Fenretinide in Treating Patients With Metastatic or Unresectable Malignant Solid Tumors

You may be eligible if

• DISEASE CHARACTERISTICS:
• Histologically or cytologically confirmed solid tumor malignancy
• * Metastatic and/or unresectable disease
• No standard curative or palliative measures exist or remain effective
• Measurable or evaluable disease
• No known brain metastases unless previously resected or irradiated with no treatment with steroids for more than 1 month
• PATIENT CHARACTERISTICS:
• ECOG performance status (PS) 0-2 or Karnofsky PS 60-100%
• Life expectancy \> 3 months
• WBC ≥ 3,000/mm³
• Absolute neutrophil count ≥ 1,500/mm³
• Platelet count ≥ 75,000/mm³
• Bilirubin \< 1.5 times upper limit of normal (ULN)
• AST and ALT ≤ 2.5 times ULN (5 times ULN for patients with known liver metastases)
• Creatinine normal OR creatinine clearance ≥ 60 mL/min
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception prior to, during, and for ≥ 6 months after completion of study treatment
• No uncontrolled diabetes mellitus at high risk for hypertriglyceridemia (i.e., fasting serum glucose concentration \> 200 mg/dL OR hemoglobin A1C \> 7.5%)
• No egg allergy
• No history of allergic reactions to compounds of similar chemical or biologic composition to fenretinide (e.g., isotretinoin, vitamin A, or tretinoin)
• No uncontrolled intercurrent illness including, but not limited to, any of the following:
• * Ongoing or active infection
• * Symptomatic congestive heart failure
• * Unstable angina pectoris
• * Cardiac arrhythmia
• * Psychiatric illness or social situation that would preclude compliance with study requirements
• No known hypertriglyceridemia requiring medication
• No identified familial hyperlipidemia disorder
• PRIOR CONCURRENT THERAPY:
• Recovered from all prior therapy
• Prior treatment with oral fenretinide is allowed provided no severe toxicity occurred
• At least 2 weeks since prior major surgery
• More than 4 weeks since prior chemotherapy or radiotherapy
• * At least 6 weeks since prior nitrosoureas or mitomycin C
• No other concurrent investigational agents
• No other concurrent anticancer chemotherapy
• No other concurrent antioxidants\*
• No concurrent hormone-ablative agents, including steroids, except for adrenal replacement or anti-inflammatory indications
• No other concurrent anticancer agents or therapies
• No concurrent herbal or other alternative therapies\*
• No concurrent vitamin supplements (e.g., vitamin A, ascorbic acid, or vitamin E)\*
• * Standard-dose multivitamin allowed
• No other concurrent medications that may act as modulators of intracellular ceramide levels or ceramide cytotoxicity, sphingolipid transport, p-glycoprotein, multidrug resistance protein 1 (MRP1), or MRP1 drug/lipid transporters, including any of the following\*:
• * Cyclosporine or any of its analogues
• * Verapamil
• * Tamoxifen or its analogue
• * Ketoconazole
• * Chlorpromazine
• * Mifepristone
• * Indomethacin
• * Sulfinpyrazone NOTE: \*Patients who have discontinued these drugs for ≥ 1 week are eligible
• No concurrent medications that may cause pseudotumor cerebri, including any of the following:
• * Tetracycline
• * Nalidixic acid
• * Nitrofurantoin
• * Phenytoin
• * Sulfonamides
• * Lithium
• * Amiodarone
• No concurrent total parenteral nutrition (TPN) with intralipids
• No concurrent combination antiretroviral therapy for HIV-positive patients