Clinical trial · Interventional
Phase I Mitomycin Combined With Bacillus Calmette-Guérin (BCG) for Bladder Cancer
Sequential Intravesical Mitomycin Plus Bacillus Calmette-Guérin for Non-Muscle Invasive Urothelial Bladder Carcinoma: Translational and Phase I Clinical Trial
NCT02311101CI-TRIAL-00020047completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The study aims to establish the safety and toxicity of a combined intravesical mitomycin C with BCG for patients with bladder cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Urinary Bladder Neoplasm | Bladder Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Mitomycin C | Drug | Mitomycin | ALIAS |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Therapy Group MMC 10/BCG Half
- description
- Intravesical Mitomycin C and intravesical BCG First intravesical mitomycin C (10 mg) is instilled for 30 minutes. Then the mitomycin is removed and the bladder is gently hand-irrigated with sterile water for 15 minutes in order to facilitate removal of mitomycin C. Then, intravesical BCG (half dose) is instilled for 2 hours under usual conditions. Full dose BCG corresponds to 1 to 8x10\^8 colony-forming units of BCG. This study targets patients with BCG-naive or BCG-refractory high-risk non-muscle invasive bladder cancer. The first 3 participants received 10mg of MMC and half dose of BCG. The dose was assigned in order of enrollment.
- interventionNames
- Drug: Mitomycin C
- type
- EXPERIMENTAL
- label
- Therapy Group MMC 10/BCG Full
- description
- First intravesical mitomycin C (10 mg) is instilled for 30 minutes. Then the mitomycin is removed and the bladder is gently hand-irrigated with sterile water for 15 minutes in order to facilitate removal of mitomycin C. Then, intravesical BCG (full dose) is instilled for 2 hours under usual conditions. Full dose BCG corresponds to 1 to 8x10\^8 colony-forming units of BCG. This study targets patients with BCG-naive or BCG-refractory high-risk non-muscle invasive bladder cancer. The following 3 participants received 10mg of MMC and full dose BCG. Dose was assigned in order of enrollment.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (1)
- BACKGROUNDHilton WM, Ercole B, Parekh DJ, Sonpavde G, Ghosh R, Svatek RS. Efficacy of combined intravesical immunotherapy and chemotherapy for non-muscle invasive bladder cancer. Expert Rev Anticancer Ther. 2011 Jun;11(6):949-57. doi: 10.1586/era.11.69. PMID 21707292