SWOG-9507, Fenretinide in Treating Patients With Neoplasia of the Mouth
- Registration Number
- NCT00003223
- Lead Sponsor
- SWOG Cancer Research Network
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 5
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description treatment fenretinide Fenretinide 200 mg PO days 1-25, q 28 days x 6 cycles.
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (15)
Veterans Affairs Medical Center - Detroit
🇺🇸Detroit, Michigan, United States
University of Michigan Comprehensive Cancer Center
🇺🇸Ann Arbor, Michigan, United States
Arizona Cancer Center
🇺🇸Tucson, Arizona, United States
Barrett Cancer Center, The University Hospital
🇺🇸Cincinnati, Ohio, United States
Veterans Affairs Medical Center - Lexington
🇺🇸Lexington, Kentucky, United States
Barbara Ann Karmanos Cancer Institute
🇺🇸Detroit, Michigan, United States
Veterans Affairs Medical Center - Kansas City
🇺🇸Kansas City, Missouri, United States
Huntsman Cancer Institute
🇺🇸Salt Lake City, Utah, United States
MBCCOP - LSU Medical Center
🇺🇸New Orleans, Louisiana, United States
Veterans Affairs Medical Center - Tucson
🇺🇸Tucson, Arizona, United States
Albert B. Chandler Medical Center, University of Kentucky
🇺🇸Lexington, Kentucky, United States
University of Texas Health Science Center at San Antonio
🇺🇸San Antonio, Texas, United States
Veterans Affairs Medical Center - Cincinnati
🇺🇸Cincinnati, Ohio, United States
Veterans Affairs Medical Center - San Antonio (Murphy)
🇺🇸San Antonio, Texas, United States
University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States