Fenretinide in Treating Patients Who Have Undergone Surgery for Bladder Cancer

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