Randomized Chemoprevention Trial With 4-HPR (Fenretinide) in Superficial Bladder Cancer

Inclusion Criteria

DISEASE CHARACTERISTICS:

- Histologically proven solitary or multifocal superficial (stage Ta, grades 1-2)
transitional cell carcinoma (TCC) of the bladder meeting 1 of the following criteria:

- Newly diagnosed and no more than 4 weeks since resection

- Secondary after being tumor free (including carcinoma in situ) for more than 12
months with no intravesical therapy within that 12 months OR

- Histologically proven Ta, T1, or Tis TCC of the bladder previously treated with
Bacillus Calmette-Guerin (BCG).

- Must have received 6 weeks of induction BCG followed by no evidence of disease
by cystoscopy and cytology and then further treatment with 3 weekly doses of
BCG.

- Visible tumor totally resected within 4 weeks prior to study entry and no further
surgery, intravesical therapy, or systemic therapy planned

- No prostatic, prostatic urethral, or upper tract TCC involvement by the index tumor
at resection

- No metastatic disease

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Performance status:

- Zubrod (Eastern Cooperative Oncology Group (ECOG)) 0-2

Life expectancy:

- At least 2 years

Hematopoietic:

- white blood count (WBC) greater than 3,000/mm^3

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

- Hemoglobin greater than 11.0 g/dL

Hepatic:

- serum glutamic oxaloacetic transaminase (SGOT) or serum glutamic pyruvic transaminase
(SGPT) less than 1.5 times upper limit of normal (ULN)

Renal:

- Creatinine less than 2.0 mg/dL

Other:

- Triglyceride level less than 2.5 times ULN

- No other concurrent malignancy except nonmelanomatous skin cancer

- No other malignancy within the past 5 years unless currently disease free, at least 6
months since prior therapy, no current or planned active therapy, and expected
disease-free survival at least 2 years

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception during and for 1 year after the
study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- See Disease Characteristics

- No concurrent systemic biologic therapy

Chemotherapy:

- See Disease Characteristics

- No prior systemic cytotoxic chemotherapy for bladder cancer

- At least 1 year since prior cytotoxic chemotherapy for nonbladder cancer

- No concurrent systemic chemotherapy

Endocrine therapy:

- Not specified

Radiotherapy:

- No prior radiotherapy to the bladder

- No concurrent radiotherapy

Surgery:

- See Disease Characteristics

Other:

- At least 3 months since prior high-dose vitamin A (greater than 25,000 IU) or beta
carotene (at least 30 mg/day)

- At least 3 months since prior retinoid therapy