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FindAStudy :: Human Studies @ UTHSCSA
328  Studies 162  Researchers 29  Categories
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  •   Cancers and Other Neoplasms

    •   Bones and joints

      •   AAML1031, A Phase III Randomized Trial for Patients with de novo AML using...
        Protocol No.
        HSC20130256X
        Official Title
        AAML1031, A Phase III Randomized Trial for Patients with de novo AML using Bortezomib and Sorafenib (IND#114480; NSC# 681239, NSC# 724772) for Patients with High Allelic Ratio FLT3/ITD
        Description
        This randomized phase III trial studies how well bortezomib and sorafenib tosylate work in treating patients with newly diagnosed acute myeloid leukemia. Bortezomib and sorafenib tosylate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving bortezomib and sorafenib tosylate together with combination chemotherapy may be an effective treatment for acute myeloid leukemia.
        Contact
        210-562-9149
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   AEWS07B1, A COG Study for Collecting and Banking Ewing Sarcoma Specimens
        Protocol No.
        HSC20090244X
        Official Title
        AEWS07B1, A COG Study for Collecting and Banking Ewing Sarcoma Specimens
        Description
        This research study is collecting and storing samples of tumor tissue, bone marrow, and blood from patients with Ewing sarcoma. Collecting and storing samples of tumor tissue, bone marrow, and blood from patients with cancer to test in the laboratory may help the study of cancer in the future.
        Contact
        210-562-9149
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
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      •   AOST06B1 A Children''s Oncology Group Protocol for Collecting and Banking...
        Protocol No.
        HSC20090245X
        Official Title
        AOST06B1 A Children''s Oncology Group Protocol for Collecting and Banking Osteosarcoma Specimens
        Description
        RATIONALE: Collecting and storing samples of tumor tissue and blood from patients to test in the laboratory may help the study of cancer in the future. PURPOSE: The purpose of this study is to collect and store samples of blood and tumor tissue from patients with osteosarcoma.
        Contact
        210-562-9149
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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    •   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
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      •   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
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      •   A Phase II, Open-Label, Multi-Center Study of ANG1005 in Her2+ Breast Cancer...
        Protocol No.
        HSC20140206H
        Official Title
        A Phase II, Open-Label, Multi-Center Study of ANG1005 in Her2+ Breast Cancer Patients with Recurrent Brain Metastases
        Description
        This is a Phase 2 study to see if an investigational drug, ANG1005, can shrink tumor cells in breast cancer patients with recurrent brain metastases.
        Contact
        210-450-5798
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   A221101 A Phase III Randomized, Double-Blind Placebo Controlled Study of...
        Protocol No.
        HSC20140301H
        Official Title
        A221101 A Phase III Randomized, Double-Blind Placebo Controlled Study of Armodafinil (Nuvigil®) To Reduce Cancer-Related Fatigue in Patients with High Grade Glioma
        Description
        Patients experiencing fatigue related to cancer will be asked to take part in this study. Cancer-related fatigue is a very common symptom in patients with cancer. Patients will receive armodafinil or placebo. The primary objective of this study is to determine preliminary efficacy measured by patient reported fatigue (Brief Fatigue Inventory - BFI) at 8 weeks of two doses (150 mg and 250 mg of armodafinil in treating moderate fatigue compared to placebo in patients with high grade glioma. The secondary objectives of the study are listed below. To evaluate the tolerability at 8 weeks of 150 mg and 250 mg armodafinil in this patient population. To assess the effect of armodafinil at 8 weeks on cognitive function in patients with glioblastoma. To assess the impact of armodafinil on global quality of life and other fatigue endpoints (i.e. usual fatigue, activity interference) in this patient population with high grade glioma. Explore the correlation between the BFI, Patient-Reported Outcomes Measurement Information System (PROMIS), and Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) measures, as well as the relationship of fatigue and cognitive difficulties. Patients will receive armodafinil or placebo for a total of 8 weeks.
        Contact
        210-450-5798
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   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
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      •   ACNS02B3: A CHILDREN''S ONCOLOGY GROUP PROTOCOL FOR COLLECTING AND BANKING...
        Protocol No.
        HSC20040266H
        Official Title
        ACNS02B3: A CHILDREN''S ONCOLOGY GROUP PROTOCOL FOR COLLECTING AND BANKING PEDIATRIC BRAIN TUMOR RESEARCH SPECIMENS
        Description
        he purpose of this study is to collect and store brain tissue samples and blood from children with brain cancer that will be tested in the laboratory. Collecting and storing samples of tumor tissue and blood from patients to test in the laboratory may help the study of cancer in the future.
        Contact
        210-562-9149
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   ACNS0831 Phase III Randomized Trial of Post-Radiation Chemotherapy in...
        Protocol No.
        HSC20110258X
        Official Title
        ACNS0831 Phase III Randomized Trial of Post-Radiation Chemotherapy in Patients with Newly Diagnosed Ependymoma Ages 1 to 21 years
        Description
        This randomized phase III trial is studying maintenance chemotherapy to see how well it works compared to observation following induction chemotherapy and radiation therapy in treating young patients with newly diagnosed ependymoma. Drugs used in chemotherapy, such as vincristine sulfate, carboplatin, cyclophosphamide, etoposide, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Radiation therapy uses high-energy x-rays to kill tumor cells. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Giving chemotherapy with radiation therapy may kill more tumor cells and allow doctors to save the part of the body where the cancer started.
        Contact
        210-562-9149
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   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
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      •   ALTE07C1 Neuropsychological, Social, Emotional, and Behavioral Outcomes in...
        Protocol No.
        HSC20090042X
        Official Title
        ALTE07C1 Neuropsychological, Social, Emotional, and Behavioral Outcomes in Children with Cancer
        Description
        This research trial studies neuropsychological (learning, remembering or thinking) and behavioral testing in younger patients with cancer. Collecting information over time from a series of tests may help doctors develop effective tests to measure neuropsychological and behavioral function of patients with cancer. Parent and child participants complete the COG Standard Neuropsychological and Behavioral Battery testing at 9, 30, and 60 months post-diagnosis in a 1-hour session conducted by a neuropsychologist or psychologist. The Battery consists of tests of intelligence, processing speed/attention, memory, language preference, general developmental progress, attention and behavior/social/emotional function, executive function, adoptive function, and quality of life. Additionally, parents complete a parent-report questionnaire to gather information about patient''s function in terms of attention, memory, executive abilities, and behavioral, social, and emotional adaption.
        Contact
        210-562-9149
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
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      •   ANBL0032, Phase III Randomized Study of Chimeric Antibody 14.18 (Ch14.18) in...
        Protocol No.
        HSC20090466H
        Official Title
        ANBL0032, Phase III Randomized Study of Chimeric Antibody 14.18 (Ch14.18) in High Risk Neuroblastoma Following Myeloablative Therapy and Autologous Stem Cell Rescue
        Description
        This partially randomized phase III trial studies isotretinoin with dinutuximab, aldesleukin, and sargramostim to see how well it works compared to isotretinoin alone following stem cell transplant in treating patients with neuroblastoma. Drugs used in chemotherapy, such as isotretinoin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as dinutuximab, may block tumor growth in different ways by targeting certain cells. Aldesleukin and sargramostim may stimulate a person''s white blood cells to kill cancer cells. It is not yet known if chemotherapy is more effective with or without dinutuximab, aldesleukin, and sargramostim following stem cell transplant in treating neuroblastoma.
        Contact
        210-562-9149
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   COG ANBLOOB1: Neuroblastoma Biology Studies
        Protocol No.
        HSC20010176X
        Official Title
        COG ANBLOOB1: Neuroblastoma Biology Studies
        Description
        This research trial studies biomarkers in tumor tissue samples from patients with newly diagnosed neuroblastoma or ganglioneuroblastoma. Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer.
        Contact
        210-562-9149
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   SCUSF0901 [ACCL0922] A Phase II Placebo-Controlled Trial of Modafinil to...
        Protocol No.
        HSC20130255X
        Official Title
        SCUSF0901 [ACCL0922] A Phase II Placebo-Controlled Trial of Modafinil to Improve Neurocognitive Deficits in Children Treated for a Primary Brain Tumor
        Description
        RATIONALE: Modafinil may help improve memory, attention, and fatigue caused by cancer treatment. PURPOSE: This phase II randomized trial studies how well modafinil works in treating children with memory and attention problems caused by cancer treatment for a brain tumor.
        Contact
        210-562-9149
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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        Learn More About This Study

         

      •   Study of DCVax®-L to Treat Newly Diagnosed GBM Brain Cancer
        Protocol No.
        HSC20120273H
        Official Title
        A Phase III Clinical Trial Evaluating DCVax®-L, Autologous Dendritic Cells Pulsed with Tumor Lysate Antigen for the Treatment of Glioblastoma Multiforme (CTRC# 12-20)
        Description
        The primary purpose of the study is to determine the usefullness of new therapy called DCVax®-L in patients who have newly diagnosed GBM and surgery is planned. Patients must enter screening at a participating site prior to surgical resection of the tumor. Patients will receive the standard of care, including radiation and temozolomide (Temodar) therapy and two out of three will additionally receive DCVax-L, with the remaining one third receiving a placebo. Patients randomized to the placebo arm will have the option to receive DCVax-L in a crossover arm upon documented disease progression. The study will enroll approximately 300 patients from at least 50 cancer centers in the US and UK. In addition to other conditions for enrollment, eligible patients have newly diagnosed, unilateral GBM (grade IV). Participants must have sufficient tumor lysate protein that was generated from the surgically obtained tumor material. Patients must also have sufficient DCVax-L product available after manufacturing.
        Contact
        210-450-5798
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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        Learn More About This Study

         

    •   Breast

      •   A Phase II Randomized, Double-Blind Placebo Controlled, Study of Letrozole...
        Protocol No.
        HSC20150373H
        Official Title
        A Phase II Randomized, Double-Blind Placebo Controlled, Study of Letrozole With or Without BYL719 or Buparlisib, for the Neoadjuvant Treatment of Postmenopausal Women With Hormone Receptor-Positive HER2-Negative Breast Cancer (CTMS# 15-2039)
        Description
        The purpose of the study is to determine whether treatment with a PI3K inhibitor plus letrozole leads to an increase in pathologic response compared to treatment with placebo plus letrozole in patients with Breast cancer
        Contact
        210-450-5798
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   A Phase III Randomized, Double-Blind, Placebo-Controlled Study of LEE011 or...
        Protocol No.
        HSC20150291H
        Official Title
        A Phase III Randomized, Double-Blind, Placebo-Controlled Study of LEE011 or Placebo In Combination With Tamoxifen and Goserelin or a Non-Sterodial Aromatose Inhibitor (NSAI) and Goserelin for the Treatment of Premenopausal Women with Hormone Receptor Positive, HER2-Negative, Advanced Breast Cancer (CTMS# 14-2030)
        Description
        This is a multi-center, randomized, double-blinded, placebo controlled trial in pre-menopausal women with advanced breast cancer.
        Contact
        210-450-5798
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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        Learn More About This Study

