Clinical Trial: Fenretinide in Treating Patients With Cervical Neoplasia

This study is no longer recruiting patients.

Sponsors and Collaborators: National Cancer Institute (NCI)
M.D. Anderson Cancer Center
Information provided by: National Cancer Institute (NCI)

Purpose

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

Official Title: Phase III Randomized, Double Blinded, Placebo Controlled Study of Fenretinide in Patients with Cervical Intraepithelial Neoplasia (CIN) Grade 2-3

Further Study Details: 

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.

Eligibility

Ages Eligible for Study:  18 Years and above

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

--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

Location Information


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   

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

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


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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