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UTHSCSA Find-A-Study
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FindAStudy :: Human Studies @ UTHSCSA
289  Studies 163  Researchers 29  Categories
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× Result: 79 studies found using "cancer"
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  •   Cancers and Other Neoplasms

    •   Brain & Nervous System

      •   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
        Locations
        UT Health Science Center
        Learn More About This Study

         

      •   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
        Learn More About This Study

         

      •   ANBL0032, Phase III Randomized Study of Chimeric Antibody 14.18 (Ch14.18) in...
        Protocol No.
        HSC20090466H
        Official Title
        ANBL0032, Phase III Randomized Study of Chimeric Antibody 14.18 (Ch14.18) in High Risk Neuroblastoma Following Myeloablative Therapy and Autologous Stem Cell Rescue
        Description
        Locations
        UT Health Science Center
        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
        Learn More About This Study

         

    •   Breast

      •   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
        Locations
        UT Health Science Center
        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
        Learn More About This Study

         

      •   A Pre-surgical Clinical Trial of Therapy with S-equol in Women with Triple...
        Protocol No.
        HSC20150231H
        Official Title
        A Pre-surgical Clinical Trial of Therapy with S-equol in Women with Triple Negative Breast Cancer (CTMS# 14-2018)
        Description
        After a baseline breast tumor core biopsy, eligible women with triple negative breast cancer (ER- alpha, PR and HER-2 receptor negative) will be treated with S-equol at a dose of 50 mg twice daily for a period of about 14 days (10-21 day range). After completion of treatment, a second breast tumor sample will be obtained to compare molecular changes between the two specimens. The second pathology specimen may be from the surgical resection of the breast tumor, or a repeat core needle biopsy, if no further surgery is planned. The primary endpoint will be the absolute change in the Ki67, which is a validated marker of tumor proliferation in breast cancer. Secondary endpoints will include assessment of total ER-beta and pY36 levels as measured by immunohistochemical staining and their correlation with S-equol effects. Further treatment after surgical resection or second core needle biopsy of the tumor will be guided by tumor size, nodal status and other standard parameters, and is at the discretion of the treating physician. The Investigator hypothesizes that S-equol will cause a measurable decrease in Ki-67 in estrogen receptor beta expressing triple negative breast cancers, indicating its potential efficacy in this tumor type.
        Contact
        210-450-5798
        Locations
        UT Health Science Center
        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

         

      •   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
        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
        Learn More About This Study

         

      •   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
        Learn More About This Study

         

    •   Cervix, Other female genital

      •   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
        Learn More About This Study

         

    •   Colon

      •   A Phase II, Multicenter, Randomized, Double-Blind Study to Evaluate the...
        Protocol No.
        HSC20140356H
        Official Title
        A Phase II, Multicenter, Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of RO5520985 Plus Folfox Versus Bevacizumab Plus Folfox in Patients with Previously Untreated Metastatic Colorectal Cancer
        Description
        This is a Phase II multicenter, randomized, parallel arms, double-blind study of RO5520985 to evaluate the efficacy and safety of RO5520985 in combination with oxaliplatin, folinic acid, and 5-fluorouracil (mFOLFOX-6) versus bevacizumab (Avastin) plus mFOLFOX-6 in patients previously untreated metastatic colorectal cancer. The study consists of an safety run-in open-label, single-arm part (Part I) and a randomized, parallel-arms, double-blind part (Part II). During Part I at least 6 eligible patients will be exposed to 2000 mg Q2W RO5520985 + mFOLFOX-6 in order to confirm the dose and schedule that will be used in Part II. All patients in Part I will receive induction and maintenance therapy as described for patients in the experimental arm of Part II. Upon completion of Part I, eligible patients will be randomized in a ratio of 1:1 to receive either mFOLFOX-6 +RO5520985 or mFOLFOX-6 + Avastin. Study treatment, induction and maintenance, will be given on Day 1 of each 14-day cycle. Induction therapy will consist of up to 8 cycles of mFOLFOX-6 plus either Avastin or RO5520985. During maintenance therapy, patients will receive 5-FU and folinic acid plus either RO5520985 or Avastin for up to 24 months or until disease progession, unacceptable toxicity, Investigator decision or consent withdrawal.
        Contact
        210-450-5798
        Locations
        UT Health Science Center
        Learn More About This Study