         

      •   A Phase III, Open Label, Randomised, Controlled, Multi-Centere Study to...
        Protocol No.
        HSC20140399H
        Official Title
        A Phase III, Open Label, Randomised, Controlled, Multi-Centere Study to Assess the Efficacy and Safety of Olaparib Monotherapy Versus Physician''s Choice Chemotherapy in the Treatment of Metastatic Breast Cancer Patients with Germline BRCA1/2 Mutations
        Description
        This open label, randomised, controlled, multi-centre phase III study will assess the efficacy and safety of single agent olaparib vs standard of care based on physician''s choice of capecitabine, vinorelbine or eribulin in metastatic breast cancer patients with gBRCA 1/2 mutations.
        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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      •   Acquisition of Digital Mammography and Breast Tomosynthesis Images for...
        Protocol No.
        HSC20140426H
        Official Title
        Acquisition of Digital Mammography and Breast Tomosynthesis Images for Clinical Evaluation of Fujifilm Digital Breast Tomosynthesis
        Description
        This image acquisition study is designed to acquire the study image data and establish and document the clinical findings for each subject. This study will create a library of image data that will be used for future projects.
        Contact
        210-450-1049
        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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      •   NSABP B-52 A Randomized Phase III Trial Evaluating Pathologic Complete...
        Protocol No.
        HSC20140202X
        Official Title
        NSABP B-52 A Randomized Phase III Trial Evaluating Pathologic Complete Response Rates in Patients with Hormone Receptor-Positive, HER2-Positive, Large Operable and Locally Advanced Breast Cancer Treated with Neoadjuvant Therapy of Docetaxel, Carboplatin, Trastuzumab, and Pertuzumab (TCHP) With or Without Estrogen Deprivation (CTRC 14-0003)
        Description
        This randomized phase III trial studies docetaxel, carboplatin, trastuzumab, and pertuzumab with estrogen deprivation to see how they work compared to docetaxel, carboplatin, trastuzumab, and pertuzumab without estrogen deprivation in treating patients with hormone receptor-positive, human epidermal growth factor receptor 2 (HER2)-positive, operable or locally advanced breast cancer. Drugs used in chemotherapy, such as docetaxel, carboplatin, trastuzumab, and pertuzumab, 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. Estrogen can cause the growth of breast cancer cells. Hormone therapy using goserelin acetate and aromatase inhibition therapy may fight breast cancer by blocking the use of estrogen by the tumor cells. Radiation therapy uses high energy x rays to kill tumor cells. Giving combination chemotherapy and radiation therapy with or without hormone therapy may be an effective treatment for hormone receptor-positive, HER2-positive, operable or locally advanced breast cancer. I. To determine whether the addition of estrogen deprivation to neoadjuvant therapy consisting of therapy of docetaxel, carboplatin, trastuzumab, and pertuzumab (TCHP) yields a greater rate of pathologic complete response (pCR) (breast and nodes) than TCHP alone when administered to women with operable, hormone receptor-positive, HER2-positive breast cancer. SECONDARY OBJECTIVES: I. To determine whether the addition of estrogen deprivation to neoadjuvant therapy consisting of TCHP will increase the pCR rate in the breast compared to TCHP alone when administered to women with operable, hormone receptor-positive, HER2-positive breast cancer. II. To determine whether the addition of estrogen deprivation to neoadjuvant therapy consisting of TCHP improves recurrence-free interval (RFI) in women with operable, hormone receptor-positive, HER2-positive breast cancer. III. To determine whether the addition of estrogen deprivation to neoadjuvant therapy consisting of TCHP improves overall survival (OS) in women with operable, hormone receptor-positive, HER2-positive breast cancer. IV. To compare the rates of second primary invasive cancer by treatment arm. V. Assessment of patterns of pCR, RFI, and OS by menopausal status. VI. To evaluate the cardiac toxicity associated with each of the regimens. VII. To compare the effect of adding estrogen deprivation to neoadjuvant therapy on endocrine-related symptoms in all patients by treatment arm. VIII. To compare the effect of adding estrogen deprivation to neoadjuvant therapy on vasomotor symptoms, musculoskeletal, and vaginal complaints as well as quality of life. IX. To determine a relationship between pCR and a potential mechanism of resistance/sensitivity in hormone receptor-positive, HER2-positive tumors. OUTLINE: Patients are randomized to 1 of 2 treatments arms.
        Contact
        210-450-5798
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   Quality of life following breast conservation therapy versus mastectomy with...
        Protocol No.
        HSC20130002H
        Official Title
        Quality of life following breast conservation therapy versus mastectomy with reconstruction in women with primary breast cancer (CTRC#12-0091)
        Description
        Our hypothesis is that women identified as high risk patients for poor outcomes after breast conservation therapy will have better cosmetic results, less dissatisfaction with their treatment and an overall better quality of life if referred for plastic and reconstructive surgery consultation preoperatively. The purposes of this study are to preoperatively identify patients at risk for poor cosmesis and dissatisfaction after breast conservation therapy and also to implement a combined approach from plastic and oncologic surgery to determine the level of patient satisfaction, quality of life and the cosmetic results at our institution.   From this study, we hope to develop a selection criterion for surgical oncology as to when it would be appropriate to refer patients to a plastic surgeon for pre-operative consultation.
        Contact
        210-567-5711
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   S1207 - Hormone Therapy With or Without Everolimus in Treating Patients with...
        Protocol No.
        HSC20140060X
        Official Title
        S1207, Phase III Randomized, Placebo-Controlled Clinical Trial Evaluating the Use of Adjuvant Endocrine Therapy +/- One Year of Everolimus in Patients with High-Risk, Hormone Receptor-Positive and HER2/neu Negative Breast Cancer (CTRC# 13-0002)
        Description
        The purpose of this study is to determine whether adding a year of everolimus to standard adjuvant hormonal therapy improves disease-free interval in patients with hormone-receptor-positive and HER2-negative breast cancer. Eligible adult patients (either sex) have a diagnosis of breast cancer and have completed surgery, radiation therapy, and/or adjuvant or neoadjuvant chemotherapy and have no evidence of disease at time of study entry. Patients with inflammatory breast cancer or metastatic disease, serious cardiac disease, uncontrolled diabetes, hepatitis, uncontrolled pulmonary disease, or impaired gastrointestinal function are not eligible. Estimated Enrollment: 3500 patients from multiple cancer centers in the US.
        Contact
        210-450-5798
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   Study of LEE011 and/or BYL719 plus Letrozole in Advanced ER-positive Breast...
        Protocol No.
        HSC20140065H
        Official Title
        A Phase Ib/II, Multicenter, Study of the Combination of LEE011 and BYL719 with Letrozole in Adult Patients with Advanced ER+ Breast Cancer (CTRC# 13-0054)
        Description
        This Phase 1/2 study is designed to evaluate the safety and effectiveness of two new drugs, LEE011 and BYL719, when combine individually and together with an old drug, letrozole, when treating advanced ER-positive breast cancer. The primary objective is to identify the best dose of LEE011 and BYL719 to use when combined with letrozole. The study will enroll approximately 300 patients from at least 32 cancer centers in the USA, Australia, France, China, Israel, Italy, and Spain. In addition to other conditions for enrollment, eligible female patients are postmenopausal, have ER-positive, HER2-negative advanced breast cancer. Patients who have a history of more than 1 prior chemotherapy regimen, brain metastases, pancreatitis, impaired cardiac function, diabetes mellitus or other severe medical conditions may not be eligible to enroll.
        Contact
        210-450-5798
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   Tamoxifen, Letrozole, Anastrozole, or Exemestane With or Without...
        Protocol No.
        HSC20110363H
        Official Title
        S1007 - A Phase III, Randomized Clinical Trial of Standard Adjuvant Endrocrine Therapy +/- Chemotherapy in Patients with 1-3 Positive Nodes, Hormone Receptor-Positive and HER2-Negative Breast Cancer with Recurrence Score (RS) of 25 or Less
        Description
        The purpose of this study is studying whether giving tamoxifen citrate, anastrozole, letrozole, or exemestane works better with or without chemotherapy when treating patients with breast cancer. The results of this study will show whether giving tamoxifen citrate, anastrozole, letrozole, or exemestane is more effective when taken with combination chemotherapy. Estrogen can cause the growth of breast cancer cells. Hormone therapy, such as tamoxifen citrate, may fight breast cancer by blocking the use of estrogen by the tumor cells. Drugs such as anastrozole, letrozole, and exemestane may fight breast cancer by lowering the amount of estrogen the body makes. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from reproducing. The primary objective is to determine the effect of the treatment in invasive disease-free survival (DFS) of women with node-positive breast cancer treated with endocrine therapy with vs without chemotherapy. The study will enroll 9,400 participants from many cancer centers in the US. In addition to other conditions for enrollment, women with a diagnosis of invasive breast cancer, 1 to 3 positive lymph nodes, estrogen receptor  and/or progesterone receptor positive, and HER-2 negative.  Eligible patients have had surgery and completed radiotherapy, if it was recommended.
        Contact
        210-450-5798
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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    •   Cervix

      •   Determinants of HPV vaccination for Hispanic parents from the...
        Protocol No.
        HSC20140358H
        Official Title
        Determinants of HPV vaccination for Hispanic parents from the Texas-Mexico border
        Description
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   RTOG 1203 A Randomized Phase III Study of Standard vs IMRT Pelvic Radiation...
        Protocol No.
        HSC20130196H
        Official Title
        RTOG 1203 A Randomized Phase III Study of Standard vs IMRT Pelvic Radiation for Post-Operative Treatment of Endometrial and Cervical Cancer (TIME-C) (CTRC#13-0004)
        Description
        This Phase III study evaluates two different methods of radiation, comparing the side effects and the effectiveness, when used as treatment for endometrial and cervical cancer after surgery. The primary objective is to evaluate and compare the acute gastrointestinal side effects of IMRT vs standard radiotherapy. The study will enroll approximately 281 patients many cancer centers in the US. In addition to other conditions for enrollment, eligible patients have endometrial or cervical cancer, have undergone a hysterectomy, and are otherwise in good health. Patients who have a history of bladder control problems, prior radiation to the pelvis, active inflammatory bowel disease, cardiac history, infection, prior treatment with platinum-based chemotherapy, or insufficient liver function may not be eligible to enroll.
        Contact
        210-450-5924
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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    •   Colon

