NCT00003223

SWOG-9507, Fenretinide in Treating Patients With Neoplasia of the Mouth

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: SWOG Cancer Research Network · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Head and Neck Cancer

Interventions

Type	Name	Description
DRUG	fenretinide	200 mg/day PO, days 1-25 q 28 days x 6 cycles.

Timeline

• Start date: 1997-12-01
• Primary completion: 2000-03-01
• Completion: 2000-03-01
• First posted: 2004-09-10
• Last updated: 2012-07-24

Locations

15 sites across 1 country: United States