         

      •   Modulation of Autophagy: A Clinical Study of Vorinostat Plus...
        Protocol No.
        HSC20150178H
        Official Title
        Modulation of Autophagy: A Clinical Study of Vorinostat Plus Hydroxychloroquine Versus Regorafenib in Refractory Metastatic Colorectal Cancer (mCRC) Patients (CTMS# 14-2015)
        Description
        The investigators will give VOR 400 mg PO daily and HCQ 600 mg PO daily in 4-week cycles. Patients will require imaging up to 6 weeks prior to enrollment and will be assessed for measureable evidence of mCRC. This will be a randomized, controlled phase II clinical trial of patients with histological documentation of metastatic colorectal cancer, who have received locally and currently approved standard therapies, excluding RGF. Patients will be randomized 1:1 to RGF or VOR/HCQ (see schema below). Also, crossover is optional after first progression on the initial therapy, and based on physician discretion and in the best interest of the patient. If crossover is not done, then the patient will be off study and can go on to receive other treatments.
        Contact
        210-450-5798
        Locations
        UT Health Science Center
        Learn More About This Study

         

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

         

    •   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
        Learn More About This Study

         

    •   Kidney

      •   An Open-Label, Non-Randomized, Multicentre, Comparative, Phase I Study to...
        Protocol No.
        HSC20150093H
        Official Title
        An Open-Label, Non-Randomized, Multicentre, Comparative, Phase I Study to Determine the Pharmacokinetics, Safety and Tolerability of AZD9291 Following A Single Oral Dose to Patients with Advanced Solid Tumours and Normal Hepatic Function or Mild or Moderate Hepatic Impairment
        Description
        This is a 2-part study in patients with advanced solid tumours. Part A will investigate the pharmacokinetics (PK) of AZD9291 in patients with mild or moderate hepatic impairment compared to patients with normal hepatic function; Part B will allow any patient with mild or moderate hepatic impairment or normal hepatic function, who completes Part A, continued access to AZD9291 after the PK phase and will provide additional safety data.
        Contact
        210-450-5798
        Locations
        UT Health Science Center
        Learn More About This Study

         

      •   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
        Locations
        UT Health Science Center
        Learn More About This Study

         

      •   Everolimus vs Nothing as Treatment for Kidney Cancer After Kidney Surgery
        Protocol No.
        HSC20110362H
        Official Title
        S0931 - EVEREST: EVErolimus for Renal Cancer Ensuing Surgical Therapy, A Phase III Study
        Description
        The purpose of this study is to see how well everolimus works as a prevention treatment for kidney cancer patients who have undergone surgery to remove all or part of a kidney. The primary objective is to determine if everolimus works better than taking nothing for preventing kidney cancer from coming back after surgery. The study will enroll 1170 participants from many cancer centers in the US. In addition to other conditions for enrollment, patients have a diagnosis of renal cell or clear cell kidney cancer but no evidence of cancer in other parts of the body.  Eligible patients have recovered from the kidney surgery and have not received any other treatment for their cancer.  Eligible patients are able to take oral medications and do not have any digestive problem that would affect how well a drug is digested.  Patients are not eligible if they have uncontrolled diabetes, impaired liver function, or impaired breathing function.
        Contact
        210-450-5798
        Locations
        UT Health Science Center
        Learn More About This Study

         

    •   Leukemia, other

      •   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
        Learn More About This Study

         

    •   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
        Learn More About This Study

         

    •   Liver

      •   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
        Learn More About This Study

         

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

         

    •   Lung

      •   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
        Learn More About This Study

         

