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Spots Global Cancer Trial Database for Fenretinide in Treating Children With Solid Tumors

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Trial Identification

Brief Title: Fenretinide in Treating Children With Solid Tumors

Official Title: A Phase I Study of Fenretinide (NSC #374551) in Children With High Risk Solid Tumors

Study ID: NCT00003191

Interventions

fenretinide

Study Description

Brief Summary: 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.

Detailed Description: 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.

Eligibility

Minimum Age:

Eligible Ages: CHILD, ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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, 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

Mayo Clinic Cancer Center, Rochester, Minnesota, United States

Children's Mercy Hospital, Kansas City, Missouri, United States

Cancer Institute of New Jersey, New Brunswick, New Jersey, United States

NYU School of Medicine's Kaplan Comprehensive Cancer Center, New York, New York, United States

Memorial Sloan-Kettering Cancer Center, New York, New York, United States

Herbert Irving Comprehensive Cancer Center, New York, New York, United States

Children's Hospital Medical Center - Cincinnati, Cincinnati, Ohio, United States

Children's Hospital of Columbus, Columbus, Ohio, United States

Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, United States

Children's Hospital of Pittsburgh, Pittsburgh, Pennsylvania, United States

Vanderbilt-Ingram Cancer Center, Nashville, Tennessee, United States

University of Texas - MD Anderson Cancer Center, Houston, Texas, United States

Primary Children's Medical Center, Salt Lake City, Utah, United States

Children's Hospital and Regional Medical Center - Seattle, Seattle, Washington, United States

University of Wisconsin Comprehensive Cancer Center, Madison, Wisconsin, United States

Princess Margaret Hospital for Children, Perth, Western Australia, Australia

Contact Details

Name: Judith G. Villablanca, MD

Affiliation: Children's Hospital Los Angeles

Role: STUDY_CHAIR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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