Clinical trial · Interventional
Fenretinide in Treating Patients With Metastatic or Unresectable Malignant Solid Tumors
Phase I Trial of Intravenous Fenretinide (4-HPR) for Patients With Malignant Solid Tumors
NCT00387504CI-TRIAL-00012054completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Unspecified Adult Solid Tumor, Protocol Specific | Adult Solid Neoplasm | ALIAS | 0.85 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| fenretinide | Drug | — | UNRESOLVED |
| pharmacological study | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (3)
- measure
- Maximum tolerated dose (MTD) of fenretinide
- timeFrame
- at end of study
- measure
- Toxicity as measured by type (organ affected or laboratory determination such as absolute neutrophil count), severity (NCI CTCAE v3.0), time of onset (course number), duration, and reversibility or outcome
- timeFrame
- ongoing
- measure
- Survival and time to failure as measured by Kaplan-Meier
- timeFrame
- at end of study
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.