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Spots Global Cancer Trial Database for Fenretinide in Treating Patients With Recurrent Malignant Glioma

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We do not endorse or review these studies in any way.

Trial Identification

Brief Title: Fenretinide in Treating Patients With Recurrent Malignant Glioma

Official Title: Phase II Evaluation of Fenretinide NSC (374551) as a Single Agent in the Treatment of Adult Patients With Recurrent Malignant Glioma

Study ID: NCT00006080

Interventions

fenretinide

Study Description

Brief Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of fenretinide in treating patients who have recurrent malignant glioma.

Detailed Description: OBJECTIVES: I. Determine the efficacy of fenretinide as assessed by 6-month progression- free survival in patients with recurrent malignant glioma. II. Determine the rate of measurable clinical response, time to progression, and overall survival of patients treated with this drug. III. Determine the unexpected toxicity of this drug in these patients. OUTLINE: This is a multicenter study. Patients are stratified according to disease type (glioblastoma multiforme (closed to accrual as of 05/31/2001) and gliosarcoma (closed to accrual as of 05/31/2001) vs anaplastic astrocytoma, anaplastic oligodendroglioma, and mixed malignant glioma). Patients receive oral fenretinide twice daily during weeks 1 and 4. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline and then before each course of chemotherapy. Patients are followed every 3 months. PROJECTED ACCRUAL: A total of 41-85 patients (21-45 with anaplastic astrocytoma, anaplastic oligodendroglioma, and mixed malignant glioma and 20-40 with glioblastoma multiforme (closed to accrual as of 05/31/2001) and gliosarcoma (closed to accrual as of 05/31/2001)) will be accrued for this study.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Jonsson Comprehensive Cancer Center, UCLA, Los Angeles, California, United States

UCSF Cancer Center and Cancer Research Institute, San Francisco, California, United States

Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support, Bethesda, Maryland, United States

Dana-Farber Cancer Institute, Boston, Massachusetts, United States

University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan, United States

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

University of Pittsburgh Cancer Institute, Pittsburgh, Pennsylvania, United States

Simmons Cancer Center - Dallas, Dallas, Texas, United States

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

University of Texas Health Science Center at San Antonio, San Antonio, Texas, United States

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

Contact Details

Name: Vinay K. Puduvalli, MD

Affiliation: M.D. Anderson Cancer Center

Role: STUDY_CHAIR

Useful links and downloads for this trial

Clinicaltrials.gov

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