Clinical Trials Actively Recruiting Patients With Genitourinary Cancers

Study Type: Observational

Study Title: Molecular Epidemiology of Pediatric Germ Cell Tumors

Study Sponsor and Collaborators: Children’s Oncology Group, National Cancer Institute (NCI)

Purpose: To study DNA samples from younger patients with germ cell tumor and their parents or siblings. Studying samples of tumor tissue and saliva from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.

Primary Outcome Measures: Pediatric germ cell tumor associated with genetic susceptibility [time frame: up to 5 years]

Principal Investigator: Jenny Poynter, PhD, Children’s Oncology Group; poynt006@umn.edu, 612-625-4232

ClinicalTrials.gov Identifier: NCT01434355

Study Type: Pilot/interventional/single-group assignment

Study Title: Pilot Study of Adjuvant Proton-Beam Teletherapy for Post-Hysterectomy Cancers of the Uterus and Cervix With Metastases to Regional Lymph Nodes

Study Sponsor and Collaborators: Massachusetts General Hospital, NCI

Purpose: To determine if proton-beam radiation is effective in controlling cancer growth. The investigators are also looking to see if proton-beam radiation can reduce side effects when compared to standard radiation treatment (photon radiation).

Primary Outcome Measures: Magnitude of radiation dose reductions, radiation side effects and delayed complications [time frame: 5 years]

Principal Investigator: Karen De Amorim Bernstein, MD, Massachusetts General Hospital; kbernstein2@partners.org

ClinicalTrials.gov Identifier: NCT01600040

Study Type: Phase I/interventional/single-group assignment

Study Title: A Phase I Study of Allogeneic Human Bone Marrow Derived Mesenchymal Stem Cells in Localized Prostate Cancer

Study Sponsor and Collaborators: Sidney Kimmel Comprehensive Cancer Center

Purpose: To determine if systemically infused allogeneic bone marrow derived mesenchymal stem cells (MSC) home to sites of prostate cancer in men with localized adenocarcinoma of the prostate that are planning to undergo a prostatectomy

Primary Outcome Measures: To quantify the amount of systemically infused MSC DNA relative to recipient DNA at sites of prostate cancer in men with localized adenocarcinoma of the prostate that are scheduled to undergo a prostatectomy [time frame: up to 3 years]

Principal Investigator: Samuel Denmeade, MD, Johns Hopkins University; contact Carolyn Chapman, RN; cchapma7@jhmi.edu, 443-287-7841

ClinicalTrials.gov Identifier: NCT01983709

Study Type: Phase I/II/interventional/single-group assignment

Study Title: A Phase 1/2 Study of Rapamycin and Cisplatin/Gemcitabine for Treatment of Patients With Bladder Cancer

Study Sponsor and Collaborators: University of Washington, NCI

Purpose: To study the side effects and best dose of sirolimus when given together with cisplatin and gemcitabine hydrochloride and to see how well they work in treating patients with bladder cancer

Primary Outcome Measures: Maximum tolerated dose of sirolimus based on the incidence of dose-limiting toxicity graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0 (phase I) [time frame: up to 28 days]; percent of patients with pathologic complete response (phase II) [time frame: 12 weeks]

Principal Investigator: Robert Montgomery, MD, Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium; 206-616-8289

ClinicalTrials.gov Identifier: NCT01938573

Study Type: Phase II pilot/interventional/single-group assignment

Study Title: A Pilot Phase II Trial of Intravenous Paclitaxel and Intraperitoneal Carboplatin Followed by Radiation in Patients With Advanced Stage Uterine Serous Carcinoma

Study Sponsor and Collaborators: Albert Einstein College of Medicine of Yeshiva University, NCI

Purpose: To study the side effects and how well paclitaxel given into the vein and carboplatin given directly into the abdominal cavity (intraperitoneally) followed by radiation therapy work in treating patients with stage IIIC-IV serous uterine cancer

Primary Outcome Measures: Degree of tolerability, estimated by the proportion of participants who complete six treatment cycles of intraperitoneal carboplatin [time frame: up to 18 weeks]

Principal Investigator: Merieme Klobocista, MD, Albert Einstein College of Medicine of Yeshiva University; mkloboci@montefiore.org, 718-405-8082

ClinicalTrials.gov Identifier: NCT02112552

Study Title: Phase II Stereotactic Body Radiotherapy and Stereotactic Hypofractioned Radiotherapy for Oligometastatic Prostate Cancer

Study Sponsor and Collaborators: University of Florida

Purpose: To evaluate the outcomes of patients treated with an investigational radiation regimen using stereotactic radiotherapy for oligometastatic prostate cancer and to establish efficacy and safety in this setting

Primary Outcome Measures: Improvement in median progression-free survival in patients with metastatic prostate cancer over historic control rates in hormone-receptive and castration-resistant subgroups [time frame: 78 months after radiation treatment]

Principal Investigator: Roi Dagan, MD, MS, University of Florida; contact Intake Coordinator at 877-686-6009

ClinicalTrials.gov Identifier: NCT01859221

Study Type: Phase III/interventional/parallel assignment

Study Title: A Phase III Surgical Trial to Evaluate the Benefit of a Standard vs an Extended Pelvic Lymphadenectomy Performed at Time of Radical Cystectomy for Muscle Invasive Urothelial Cancer

Study Sponsor and Collaborators: Southwest Oncology Group, NCI

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

Primary Outcome Measures: Disease-free survival [time frame: up to 6 years from date of step 2 registration]

Principal Investigator: Seth P. ­Lerner, MD, Baylor College of Medicine; contact Jennifer I. Scott, jscott@swog.org, 210-614-8808 ext 1007

ClinicalTrials.gov Identifier: NCT01224665

Study Title: A Randomized Study of Radiation Hypofractionation Via Extended vs Accelerated Therapy for Prostate Cancer

Study Sponsor and Collaborators: University of Miami

Purpose: To study if accelerated hypofractionation radiotherapy for prostate cancer of 36.25 Gy delivered in 5 fractions will not be inferior to the standard treatment of 70.2 Gy given in 26 fractions with respect to 2-year failure defined as a positive biopsy 2 years post treatment completion or earlier evidence of biochemical or clinical failure.

Primary Outcome Measures: Compare the 2-year failure rates between the treatment arms using a noninferiority margin of 12% [time frame: 2 years]

Principal Investigator: Matthew Abramowitz, MD, University of Miami; mabramowitz@med.miami.edu, 305-243-4200

ClinicalTrials.gov Identifier: NCT01794403 ■