A phase III Randomized Trial to Evaluate the Influence of BCG Strain Differences and T Cell Priming with Intradermal BCG Before Intravesical Therapy for BCG-Naive, High Grade Non-Muscle Invasive Bladder Cancer.

Investigator: Raj Satkunasivam, MD

Study Coordinator: Cinthya Yesenia Obando Perez

Status: Enrolling

ClinicalTrials.gov Number: NCT03091660

Phone: 346.238.6123

Protocol Number: Pro00021110

Description

This study is for subjects that have high grade bladder cancer that has not entered the muscle. In the U.S., people who are not in a study are usually treated with BCG LIVE (TICE® BCG) (an abbreviation for Bacillus Calmette–Guérin), which is a bacterium. When it is given directly into the bladder, BCG stimulates the immune system to fight the bladder cancer. BCG is usually tolerated well by patients with normal immune system function. For patients who receive the usual approach for bladder cancer, about 40 out of 100 are free of cancer at five years. The purpose of this study is compare any good and bad effects of using the Tokyo-172 version of BCG with the currently used BCG LIVE (TICE® BCG) version of BCG on people with bladder cancer receiving BCG in the bladder
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