The information in this Clinical Trials Resource Guide includes actively recruiting clinical studies for patients with bladder cancer. The list includes randomized and nonrandomized phase 0 to III studies as well as observational clinical trials evaluating new therapies, surgical techniques, and devices; image-guided radiation and radiation doses; noninvasive assays to detect bladder cancer cells; molecular profiling; and quality of life. All of the studies are listed on the National Institutes of Health website at ClinicalTrials.gov.
Bladder Cancer
Study Type: Phase 0/interventional/randomized
Study Title: An Immunopharmacodynamic Phase 0/I Study of Rapamycin in Patients Undergoing Radical Cystectomy for Bladder Cancer
Study Sponsor and Collaborators: The University of Texas Health Science Center at San Antonio
Purpose: To evaluate the effects of rapamycin directly on bladder tumors and the effects of rapamycin on the immune system of patients with bladder cancer
Ages Eligible for Study: 18 years and older
Genders Eligible for Study: Both
Accepts Health Volunteers: No
Primary Outcome Measures: Tissue pharmacodynamic response to TORC1 inhibition (time frame: 30 days)
Principal Investigator: Robert S. Svatek, MD, MSCI, UT Health Science Center San Antonio; 210-567-5676
For More Information: Visit ClinicalTrials.gov and refer to this study by its identifier: NCT01827618
Study Type: Phase 0/interventional/single-group assignment
Study Title: Impact of Valproate on Angiogenesis and Histone Deacetylation in Bladder Cancer
Study Sponsor and Collaborators: State University of New York-Upstate Medical University
Purpose: To test whether the drug valproic acid can cause changes in bladder tumors that might inhibit their growth
Ages Eligible for Study: 21 years and older
Genders Eligible for Study: Both
Accepts Health Volunteers: No
Primary Outcome Measures: Thrombospondin-1 gene expression (time frame: 1 day)
Principal Investigator: Oleg Shapiro, MD, State University of New York-Upstate Medical University. Contact: Barbara McConnell; 315-464-4473; mcconneb@upstate.edu
For More Information: Visit ClinicalTrials.gov and refer to this study by its identifier: NCT01738815
Study Type: Phase 0/interventional/single-group assignment
Study Title: Noninvasive Vibrational Device to Improve Sensitivity of Urine Cytology for Bladder Cancer
Study Sponsor and Collaborators: Johns Hopkins University
Purpose: To test whether a commercially available vibrating chair can increase the number of urothelial cells in a urine sample of healthy participants noninvasively.
Ages Eligible for Study: 18 to 80 years
Genders Eligible for Study: Male
Accepts Health Volunteers: No
Primary Outcome Measures: Number of cancer cells (time frame: up to 24 weeks)
Principal Investigator: Trinity Bivalacqua, MD, PhD, Johns Hopkins University. Contact: John J. Kim, BS; 805-220-8765; jkim324@jhu.edu
For More Information: Visit ClinicalTrials.gov and refer to this study by its identifier: NCT01826097
Study Type: Interventional/nonrandomized/single-group assignment
Study Title: Pilot Pre-cystectomy Trial of Broccoli Extract in Patients With Superficial or Locally Advanced Bladder Cancer
Study Sponsor and Collaborators: Roswell Park Cancer Institute; Johns Hopkins University
Purpose: To study the side effects of broccoli sprout extract in treating patients with transitional cell bladder cancer undergoing surgery
Ages Eligible for Study: 18 years and older
Genders Eligible for Study: Both
Accepts Health Volunteers: No
Primary Outcome Measures: Toxicity as assessed by National Cancer Institute Common Toxicity Criteria version 3.0 (time frame: 14 days)
Principal Investigator: Roberto Pili, MD, Roswell Park Cancer Institute. Contact: AskRPCI, MD 877-275-7724; askrpci@roswellpark.org
For More Information: Visit ClinicalTrials.gov and refer to this study by its identifier: NCT01108003
Study Type: Phase I/interventional/nonrandomized
Study Title: Phase I Dose-Escalation Study of Image-Guided Radiation Therapy for Bladder-Cancer Patients Undergoing Radiotherapy and Concurrent Gemcitabine Chemotherapy
Study Sponsor and Collaborators: Memorial Sloan Kettering Cancer Center
Purpose: To test the safety of different doses of external-beam radiation therapy combined with chemotherapy
Ages Eligible for Study: 18 years and older
Genders Eligible for Study: Both
Accepts Health Volunteers: No
Primary Outcome Measures: To determine the dose limiting toxicity and establish the maximal tolerated dose (time frame: 2 years)
Principal Investigator: Marisa Kollmeier, MD, Memorial Sloan Kettering Cancer Center; 212-639-3952
For More Information: Visit ClinicalTrials.gov and refer to this study by its identifier: NCT01104350
