure if circulating plasma proteasome (cProt) levels post treatment correlate with response to therapy and overall survival 4. To measure if the levels of proteasome activity and resistance to carfilzomib correlates with toxicity and/or response to treatment. 5. To measure if inhibition of proteasome activity by carfilzomib results in alteration in a number of autophagy and apoptosis related proteins, providing means to evaluate correlates of activity of carfilzomib. 6. To measure the level of proteasome inhibition in patient PBMCs before and during treatment by determination of the level of protein ubiquitination. 7. To determine in vitro sensitivity of patient leukemias and solid tumors to carfilzomib alone and in combination with study chemotherapeutic agents in order to generate a predictive model of drug sensitivity. 8. To expand patient leukemia and solid tumor samples in order to save tissue for future studies but also to serve as a pre-clinical in vivo model to be included in the generation and testing of a drug sensitivity predictive model. 9. To perform whole exome sequencing (WES) and RNA seq on patient leukemia and solid tumor samples and WES on germ line DNA in order to determine potential mechanisms of drug sensitivity or resistance as well as contribute to testing a computer `learning engine¿ (Bionet) for predicting clinical responses from genomic and drug sensitivity data.
        Contact
        210-562-9149
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   Phase II Trial of Eribulin and Lenvatinib in Advanced Solid Tumors (CTMS#...
        Protocol No.
        HSC20150891H
        Official Title
        Phase II Trial of Eribulin and Lenvatinib in Advanced Solid Tumors (CTMS# 15-2139)
        Description
        The overall purpose of this study is to determine the overall response rate, efficacy and safety of the combination of eribulin and Lenvatinib.
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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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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      •   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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      •   Safety, Tolerability & PK of KX2-361 in Subjects with advanced malignancies...
        Protocol No.
        HSC20150481H
        Official Title
        A Phase 1 Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetics of KX2-361 in Subjects with Advanced Malignancies that are Refractory to Conventional Therapies (CTMS# 15-2063)
        Description
        Study Objectives: Primary Objective: To define the maximum tolerated dose (MTD) of KX2-361 in subjects with advanced refractory malignancies when administered as single and multiple oral doses. Secondary Objectives: To determine the safety and tolerability of KX2-361 after single and multiple oral doses, in subjects with advanced refractory malignancies. To characterize the pharmacokinetic profile of KX2-361 after single and multiple oral doses. To evaluate the activity of KX2-361 in both the Dose Escalation Cohort and the Expansion Cohort of subjects with high-grade glioma.
        Contact
        210-450-5798
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   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
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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
        View all Cancer Therapy & Research Center clinical trials
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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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      •   A Randomized study of rapamycin combined with intravesical BCG in patients...
        Protocol No.
        HSC20160162H
        Official Title
        A Randomized study of rapamycin combined with intravesical BCG in patients with non-muscle invasive bladder cancer
        Description
        1.1 The primary objectives of the study are to determine: a. The effect of Sirolimus on BCG-specific immunity during treatment of non-muscle invasive bladder cancer with maintenance BCG 1.2 Secondary objectives of the study are to determine: a. The compare the effects of very low-dose versus low-dose Sirolimus on BCG-specific immunity during treatment of non-muscle invasive bladder cancer with maintenance BCG
        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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      •   RADICAL CYSTECTOMY COMPARED WITH CHEMORADIATION FOR MUSCLE INVASIVE BLADDER...
        Protocol No.
        HSC20150620H
        Official Title
        RADICAL CYSTECTOMY COMPARED WITH CHEMORADIATION FOR MUSCLE INVASIVE BLADDER CANCER: A PILOT RANDOMIZED CONTROLLED NON-INFERIORITY TRIAL
        Description
        Our study will be a pilot, prospective, single-center, randomized trial to determine the feasibility and patient acceptability of a randomized trial of radical cystectomy versus Combined-modality treatment (CMT) in bladder cancer and to determine compliance rates with assigned treatment. Patients diagnosed with muscle invasive bladder cancer after transurethral resection of bladder tumor and are surgical candidates will be randomized to either radical cystectomy (with neoadjuvant chemotherapy if suitable candidate) or combined modality treatment with chemotherapy and radiation therapy. Both treatment methods are considered ¿standard of care¿ recommended by the NCCN Clinical Practice Guidelines (http://www.nccn.org/professionals/physician_gls/pdf/bladder.pdf) in treating bladder cancer, pending on the performance status and comorbidities of the patients.
        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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      •   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
        To characterize the relationship of DDMVAC- and COXEN scores in terms of pTO rate at cystectomy in patients treated with neoadjuvant chemotherapy. This will be done in two ways: ¿ By assessing whether the treatment-specific COXEN score is prognostic of pTO rate or s; pT1 in this patient population and to assess in a preliminary fashion whether the COXEN score is a predictive factor distinguishing between these two chemotherapy regimens. ¿ By evaluating the correlation between the GC- and the DDMVAC-COXEN score.
        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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  •   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
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    •   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
      Blood and Urine Samples Needed From Bladder Cancer Patients and Healthy Volunteers
      Contact
      210-716-1055
      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
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  •   Women's Health

    •   The attractive exterior female genitalia: Defining the undefined
      Protocol No.
      HSC20150480H
      Official Title
      The Attractive External Female Genitalia: A Photomorphometric Analysis
      Description
      There are studies describing the ideal breast, nose, lips, etc, but none on female genitalia. We want to identify what makes the female genitalia attractive. Information will be used for vaginal reconstruction following trauma, cancers, and rejuvenation.
      Contact
      610-360-2594
      Locations
      UT Health Science Center
      Learn More About This Study