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

This study has been completed.
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: August 21, 2012
Last verified: August 2012
  Purpose

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.


Condition Intervention Phase
Bladder Cancer
Drug: Mitomycin C (MMC)
Biological: Bacillus Calmette-Guerin (BCG)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Mitomycin C Versus Bacillus Calmette-Guerin in the Intravesical Treatment of Non-Muscle-Invasive Bladder Cancer Patients: A Randomized Phase III Non-inferiority Trial

Resource links provided by NLM:


Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:
  • To test non-inferiority of intravesical chemo using optimized dose of MMC to intravesical BCG immunotherapy in the prevention of bladder cancer recurrence at 2 years among non-muscle-invasive UBC patients. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To investigate the efficacy of intravesical chemotherapy using optimized dose of MMC versus intravesical BCG immunotherapy in the prevention of bladder cancer progression or radical cystectomy at 2 years among non-muscle-invasive UBC patients. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • To evaluate the adverse events related to intravesical MMC and intravesical BCG in patients with UBC receiving induction followed by maintenance schedule. [ Time Frame: Assessment of toxicity prior to each administration of chemotherapy ] [ Designated as safety issue: Yes ]

Enrollment: 50
Study Start Date: September 2009
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: pts getting 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.
Drug: 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.
Experimental: pts getting 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.
Biological: 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00974818

Locations
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065
Weill Medical College of Cornell University
New York, New York, United States, 10021
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
New York Presbyterian Hospital
Weill Medical College of Cornell University
Investigators
Principal Investigator: Guido Dalbagni, MD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

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
Last Updated: August 21, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Memorial Sloan-Kettering Cancer Center:
Bladder
Mitomycin C
MMC
TheracysR Bacillus Calmette-Guerin
BCG
intravesical
09-118

Additional relevant MeSH terms:
Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases
Mitomycins
Mitomycin
BCG Vaccine
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 16, 2014