A Single Arm, Phase II Study to Determine the Safety and Efficacy of 4-HPRN-(4-Hydroxyphenyl) Retinamide for Treating Oral Intraepithelial Neoplasia

SWOG Cancer Research Network15 sites in 1 country5 target enrollmentDecember 1997

ConditionsHead and Neck Cancer

Interventionsfenretinide

Drugsfenretinide

Overview

Phase: Phase 2
Intervention: fenretinide
Conditions: Head and Neck Cancer
Sponsor: SWOG Cancer Research Network
Enrollment: 5
Locations: 15
Status: Terminated
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. The use of fenretinide may be an effective way to prevent the development of cancer in patients with neoplasia of the mouth.

PURPOSE: Phase II trial to study the effectiveness of fenretinide in preventing cancer in patients who have neoplasia of the mouth.

Detailed Description

OBJECTIVES: I. Evaluate the efficacy of fenretinide in patients with oral intraepithelial neoplasia. II. Assess the toxicity of fenretinide in these patients. OUTLINE: Patients receive oral fenretinide on days 1-25 every 28 days for a maximum of 6 courses. After 6 courses, patients receive a post-treatment biopsy. Patients exhibiting disease progression or unacceptable toxicities are removed from the study. Patients are followed at 3 and 6 months. PROJECTED ACCRUAL: A total of 51 patients will be accrued.

Registry

clinicaltrials.gov

Start Date

December 1997

End Date

March 2000

Last Updated

13 years ago

Study Type

Interventional

Study Design

Single Group