Spots Global Cancer Trial Database for SWOG-9507, Fenretinide in Treating Patients With Neoplasia of the Mouth
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Trial Identification
Brief Title: SWOG-9507, Fenretinide in Treating Patients With Neoplasia of the Mouth
Official Title: A Single Arm, Phase II Study to Determine the Safety and Efficacy of 4-HPRN-(4-Hydroxyphenyl) Retinamide for Treating Oral Intraepithelial Neoplasia
Study ID: NCT00003223
Conditions
Interventions
Study Description
Brief Summary: RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. The use of fenretinide may be an effective way to prevent the development of cancer in patients with neoplasia of the mouth. PURPOSE: Phase II trial to study the effectiveness of fenretinide in preventing cancer in patients who have neoplasia of the mouth.
Detailed Description: OBJECTIVES: I. Evaluate the efficacy of fenretinide in patients with oral intraepithelial neoplasia. II. Assess the toxicity of fenretinide in these patients. OUTLINE: Patients receive oral fenretinide on days 1-25 every 28 days for a maximum of 6 courses. After 6 courses, patients receive a post-treatment biopsy. Patients exhibiting disease progression or unacceptable toxicities are removed from the study. Patients are followed at 3 and 6 months. PROJECTED ACCRUAL: A total of 51 patients will be accrued.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Veterans Affairs Medical Center - Tucson, Tucson, Arizona, United States
Arizona Cancer Center, Tucson, Arizona, United States
University of Kansas Medical Center, Kansas City, Kansas, United States
Veterans Affairs Medical Center - Lexington, Lexington, Kentucky, United States
Albert B. Chandler Medical Center, University of Kentucky, Lexington, Kentucky, United States
MBCCOP - LSU Medical Center, New Orleans, Louisiana, United States
University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan, United States
Veterans Affairs Medical Center - Detroit, Detroit, Michigan, United States
Barbara Ann Karmanos Cancer Institute, Detroit, Michigan, United States
Veterans Affairs Medical Center - Kansas City, Kansas City, Missouri, United States
Barrett Cancer Center, The University Hospital, Cincinnati, Ohio, United States
Veterans Affairs Medical Center - Cincinnati, Cincinnati, Ohio, United States
University of Texas Health Science Center at San Antonio, San Antonio, Texas, United States
Veterans Affairs Medical Center - San Antonio (Murphy), San Antonio, Texas, United States
Huntsman Cancer Institute, Salt Lake City, Utah, United States
Contact Details
Name: Omer Kucuk, MD
Affiliation: Barbara Ann Karmanos Cancer Institute
Role: STUDY_CHAIR
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