Fenretinide In Treating Patients With Advanced or Metastatic Hormone-Refractory Prostate Cancer

You may be eligible if

• DISEASE CHARACTERISTICS:
• Histologically or cytologically confirmed adenocarcinoma of the prostate
• * Measurable or non-measurable disease
• * Metastatic disease allowed
• Castrate levels of serum testosterone (either after orchiectomy or maintained on a luteinizing hormone-releasing hormone agonist or antagonist)
• Prostate-specific antigen (PSA) greater than 10 ng/mL at baseline and rising, with 2 consecutive increases measured at least 1 week apart\*
• No known brain metastases NOTE: \*If the third PSA value has not risen above the second PSA value, a fourth measurement must be obtained that is higher than the second value
• PATIENT CHARACTERISTICS:
• Age
• Over 18
• Performance status
• ECOG 0-1
• Life expectancy
• More than 12 weeks
• Hematopoietic
• Absolute neutrophil count greater than 1,500/mm\^3
• WBC greater than 3,000/mm\^3
• Platelet count greater than 100,000/mm\^3
• Hepatic
• AST and ALT no greater than 2.5 times upper limit of normal
• Bilirubin normal
• Renal
• Creatinine normal OR
• Creatinine clearance greater than 60 mL/min
• Cardiovascular
• No symptomatic congestive heart failure
• No unstable angina pectoris
• No cardiac arrhythmia
• Other
• Able to tolerate oral medication
• Fertile patients must use effective contraception
• No prior allergic reaction to compounds of similar chemical or biological composition to fenretinide
• No other concurrent uncontrolled illness
• No ongoing or active infection
• No psychiatric illness or social situation that would preclude study compliance
• PRIOR CONCURRENT THERAPY:
• Biologic therapy
• Not specified
• Chemotherapy
• No prior cytotoxic chemotherapy
• Endocrine therapy
• See Disease Characteristics
• At least 6 weeks since prior antiandrogen therapy with any of the following:
• * Cyproterone
• * Flutamide
• * Bicalutamide
• * Nilutamide
• Concurrent corticosteroids allowed provided therapy was initiated before study entry
• Radiotherapy
• At least 4 weeks since prior radiotherapy and recovered
• No concurrent radiotherapy, including for pain
• No concurrent radioisotopes (e.g., strontium chloride Sr 89 or samarium Sm 153 lexidronam pentasodium)
• Other
• More than 4 weeks since prior investigational agents
• No concurrent antioxidants (e.g., ascorbic acid or vitamin E), vitamin A, or beta carotene supplements
• No concurrent combination antiretroviral therapy for HIV-positive patients
• No other concurrent investigational or commercial anticancer agents or therapies