Biological Therapy in Treating Patients With Bladder Cancer
RATIONALE: Biological therapies such as BCG use different ways to stimulate the immune system and stop cancer cells from growing. It is not yet known which type of BCG is more effective for bladder cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of two different types of BCG in treating patients who have bladder cancer.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Prospective Randomized Trial for the Comparison of Two BCG Strains (Bacille Calmette-Guerin) in the Prophylaxis of Papollary Bladder Tumors Stage Ta and T1 and Treatment of Carcinoma in Situ|
- Assess role of prior exposition to mycobacteria [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
- Define role of fever occurrence as potential indicator for BCG reactivity [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||November 1998|
|Study Completion Date:||June 2010|
|Primary Completion Date:||June 2001 (Final data collection date for primary outcome measure)|
|Active Comparator: BCG-Connaught||
Compare two strains of BCG
|Active Comparator: BCG Onko-Tice||
Compare two strains of BCG
OBJECTIVES: I. Compare two strains of BCG (Connaught vs Tice) in terms of efficacy (yearly relapse rate) and tolerability in patients with Ta or T1 papillary carcinoma of the urinary bladder or carcinoma in situ of the urinary bladder. II. Assess the role of prior exposition to mycobacteria (vaccination/Tbc) for BCG treatment efficacy in these patients. III. Define the role of fever occurrence as a potential indicator for BCG reactivity in these patients. IV. Evaluate the p53 status of the resected tumors and IL-8 secretion into the urine as predictive factors of BCG reactivity in these patients. V. Evaluate disease free interval and disease free survival, time to progression, and overall survival in these patients. VI. Evaluate quality of life in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to center, T stage (Ta vs T1 vs CIS), and BCG immunization status (positive, i.e., greater than 10 mm diameter vs negative-indeterminate, i.e., less than 10 mm diameter). All patients undergo complete transurethral resection (TURB) to remove bladder tumors. A Mantoux test is performed. Patients with stage T1 disease undergo a second resection within 2-4 weeks after initial TURB. Patients are randomized to receive either BCG Onko-Tice (arm I) or BCG Connaught (arm II). Both arms receive BCG by catheter beginning 2-14 days after the last TURB. Patients must hold the BCG in the bladder for 2 hours. BCG is instilled once a week for 6 weeks. Quality of life is assessed before randomization, daily during first and last weeks of treatment, every 6 months for the first 2 years, and then annually thereafter. Patients are followed every 6 months for the first 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A minimum of 300 patients will be accrued for this study within 6 years.
|Bern, Switzerland, CH-3010|
|Study Chair:||George N. Thalmann, MD||University Hospital Inselspital, Berne|