Phase II Study of Intravesical Therapy With AD 32 in Patients With Papillary Urothelial Carcinoma or Carcinoma in Situ (CIS) Refractory to Prior Therapy With Bacillus Calmette-Guerin

Inclusion Criteria

DISEASE CHARACTERISTICS:

- Histologically confirmed recurrent superficial bladder cancer defined as papillary
transitional cell carcinoma (stage Ta/T1) and/or carcinoma in situ (stage Tis) of the
urinary bladder

- No evidence of invasion of the underlying muscle (stage T2) at baseline

- Must meet 1 of the following criteria:

- Failure of at least 2 prior courses of intravesical therapy, 1 of which must
have been a course of BCG

- Recurrent or persistent disease within 6 months after failing a 6-week course of
BCG followed by maintenance therapy

- Inability or ineligibility to complete 1 course of intravesical therapy with
BCG, and failure of 2 prior courses of intravesical therapy with an alternative
agent

- Diagnosis must have been made no more than 24 months after completion of prior
treatment with intravesical immunotherapy or chemotherapy

- If carcinoma in situ is current or previous diagnosis, the biopsies must be obtained
from at least 4 sites (bladder mapping)

- If prostatic urothelial biopsy discloses carcinoma in situ, transurethral prostatic
resection must be carried out prior to study

- Papillary disease must have undergone complete transurethral resection (TURBT) within
28 days before study

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Performance status:

- ECOG 0-1

Life expectancy:

- Not specified

Hematopoietic:

- WBC greater than 4,000/mm^3

- Platelet count greater than 100,000/mm^3

Hepatic:

- Bilirubin less than 2 times upper limit of normal (ULN)

- SGOT and SGPT less than 3 times ULN

Renal:

- Creatinine no greater than 2.5 mg/dL

Other:

- Normal upper tract (ureter and renal pelvic) evaluation within 6 months

- No known sensitivity to anthracyclines or to Cremophor EL

- HIV negative

- No known AIDS or HIV-1 associated complex

- No other significant concurrent illness

- No other prior malignancy within the past 3 years except superficial bladder cancer,
adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of
the cervix

- Not pregnant or nursing

- Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- See Disease Characteristics

- No concurrent biological response modifier therapy

Chemotherapy:

- See Disease Characteristics

- Prior oral bropirimine for bladder cancer allowed

- No prior AD 32 for bladder cancer

- No other intravenously administered systemic chemotherapy for bladder cancer

- No concurrent chemotherapy for any other malignancy

Endocrine therapy:

- No concurrent hormonal therapy

Radiotherapy:

- No prior radiotherapy

- No concurrent radiotherapy

Surgery:

- See Disease Characteristics