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-Naïve High-Grade Non-Muscle Invasive Bladder Cancer.

Protocol No
SWOG-S1602
Principal Investigator
Scott Johnson
Phase
III
Summary
The purpose of this study is to test two things: 1) 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. The study will be considered successful if approximately the same number of patients who receive the different treatments are free from high grade recurrence of their bladder cancer after one year of treatment. 2) Using the Tokyo-172 version of BCG, compare any good and bad effects of adding a BCG vaccination (given under the skin) in addition to placing BCG in only the bladder. The study will be considered successful if the vaccination results in an 8% improvement in the number of patients who are free from high grade recurrence of their bladder cancer after one year of treatment. The Tokyo-172 version of BCG is commonly used in other parts of the world to treat high grade bladder cancer. However, the TOKYO-172 version of BCG is not approved by the U.S. Food and Drug Administration and is considered investigational for this study. The side effects of the Tokyo-172 version of BCG are believed to be similar to the BCG LIVE (TICE® BCG) version currently used in the United States. In this study of 969 people, the response to and side effects of the TOKYO-172 version of BCG will be compared to BCG LIVE (TICE® BCG) which is currently used in the United States. Some patients on the study will also receive a vaccination (injected under the skin) of Tokyo-172 BCG prior to receiving the BCG directly in the bladder. The benefits and potential side effects of this additional vaccine are unknown. This study will allow the researchers to know whether the Tokyo-172 version with or without the vaccination is better, the same, or worse than the usual approach using the BCG LIVE (TICE® BCG) version in the bladder alone. About 969 people will take part in this study.
Description
This randomized phase III trial studies Tokyo-172 strain bacillus Calmette-Guerin (BCG) solution with or without a vaccination using Tokyo-172 strain BCG to see how well it works compared with TICE BCG solution in treating patients with bladder cancer that has not spread to muscle. BCG is a non-infectious bacteria that when instilled into the bladder may stimulate the immune system to fight bladder cancer. Giving different versions of BCG with vaccine therapy may prevent bladder cancer from returning.
Participating Institutions
Froedtert Hospital
Status
OPEN TO ACCRUAL
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