      •   A Phase III Trial of 6 Versus 12 Treatments of Adjuvant FOLFOX Plus...
        Protocol No.
        HSC20150182X
        Official Title
        A Phase III Trial of 6 Versus 12 Treatments of Adjuvant FOLFOX Plus Celecoxib or Placebo for Patients with Resected Stage III Colon Cancer (CTMS# 14-2011)
        Description
        Drugs used in chemotherapy, such as oxaliplatin, leucovorin calcium, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Celecoxib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether giving oxaliplatin, leucovorin calcium, and fluorouracil is more effective with or without celecoxib in treating colon cancer. PURPOSE: This randomized phase III trial is studying giving oxaliplatin, leucovorin calcium, and fluorouracil together to compare how well they work when given together with or without celecoxib in treating patients with stage III colon cancer previously treated with surgery.   OBJECTIVES: Primary To compare disease-free survival of patients with resected stage III colon cancer treated with adjuvant FOLFOX chemotherapy comprising oxaliplatin, fluorouracil, and leucovorin calcium with versus without celecoxib. Secondary To contribute to an international prospective pooled analysis comparing disease-free survival of patients treated with these regimens. To compare overall survival at 3 years of patients treated with these regimens. To contribute to an international prospective pooled analysis comparing disease-free survival of patients treated with 6 versus 12 courses of FOLFOX chemotherapy. To assess toxicities of celecoxib as maintenance adjuvant therapy in these patients. To assess differences in cardiovascular-specific events in patients treated with versus without celecoxib. To evaluate differences in toxicities, particularly cumulative peripheral neuropathy, in patients treated with 6 versus 12 courses of FOLFOX chemotherapy. OUTLINE: This is a multicenter study. Patients are stratified according to number of positive lymph nodes* (1-3 vs 4 or more) and concurrent regular low-dose of aspirin (yes vs no). Patients are randomized to 1 of 4 treatment arms. NOTE: *Patients with N1c-only disease (i.e., no positive nodes but N1c disease by AJCC 7) should be stratified to 1-3 nodes.
        Contact
        210-450-5798
        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 study is designed to evaluate   hydroxychloroquine (HCQ) with vorinostat the safety and antitumor activity of   this drug combination in advanced cancer patients. The primary objective is to determine   the best dose and evaluate the safety and effectiveness of this drug   combination. The study will enroll   approximately 48 from one cancer center in San Antonio. In addition to other conditions   for enrollment, eligible patients have cancer that has not improved or has   come back after prior treatment but are otherwise in good health. After identifying   the best dose is identified, only patients with advanced renal cell cancer   and colorectal cancer will be enrolled. Patients who have a history of prior   treatment with vorinostat, hepatitis or active infections, inability to take   oral medication, gastrointestinal disorder that affects complete digestion or   other severe medical conditions may not be eligible to enroll.  
        Contact
        210-450-5798
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   Modulation of Autophagy: A Clinical Study of Vorinostat Plus...
        Protocol No.
        HSC20150178H
        Official Title
        Modulation of Autophagy: A Clinical Study of Vorinostat Plus Hydroxychloroquine Versus Regorafenib in Refractory Metastatic Colorectal Cancer (mCRC) Patients (CTMS# 14-2015)
        Description
        The investigators will give VOR 400 mg PO daily and HCQ 600 mg PO daily in 4-week cycles. Patients will require imaging up to 6 weeks prior to enrollment and will be assessed for measureable evidence of mCRC. This will be a randomized, controlled phase II clinical trial of patients with histological documentation of metastatic colorectal cancer, who have received locally and currently approved standard therapies, excluding RGF. Patients will be randomized 1:1 to RGF or VOR/HCQ (see schema below). Also, crossover is optional after first progression on the initial therapy, and based on physician discretion and in the best interest of the patient. If crossover is not done, then the patient will be off study and can go on to receive other treatments.
        Contact
        210-450-5798
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   S1406, Randomized Phase II Study of Irinotecan and Cetuximab With or Without...
        Protocol No.
        HSC20150273X
        Official Title
        S1406, Randomized Phase II Study of Irinotecan and Cetuximab With or Without Vemurafenib in BRAF Mutant Metastatic Colorectal Cancer (CTMS# 14-2023)
        Description
        This randomized phase II trial studies how well irinotecan hydrochloride and cetuximab with or without vemurafenib works in treating patients with colorectal cancer that has spread to nearby tissue or lymph nodes, that has spread to other places in the body, or cannot be removed by surgery. Irinotecan hydrochloride and vemurafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as cetuximab, may block the ability of tumor cells to grow and spread. It is not yet known whether irinotecan hydrochloride and cetuximab are more effective with or without vemurafenib in treating colorectal cancer.
        Contact
        210-450-5798
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   SWOG S0820, Adenoma and Second Primary Colorectal Cancer Prevention Trial...
        Protocol No.
        HSC20130412H
        Official Title
        S0820 - A Double Blind Placebo-Controlled Trial of Eflornithine and Sulindac to Prevent Recurrence of High Risk Adenomas and Second Primary Colorectal Cancers in Patients with Stage 0-III Colon Cancer, Phase III - Preventing Adenomas of the Colon with Eflornithine and Sulindac (PACES) (CTRC#13-0036)
        Description
        The study is designed to investigate whether eflornithine, sulindac or both are effective in preventing or delaying adenomas and second primary colorectal cancers in patients previously treated for Stages 0 through III colon cancer. The primary objective is to assess whether eflornithine and/or sulindac are effective in reducing the recurrence rate at 3 years. The study will enroll approximately 1340 participants from hundreds of cancer centers in the US. In addition to other conditions for enrollment, eligible patients have a history of stage 0-III colon cancer that was surgically removed up to 1 year previously; rectosigmoid cancers are eligible if no prior radiation therapy, no evidence of cancer by colonoscopy exam at time of study entry, and able to take oral medications. Patients who have a history of uncontrolled hypertension or gastric/duodenal ulcer within past year or other medical conditions may not be eligible to enroll.
        Contact
        210-450-5798
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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    •   Esophagus

      •   A Two Part, Phase 1, Multi-Center, Open-Label Study of DKN-01 in Combination...
        Protocol No.
        HSC20140189H
        Official Title
        A Two Part, Phase 1, Multi-Center, Open-Label Study of DKN-01 in Combination with Weekly Paclitaxel; Arm A: A Dose-Escalation Study in Patients with Relapsed or Refractory Esophageal Cancer or Gastro-Esophageal Junction Tumors; Arm B: An Expansion Cohort in Patients with Relapsed or Refractory Esophageal Cancer or Gastro-Esophageal Junction Tumors
        Description
        A study to evaluate the safety and tolerability of DKN-01 in combination with weekly paclitaxel in participants with refractory/recurrent esophageal or gastro-esophageal junction cancer Part A is a Dose-Escalation Study in Participants with Relapsed or Refractory Esophageal Cancer or Gastro-Esophageal Junction Tumors. Part B is an Expansion Cohort in Participants with Relapsed or Refractory Esophageal Cancer or Gastro-Esophageal Junction Tumors
        Contact
        210-450-5798
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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    •   Hodgkin's Lymphoma

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

      •   An Open-Label, Non-Randomized, Multicentre, Comparative, Phase I Study to...
        Protocol No.
        HSC20150093H
        Official Title
        An Open-Label, Non-Randomized, Multicentre, Comparative, Phase I Study to Determine the Pharmacokinetics, Safety and Tolerability of AZD9291 Following A Single Oral Dose to Patients with Advanced Solid Tumours and Normal Hepatic Function or Mild or Moderate Hepatic Impairment
        Description
        This is a 2-part study in patients with advanced solid tumours. Part A will investigate the pharmacokinetics (PK) of AZD9291 in patients with mild or moderate hepatic impairment compared to patients with normal hepatic function; Part B will allow any patient with mild or moderate hepatic impairment or normal hepatic function, who completes Part A, continued access to AZD9291 after the PK phase and will provide additional safety data.
        Contact
        210-450-5798
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   AREN03B2 Renal Tumors Classification, Biology and Banking Study
        Protocol No.
        HSC20070394X
        Official Title
        AREN03B2 Renal Tumors Classification, Biology and Banking Study
        Description
        This research trial studies kidney tumors in younger patients. Collecting and storing samples of tumor tissue, blood, and urine from patients with cancer to study in the laboratory may help doctors learn more about changes that occur in deoxyribonucleic acid (DNA) and identify biomarkers related to cancer.
        Contact
        210-562-9149
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   COG 9442: National Wilm''s Tumor Study #5 Late Effects
        Protocol No.
        HSC19960123H
        Official Title
        COG 9442: National Wilm''s Tumor Study #5 Late Effects
        Description
        National Wilm''s Tumor Study #5 Late Effects
        Contact
        210-562-9149
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   Everolimus vs Nothing as Treatment for Kidney Cancer After Kidney Surgery
        Protocol No.
        HSC20110362H
        Official Title
        S0931 - EVEREST: EVErolimus for Renal Cancer Ensuing Surgical Therapy, A Phase III Study
        Description
        The purpose of this study is to see how well everolimus works as a prevention treatment for kidney cancer patients who have undergone surgery to remove all or part of a kidney. The primary objective is to determine if everolimus works better than taking nothing for preventing kidney cancer from coming back after surgery. The study will enroll 1170 participants from many cancer centers in the US. In addition to other conditions for enrollment, patients have a diagnosis of renal cell or clear cell kidney cancer but no evidence of cancer in other parts of the body.  Eligible patients have recovered from the kidney surgery and have not received any other treatment for their cancer.  Eligible patients are able to take oral medications and do not have any digestive problem that would affect how well a drug is digested.  Patients are not eligible if they have uncontrolled diabetes, impaired liver function, or impaired breathing function.
        Contact
        210-450-5798
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   Viral Reporters to Determine Circulating Tumor Cells Level and Viability in...
        Protocol No.
        HSC20140294
        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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    •   Leukemia, other

