A Randomized Phase II Trial of Sequential Chemo-Immunotherapy Versus Immunotherapy Alone in Carcinoma in Situ of the Urinary Bladder

Inclusion 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