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Fenretinide in Treating Patients With Cervical Neoplasia



Fenretinide in Treating Patients With Cervical Neoplasia

For Condition: Cervical Cancer,prevention of cervical cancer
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , M.D. Anderson Cancer Center
Synopsis: 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.
Details: OBJECTIVES: I. Determine the efficacy of femretinide (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. PROTOCOL OUTLINE: This is a double blinded study. Patients are randomized to receive either fenretinide or placebo. Patients are administered fenretinide or a placebo 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.
Eligibility:
Study Type:  Interventional, Prevention
Minimum Age/Maximum Age: 18 Years/
Genders: 
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --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 --Prior/Concurrent Therapy-- - Not specified --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
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
MicheleFollen,  Study Chair,  M.D. Anderson Cancer Center

University of Texas - MD Anderson Cancer Center
Houston,  Texas,  77030
United States
 


Additional Information:
Study ID Numbers:  CDR0000065761;  MDA-ID-92027,NCI-P97-0092
Study Start Date: September 1992
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003075

Other Prevention Of Cervical Cancer Studies:
1. Fenretinide in Treating Patients With Cervical Neoplasia

2. Eflornithine To Prevent Cervical Cancer in Patients With Cervical Intraepithelial Neoplasia

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