      •   AALL1131, A Phase III Randomized Trial for Newly Diagnosed High Risk...
        Protocol No.
        HSC20120250X
        Official Title
        AALL1131, A Phase III Randomized Trial for Newly Diagnosed High Risk B-precursor Acute Lymphoblastic Leukemia (ALL) Testing Clofarabine (IND# 73789, NSC# 606869) in the Very High Risk Stratum
        Description
        This randomized phase III trial is studying how well combination chemotherapy works in treating young patients with newly diagnosed high-risk acute lymphoblastic leukemia. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) and giving the drugs in different doses and in different combinations may kill more cancer cells.
        Contact
        210-562-9149
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   ACCL0934, A Randomized Trial of Levofloxacin to Prevent Bacteremia in...
        Protocol No.
        HSC20110480X
        Official Title
        ACCL0934, A Randomized Trial of Levofloxacin to Prevent Bacteremia in Children Being Treated for Acute Leukemia (AL) or Undergoing Hematopoietic Stem Cell Transplantation (HSCT)
        Description
        This randomized phase III trial studies how well levofloxacin works in preventing infection in young patients with acute leukemia receiving chemotherapy or undergoing stem cell transplant. Giving antibiotics may be effective in preventing or controlling early infection in patients receiving chemotherapy or undergoing stem cell transplant for acute leukemia. It is not yet known whether levofloxacin is effective in preventing infection.
        Contact
        210-562-9149
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   ACCL1033, A Comprehensive Approach to Improve Medication Adherence in...
        Protocol No.
        HSC20130254X
        Official Title
        ACCL1033, A Comprehensive Approach to Improve Medication Adherence in Pediatric ALL
        Description
        This randomized phase III trial studies compliance to a mercaptopurine treatment intervention compared to standard of care in younger patients with acute lymphoblastic leukemia in remission. Assessing ways to help patients who have acute lymphoblastic leukemia to take their medications as prescribed may help them in taking their medications more consistently and may improve treatment outcomes.
        Contact
        210-562-9149
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   COG AALL05B1, A Children''s Oncology Group Protocol for Collecting and...
        Protocol No.
        HSC20070100X
        Official Title
        COG AALL05B1, A Children''s Oncology Group Protocol for Collecting and Banking Relapsed Acute Lymphoblastic Leukemia Research Specimens
        Description
        RATIONALE: Collecting and storing samples of bone marrow and blood from patients with cancer to study in the laboratory may help doctors learn more about cancer and help predict the recurrence of cancer. PURPOSE: This research study is collecting and storing samples of bone marrow and blood from patients with relapsed acute lymphoblastic leukemia or relapsed non-Hodgkin lymphoma.
        Contact
        210-562-9149
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   TREX2''s Role in the Development of MDS and AML
        Protocol No.
        HSC20140441H
        Official Title
        TREX2''s Role in the Development of MDS and AML
        Description
        To determine the expression level of TREX2 and other DNA repair genes (BRCA1, BRAC2, FANCB, FANCD2, ERCC1, MRE11a, MSH2, RAD51 , ERCC4, XRCC6, and XRCC5) in blood and bone marrow from patients with Myelodysplastic Syndrome and Acute Myeloid Leukemia. In addition, blood from healthy volunteers will also be evaluated for expression levels of TREX2 and other DNA repair genes This minimal risk study involves the collection of blood samples by finger stick, heel stick, ear stick, or venipuncture from healthy, non-pregnant adults who weigh at least 110 pounds and the amounts drawn will not exceed 550 ml in an 8 week period and collection will not occur more frequently than 2 times per week.
        Contact
        210-450-5798
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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    •   Lip, Oral Cavity and Pharynx

      •   Texas Cancer Diagnostics Pipeline: Oral Cancer Subproject
        Protocol No.
        HSC20110108H
        Official Title
        Texas Cancer Diagnostics Pipeline: Oral Cancer Subproject
        Description
        This program combines the expertise of the leading group in the development of programmable nano-bio-chip (PNBC) sensors for clinical applications from Rice University alongside experts in pathology, oral medicine and oral cancer from the Universities of Texas Health Science Center at Houston and San Antonio.  We propose here an accelerated clinical translation effort to evaluate the use of a PNBC sensor approach to validate biomarkers for the diagnosis, prognosis and monitoring of potentially malignant lesions (PML) of the oral cavity at the point-of- are. The PNBC to be developed through this program will allow for the analysis of cellular samples obtained from a minimally invasive brush biopsy sample. The cell suspensions collected in this manner will allow for the simultaneous quantification of cell morphometric data and expression of molecular biomarkers of malignant potential in an automated manner using refined image analysis algorithms based on pattern recognition techniques and advanced statistical methods. This novel NBC approach could turn around biopsy results in a matter of minutes as compared to days for traditional pathology methods. These efforts are unique in scope in terms of their capacity to combine nano science and engineering, state-of-the-art imaging methods, microfluidics concepts for sample processing, and multiplexed biomarker panel analysis for the development of integrated test ensembles suitable for cancer screening and diagnostic testing.
        Contact
        210-567-4973
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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    •   Liver

      •   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
        View all Cancer Therapy & Research Center clinical trials
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      •   HepaSphere/Quadrasphere Microspheres for Delivery of Doxorubicin for the...
        Protocol No.
        HSC20120330H
        Official Title
        Phase 3 Prospective, Randomized, Blinded and Controlled Investigation of Hepasphere/Quadrasphere Microspheres for Delivery of Doxorubicin for the Treatment of Hepatocellular Cancer
        Description
        The purpose of this study is to evaluate overall survival in patients treated with HepaSphere/Quadrasphere compared to conventional transarterial chemoembolization with particle PVA. Eligible adult patients have a diagnosis of hepatocellular cancer and are not currently or previously treated with chemo- or radiation therapy or sorafenib. Estimated Enrollment: 520 from multiple cancer centers in the US and Europe.
        Contact
        210-567-5564
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   Pharmacokinetics of Oral Alisertib (MLN8237) in Adult Patients With Advanced...
        Protocol No.
        HSC20140397H
        Official Title
        Pharmacokinetics of Oral Alisertib (MLN8237) in Adult Patients With Advanced Solid Tumors or Relapsed/Refractory Lymphoma With Varying Degrees of Hepatic Function
        Description
        The drug being tested in this study is called alisertib. Alisertib is being tested to assess how it is processed by the body in participants with advanced solid tumors or relapsed/refractory lymphoma with varying degrees of liver function. This study will also assess laboratory results and safety. The study will enroll approximately 48 participants. Participants will be assigned to 1 of the 3 treatment groups based on the status of their liver function: Normal hepatic function (Total bilirubin ≤ upper limit of the normal range [ULN] and alanine aminotransferase [ALT] level ≤ ULN), moderate hepatic impairment (Total bilirubin > 1.5-3 x ULN and ALT level = Any), or severe hepatic impairment (Total bilirubin > 3 x ULN and ALT level = Any). All participants will be administered one 50 mg dose of alisertib on Day 1, Cycle 1. Alisertib will be administered again on Days 8 through 14 of Cycle 1, followed by a 14-day rest period. Doses administered on Days 8-14 will be 50, 30, or 20 mg of alisertib, depending on hepatic function. Alisertib may then be continued at the same dose as in Cycle 1, Days 8-14 in 21-day cycles (7 days of alisertib followed by a 14-day rest period) for up to 1 year (approximately 16 cycles). This multicenter trial will be conducted in USA only. The overall time to participate in this study is up to 13 months unless it is determined by the investigator, with agreement by the sponsor, that a participant would derive clinical benefit from continued treatment beyond 12 months. Participants will make up to 51 visits to the clinic including an end-of-study visit 30 days after the last dose of study drug for a follow-up assessment.
        Contact
        210-450-5798
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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    •   Lung

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

         

