Trial Evaluating the Effectiveness and the Safety of MITOMYCIN (MMC) Mixed with Study Gel (TC3) on Chemical Removal of Upper Urinary Tract Urothelial Carcinoma (UroGen TC-UT-03-P)
Technical Title: A Phase 3 Multicenter Trial Evaluating the Efficacy and Safety of MitoGel™ on Ablation of Upper Urinary Tract Urothelial Carcinoma
Disease Type: Low-grade upper urinary urothelial carcinoma (UTUC)
The purpose of this research study is to test the ability of UroGen’s MitoGel™ procedure to treat urothelial carcinoma tumors from the upper urinary tract. MitoGel™ is a combination of TC-3 gel and Mitomycin C, a type of chemotherapy. Mitomycin C alone is FDA-approved for other diseases and commercially available for the treatment of bladder cancer. UroGen’s MitoGel™ has not been approved by the FDA and is not commercially available.
Research Procedures (not a complete list):
You will receive treatment with MitoGel once a week for 6 weeks. Each treatment will last approximately 30 minutes. During each visit, you will need to complete blood and urine tests, physical exams, and pain questionnaires.
About five weeks after the completion of treatment visits, you will be scheduled for a disease evaluation visit where you will complete a physical exam, blood tests, urine tests, and a ureteroscopy to see if cancer can be detected.
If no cancer was detected in the ureteroscopy, you will continue to be treated with MitoGel. You will have monthly visits where you receive treatment and complete blood and urine tests and physical exams. You will also complete routine care visits every 3 months with endoscopy of the kidney and cytology testing done to see if cancer can be detected. You will continue to be treated until your disease recurs.
Eligibility Criteria (Not a complete list):
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