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.

Condition	Treatment or Intervention	Phase
Cervical Cancer prevention of cervical cancer	Drug: fenretinide	Phase III

Further Study 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.

Ages Eligible for Study:  18 Years and above

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

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

Study chairs or principal investigators

Michele Follen,  Study Chair,  M.D. Anderson Cancer Center   

Study ID Numbers:  CDR0000065761; MDA-ID-92027; NCI-P97-0092
Record last reviewed:  May 2004
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00003075
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08