      •   A081105, Randomized Double Blind Placebo Controlled Study of Erlotinib or...
        Protocol No.
        HSC20150127X
        Official Title
        A081105, Randomized Double Blind Placebo Controlled Study of Erlotinib or Placebo in Patients with Completely Resected Epidermal Growth Factor Receptor (EGFR) Mutant Non-Small Cell Lung Cancer (CTMS# 14-2009)
        Description
        This randomized phase III trial studies how well erlotinib hydrochloride compared to placebo works in treating patients with stage IB-IIIA non-small cell lung cancer that has been completely removed by surgery. Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.   PRIMARY OBJECTIVES: I. To assess whether adjuvant therapy with erlotinib (erlotinib hydrochloride) will result in improved overall survival (OS) over placebo for patients with completely resected stage IB (>= 4 cm)-IIIA epidermal growth factor receptor (EGFR) mutant non-small cell lung cancer (NSCLC) (confirmed centrally) following complete resection and standard post-operative therapy. SECONDARY OBJECTIVES: I. To assess whether adjuvant therapy with erlotinib will result in improved disease free survival (DFS) over placebo for patients with completely resected stage IB (>= 4 cm)-IIIA EGFR mutant NSCLC (confirmed centrally) following complete resection and standard post-operative therapy, both overall and within the stage subgroups: IB and II/IIIA. II. To evaluate the safety profile of erlotinib in the adjuvant setting. III. To assess whether adjuvant therapy with erlotinib will result in improved DFS rate at 2 years, and OS rate at 5 years over placebo for patients with completely resected stage IB (>= 4cm)-IIIA EGFR mutant NSCLC (confirmed centrally) following complete resection and standard post-operative therapy, both overall and within the stage subgroups: IB and II/IIIA. IV. To assess the primary and secondary objectives in all randomized patients, regardless of central confirmation of the EGFR mutant status. OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM I: Patients receive erlotinib hydrochloride orally (PO) once daily (QD) on days 1-21. Treatment repeats every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity. ARM II: Patients receive placebo PO QD on days 1-21. Treatment repeats every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 6 months for 5 years.
        Contact
        210-450-5798
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   A151216, Adjuvant Lung Cancer Enrichment Marker Identification and...
        Protocol No.
        HSC20150120X
        Official Title
        A151216, Adjuvant Lung Cancer Enrichment Marker Identification and Sequencing Trial (ALCHEMIST) (CTMS# 14-2008)
        Description
        This research trial studies genetic testing in screening patients with stage IB-IIIA non-small cell lung cancer that has been or will be removed by surgery. Studying the genes in a patient''s tumor cells may help doctors select the best treatment for patients that have certain genetic changes. Patients undergo collection of blood and tissue samples for EGFR and ALK testing via direct sequencing and fluorescence in situ hybridization (FISH). Patients that have had surgery prior to pre-registration will submit samples from the previous surgery for testing. After completion of study, patients that are not enrolled on either A081105 or E4512 are followed up every 6 months for 5 years.
        Contact
        210-450-5798
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   Dose Escalating Study of IMGN853 for Patients with Cancer
        Protocol No.
        HSC20120333H
        Official Title
        A Phase 1, First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of IMGN853 in Adults with Ovarian Cancer and other FOLR1- Positive Solid Tumors (CTRC# 12-0064)
        Description
        The purpose of this study is to determine the best dose of IMGN853 to use when treating people with cancer, in particular, ovarian cancer, that has spread to other areas in the body and/or cannot be removed surgically. The primary objective is to identify the side effects and right dose of IMGN853 and to find out if IMGN853 works as a treatment for patients with specific types of cancer. The study will enroll approximately 64 participants from no more than 6 cancer centers in the US. In addition to other conditions for enrollment, eligible adult patients are those whose tumors have become worse in spite of treatment and who otherwise are in good health.  The tumors of all potential participants will be tested for the presence of a specific protein and results of the test will help determine if the patient is a candidate for treatment with IMGN853. Likely tumors are those that began in the ovary or fallopian tube, but some types of lung cancer and kidney cancer might also have this protein present. Participants cannot have a history of bone marrow transplant, cornea (eye) problems, active infection, significant heart history, multiple sclerosis or nerve damage.
        Contact
        210-450-5798
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   E4512, A Phase III Double-Blind Trial for Surgically Resected Early Stage...
        Protocol No.
        HSC20150129X
        Official Title
        E4512, A Phase III Double-Blind Trial for Surgically Resected Early Stage Non-Small Cell Lung Cancer: Crizotinib versus Placebo for Patients with Tumors Harboring the Anaplastic Lymphoma Kinase (ALK) Fusion Protein (CTMS# 14-2010)
        Description
        This randomized phase III trial studies how well crizotinib works and compares it to placebo in treating patients with stage IB-IIIA non-small cell lung cancer that has been removed by surgery and has a mutation in a protein called ALK. Mutations, or changes, in ALK can make it very active and important for tumor cell growth and progression. Tumors with this mutation may respond to treatments that target the mutation, such as crizotinib. Crizotinib may stop the growth of tumor cells by blocking the ALK protein from working. It is not yet known if crizotinib may be an effective treatment for treating non-small cell lung cancer with an ALK fusion mutation.   PRIMARY OBJECTIVES: I. To evaluate whether adjuvant therapy with crizotinib will result in improved overall survival (OS) over placebo for patients with stage IB >= 4 cm, II and IIIA, anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC) following surgical resection. SECONDARY OBJECTIVES: I. To evaluate and compare disease-free survival (DFS) associated with crizotinib and placebo. II. To evaluate the safety profile of crizotinib when given in the adjuvant therapy setting. III. To collect tumor tissue and blood specimens for future research. OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM A: Patients receive crizotinib orally (PO) twice daily (BID) on days 1-21. Treatment repeats every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity. ARM B: Patients receive placebo PO BID on days 1-21. Treatment repeats every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3 months for 2 years, every 6 months for 3 years, and then yearly for 5 years.
        Contact
        210-450-5798
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   Hypofractionated Image-Guided Radiation Therapy (IGRT) for patients with...
        Protocol No.
        HSC20120093H
        Official Title
        Phase III Randomized Study of Standard versus Accelerated Hypofractionated Image-Guided Radiation Therapy (IGRT) in Patients with Stage II-III Non-Small Cell Lung Cancer and Poor Performance Status
        Description
        The study is designed to determine whether an accelerated course of hypofractionated radiation therapy with daily image guidance and motion assessment/control will allow more effective treatment of poor performance status patients with stage II-III non-small cell lung cancer (NSCLC), who would benefit from local therapy compared to standard radiation therapy (60 Gy in 2 Gy per fraction). The primary objective is to compare one type of radiation therapy with another type in order to determine if one is better than the other.    The study will enroll approximately 226 patients from 5 cancer centers in Texas. In addition to other conditions for enrollment, eligible patients have state II or III NSCLC and are otherwise in good health. Patients who have a history of radiotherapy to the area that overlaps the area to be treated may not be eligible to enroll.
        Contact
        210-450-5924
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   Open-Label, Multicenter Phase 1 Study of Mogamulizumab (KW-0761) in...
        Protocol No.
        HSC20150316H
        Official Title
        Open-Label, Multicenter Phase 1 Study of Mogamulizumab (KW-0761) in Combination with Docetaxel as Second-Line Treatment in Subjects with Non-Small Cell Lung Cancer (NSCLC) (CTMS# 14-2020)
        Description
        The purpose of this study is to evaluate the safety of mogamulizumab in combination with docetaxel in adult subjects with locally advanced or metastatic non-small cell lung cancer.
        Contact
        210-450-5798
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   S1400 - Phase II/III Biomarker-Driven Master Protocol for Second Line...
        Protocol No.
        HSC20150302X
        Official Title
        S1400 - Phase II/III Biomarker-Driven Master Protocol for Second Line Therapy of Squamous Cell Lung Cancer
        Description
        This screening and multi-sub-study randomized phase II/III trial will establish a method for genomic screening of similar large cancer populations followed by assigning and accruing simultaneously to a multi-sub-study "Master Protocol". The type of cancer trait (biomarker) will determine to which sub-study, within this protocol, a participant will be assigned to compare new targeted cancer therapy, designed to block the growth and spread of cancer, or combinations to standard of care therapy with the ultimate goal of being able to approve new targeted therapies in this setting. In addition, the protocol includes a "non-match" sub-study which will include all screened patients not eligible for any of the biomarker-driven sub-studies. This sub-study will compare a non-match therapy to standard of care also with the goal of approval.
        Contact
        210-450-5798
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   S1403, A Randomized Phase II/III Trial of Afatinib Plus Cetuximab Versus...
        Protocol No.
        HSC20150454X
        Official Title
        S1403, A Randomized Phase II/III Trial of Afatinib Plus Cetuximab Versus Afatinib Alone in Treatment-Niave Patients with Advanced, EGFR Mutation Positive Non-Small Cell Lung Cancer (NSCLC) (CTMS# 15-2060)
        Description
        This randomized phase II/III trial studies how well afatinib dimaleate with cetuximab works and compares it with afatinib dimaleate alone in treating patients with newly diagnosed stage IV or recurrent (has come back), epidermal growth factor receptor (EGFR) mutation positive non-small cell lung cancer. Afatinib dimaleate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as cetuximab, may block tumor growth in different ways by targeting certain cells. It is not yet known whether afatinib dimaleate is more effective when given alone or with cetuximab in treating patients with non-small cell lung cancer.
        Contact
        210-450-5798
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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    •   Lymphoid Leukemia

      •   A Phase I Trial of SGN-CD70A In Patients with CD70-Positive Malignancies
        Protocol No.
        HSC20140423H
        Official Title
        A Phase I Trial of SGN-CD70A In Patients with CD70-Positive Malignancies
        Description
        This study will examine the safety profile of SGN-CD70A. The study will test increasing doses of SGN-CD70A given every 3 weeks to small groups of patients. The goal is to find the highest dose of SGN-CD70A that can be given to patients without causing unacceptable side effects. The pharmacokinetics and antitumor activity of SGN-CD70A will also be evaluated.
        Contact
        210-450-5798
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   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
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        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
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      •   E1912: A Randomized Phase III Study of Ibrutinib (PCI-32736)-Based Therapy...
        Protocol No.
        HSC20140340X
        Official Title
        E1912: A Randomized Phase III Study of Ibrutinib (PCI-32736)-Based Therapy vs Standard Fludarabine, Cyclophosphamide, and Rituximab (FCR) Chemoimmunotherapy in Untreated Younger Patients with Chronic Lymphocytic Leukemia (CLL)
        Description
        PRIMARY OBJECTIVES: I. To evaluate the ability of Ibrutinib-based induction therapy to prolong progression free survival (PFS) compared to standard fludarabine phosphate, cyclophosphamide, and rituximab (FCR) chemoimmunotherapy for younger patients with chronic lymphocytic leukemia (CLL). SECONDARY OBJECTIVES: I. Evaluate overall survival (OS) of patients based on treatment arm. II. Monitor and assess toxicity of treatment with Ibrutinib-based induction relative to standard FCR chemotherapy. III. To compare quality of life (QOL) in CLL patients during the first 6 months of treatment among patients receiving Ibrutinib-based induction therapy relative to standard FCR chemoimmunotherapy. IV. To compare QOL over the long-term in CLL patients receiving continuous therapy using Ibrutinib to that of CLL patients who completed FCR therapy. V. Determine the effect of pretreatment clinical and biological characteristics (e.g. disease stage, immunoglobulin heavy chain variable region gene [IGHV] mutation status, fluorescent in situ hybridization [FISH]) on clinical outcomes (e.g. complete response, PFS) of the different arms. VI. Determine if the minimal residual disease (MRD) status as assessed by flow cytometry at different time points during and after treatment is an effective surrogate marker for prolonged PFS and overall survival. VII. Compare the genetic abnormalities and dynamics of intra-clonal architecture of CLL patients before and after treatment with chemoimmunotherapy (CIT) and non-CIT approaches and explore relationships with treatment resistance. VIII. Explore the effects of FCR and Ibrutinib-based therapy on T-cell immune function. IX. Conduct confirmatory validation genotyping of single nucleotide polymorphisms (SNPs) associated with the efficacy and toxicity of fludarabine-based therapy as in a prior Eastern Cooperative Oncology Group (ECOG) genome-wide association study (GWAS) analysis in the E2997 trial. X. Evaluate the ability of prognostic model that incorporates clinical and biologic characters to predict a response to therapy and clinical outcome (PFS, OS). XI. Evaluate signaling networks downstream of the B-cell receptor in patients receiving Ibrutinib-based therapy. XII. Collect relapse samples to study mechanisms of resistance to both FCR and Ibrutinib-based therapy. OUTLINE: Patients are randomized to 1 of 2 treatment arms.
        Contact
        210-450-5798
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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    •   Multiple Myeloma

