BCG With or Without Mitomycin in Treating Patients With Bladder Cancer

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Biological therapies such as BCG use different ways to stimulate the immune system and stop tumor cells from growing. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with biological therapy may kill more tumor cells. It is not yet known if BCG is more effective with or without mitomycin.

PURPOSE: Randomized phase II trial to compare the effectiveness of BCG plus mitomycin with that of BCG alone in treating patients who have bladder cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: European Organisation for Research and Treatment of Cancer - EORTC
• Treatments: BCG Vaccine; Mitomycin; Mitomycins

Criteria

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