RATIONALE: Chemoprevention uses drugs to try and prevent development of cancer. Fenretinide
may be effective in treating cervical neoplasia and preventing cervical cancer.
PURPOSE: Randomized double-blinded phase III trial to compare the effectiveness of
fenretinide to placebo in treating patients with cervical neoplasia.
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.
DISEASE CHARACTERISTICS: Histologically diagnosed new or recurrent cervical
intraepithelial neoplasia grade 2-3 lesion involving at least one quadrant of the
transformation zone of the cervix
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Zubrod 0-2 Life expectancy:
At least 12 months Hematopoietic: Absolute granulocyte count greater than 1500/mm3
Platelet count greater than 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL
Renal: Creatinine no greater than 1.5 mg/dL Other: Fertile patients must use effective
contraception Fasting triglyceride less than 2 times normal No prior malignancy Must
consent to colposcopy and cervical biopsy
PRIOR CONCURRENT THERAPY: Not specified