      •   Hypofractionated Image-Guided Radiation Therapy (IGRT) for patients with...
        Protocol No.
        HSC20120093H
        Official Title
        Phase III Randomized Study of Standard versus Accelerated Hypofractionated Image-Guided Radiation Therapy (IGRT) in 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
        Learn More About This Study

         

    •   Lymphoid Leukemia

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

         

    •   Multiple Myeloma

      •   A Phase 1a/1b Multicenter, Single-Arm, Open-Label, Dose-Escalation Study to...
        Protocol No.
        HSC20150341H
        Official Title
        A Phase 1a/1b Multicenter, Single-Arm, Open-Label, Dose-Escalation Study to Determine the Maximum Tolerated Dose, Safety, and Preliminary Activity of Oral ACY-241 Alone and in Combination With Pomalidomide and Low-Dose Dexamethasone in Patients With Relapsed or Relapsed-and-Refractory Multiple Myeloma (CTMS# 15-2041)
        Description
        Locations
        UT Health Science Center
        Learn More About This Study

         

      •   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
        Contact
        210-450-5798
        Locations
        UT Health Science Center
        Learn More About This Study

         

      •   A Phase 1B/2 Multi-Center Open Label, Dose-Escalation Study to Determine the...
        Protocol No.
        HSC20140261H
        Official Title
        A Phase 1B/2 Multi-Center Open Label, Dose-Escalation Study to Determine the Maximum Tolerated Dose, Safety, and Efficacy of Acy-1215 in Combination with Pomalidomide and Low-Dose Dexamethasone in Patients with Relapsed-and-Refractory Multiple Myeloma
        Description
        Phase 1b: To evaluate the side effects and determine the best dose of ACY-1215 in combination with Pomalidomide and low-dose dexamethasone in patients with relapsed-and-refractory multiple myeloma. Phase 2: To determine the overall response rate of ACY-1215 in combination with Pomolidomide and low-dose dexamethasone in patients with relapsed-and-refractory multiple myeloma
        Contact
        210-450-5798
        Locations
        UT Health Science Center
        Learn More About This Study

         

      •   This is a two-part study. The Phase I part of the study is a dose-escalation...
        Protocol No.
        HSC20120168H
        Official Title
        A Phase I/IIa Multi-Dose Escalation Study of BT062 in Combination with Lenalidomide or Pomalidomide and Dexamethasone in Subjects with Relapsed or Relapsed/Refractory Multiple Myeloma (CTRC# 12-09)
        Description
        This is a two-part study. The Phase I part of the study is a dose-escalation study designed to evaluate the safety and tolerability of BT026 when used in combination with lenalidomide and dexamethasone.  The Phase II part of the study is designed to evaluate the effectiveness of the 3-drug combination when treating patients with relapsed or refractory multiple myeloma. The study will enroll up to 18 patients in Part 1 and up to 31 patients in Part 2 from 4 cancer centers in the US. In addition to other conditions for enrollment, eligible patients are those whose disease has become worse in spite of treatment and who are otherwise in good health. Eligible patients are able to swallow capsules and comply with taking oral medications. Adult patients who have a history of blood clots, active infection including hepatitis, uncontrolled hypertension, heart attack or other cardiac complications may not be eligible to enroll.
        Contact
        210-450-5798
        Locations
        UT Health Science Center
        Learn More About This Study

         

    •   Multiple sites

      •   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

         

      •   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
        Learn More About This Study

         

      •   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.  
        Locations
        UT Health Science Center
        Learn More About This Study

         

      •   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.
        Locations
        UT Health Science Center
        Learn More About This Study

         

      •   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
        Learn More About This Study

         

      •   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
        Learn More About This Study

         

      •   A Phase I, Multicenter, Open-Label Dose Escalation and Expansion Study of...
        Protocol No.
        HSC20150289H
        Official Title
        A Phase I, Multicenter, Open-Label Dose Escalation and Expansion Study of PCA062, Administered Intravenously In Adult Patients With pCAD-Positive Tumors (CTMS# 14-2019)
        Description
        Locations
        UT Health Science Center
        Learn More About This Study

