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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
21
4-HPR (Fenretinide) is given as a continuous intravenous infusion (CIV) for five consecutive days. Cycle is repeated every 3 weeks, if PR, CR or stable disease for 6 cycles.
samples drawn per protocol
City of Hope Comprehensive Cancer Center
Duarte, California, United States
Childrens Hospital Los Angeles
Los Angeles, California, United States
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, United States
Contra Costa Regional Medical Center
Martinez, California, United States
Maximum tolerated dose (MTD) of fenretinide
Time frame: at end of study
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
Time frame: ongoing
Survival and time to failure as measured by Kaplan-Meier
Time frame: at end of study
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City of Hope Medical Group
Pasadena, California, United States
University of California Davis Cancer Center
Sacramento, California, United States
Texas Tech University Health Sciences Center
Lubbock, Texas, United States