Study Type: Phase I/II/interventional/single-group assignment
Study Title: A Phase I-II Study of Rapamycin and Cisplatin/Gemcitabine for Treatment of Patients With Bladder Cancer
Study Sponsor and Collaborators: University of Washington; National Cancer Institute
Purpose: To investigate the side effects and the best dose of sirolimus when given together with cisplatin and gemcitabine hydrochloride and how well it works in treating patients with bladder cancer
Ages Eligible for Study: 18 years and older
Genders Eligible for Study: Both
Accepts Health Volunteers: No
Primary Outcome Measures: Maximum tolerated dose of sirolimus based on the incidence of dose-limiting toxicity graded according to the National Cancer Institute’s Common Terminology Criteria for Adverse Events version 4.0 (phase 1) (time frame: up to 28 days)
Principal Investigator: Robert B. Montgomery, MD, Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium; 206-616-8289
For More Information: Visit ClinicalTrials.gov and refer to this study by its identifier: NCT01938573
Study Type: Phase II/interventional/randomized
Study Title: A Multicenter Phase II Study of Enhancement of Immune Reconstitution and Vaccine Responses With Administration of Glyco-Recombinant Human IL-7 in Older Subjects Following Chemotherapy
Study Sponsor and Collaborators: National Cancer Institute
Purpose: To study the effects of IL-7 on immune system function in two different groups of older people. One group will be people who have completed chemotherapy treatment for breast, colon, or bladder cancer. The other group will be people who have never received chemotherapy.
Ages Eligible for Study: 60 years and older
Genders Eligible for Study: Both
Accepts Health Volunteers: Yes
Primary Outcome Measures: Vaccines responses (time frame: up to 1 year); quality of immune responses (time frame: 8 weeks); safety of rhIL-7 (time frame: up to 1 year)
Principal Investigator: Ronald E. Gress, MD, National Cancer Institute; 301-496-1791; gressr@mail.nih.gov
For More Information: Visit ClinicalTrials.gov and refer to this study by its identifier: NCT01339000
Study Type: Phase II/interventional/nonrandomized
Study Title: A Multi-Histology Phase II Study of 5-Fluoro-2’-Deoxycytidine With Tetrahydrouridine (FdCyd + THU)
Study Sponsor and Collaborators: National Cancer Institute
Purpose: To determine the effectiveness, safety, and tolerability of FdCyd and THU when given together to control tumor growth in patients with bladder cancer, non–small cell lung cancer, breast cancer, or head or neck cancer that has progressed after receiving standard treatment or for which no effective therapy exists
Ages Eligible for Study: 18 years and older
Genders Eligible for Study: Both
Accepts Health Volunteers: No
Primary Outcome Measures: Determine progression-free survival and/or the response rate (complete plus parital responses) of FdCyd administered 5 days/week for 2 weeks, in 28-day cycles, by intravenous infusion with THU in patients with breast cancer, head and neck cancer, non–small cell lung cancer, and bladder cancer.
Principal Investigator: James H. Doroshow, MD, National Cancer Institute; 301-496-4291; doroshoj@mail.nih.gov
For More Information: Visit ClinicalTrials.gov and refer to this study by its identifier: NCT00978250
Study Type: Phase II/interventional/single-group assignment
Study Title: Phase II Study of Neoadjuvant Dose Dense Gemcitabine and Cisplatin (DD GC) In Patients With Muscle-Invasive Bladder Cancer
Study Sponsor and Collaborators: Memorial Sloan Kettering Cancer Center; University of North Carolina, Chapel Hill; New York University
Purpose: To determine if standard chemotherapy (gemcitabine and cisplatin) given on a dose-dense treatment schedule (with less time between treatments) can help shrink the tumor better than standard chemotherapy given on a standard treatment schedule before the patient undergoes surgery for bladder cancer
Ages Eligible for Study: 18 years and older
Genders Eligible for Study: Both
Accepts Health Volunteers: No
Primary Outcome Measures: Pathologic response rate (time frame: 1 year)
Principal Investigator: Dean Bajorin, MD, Memorial Sloan Kettering Cancer Center; 646-422-4333
For More Information: Visit ClinicalTrials.gov and refer to this study by its identifier: NCT01589094
Study Type: Phase II/interventional/single-group assignment
Study Title: Phase II Study of Adjuvant Conformal Radiotherapy in High Risk Bladder Cancer
Study Sponsor and Collaborators: Emory University
Purpose: To study how well modern, conformal radiation therapy after surgery works in treating patients with high-risk bladder cancer. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue.
