Fenretinide in Treating Patients With Leukoplakia of the Mouth

Phase 2

Completed

• Conditions: Head and Neck Cancer
• Interventions: Drug: fenretinide; Drug: Placebo

• Registration Number: NCT00004161
• Lead Sponsor: University of Alabama at Birmingham

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 Timeline

• Study Start: 1997-06
• Study First Submitted: 1999-12-10
• Primary Completion: 2004-01
• Study Completion: 2004-01
• Study First Submitted QC: 2004-06-03
• Study First Posted: 2004-06-04
• Status Verified: 2013-04
• Last Update Submitted: 2013-04-10
• Last Update Posted: 2013-04-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm I	fenretinide	Patients receive oral fenretinide 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.
Arm II	Placebo	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.

Primary Outcome Measures

Name	Time	Method
Determine modulation by fenretinide of surrogate endpoint markers of oral mucosal carcinogenesis in patients with oral dysplastic leukoplakia.	baseline to 6 months

Secondary Outcome Measures

Name	Time	Method
Determine whether fenretinide will cause significant modulation of intermediate endpoint markers and significant regression of oral dysplastic leukoplakia in this patient population.	baseline to 6 months
Compare the ability of fenretinide and placebo to modulate surrogate endpoint biomarkers in this patient population.	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.	baseline to 6 months

Trial Locations

Locations (1)

University of Alabama Comprehensive Cancer Center; 🇺🇸 Birmingham, Alabama, United States