S1602 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
Johns Hopkins Kimmel Cancer Center in Baltimore
The purpose of this study is to test two things:•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.•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.
Patients with high grade bladder cancer that has not entered the muscle may be eligible.
This study has three study groups.•Group 1 will receive the usual BCG LIVE (TICE® BCG) version of BCG in the bladder.•Group 2 will receive BCG in the bladder but it will be the Tokyo-172 version of BCG instead of the BCG LIVE (TICE® BCG) version.•Group 3 will receive a vaccination as an injection under the skin with the Tokyo-172 version of BCG followed by receiving the Tokyo-172 version in the bladder.The BCG administration into the bladder requires the insertion of a catheter tube in your bladder through the urethra. The liquid containing the study drugs will be instilled into your bladder after all the urine has been drained out.BCG vaccination for Group 3 is given as a shot just under your skin.A computer will assign you to treatment groups in the study by chance. This is called randomization. This is done by chance because no one knows if one study group is better or worse than the others. Neither you nor your doctor will be able to choose your treatment.In Groups 1, 2 or 3, you will receive BCG in your bladder once a week for six (6) consecutive weeks (this is called Induction) and then weekly for three (3) consecutive weeks at 3 months, 6, 12, 18, 24, 30, and 36 months (this is called Maintenance) following the start of BCG. This is the usual way that BCG is provided to people with bladder cancer. Only Group 3 will receive a BCG vaccination prior to starting Induction.After you finish BCG treatment, your doctor will continue to watch you for side effects and follow your condition for 2 more years. This will include office visits and cystoscopies (a visual examination of the bladder through a small viewing device inserted through the urethra with local anesthesia) every 6 months for 2 years. Thus the study is 5 years long including 3 years of treatment and 2 additional years of follow-up.
02/18/2020 05:03 AM