      •   A Phase 1a/1b Multicenter, Single-Arm, Open-Label, Dose-Escalation Study to...
        Protocol No.
        HSC20150341H
        Official Title
        A Phase 1a/1b Multicenter, Single-Arm, Open-Label, Dose-Escalation Study to Determine the Maximum Tolerated Dose, Safety, and Preliminary Activity of Oral ACY-241 Alone and in Combination With Pomalidomide and Low-Dose Dexamethasone in Patients With Relapsed or Relapsed-and-Refractory Multiple Myeloma (CTMS# 15-2041)
        Description
        This is a phase 1a/1b, multicenter, single-arm, open-label, dose escalation study to determine the maximum tolerated dose (MTD) and evaluate the safety and preliminary antitumor activity of ACY-241 for oral administration as monotherapy and in combination therapy with orally administered pomalidomide and low-dose dexamethasone in eligible patients with relapsed or relapsed-and-refractory multiple myeloma (MM).
        Contact
        210-450-5798
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   A Phase 1B Multicenter, Open-Label, Dose-Escalation Study to Determine the...
        Protocol No.
        HSC20140438H
        Official Title
        A Phase 1B Multicenter, Open-Label, Dose-Escalation Study to Determine the Maximum Tolerated Dose, Safety, and Antitumor Activity of an Alternative Liquid Formulation of ACY-1215 (Ricolinostat) in Combination with Pomalidomide and Low-Dose Dexamethasone in Patients with Relapsed-and-Refractory Multiple Myeloma
        Description
        To determine the maximum tolerated dose (MTD), if present, and to identify a recommended dose and schedule of ricolinostat administered in an alternative liquid formulation (ALF) (10mg/mL) in combination with pomalidomide and low-dose dexamethasone in patients with relapsed or relapsed-and-refractory multiple myeloma. To evaluate the safety and any anti-tumor activity of ricolinostat administered in combination with pomalidomide and dexamethasone as treatment for patients with relapsed or relapsed-and-refractory multiple myeloma, including duration of response. To assess the Pharmacokinetics and Pharmacodynamics of all three medications administered in combination, and to assess the Pharmacokinetics of ricolinostat and pomalidomide specifically. An evaluation of the relationship between response and biomarkers relating to interacellular acetylation may also be completed.
        Contact
        210-450-5798
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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    •   Multiple sites

      •   A Phase I/II, Open Label, Multicenter Study of the Safety and Efficacy of...
        Protocol No.
        HSC20150421H
        Official Title
        A Phase I/II, Open Label, Multicenter Study of the Safety and Efficacy of LAG525 Single Agent and in Combination with PDR001 Administered to Patients with Advanced Malignancies (CTMS# 15-2054)
        Description
        This study is to characterize the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and anti-tumor activity of LAG525 as a single agent and in combination with PDR001 to adult patients with solid tumors. The study consists of a dose escalation phase (Ib) to determine the maximum tolerated dose (MTD) or recommended Phase 2 dose (RP2D) for LAG525 as a single agent and in combination with PDR001, and a dose expansion phase (II) which will characterize treatment of LAG525 as a single agent and in combination with PDR001 at the MTD or RP2D.
        Contact
        210-450-5798
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   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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      •   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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    •   Myeloid and Monocytic Leukemia

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

      •   IMGN529 as Treatment for Patients with Advanced Non-Hodgkin''s Lymphoma
        Protocol No.
        HSC20130331H
        Official Title
        A Phase I, Multi-Center, Open-Label Study of IMGN529 Administered Intravenously in Adult Patients with Relapsed or Refractory Non-Hodgkin''s Lymphoma and Chronic Lymphocytic Leukemia (CTRC# 13-0025)
        Description
        This Phase 1 study is designed to evaluate the safety and tolerability of IMGN529 when used to treat patients with relapsed or refractory non-Hodgkin''s lymphoma (NHL). The study will enroll approximately 46 patients from at least 5 cancer centers in the US and Switzerland. In addition to other conditions for enrollment, eligible patients have relapsed or refractory non-Hodgkin''s lymphoma that has not improved or has come back after prior treatment and are otherwise in good health. Patients who have a history of allogeneic stem cell transplantation or known lymphoma involving the central nervous system, including brain metastases, or other severe medical conditions may not be eligible to enroll.
        Contact
        210-450-5798
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   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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    •   Other Digestive Organ

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

      •   An Open-Label, Dose Escalation, Phase 1, First-In-Human Study of TAK-659 in...
        Protocol No.
        HSC20150255H
        Official Title
        An Open-Label, Dose Escalation, Phase 1, First-In-Human Study of TAK-659 in Adult Patients with Advanced Solid Tumors and Lymphoma Malignancies (CTMS# 14-2013)
        Description
        his study is an open-label, multicenter, phase 1, dose escalation study of TAK-659 in adult patients with advanced solid tumor and lymphoma malignancies. This study will be the first to administer TAK-659 to humans. The patient population during dose escalation (Part A) will consist of adults previously diagnosed with any form of a solid tumor or lymphoma for which standard, curative, or life-prolonging treatment does not exist or is no longer effective. This first-in-human (FIH) study will include 2 dose expansion cohorts in refractory and/or relapsed CLL and DLBCL (Part B) following completion of dose escalation (Part A).
        Contact
        210-450-5798
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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    •   Other Respiratory and Intrathoracic Organs

      •   A Randomized, Double-Blind Phase 2 Study of Ruxolitinib or Placebo in...
        Protocol No.
        HSC20140479H
        Official Title
        A Randomized, Double-Blind Phase 2 Study of Ruxolitinib or Placebo in Combination with Pemetrexed/Cisplatin and Pemetrexed Maintenance for Initial Treatment of Subjects with Nonsquamous Non-Small Cell Lung Cancer That Is Stage IIIB, Stage IV, or Recurrent
        Description
        The study consists of an open-label, safety run-in (consisting of 1 to 4 cohorts of 9 subjects each), to confirm the safety of ruxolitinib in combination with pemetrexed/cisplatin in subjects with nonsquamous non-small cell lung cancer (NSCLC) that is Stage IIIB, Stage IV, or recurrent. Subjects in the safety run-in will receive open-label ruxolitinib and pemetrexed and cisplatin. In the second part of the study, subjects will be enrolled and randomized to receive pemetrexed and cisplatin (open-label) and either ruxolitinib or placebo in a blinded manner. The dose of ruxolitinib administered will be determined from the data produced in the safety run-in phase. Treatment will consist of repeating 21-day cycles. Subjects will receive infusions of pemetrexed and cisplatin on Day 1 of each cycle and ruxolitinib/placebo will be self-administered during the entire cycle. Maintenance therapy with ruxolitinib or placebo in combination with pemetrexed, based on the original treatment assignment, will be allowed for subjects eligible for maintenance therapy.
        Contact
        210-450-5798
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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    •   Pancreas

      •   A Phase 2 Trial of MLN0264 in Previously Treated Patients With Advanced or...
        Protocol No.
        HSC20140455H
        Official Title
        A Phase 2 Trial of MLN0264 in Previously Treated Patients With Advanced or Metastatic Pancreatic Adenocarcinoma Expressing Guanylyl Cyclase C (GCC)
        Description
        The drug being tested in this study is called MLN0264. MLN0264 is being tested to treat tumors in people who have metastatic adenocarcinoma of the pancreas expressing guanylyl cyclase C (GCC). This study will assess tumor size reduction in patients who are administered MLN0264. The study will enroll 42 to 81 patients. All participants will be administered MLN0264 at 1.8 mg/kg as a single, 30-minute, intravenous (IV) infusion on Day 1 of each 3-week treatment cycle, followed by a rest period of 20 days. Participants will continue to receive MLN0264 for up to 1 year or until disease progression or unacceptable toxicity occurs. This multi-centre trial will be conducted worldwide. The overall time to participate in this study is approximately 19 months. Participants will make 3 to 6 visits to the clinic per treatment cycle, an end-of-treatment visit will occur 30 days after the last dose of study medication, and follow-up assessments will occur every 12 weeks until death or 6 months after the last patient completes treatment - whichever occurs first.
        Contact
        210-450-5798
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   M402 plus gemcitabine compared to gemcitabine alone as treatment for...
        Protocol No.
        HSC20120151H
        Official Title
        A Phase I/II, Two-Part, Multicenter Study to Evaluate the Safety and Efficacy of M402 in Combination with nab-Paclitaxel and Gemcitabine in Patients with Metastatic Pancreatic Cancer (CTRC# 12-11)
        Description
        This is a Phase I/II study comparing gemcitabine alone to gemcitabine plus M402 as treatment for metastatic pancreatic cancer.  The primary objective is to compare overall survival in patients treated with M402 in combination with gemcitabine compared with gemcitabine alone. The study will enroll approximately 138 patients from 6 cancer centers in the US. In addition to other conditions for enrollment, eligible patients are those whose pancreatic cancer has become spread but has not been treated with chemotherapy and who are otherwise in good health. Adult patients who have a history of treatment with gemcitabine, blood clotting disorders, needing anti-platelet therapy, coronary artery disease, active infection including hepatitis B or C may not be eligible to enroll.
        Contact
        210-450-5798
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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    •   Prostate

