Phase I Mitomycin Combined With Bacillus Calmette-Guérin (BCG) for Bladder Cancer

• Status: Completed
• Trial end date: 2015-04-01
• Target enrollment: 0
• Participant gender: All

Summary

The study aims to establish the safety and toxicity of a combined intravesical mitomycin C with BCG for patients with bladder cancer.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The University of Texas Health Science Center at San Antonio
• Treatments: BCG Vaccine; Mitomycin; Mitomycins

Criteria

Inclusion Criteria:

1. Newly diagnosed or recurrent multi-focal Ta, large Ta, high-grade Ta, CIS, or T1 bladder cancer

2. In urologist's opinion a good candidate for BCG induction therapy

3. Be able to give informed consent

4. Be age 18 or older.

Exclusion Criteria:

1. Inadequate marrow function (defined as granulocytes less than 1,500 cells/mm3 and platelets less than 150,000 cells/mm3)

2. Immunosuppressed state (e.g. HIV, use of chronic steroids)