Clinical Trial: Fenretinide in Treating Patients With Leukoplakia of the Mouth

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Randomized, Double Blind, Placebo-Controlled Phase II Clinical Trial of N(4-Hydroxy-phenyl)Retinamide (Fenretinide, 4HPR) in Oral Leukoplakia

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 Summary:

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.


Sponsor: University of Alabama at Birmingham

Current Primary Outcome: Determine modulation by fenretinide of surrogate endpoint markers of oral mucosal carcinogenesis in patients with oral dysplastic leukoplakia. [ Time Frame: baseline to 6 months ]

Original Primary Outcome:

Current Secondary Outcome:

  • Determine whether fenretinide will cause significant modulation of intermediate endpoint markers and significant regression of oral dysplastic leukoplakia in this patient population. [ Time Frame: baseline to 6 months ]
  • Compare the ability of fenretinide and placebo to modulate surrogate endpoint biomarkers in this patient population. [ Time Frame: baseline to 6 months ]
  • Document the degree of recurrence of oral dysplastic leukoplakia after the administration of fenretinide, both at the same site and at new sites. [ Time Frame: baseline to 6 months ]


Original Secondary Outcome:

Information By: University of Alabama at Birmingham

Dates:
Date Received: December 10, 1999
Date Started: June 1997
Date Completion:
Last Updated: April 10, 2013
Last Verified: April 2013