Spots Global Cancer Trial Database for Fenretinide in Treating Patients With Metastatic or Unresectable Malignant Solid Tumors

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Trial Identification

Brief Title: Fenretinide in Treating Patients With Metastatic or Unresectable Malignant Solid Tumors

Official Title: Phase I Trial of Intravenous Fenretinide (4-HPR) for Patients With Malignant Solid Tumors

Study ID: NCT00387504

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Interventions

fenretinide

pharmacological study

Study Description

Brief 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.

Detailed Description: OBJECTIVES: * Determine the maximum tolerated dose of fenretinide in patients with metastatic or unresectable malignant solid tumors. * Determine the toxic effects of this drug in these patients. * Determine the pharmacokinetics and in vivo activity of this drug in these patients. * Determine, preliminarily, disease or tumor response in patients treated with this drug. OUTLINE: This is a dose-escalation, multicenter study. Patients receive fenretinide IV continuously on days 1-5. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve a complete or partial response may continue to receive fenretinide at the discretion of the study chair. Cohorts of 3-6 patients receive escalating doses of fenretinide until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. At least 6 patients are treated at the MTD. Patients undergo blood sample collection to determine plasma concentrations (pharmacokinetics) of fenretinide periodically during course 1 and at the end of courses 2-6. After completion of study treatment, patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 21 patients will be accrued for this study.