Clinical trial NCT00974818
Conditions: Bladder Cancer
Keywords: Bladder Mitomycin C MMC TheracysR Bacillus Calmette-Guerin BCG intravesical 09-118
Sponsor: Memorial Sloan Kettering Cancer Center
Start date: 2009-09-01; Completion date: 2012-03-01
Enrollment: 50 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare the bladder cancer treatments, Mitomycin C (MMC) and Bacillus Calmette Guerin (BCG), to find out which is better. In this study, the patient will get either the Mitomycin C (MMC) or the Bacillus Calmette Guerin (BCG). They will not get both.

The patient had a Transurethral Resection (TUR) or an in office cystoscopy to make the diagnosis of bladder cancer. A biopsy was done and removed any tumors the doctor saw. Even after the doctor removes the tumors, the cancer can return. In this case, the doctor will put medicine into the bladder to destroy cancer cell. This is called intravesical therapy. The two most commonly used drugs for this purpose are MMC and BCG.

Both drugs have been studied for many years. They both show good results when compared to other treatments. They have not been studied using the schedule that will be used in the study. The doctor does not know if these two drugs are equally effective in treating the cancer and preventing recurrence.

BCG has been studied more often than MMC. The studies have shown that a long schedule of BCG is better than a short schedule of MMC. They have also shown that the side effects of BCG are more intense than with MMC. A recent study showed that a new dose of MMC is better than the old standard dose. Since the side effects of MMC occur less often, it is important to learn whether the two drugs are equally effective. That could help us decide between the treatments. In this study, the doctor will compare MMC and BCG when given for the same amount of time. The doctor hopes the study will tell us which drug is more effective in preventing the return of the cancer.

Detailed description:

Arms: arm 1: Patients will receive a induction course of 6 cycles of weekly intravesical therapy of MMC, followed by a maintenance schedule consisting of 3 weekly cycles of the same drug at 3, 6, 12, 18, and 24 months. arm 2: Patients will receive a induction course of 6 cycles of weekly intravesical therapy of either BCG, followed by a maintenance schedule consisting of 3 weekly cycles of the same drug at 3, 6, 12, 18, and 24 months.
Interventions: intervention 1: Mitomycin C (MMC) intervention 2: Bacillus Calmette-Guerin (BCG)
Intervention descriptions: intervention 1: Patients randomized to this group will receive six weekly cycles of 40 mg of intravesical MMC (dissolved in a total volume of 20 mL sterile water). Patients will receive three weekly cycles of 40 mg of intravesical MMC (dissolved in a total volume of 20 mL sterile water) 3, 6, 12, 18, and 24 months after the induction course. intervention 2: Patients randomized to this group will receive six weekly cycles of 81 mg of intravesical BCG (dissolved in a total volume of 53 mL of diluent and saline). Patients will receive three weekly cycles of 27 mg of intravesical BCG (dissolved in a total volume of 53 mL of diluent and saline) 3, 6, 12, 18, and 24 months after the induction course.

Protocol documents: