BCG With or Without Mitomycin in Treating Patients With Bladder Cancer

OBJECTIVES:

• Compare the complete response rate of patients with carcinoma in situ of the bladder treated with adjuvant intravesical BCG with or without intravesical mitomycin following transurethral resection.
• Compare the disease-free interval and type of recurrence after complete response in patients treated with these regimens.
• Compare the side effects of these regimens in these patients.

OUTLINE: This is a randomized, open-label, multicenter study. Patients are randomized to one of two treatment arms.

Arm I:

• Induction therapy: Patients receive intravesical mitomycin over 1 hour once weekly on weeks 1-6 and intravesical BCG once weekly on weeks 7-12. Patients with visible lesions or disease recurrence or progression undergo transurethral resection (TUR) during weeks 16-18 and receive one additional course of intravesical therapy.
• Maintenance therapy:Patients with a complete response after either course of induction therapy proceed to maintenance therapy comprising intravesical mitomycin once on week 1 and intravesical BCG once weekly on weeks 2 and 3. Maintenance therapy repeats every 6 months through year 3.

Arm II:

• Induction therapy:Patients receive intravesical BCG once weekly on weeks 1-6 and 10-12. Patients with visible lesions or disease recurrence or progression undergo transurethral resection (TUR) during weeks 16-18 and receive one additional course of intravesical therapy.
• Maintenance therapy: Patients with a complete response after either course of induction therapy receive maintenance therapy comprising intravesical BCG once weekly on weeks 1-3. Maintenance therapy repeats every 6 months through year 3.

Patients are followed every 6 months for 5 years and then annually thereafter.

PROJECTED ACCRUAL: A total of 84-126 patients (42-63 per treatment arm) will be accrued for this study within 3.5 years.

DISEASE CHARACTERISTICS:

• Histologically confirmed carcinoma in situ (CIS) of the bladder with urinary cytology

• Primary CIS (no prior history of CIS, papillary, or solid transitional cell carcinoma [TCC] of the bladder and no concurrent papillary or solid TCC) OR
• Secondary CIS (detected after complete resection of superficial Ta/T1 TCC of the bladder) OR
• Concurrent CIS (in the presence of superficial primary or recurrent Ta/T1 TCC of the bladder)
• No more than 28 days since prior transurethral resection (TUR) of all visible lesions
• No muscle involvement
• No prior or concurrent upper urinary tract tumors
• No urethral strictures that would prevent endoscopic procedures and repeated catheterization
• No upper urinary tract disease (e.g., vesico-ureteral reflux or massive stones) that would make multiple transurethral procedures risky

PATIENT CHARACTERISTICS:

Age:

• Not specified

Performance status:

• WHO 0-2

Life expectancy:

• Not specified

Hematopoietic:

• Not specified

Hepatic:

• Not specified

Renal:

• Not specified

Other:

• Not pregnant or nursing
• No active tuberculosis (highly positive skin tests allowed if no active disease)
• No disease that would preclude general anesthesia
• No active intractable or uncontrollable infection
• No other prior or concurrent malignancy except cured basal cell skin cancer
• No psychological, familial, sociological, or geographical condition that would preclude study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• No prior BCG

Chemotherapy:

• More than 3 months since prior chemotherapy

Endocrine therapy:

• Not specified

Radiotherapy:

• No prior radiotherapy to the pelvis

Surgery:

• See Disease Characteristics

Other:

• More than 3 months since prior intravesical cytostatic agents