Bladder Cancer Clinical Trial
Official title:
A National Phase II Trial of Intron (Interferon-alfa 2b) Plus BCG for Treatment of Superficial 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.
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.
;
Primary Purpose: Treatment
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