Ages Eligible for Study: 18 years and older
Genders Eligible for Study: Both
Accepts Health Volunteers: No
Primary Outcome Measures: Gastrointestinal late effects, assessed using Radiation Therapy Oncology Group Late Effects in Normal Tissues Subjective, Objective, Management and Analytic Scales (time frame: 3 months)
Principal Investigator: Joseph W. Shelton, MD, Emory University; 404-616-6343; jwshelt@emory.edu
For More Information: Visit ClinicalTrials.gov and refer to this study by its identifier: NCT01954173
Study Type: Phase II/interventional/single-group assignment
Study Title: A Phase II Protocol for Patients With Stage T1 Bladder Cancer to Evaluate Selective Bladder Preserving Treatment by Radiation Therapy Concurrent With Radiosensitizing Chemotherapy Following a Thorough Transurethral Surgical Restaging
Study Sponsor and Collaborators: Radiation Therapy Oncology Group; National Cancer Institute; NRG Oncology Foundation, Inc
Purpose: To study how well radiation therapy given together with chemotherapy works in treating patients with stage I bladder cancer
Ages Eligible for Study: 18 years and older
Genders Eligible for Study: Both
Accepts Health Volunteers: No
Primary Outcome Measures: Rate of freedom from radical cystectomy at 3 years (time frame: 3 years from date of registration)
Principal Investigator: William U. Shipley, MD, FACR, Massachusetts General Hospital. See individual clinical trial locations for contact information.
For More Information: Visit ClinicalTrials.gov and refer to this study by its identifier: NCT00981656
Study Type: Phase III/interventional/randomized
Study Title: A Phase III Surgical Trial to Evaluate the Benefit of a Standard Versus an Extended Pelvic Lymphadenectomy Performed at Time of Radical Cystectomy for Muscle Invasive Urothelial Cancer
Study Sponsor and Collaborators: Southwest Oncology Group; National Cancer Institute
Purpose: To study standard pelvic lymphadenectomy to see how well it works compared to extended pelvic lymphadenectomy in treating patients undergoing surgery for invasive bladder cancer
Ages Eligible for Study: 18 years and older
Genders Eligible for Study: Both
Accepts Health Volunteers: No
Primary Outcome Measures: Disease-free progression
Principal Investigator: Seth P. Lerner, MD, Baylor College of Medicine; 713-798-6841
For More Information: Visit ClinicalTrials.gov and refer to this study by its identifier: NCT01224665
Study Type: Observational/patient registry
Study Title: Pilot Study of Role of MRI in Neoadjuvant Chemotherapy for Bladder Cancer
Study Sponsor and Collaborators: New York University School of Medicine
Purpose: This is a prospective study of pretreatment DW-MRI to identify potential imaging biomarkers predictive of response to neoadjuvant chemotherapy in patients with muscle-invasive bladder cancer
Ages Eligible for Study: 18 years and older
Genders Eligible for Study: Both
Accepts Health Volunteers: No
Primary Outcome Measures: Complete pathologic response (time frame: < 1 year)
Principal Investigator: Arjun Balar, MD, NYU Langone Medical Center. Contact: Simone Rainey; 212-263-2710; simone.rainey@nyumc.org
For More Information: Visit ClinicalTrials.gov and refer to this study by its identifier: NCT01922232
Study Type: Observational
Study Title: PORCH: A Registry of Prospective Outcomes of Radical Cystectomy With or Without Chemotherapy
Study Sponsor and Collaborators: UNC Lineberger Comprehensive Cancer Center
Purpose: To create a registry of older patients undergoing surgical and/or medical treatment for bladder cancer. The registry will record side effects and outcomes related to the treatment using different surveys and biological measures.
Ages Eligible for Study: 18 years and older
Genders Eligible for Study: Both
Accepts Health Volunteers: No
Primary Outcome Measures: To collect the number of changes in functional status, surgical complications, and survival status collected in a prospective database of patients undergoing a radical cystectomy with or without chemotherapy (time frame: 1 year)
Principal Investigator: Angela Smith, MD, University of North Carolina Lineberger Comprehensive Cancer Center
For More Information: Visit ClinicalTrials.gov and refer to this study by its identifier: NCT01776138
Study Type: Observational
Study Title: A Prospective Study of Quality of Life in Patients With Bladder Cancer
Study Sponsor and Collaborators: Memorial Sloan Kettering Cancer Center; Albert Einstein College of Medicine of Yeshiva University; North Shore Long Island Jewish Health System
Purpose: To learn about the quality of life of people living with bladder cancer. The researchers are interested in learning how treatments for bladder cancer affect people. Their findings could help provide better care and information to patients with bladder cancer.
Ages Eligible for Study: 18 years and older
Genders Eligible for Study: Both
Accepts Health Volunteers: No
Primary Outcome Measures: Prospectively characterize the impact of radical cystectomy and different urinary diversions on quality of life of patients with bladder cancer
Principal Investigator: Bernard Bochner, MD, Memorial Sloan Kettering Cancer Center; 646-422-4387
For More Information: Visit ClinicalTrials.gov and refer to this study by its identifier: NCT00745355 ■