      •   Biomarkers and clinical parameters associated with Gleason score upgrading
        Protocol No.
        HSC20140367H
        Official Title
        Biomarkers and clinical parameters associated with Gleason score upgrading
        Description
        This study involves the collection of blood samples by finger stick, heel stick, ear stick, or venipuncture from unhealthy adults, pregnant adults or children.  Considering the person’s age, weight, and health, the collection procedure, the amount of blood to be collected, and the frequency with which it will be collected the blood samples intended for this study are minimal risk.
        Contact
        210-567-0178
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   Castration Compared to Castration Plus Metformin as First Treatment for...
        Protocol No.
        HSC20110273H
        Official Title
        Phase II, Randomized,Placebo Controlled, Double Blind, Prospective Study of Castration Compared to Castration Plus Metformin as First Line Treatment for Patients with Advanced Prostate Cancer (IDD# 10-21)
        Description
        This is a Phase II double blind study comparing castration alone vs castration plus metformin. Double blind means neither the patient nor the doctor know whether the study participant is getting metformin or the placebo.  The primary objective is to determine if adding metformin to castration is better or different compared to castration alone. The study will enroll 94 patients at the CTRC. In addition to other conditions for enrollment, eligible patients have metastatic prostate cancer that require castration therapy by using either an LHRH analogue or surgical castration and are otherwise in good health. Men who have a history of inadequate heart, kidney, or liver function, serious infections, alcohol abuse, or lactic/metabolic acidosis may not be eligible to enroll.
        Contact
        210-450-5798
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   Dynamic Multi-Cohort Prediction Modeling of Prostate Biopsy Outcome
        Protocol No.
        HSC20150050H
        Official Title
        Dynamic Multi-Cohort Prediction Modeling of Prostate Biopsy Outcome
        Description
        Dynamic Multi-Cohort Prediction Modeling of Prostate Biopsy Outcome
        Contact
        210-450-0754
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   Hormonal Therapy plus Radiation Therapy as Treatment for Prostate Cancer
        Protocol No.
        HSC20130062H
        Official Title
        RTOG 0924 Androgen Deprivation Therapy and High Dose Radiotherapy With or Without Whole-Pelvic Radiotherapy in Unfavorable Intermediate or Favorable High Risk Prostate Cancer: A Phase III Randomized Trial
        Description
        The purpose of this study is determine which type of anti-hormonal therapy and radiation therapy will result in an improvement in survival in patients with “unfavorable” intermediate risk or “favorable” high risk prostate cancer.  The risk is the possibility or chances of the prostate cancer coming back after being treated. The primary objective is to see which treatment improves the duration of survival. The study will enroll 2,580 participants from many cancer centers in the US. In addition to other conditions for enrollment, men who were diagnosed with prostate cancer within the past 180 days and have no evidence of lymph node involvement by CT scan or MRI within the past 90 days may be enrolled. Men are not eligible for this study if the prostate or testes have been surgically removed. Men who have already been treated with brachytherapy or radiation to the pelvis or hormonal therapy are not enrolled. Patients with a history of other cancers may not be eligible.
        Contact
        210-450-5924
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   Identification of Protein and Genetic Biomarkers of Prostate Cancer and Risk...
        Protocol No.
        HSC20020380H
        Official Title
        Identification of Protein and Genetic Biomarkers of Prostate Cancer and Risk Factors for Progression of Disease
        Description
        The purpose of this study is to identify genetic variants that predict progression of prostate cancer.
        Contact
        210-567-0178
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   Improving Prostate Biopsy Efficiency: The Finasteride Challenge Test
        Protocol No.
        HSC20100352H
        Official Title
        Improving Prostate Biopsy Efficiency: The Finasteride Challenge Test
        Description
        The investigators will propose a novel method to improve prostate cancer screening with PSA, using a 3-month treatment with finasteride (vs. placebo), a drug used to treat Benign Prostatic Hyperplasia (BPH) and proven to reduce a man''s risk of developing prostate cancer. The investigators will also examine three additional promising tests that may further improve diagnosis of prostate cancer.
        Contact
        210-567-1995
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   Prostate Wash Epithelial Cell Repository (PWER) (CTRC#12-0070)
        Protocol No.
        HSC20120262H
        Official Title
        Prostate Wash Epithelial Cell Repository (PWER) (CTRC#12-0070)
        Description
        This tissue bank will store epithelial cell samples from prostate biopsies and measure Prostate Specific Antigen (PSA) and Prostate Specific Membrane Antigen (PSMA) in the urine specimens for future scientific research studies.  The stored specimens will be used for research investigating the causes of prostate diseases, the methods for improving diagnosis, and highly aggressive forms from less aggressive forms of prostate cancers.
        Contact
        210-450-0754
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   REASSURE-Radium-223 alpha Emitter Agent in Safety Study in mCRPC popUlation...
        Protocol No.
        HSC20150164H
        Official Title
        REASSURE-Radium-223 alpha Emitter Agent in Safety Study in mCRPC popUlation for long-teRm Evaluation
        Description
        REASSURE
        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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      •   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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      •   AEWS1031 A Phase III Randomized Trial of Adding...
        Protocol No.
        HSC20110367X
        Official Title
        AEWS1031 A Phase III Randomized Trial of Adding Vincristine-topotecan-cyclophosphamide to Standard Chemotherapy in Initial Treatment of Non-metastatic Ewing Sarcoma
        Description
        This randomized phase III trial studies combination chemotherapy to see how well it works compared to combination chemotherapy with topotecan hydrochloride in treating patients with non-metastatic extracranial Ewing sarcoma. Drugs used in chemotherapy, such as vincristine sulfate, doxorubicin hydrochloride, cyclophosphamide, ifosfamide, etoposide, and topotecan hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. It is not yet known whether combination chemotherapy is more effective with topotecan hydrochloride in treating Ewing sarcoma.
        Contact
        210-562-9149
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   YONDELIS® (trabectedin) as Treatment for Locally Advanced or Metastatic Soft...
        Protocol No.
        HSC20130148H
        Official Title
        A Multicenter, Open-Label Single-Arm Study of YONDELIS® (trabectedin) for Subjects With Locally Advanced or Metastatic Soft Tissue Sarcoma Who Have Relapsed or Are Refractory to Standard of Care Treatment (CTRC#12-0107)
        Description
        The purpose of this study is to facilitate access to trabectedin for eligible, previously treated patients with soft tissue sarcoma, excluding liposarcoma and leiomyosarcoma (L-type sarcoma), who cannot be expected to benefit from currently available therapeutic options but who may benefit from treatment with trabectedin. The safety profile of trabectedin will be evaluated to further assess the potential risks of trabectedin treatment. The study will enroll approximately 3,000 patients from at least 36 cancer centers in the US, Canada, and Israel. In addition to other conditions for enrollment, eligible patients are at least 15 years old, have soft tissue sarcoma excluding liposarcoma and leiomyosarcoma (L-type soft tissue sarcoma) that cannot be surgically removed and is in an advanced stage or has spread. Patients who have symptomatic viral hepatitis or chronic liver disease, a significant uncontrolled cardiac condition, active infection, or other severe medical conditions may not be eligible to enroll.
        Contact
        210-450-5798
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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    •   Thyroid

      •   A Phase 1 Study of CBL0137 in Patients with Metastatic or Unresectable...
        Protocol No.
        HSC20130328H
        Official Title
        A Phase 1 Trial of CBL0137 In patients With Metastatic or Unresectable Advanced Solid Neoplasms or Refractory Lymphomas (CTRC# 13-0031)
        Description
        This Phase 1 study is designed to determine the best dose of CBL0137 to use when treating patients with metastatic or unresectable advanced solid tumors or lymphoma. The study will enroll up to 48 patients from at least 2 cancer centers in the US. In addition to other conditions for enrollment, eligible patients have cancer that has not improved or has come back after prior treatment and are otherwise in good health. Patients who have a history of active infection, cancer involving the central nervous system, a particular EKG abnormality or other serious medical conditions may not be eligible to enroll.
        Contact
        210-450-5798
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   A Phase 1, Dose Escalation Study of MLN7243 in Adult Patients with Advanced...
        Protocol No.
        HSC20140098H
        Official Title
        A Phase I, Open-Label, Multicenter, Dose Escalation Study to Assess the Safety and Tolerability of MLN7243, an Inhibitor of Ubiquitin-Activating Enzyme (UAE), in Adult Patients With Advanced Solid Tumors
        Description
        This Phase 1 is designed to evaluate safety, tolerability, and antitumor effectiveness of MLN7243 in adult patients with advanced cancer. The primary objective is to identify the best dose of MLN7243 to use in treating cancer. The study will enroll approximately 119 patients from at least 2 cancer centers in the US. In addition to other conditions for enrollment, eligible patients have advanced cancer for which no standard therapy is available and otherwise in good health. Patients who have a history of cardiac impairment, brain metastases, active infection, or other severe medical conditions may not be eligible to enroll.
        Contact
        210-450-5798
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   A 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 I, Multicenter, Open-Label Dose Escalation and Expansion Study of...
        Protocol No.
        HSC20150289H
        Official Title
        A Phase I, Multicenter, Open-Label Dose Escalation and Expansion Study of PCA062, Administered Intravenously In Adult Patients With pCAD-Positive Tumors (CTMS# 14-2019)
        Description
        A first-in-human study using PCA062 in patients with p-CAD positive solid tumors.
        Contact
        210-450-5798
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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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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      •   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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      •   Crizotinib in cancer patients with liver function impairment
        Protocol No.
        HSC20120328H
        Official Title
        A Phase 1 Study to Evaluate the Effect of Hepatic Impairment on the Pharmacokinetics and Safety of Crizotinib in Advanced Cancer Patients (CTRC#12-0059 )
        Description
        This Phase I study is designed to evaluate the potential effect of hepatic impairment on the pharmacokinetic profile and safety of crizotinib in advanced cancer patients. The primary objective is to compare the amount of drug in the blood between the different groups of patients with various degrees of liver function. The study will enroll approximately 50 from at least 4 cancer centers in the US. In addition to other conditions for enrollment, eligible patients have advanced cancer with mild, moderate or severe liver dysfunction as well as patients with normal liver function. Patients who have a history of uncontrolled ascites, prior treatment with crizotinib, spinal cord compression, congestive heart failure, severe lung disease, infection, or other severe medical conditions may not be eligible to enroll.
        Contact
        210-450-5798
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   Modular Phase II Study to Link Targeted Therapy to Patients with Pathway...
        Protocol No.
        HSC20150166X
        Official Title
        Modular Phase II Study to Link Targeted Therapy to Patients with Pathway Activated Tumors: Module 6 - BGJ398 for Patients with Tumors with FGFR Genetic Alterations (CTMS# 14-2025)
        Description
        The purpose of this signal seeking study is to determine whether treatment with BGJ398 demonstrates sufficient efficacy in select FGFR pathway-regulated solid tumors and/or hematologic malignancies to warrant further study.
        Contact
        210-450-5798
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   Phase 1 Study of Carfilzomib in Patients with Advanced Cancers and Various...
        Protocol No.
        HSC20130446H
        Official Title
        An Open-Label, Single Arm, Phase 1 Study of the Pharmacokinetics and Safety of Carfilzomib in Subjects with Advanced Malignancies and Varying Degrees of Hepatic Impairment (CTRC#13-0043)
        Description
        The purpose of this study is to compare the safety and effectiveness of carfilzomib, a drug that has not been FDA approved and is still in investigational status. The objective is to measure the amount of the drug in the blood at specific times following dosing. This study is being done in people with varying degrees of liver function to see if they respond differently to the study drug. The study will enroll approximately 40 from at least 3 cancer centers in the US. In addition to other conditions for enrollment, eligible patients have advanced cancer, either solid tumor or hematologic malignancy as well as chronic liver impairment that has been stable with no sudden worsening within one month prior to enrollment. Patients who have a history of inadequate kidney function, congestive heart failure or other serious heart condition, brain metastasis, chronic infection, or other severe medical conditions may not be eligible to enroll.
        Contact
        210-450-5798
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   Phase I Study to Evaluate the Effect of LDE225 on the Pharmacokinetics of...
        Protocol No.
        HSC20130180H
        Official Title
        A Phase Ib, Multi-Center, Two Parallel Group, Open-Label, Drug-Drug Interaction Study to Assess the Effect of LDE225 on the Pharmacokinetics of Bupropion and Warfarin in Patients with Advanced Solid Tumors (CTRC# 12-0111)
        Description
        This Phase I study is designed to evaluate a possible drug-drug interaction between LDE225 on warfarin and bupropion in patients with advanced cancer.   The primary objective is to determine if LDE225 has a drug interaction with bupropion and warfarin.    The study will enroll approximately 60 patients at several cancer centers in the US. In addition to other conditions for enrollment, eligible patients have advanced cancer that has become worse in spite of therapy and are otherwise in good health. Patients who have a history of brain metastases, bleeding disorders, neuromuscular disorders, infection including hepatitis, or are already on bupropion (Wellbutrin), warfarin (Coumadin), or vitamin K therapy may not be eligible to enroll.
        Contact
        210-450-5798
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   Phase Ib study of BGJ398 in combination with BYL719 in patients with...
        Protocol No.
        HSC20140022H
        Official Title
        A phase Ib, open-label study of oral BGJ398 in combination with oral BYL719 in adult patients with select advanced solid tumors
        Description
        This Phase 1 study is designed to evaluate the combination of BGJ398 and BYL719. in patients with cancers that have a specific genetic mutation. The objective of the study is to determine the safety and effectiveness of the combination of BGJ398 and BYL719. The primary objective of the study is to evaluate the safety and effectiveness of the combination of BGJ398 with BYL719 in patients whose tumors express mutations to PIK3CA 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 with diabetes mellitus, particularly those requiring treatment with insulin, may not be eligible. The study will enroll approximately 55 patients from at least 27 cancer centers in the US, Europe, and Asia.
        Contact
        210-450-5798
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   Prognostic and predictive markers in patients with advanced metastatic tumors
        Protocol No.
        HSC20130219H
        Official Title
        Numeration and Single-Cell Molecular Profiling of Circulating Tumor Cells as Prognostic and Predictive Marker In Patients with Advanced Metastatic Tumors (CTRC#13-0001)
        Description
        This study will research possible associations between circulating tumor cells (CTC) quantities or gene profile characteristics and clinical outcomes. The primary objective is to obtain blood samples from participants over an 8-week period for research analysis.  The study will enroll approximately 200 patients at the CTRC. In addition to other conditions for enrollment, eligible patients have advanced metastatic cancer.
        Contact
        210-450-5798
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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        Learn More About This Study

