Study Stopped
Lack of accrual
Mitomycin C Versus Bacillus Calmette-Guerin in the Intravesical Treatment of Non-Muscle-Invasive Bladder Cancer Patients
1 other identifier
interventional
50
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Sep 2009
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2009
CompletedFirst Submitted
Initial submission to the registry
September 9, 2009
CompletedFirst Posted
Study publicly available on registry
September 10, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2012
CompletedResults Posted
Study results publicly available
November 20, 2015
CompletedNovember 20, 2015
October 1, 2015
2.5 years
September 9, 2009
October 20, 2015
October 20, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Response to Treatment
will be assessed by cystoscopy every 3 months (+/- 3 weeks) in the first 2 years after induction.
2 years
Study Arms (2)
pts getting Mitomycin C (MMC)
EXPERIMENTALPatients 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.
pts getting Bacillus Calmette-Guerin (BCG)
EXPERIMENTALPatients 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
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Memorial Sloan Kettering Cancer Centerlead
- New York Presbyterian Hospitalcollaborator
- Weill Medical College of Cornell Universitycollaborator
Study Sites (2)
Weill Medical College of Cornell University
New York, New York, 10021, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Guido Dalbagni
- Organization
- Memorial Slaon Kettering Cancer Center
Study Officials
- PRINCIPAL INVESTIGATOR
Guido Dalbagni, MD
Memorial Sloan Kettering Cancer Center
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 9, 2009
First Posted
September 10, 2009
Study Start
September 1, 2009
Primary Completion
March 1, 2012
Study Completion
March 1, 2012
Last Updated
November 20, 2015
Results First Posted
November 20, 2015
Record last verified: 2015-10