         

      •   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
        Learn More About This Study

         

      •   ANUR1131, Music Video for AYA-Parent Communication and Resilience (CTRC#13-0023)
        Protocol No.
        HSC20110484H
        Official Title
        ANUR1131, Music Video for AYA-Parent Communication and Resilience (CTRC#13-0023)
        Description
        This randomized trial studies how well music therapy and parents'' education work in improving communication, emotional distress, and recovery in adolescents/young adult patients undergoing treatment for high-risk cancer and their parents. Making a music therapy video may improve communication, emotional distress, and recovery in younger patients undergoing treatment for cancer. It is not yet known whether music therapy and counseling for parents is more effective than information handouts for parents in improving communication and emotional distress in patients undergoing treatment for cancer.   OUTLINE: This is a multicenter study. Patients are stratified according to age in years (11-13 vs 14-17 vs 18-24). Parents are randomized to 1 of 2 intervention arms. ARM I: AYA patients undergo 60-minute sessions, delivered in a private setting during outpatient clinic visits or hospitalizations, within a 6-8 weeks period with board-certified music therapists. The music therapists help patients in brainstorming and lyric writing, singing and creatively exploring how AYA lyrics and structure of the selected music fit together, recording their song with a digital accompaniment track, completing video layout worksheets, taking and gathering photos or making drawings for the video, and viewing clip art and pictures on a computer. The music therapist then digitally formats, compiles, and transfers the AYA-developed music video to a DVD. When completed, the therapist shares the video with the AYA and offers the option of having a video "premiere." AYAs who choose a premiere select a date and time for the viewing and identify individuals they wish to attend. After the viewing, AYAs receive a copy of their DVD to keep. Parents'' presence and involvement during all sessions are directed by the AYAs. Parents receive 2 sessions over 15-60 minutes with a trained study team. During the first session, parents receive handouts of helpful website resources that have specific information to help parents support their AYAs. Team members also assure that parents know how to assess the sites. During the second session, parents receive audio-recorded, telephone-based contact by a trained nurse who asks them questions focusing on the content available on the provided website. The trained nurse also answers any questions parents may have. ARM II: AYA patients receive intervention as patients in arm I. Parents receive 3 tailored 60-minute sessions with a trained nurse intervener. Sessions are recorded to make sure study nurse delivers the sessions according to the study protocol. Study nurse provides support information to parents using the Robb''s Contextual Support Model, including Managing the Chaos: Self Care as the First Step to Caring for Your AYA, Relationship Support: How to Listen to and Encourage Your AYA to Talk; and Strategies for AYA Autonomy Support: Understanding AYA''s Ways of Coping. Session 3 content is also based on the Resilience in Illness model. Sessions are also tailored to parents'' needs, skills practice and/or role playing, and reflection on and reinforcement of learning. Parents receive written materials on tips and prescribed skills practice plans. AYA and parents complete questionnaires including Illness-Related Distress, Defensive Coping, Spiritual Perspective, Social Integration, Family Environment questionnaires, Hope-Derived Meaning, Self-Transcendence, Positive Coping, Resilience, Parent Distress, and Quality of Life at baseline, at 2 weeks after final session, and then at 90 days after final intervention session. Medical background, intensity of treatment rating scale, and family demographics are also collected.
        Locations
        UT Health Science Center
        Learn More About This Study

         

      •   Circulating Tumor Cells in Pediatric Solid Tumors
        Protocol No.
        HSC20150037H
        Official Title
        Circulating Tumor Cells in Pediatric Solid Tumors
        Description
        Locations
        UT Health Science Center
        Learn More About This Study

         

      •   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.
        Locations
        UT Health Science Center
        Learn More About This Study

         

