Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 12:20 PM
Ignite Modification Date:
2025-12-24 @ 12:20 PM
NCT ID:
NCT00004161
Brief Summary:
RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development of or treat early cancer. Fenretinide may be an effective drug in treating leukoplakia.
PURPOSE: Randomized phase II trial to study the effectiveness of fenretinide in treating patients who have leukoplakia of the mouth.
Detailed Description:
OBJECTIVES: I. Determine modulation by fenretinide of surrogate endpoint markers of oral mucosal carcinogenesis in patients with oral dysplastic leukoplakia. II. Determine whether fenretinide will cause significant modulation of intermediate endpoint markers and significant regression of oral dysplastic leukoplakia in this patient population. III. Compare the ability of fenretinide and placebo to modulate surrogate endpoint biomarkers in this patient population. IV. Document the degree of recurrence of oral dysplastic leukoplakia after the administration of fenretinide, both at the same site and at new sites.
OUTLINE: This is a randomized, double blind, placebo controlled study. Patients are randomized to 1 of 2 treatment arms: Arm I: Patients receive oral fenretinide daily (except days 1-3 each month) for 6 months. Arm II: Patients receive oral placebo daily (except days 1-3 each month) for 6 months. Patients then receive oral fenretinide daily (except days 1-3 each month) for 6 months. Patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.
Study:
NCT00004161
Study Brief:
Protocol Section:
NCT00004161