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Mitomycin C Versus Bacillus Calmette-Guerin in the Intravesical Treatment of Non-Muscle-Invasive Bladder Cancer Patients

This study has been terminated.
(Lack of accrual)
Sponsor:
Collaborators:
New York Presbyterian Hospital
Weill Medical College of Cornell University
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00974818
First received: September 9, 2009
Last updated: October 20, 2015
Last verified: October 2015
Results First Received: October 20, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Bladder Cancer
Interventions: Drug: Mitomycin C (MMC)
Biological: Bacillus Calmette-Guerin (BCG)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Mitomycin C (MMC)

Patients 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.

Mitomycin C (MMC): 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.

Bacillus Calmette-Guerin (BCG)

Patients 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.

Bacillus Calmette-Guerin (BCG): 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.


Participant Flow:   Overall Study
    Mitomycin C (MMC)   Bacillus Calmette-Guerin (BCG)
STARTED   25   25 
COMPLETED   25   25 
NOT COMPLETED   0   0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Mitomycin C (MMC)

Patients 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.

Mitomycin C (MMC): 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.

Bacillus Calmette-Guerin (BCG)

Patients 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.

Bacillus Calmette-Guerin (BCG): 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.

Total Total of all reporting groups

Baseline Measures
   Mitomycin C (MMC)   Bacillus Calmette-Guerin (BCG)   Total 
Overall Participants Analyzed 
[Units: Participants]
 25   25   50 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   11   8   19 
>=65 years   14   17   31 
Gender 
[Units: Participants]
     
Female   5   4   9 
Male   20   21   41 


  Outcome Measures

1.  Primary:   Response to Treatment   [ Time Frame: 2 years ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Guido Dalbagni
Organization: Memorial Slaon Kettering Cancer Center
phone: 646-422-4394
e-mail: Dalbagng@mskcc.org



Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00974818     History of Changes
Other Study ID Numbers: 09-118
Study First Received: September 9, 2009
Results First Received: October 20, 2015
Last Updated: October 20, 2015
Health Authority: United States: Institutional Review Board