      •   Dose Escalating Study of IMGN853 for Patients with Cancer
        Protocol No.
        HSC20120333H
        Official Title
        A Phase 1, First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of IMGN853 in Adults with Ovarian Cancer and other FOLR1- Positive Solid Tumors (CTRC# 12-0064)
        Description
        The purpose of this study is to determine the best dose of IMGN853 to use when treating people with cancer, in particular, ovarian cancer, that has spread to other areas in the body and/or cannot be removed surgically. The primary objective is to identify the side effects and right dose of IMGN853 and to find out if IMGN853 works as a treatment for patients with specific types of cancer. The study will enroll approximately 64 participants from no more than 6 cancer centers in the US. In addition to other conditions for enrollment, eligible adult patients are those whose tumors have become worse in spite of treatment and who otherwise are in good health.  The tumors of all potential participants will be tested for the presence of a specific protein and results of the test will help determine if the patient is a candidate for treatment with IMGN853. Likely tumors are those that began in the ovary or fallopian tube, but some types of lung cancer and kidney cancer might also have this protein present. Participants cannot have a history of bone marrow transplant, cornea (eye) problems, active infection, significant heart history, multiple sclerosis or nerve damage.
        Contact
        210-450-5798
        Locations
        UT Health Science Center
        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
        Locations
        UT Health Science Center
        Learn More About This Study

         

      •   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
        Learn More About This Study

         

      •   Improving Quality of Life Among Hispanic/Latino Breast, Colorectal &...
        Protocol No.
        HSC20110094H
        Official Title
        Improving Quality of Life Among Hispanic/Latino Breast, Colorectal & Prostate Cancer Survivors: A Randomized Control Trial of Patient Navigators Using the LIVESTRONG SurvivorCare Program
        Description
        Hispanic/Latinos (HL) are the largest and fastest-growing minority population in the nation. HLs generally have lower survival rates for most cancers, even after accounting for differences in age and stage distribution, which may reflect less access to timely, high-quality treatment. They also experience disproportionately higher health disparities in quality of care and access to care. The experience of cancer survivorship is often characterized by significant challenges. Despite these challenges and significant disparities observed among HLs, there is very limited knowledge of survivorship-related issues and priorities among HLs, specifically the effectiveness of using promotores/patient navigators (PN) in linking HL cancer survivors with unmet psychosocial needs to appropriate psychosocial services. The existing community-based infrastructure of the Lance Armstrong Foundation (LAF) LIVESTRONG Cancer Navigation Services (LCNS) PN program provides an excellent opportunity to evaluate its efficacy in improving QOL among HLs. This proposed 5-year Redes En Acción research study involves a mixed-methods approach that occurs in two phases across two distinct and diverse HL communities. Phase I will use a community-based participatory research (CBPR) approach to engage community-based partners that provide services to breast, colorectal and prostate HL cancer survivors. In this phase, the investigators will gather community partners for action-oriented group meetings at each site to present components and targets of the combined PN and LCNS PN program (PNLCNS). Through this CBPR approach to generate valuable community feedback, the investigators will enhance the role of the PN, develop and extend existing cooperative relationships to facilitate participant recruitment, and prepare community-based partners to disseminate and implement the PNLCNS program upon the established efficacy of the proposed randomized controlled trial (RCT) of Phase II. Phase II will test a RCT to evaluate the efficacy of a culturally tailored PNLCNS program on improving general and disease-specific quality of life (QOL) and treatment follow-up compliance among breast, colorectal and prostate HL cancer survivors. Phase II also will evaluate the extent to which intervention-associated improvements in these outcomes are mediated by targets of the PNLCNS program. The RCT involves a 2 X 4 randomized repeated measures design with experimental condition as the between-groups factor, and time-point (baseline/pre-randomization [T1]; post-PNLCNS [about 3-months post-T1; T2], and about 6- [T3] and about 12-months [T4] follow-up post-T2) as the within-groups factor; total follow-up is 15 months. The investigators will compare the effects of the PNLCNS and PN only conditions on QOL and treatment follow-up compliance in 300 (after attrition; n=100, Chicago and n=100, San Antonio) breast, colorectal and prostate HL cancer survivors with no evidence of metastatic disease. To understand the mechanisms by which the PNLCNS significantly impacts QOL and treatment compliance outcomes, the investigators also will examine changes in unmet cancer needs, communication with the medical team, health behaviors, psychological distress, worry, coping and general self-efficacy as potential mediators of the intervention effects. The investigators will also evaluate the extent to which other factors such as preparation for consultation and satisfaction with cancer care are associated with our QOL and treatment follow-up compliance outcomes. Study findings will fill a significant gap in our understanding of the extent to which PN programs and existing community-based resources targeting survivors can improve the QOL of a growing number of HL cancer survivors who experience an unequal burden of unmet needs after cancer treatment.
        Contact
        210-562-6502
        Locations
        UT Health Science Center
        Learn More About This Study

