Status:
COMPLETED
Phase I Mitomycin Combined With Bacillus Calmette-Guérin (BCG) for Bladder Cancer
Lead Sponsor:
The University of Texas Health Science Center at San Antonio
Conditions:
Urinary Bladder Neoplasm
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The study aims to establish the safety and toxicity of a combined intravesical mitomycin C with BCG for patients with bladder cancer.
Detailed Description
Urine Sample Collection and Handling: Voided urine will be collected pre and post BCG procedure. Urinalysis will be performed if participant presents with urinary symptoms. Analysis of urinary cytokin...
Eligibility Criteria
Inclusion
- Newly diagnosed or recurrent multi-focal Ta, large Ta, high-grade Ta, CIS, or T1 bladder cancer
- In urologist's opinion a good candidate for BCG induction therapy
- Be able to give informed consent
- Be age 18 or older.
Exclusion
- Inadequate marrow function (defined as granulocytes less than 1,500 cells/mm3 and platelets less than 150,000 cells/mm3)
- Immunosuppressed state (e.g. HIV, use of chronic steroids)
Key Trial Info
Start Date :
March 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2015
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT02311101
Start Date
March 1 2012
End Date
April 1 2015
Last Update
December 3 2015
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
The University of Texas Health Science Center
San Antonio, Texas, United States, 78229