         

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

      •   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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      •   Repository for Bladder Cancer
        Protocol No.
        HSC20120159H
        Official Title
        Repository for Bladder 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
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

      •   S1314, A Randomized Phase II Study of Co-Expression Extrapolation (COXEN)...
        Protocol No.
        HSC20150027X
        Official Title
        S1314, A Randomized Phase II Study of Co-Expression Extrapolation (COXEN) with Neoadjuvant Chemotherapy for Localized, Muscle-Invasive Bladder Cancer (CTMS# 14-2007)
        Description
        The primary focus of this study is to see if looking at tumor biomarkers using a program called coexpression extrapolation or "COXEN" may predict a patient''s response to chemotherapy before surgery.   The COXEN program will not select a patient''s therapy, but the type of chemotherapy that he/she will receive will be randomly decided. The patient''s response to chemotherapy will be used to test the usefulness of the COXEN program, which is the main goal of this trial. Other potential tests to predict a patient''s response to chemotherapy will also be evaluated. In this study, the patient may receive the treatment in Arm 1 (gemcitabine and cisplatin) or the treatment in Arm 2 [methotrexate, vinblastine, doxorubicin, cisplatin, and filgrastim (or pegfilgrastim)]. There will be about 184 people taking part in this study (92 in each arm).
        Contact
        210-450-5798
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
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      •   Standard or Extended Pelvic Lymph Node Surgery as Part of Treatment for...
        Protocol No.
        HSC20110462H
        Official Title
        S1011: A Phase III Surgical Trial to Evaluate the Benefit of a Standard Versus an Extended Pelvic Lymphadenectomy Performed at Time of Radial Cystectomy for Muscle Invasive Urothelial Cancer (IDD# 11-46)
        Description
        This purpose of this study is to determine whether standard surgery to remove the pelvic lymph nodes works the same, better, or worse than extended pelvic lymph node removal when treating patients with surgery for invasive bladder cancer. The primary objective is to compare the difference, if there is any, in the length of time it takes bladder cancer to come back and/or spread to other parts of the body in patients who have been diagnosed with muscle-invasive bladder cancer who are undergoing surgery to remove the entire bladder.  Study participants will have either extended pelvic lymph node removal or standard pelvic lymph node removal. The study will enroll 620 participants from many cancer centers in the US. In addition to other conditions for enrollment, patients have urothelial cancer of the bladder and require surgery for definitive treatment.  Eligible patients have not had prior surgery to remove part of the bladder or any pelvic lymph node s. Eligible patients have not had prior pelvic radiation therapy.
        Contact
        210-567-1995
        Locations
        UT Health Science Center
        CTRC Clinical Trials Website
        View all Cancer Therapy & Research Center clinical trials
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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
        View all Cancer Therapy & Research Center clinical trials
        Learn More About This Study

         

  •   Diagnostic

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

       

  •   Genetics

    •   Development of potential response to radiation phenotypes (RRPs) for genetic...
      Protocol No.
      HSC20130198H
      Official Title
      Development of potential response to radiation phenotypes (RRPs) for genetic studies: a pilot study
      Description
      Although cancer treatment with radiation can produce high cure rates, adverse effects often result from radiotherapy. Therefore, the major objective of this pilot project is to develop potential response to radiation phenotypes (RRPs) and to explore their genetic basis.
      Contact
      210-258-9532
      Locations
      UT Health Science Center
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  •   Healthy Subjects Needed

    •   ANUR1131, Music Video for AYA-Parent Communication and Resilience.
      Protocol No.
      HSC20110484H
      Official Title
      ANUR1131, Music Video for AYA-Parent Communication and Resilience.
      Description
      We are trying to find out if the music video and a parent support programs can be used to help decrease distress, enhance family communication, and improve quality of life during cancer treatment.
      Contact
      210-562-9149
      Locations
      UT Health Science Center
      Learn More About This Study

       

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

       

    •   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

       

    •   Phase I Study of BAX69 for Patients with Solid Tumors
      Protocol No.
      HSC20120141H
      Official Title
      A Phase 1 Open-Label Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BAX69 in Subjects with Malignant Solid Tumors (CTRC# 12-03)
      Description
      The purpose of this study is to determine the best dose of BAX69 to use when treating people with cancer that has spread to other areas in the body and/or cannot be removed surgically. The primary objective is to identify the side effects of BAX69 and to find out if BAX69 works as a treatment for cancer patients. The study will enroll approximately 32 to 44 participants from a several cancer centers in the US. In addition to other conditions for enrollment, eligible patients are those whose tumors have become worse in spite of treatment and who are otherwise in good health.  Adult patients who have a history of cancer involving the central nervous system (brain), recent heart problems, uncontrolled blood pressure problems, recent major surgery, inflammatory arthritis, or hepatitis may not be eligible to enroll.
      Contact
      210-450-5798
      Locations
      UT Health Science Center
      Learn More About This Study

       

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

       

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

       

  •   Heart, Vascular and Blood

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

       

    •   Epidemiology of MRI-confirmed Cardiac Late Effects in Anthracycline Exposed...
      Protocol No.
      HSC20140173H
      Official Title
      Epidemiology of MRI-confirmed Cardiac Late Effects in Anthracycline Exposed Survivors of Childhood Cancer
      Description
      Epidemiology of MRI-confirmed Cardiac Late Effects in Anthracycline Exposed Survivors of Childhood Cancer
      Contact
      210-567-0854
      Locations
      UT Health Science Center
      Learn More About This Study

       

  •   Men's Health

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

       

  •   Minority Studies

    •   Persistent tanning as a novel adaptation to ultraviolet radiation in...
      Protocol No.
      HSC20130334H
      Official Title
      Persistent tanning as a novel adaptation to ultraviolet radiation in Indigenous Americans
      Description
      A study of tanning response in Mexican American individuals. We want to learn whether an individual’s ability to tan and the length of time that tan persists is related to Native American ancestry and specific genes. We are testing the hypothesis that increased tanning may have evolved in Native Americans to adapt to intense ultraviolet radiation (UVR) in tropical and subtropical regions. We are interested in tanning response because it is a risk factor for skin cancer and vitamin D deficiency, a risk factor for a number of diseases.
      Contact
      210-258-9470
      Locations
      UT Health Science Center
      Learn More About This Study

       

    •   Increasing Access of Latinas into Breast Cancer Clinical Trials
      Protocol No.
      HSC20090165H
      Official Title
      Increasing Access of Latinas into Breast Cancer Clinical Trials
      Description
      The study hypothesizes that Latinas who receive an interactive, technology-infused communications intervention—using a culturally relevant computer video, a tailored brochure and a community health worker (CHW)—will increase self-efficacy and informed decision-making to enter breast cancer clinical trials, and they will have 15% higher acceptance rate than control group (N=112). The study randomizes Latina breast cancer patients from the CTRC to an intervention or usual care control group. The intervention group will receive three components: 1) a culturally sensitive and individually tailored, 20-minute computer-based video; 2) a bilingual, low literacy brochure that encourages patients to communicate with family and friends; and 3) support from a community health worker. The usual care control group will receive usual-care NCI breast cancer clinical trial information materials.
      Contact
      210-562-6513
      Locations
      UT Health Science Center
      Learn More About This Study

       

  •   Women's Health

    •   A Phase 0, Investigator Initiated Study, Evaluating the Impact of COX2...
      Protocol No.
      HSC20130426H
      Official Title
      A Phase 0, Investigator Initiated Study, Evaluating the Impact of COX2 Inhibition on Human Sera Biomarkers from Obese Subjects (CTRC#13-0041)
      Description
      The study is to determine that some postmenopausal, overweight breast cancer patients who use common anti-inflammatory drugs like aspirin or ibuprofen have significantly lower breast cancer recurrence rates. It is open to any healthy, cancer-free woman who are post-menopausal and not currently taking aspirin or omega-3 fatty acids.
      Contact
      210-450-5798
      Locations
      UT Health Science Center
      Learn More About This Study

       

    •   ENLACE: A Promotora-Led Physical Activity Intervention Trial for Latinas in...
      Protocol No.
      HSC20110460H
      Official Title
      ENLACE: A Promotora-Led Physical Activity Intervention Trial for Latinas in Texas
      Description
      A research study of the promotion of physical activity. Latino women in the United States have among the highest rates of overweight and sedentary lifestyle. Both of these are important risk factors for heart disease, diabetes, high cholesterol and some cancers. Increasing daily physical activity can prevent weight gain and improve overall health and mental well-being. In partnership with communities, the researchers hope to determine the most effective methods for promoting physical activity among women.
      Contact
      210-562-6514
      Locations
      UT Health Science Center
      Learn More About This Study