         

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

         

      •   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
        Learn More About This Study

         

      •   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.
        Locations
        UT Health Science Center
        Learn More About This Study

         

      •   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.
        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

         

      •   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.
        Locations
        UT Health Science Center
        Learn More About This Study

         

      •   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.
        Locations
        UT Health Science Center
        Learn More About This Study

         

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

         

      •   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
        Learn More About This Study

         

      •   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
        Locations
        UT Health Science Center
        Learn More About This Study

         

    •   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
        Learn More About This Study

         

    •   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
        Learn More About This Study

         

    •   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
        Learn More About This Study

         

      •   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
        Learn More About This Study

         

    •   Prostate

      •   Biomarkers and clinical parameters associated with Gleason score upgrading
        Protocol No.
        HSC20140367H
        Official Title
        Biomarkers and clinical parameters associated with Gleason score upgrading
        Description
        This study involves the collection of blood samples by finger stick, heel stick, ear stick, or venipuncture from unhealthy adults, pregnant adults or children.  Considering the person’s age, weight, and health, the collection procedure, the amount of blood to be collected, and the frequency with which it will be collected the blood samples intended for this study are minimal risk.
        Contact
        210-567-0178
        Locations
        UT Health Science Center
        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

         

      •   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
        Learn More About This Study

         

      •   Dynamic Multi-Cohort Prediction Modeling of Prostate Biopsy Outcome
        Protocol No.
        HSC20150050H
        Official Title
        Dynamic Multi-Cohort Prediction Modeling of Prostate Biopsy Outcome
        Description
        Dynamic Multi-Cohort Prediction Modeling of Prostate Biopsy Outcome
        Contact
        210-450-0754
        Locations
        UT Health Science Center
        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

         

      •   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
        Learn More About This Study

         

      •   Identification of Protein and Genetic Biomarkers of Prostate Cancer and Risk...
        Protocol No.
        HSC20020380H
        Official Title
        Identification of Protein and Genetic Biomarkers of Prostate Cancer and Risk Factors for Progression of Disease
        Description
        The purpose of this study is to identify genetic variants that predict progression of prostate cancer.
        Contact
        210-567-0178
        Locations
        UT Health Science Center
        Learn More About This Study

         

      •   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
        Learn More About This Study

         

      •   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
        Locations
        UT Health Science Center
        Learn More About This Study

         

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

         

    •   Soft Tissue

      •   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
        Learn More About This Study

         

    •   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
        Learn More About This Study

         

      •   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
        Learn More About This Study

         

      •   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
        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
      Learn More About This Study

       

  •   Healthy Subjects Needed

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

       

    •   Viral Reporters to Determine Circulating Tumor Cells Level and Viability in...
      Protocol No.
      HSC20140107H
      Official Title
      Viral Reporters to Determine Circulating Tumor Cells Level and Viability in Patients with Bladder Cancer: A Pilot Study
      Description
      Blood and Urine Samples Needed From Bladder Cancer Patients and Healthy Volunteers
      Contact
      210-716-1055
      Locations
      UT Health Science Center
      Learn More About This Study

       

  •   Heart, Vascular and Blood

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

       

  •   Women's Health

    •   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