BCG Plus Interferon Alfa 2b 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. Interferon alfa may interfere with the growth of cancer cells. Combining these therapies may be an effective treatment for bladder cancer.
PURPOSE: Phase II trial to study the effectiveness of BCG plus interferon alfa 2b in treating patients who have bladder cancer.
|Bladder Cancer||Biological: BCG vaccine Biological: recombinant interferon alfa||Phase 2|
|Study Design:||Primary Purpose: Treatment|
|Official Title:||A National Phase II Trial of Intron (Interferon-alfa 2b) Plus BCG for Treatment of Superficial Bladder Cancer|
|Study Start Date:||July 1999|
|Primary Completion Date:||April 2001 (Final data collection date for primary outcome measure)|
OBJECTIVES: I. Compare the efficacy of BCG combined with interferon alfa 2b in patients with superficial bladder cancer. II. Determine the relative local and systemic toxicities of this regimen and its effect on quality of life in these patients. III. Evaluate the effect of BCG dose reduction during therapy on symptom tolerance and ability to maintain an extended treatment plan in these patients.
OUTLINE: This is a multicenter study. Patients are stratified according to prior BCG exposure and BCG tolerance (no prior BCG exposure vs prior BCG exposure, BCG tolerant vs prior BCG and interferon alfa treatment failure, BCG intolerant). Patients receive induction therapy consisting of varying strengths of BCG plus interferon alfa intravesically weekly for 6 weeks. Patients with disease recurrence which is resectable and/or amenable to intravesical therapy following the first induction course may receive an additional course of induction therapy. At 3 months, patients undergo evaluatory cystoscopy and cytology. At 4 months, patients with no evidence of disease receive varying strengths of maintenance therapy consisting of BCG and interferon alfa intravesically weekly for 3 weeks. Treatment repeats every 6 months for 3 courses. Quality of life is assessed within 1 week following the last induction and maintenance treatment and prior to cystoscopy. Patients are followed every 3 months for 6 months, every 6 months for 1.5 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 660 patients will be accrued for this study within 2.5 years.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004122
|United States, New York|
|Roswell Park Cancer Institute|
|Buffalo, New York, United States, 14263-0001|
|Study Chair:||David A. Corral, MD||Triangle Urological Group|