Mitomycin C Versus Bacillus Calmette-Guerin in the Intravesical Treatment of Non-Muscle-Invasive Bladder Cancer Patients
Condition: Bladder Cancer
MeSH terms: Urinary Bladder Neoplasms; Non-Muscle Invasive Bladder Neoplasms
Intervention: Mitomycin C (MMC); Bacillus Calmette-Guerin (BCG)
Intervention description: 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.; 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.
Intervention MeSH terms: Mitomycins; Mitomycin; BCG Vaccine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 50.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Bladder; Mitomycin C; MMC; TheracysR Bacillus Calmette-Guerin; BCG; intravesical; 09-118

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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 18 years or older

          -  Patients must have pathologically confirmed non-muscle invasive urothelial bladder
             carcinoma by the Department of Pathology New York Presbyterian Hospital, Weill Medical
             College of Cornell University or Memorial Sloan Kettering Cancer Center or a
             documented past history of Ta or T1 non-muscle invasive urothelial bladder tumors.

          -  Intermediate Risk UBC patients: Recurrence Total Score = 1 to 9

        Exclusion Criteria:

          -  Any intravesical therapy within the past six months prior to current diagnosis

          -  Currently being treated or scheduled to have radiation treatment for bladder cancer
             during the study

          -  Scheduled to have surgery for bladder cancer during the study

          -  Currently being treated or scheduled to have treatment with any chemotherapeutic agent
             during the study