A Randomized Double-Blind Study of N-(4-hydroxyphenyl) Retinamide (4-HPR) Versus Placebo in Patients With Cervical Intraepithelial Neoplasia (CIN) Grade 2-3
OBJECTIVES: I. Determine the efficacy of fenretinide (N-(4-hydroxyphenyl) retinamide; 4-HPR)
at regressing cervical intraepithelial neoplasia (CIN). II. Document the qualitative and
quantitative toxicity of 4-HPR in women with CIN.
OUTLINE: This is a double blinded study. Patients are randomized to receive either
fenretinide or placebo. Patients are administered fenretinide or a placebo by mouth (PO)
daily for 6 months with 3 days of rest every month. Patients undergo colposcopy,
colpophotography, and Pap smears at 3, 6, 9, and 12 months. Patients undergo cervical biopsy
at 6 and 12 months to assess changes.
PROJECTED ACCRUAL: 84-100 patients will be accrued.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention
Efficacy of Fenretinide at Regressing CIN
Michele Follen, MD, PhD
M.D. Anderson Cancer Center
United States: Institutional Review Board
|University of Texas - MD Anderson Cancer Center||Houston, Texas 77030-4009|