Fenretinide in Treating Patients With Metastatic or Unresectable Malignant Solid Tumors

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy, such as fenretinide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.

PURPOSE: This phase I trial is studying the side effects and best dose of fenretinide in treating patients with metastatic or unresectable malignant solid tumors.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: California Cancer Consortium
• Collaborator: National Cancer Institute (NCI)
• Treatments: Fenretinide

Criteria

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