A Randomized, Double Blind, Placebo-Controlled Phase II Clinical Trial of N(4-Hydroxy-phenyl)Retinamide (Fenretinide, 4HPR) in Oral Leukoplakia
OBJECTIVES: I. Determine modulation by fenretinide of surrogate endpoint markers of oral
mucosal carcinogenesis in patients with oral dysplastic leukoplakia. II. Determine whether
fenretinide will cause significant modulation of intermediate endpoint markers and
significant regression of oral dysplastic leukoplakia in this patient population. III.
Compare the ability of fenretinide and placebo to modulate surrogate endpoint biomarkers in
this patient population. IV. Document the degree of recurrence of oral dysplastic
leukoplakia after the administration of fenretinide, both at the same site and at new sites.
OUTLINE: This is a randomized, double blind, placebo controlled study. Patients are
randomized to 1 of 2 treatment arms: Arm I: Patients receive oral fenretinide daily (except
days 1-3 each month) for 6 months. Arm II: Patients receive oral placebo daily (except days
1-3 each month) for 6 months. Patients then receive oral fenretinide daily (except days 1-3
each month) for 6 months. Patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention
Determine modulation by fenretinide of surrogate endpoint markers of oral mucosal carcinogenesis in patients with oral dysplastic leukoplakia.
baseline to 6 months
Samuel W. Beenken, MD
University of Alabama at Birmingham
United States: Federal Government
|University of Alabama Comprehensive Cancer Center||Birmingham, Alabama 35294|