Fenretinide in Treating Patients With Cervical Neoplasia
- Conditions
- Cervical CancerPrecancerous Condition
- Interventions
- Other: Placebo
- Registration Number
- NCT00003075
- Lead Sponsor
- M.D. Anderson Cancer Center
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 39
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Placebo Placebo - Fenretinide Fenretinide -
- Primary Outcome Measures
Name Time Method Efficacy of Fenretinide at Regressing CIN 6 months
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University of Texas - MD Anderson Cancer Center
🇺🇸Houston, Texas, United States