Fenretinide in Treating Patients With Cervical Neoplasia - Article
Clinical Trial: Fenretinide in Treating Patients With Cervical Neoplasia
This study is no longer recruiting patients.
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 |
MedlinePlus related topics: Cervical Cancer
Study Type: Interventional
Study Design: Prevention
Study start: September 1992
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
PROTOCOL ENTRY CRITERIA:
- Histologically diagnosed new or recurrent cervical intraepithelial neoplasia grade 2-3 lesion involving at least one quadrant of the transformation zone of the cervix
- Not specified
- 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
University of Texas - MD Anderson Cancer Center, Houston, Texas, 77030, United States
Michele Follen, Study Chair, M.D. Anderson Cancer Center
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
Cache Date: April 9, 2005