At a glance
ClinicalIndex Comparison Record- ✓Bladder tumor confirmed by diagnostic office cystoscopy within 60 days of enrollment
- ✓No evidence of distant metastasis; primary tumor can be initial diagnosis or recurrent disease of any clinical stage
- ✓Candidate for cystoscopy/TURBT or complete or partial cystectomy
- ✓ECOG performance status 0 or 1
- ✕Prior pelvic irradiation for any reason
- ✕Any other treatment for bladder cancer between pre-enrollment cystoscopy and subsequent surgery
- ✕Concurrent investigational agents
- ✕Concurrent systemic cancer treatment for other cancers
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase II Study of Isoflavone G-2535 (Genistein) in Patients With Bladder Cancer
In Brief
A Phase 2 clinical trial evaluating Genistein, Laboratory Biomarker Analysis, and 3 other interventions for Recurrent Bladder Carcinoma and 3 related conditions. Completed, enrolled 60 participants across 10 sites.
Detailed Summary
Studying samples of blood, urine, and tissue from patients with cancer in the laboratory may help doctors learn more about changes that may occur in DNA and identify biomarkers related to cancer. It may also help doctors learn how genistein or placebo works in patients with bladder cancer. This randomized phase II trial is studying genistein or placebo to compare how they work in patients who are undergoing surgery for bladder cancer.
Study Details
Timeline
Interventions
Given orally
Correlative studies
Correlative studies
Given orally
Undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.