Phase I trial to study the effectiveness of fenretinide in treating children who have solid tumors that have not responded to standard therapy. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
OBJECTIVES: I. Determine the maximum tolerated dose of fenretinide (HPR) in children with high risk solid tumors. II. Determine the toxicities of HPR in these patients. III. Determine the pharmacokinetics of HPR in these patients. IV. Determine the CSF level of HPR in patients whom cerebrospinal fluid is obtained for routine purposes while on this study. V. Determine the effect of HPR on plasma retinol levels in these patients. VI. Determine the activity of HPR in these patients. VII. Determine the antitumor activity of HPR on minimal residual bone marrow disease in neuroblastoma. OUTLINE: This is a dose escalation study. Patients receive oral fenretinide 3 times a day on days 1-7. Treatment repeats every 3 weeks for up to 8 courses. Patients may receive an additional 22 courses of therapy in the presence of stable or responding residual tumor. Patients with recurrent neuroblastoma, after prior myeloablative therapy with no measurable disease, will stop treatment after 8 courses. 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. Patients are followed until death.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
18
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Cancer Center and Beckman Research Institute, City of Hope
Duarte, California, United States
Long Beach Memorial Medical Center
Long Beach, California, United States
Children's Hospital Los Angeles
Los Angeles, California, United States
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, United States
Children's Hospital of Orange County
Orange, California, United States
UCSF Cancer Center and Cancer Research Institute
San Francisco, California, United States
Children's National Medical Center
Washington D.C., District of Columbia, United States
Indiana University Cancer Center
Indianapolis, Indiana, United States
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States
University of Minnesota Cancer Center
Minneapolis, Minnesota, United States
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