Fenretinide in Treating Patients With Cervical Neoplasia
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|ClinicalTrials.gov Identifier: NCT00003075|
Recruitment Status : Completed
First Posted : May 27, 2004
Last Update Posted : July 30, 2012
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 or disease||Intervention/treatment||Phase|
|Cervical Cancer Precancerous Condition||Drug: Fenretinide Other: Placebo||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||39 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||A Randomized Double-Blind Study of N-(4-hydroxyphenyl) Retinamide (4-HPR) Versus Placebo in Patients With Cervical Intraepithelial Neoplasia (CIN) Grade 2-3|
|Study Start Date :||September 1992|
|Actual Primary Completion Date :||September 2000|
|Actual Study Completion Date :||May 2001|
Oral Fenretinide daily for 6 months with 3 days of rest every month.
Other Name: 4-HPR
|Placebo Comparator: Placebo||
Oral placebo daily for 6 months with 3 days of rest every month.
- Efficacy of Fenretinide at Regressing CIN [ Time Frame: 6 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003075
|United States, Texas|
|University of Texas - MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Study Chair:||Michele Follen, MD, PhD||M.D. Anderson Cancer Center|