Biological Therapy in Treating Patients With Bladder Cancer
|ClinicalTrials.gov Identifier: NCT00003779|
Recruitment Status : Completed
First Posted : March 15, 2004
Last Update Posted : May 17, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Bladder Cancer||Biological: Connaught Biological: Tice||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Factorial Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||November 1998|
|Primary Completion Date :||June 2001|
|Study Completion Date :||June 2010|
|Active Comparator: BCG-Connaught||
Compare two strains of BCG
|Active Comparator: BCG Onko-Tice||
Compare two strains of BCG
- Assess role of prior exposition to mycobacteria [ Time Frame: 6 weeks ]
- Define role of fever occurrence as potential indicator for BCG reactivity [ Time Frame: 6 weeks ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003779
|Bern, Switzerland, CH-3010|
|Study Chair:||George N. Thalmann, MD||University Hospital Inselspital, Berne|