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

Overview

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.

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Prevention
    • Masking: None (Open Label)
  • Study Primary Completion Date: March 2000

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.

Interventions

  • Drug: fenretinide
    • 200 mg/day PO, days 1-25 q 28 days x 6 cycles.

Arms, Groups and Cohorts

  • Experimental: treatment
    • Fenretinide 200 mg PO days 1-25, q 28 days x 6 cycles.

Participating in This Clinical Trial

DISEASE CHARACTERISTICS: Histologically proven oral mucosal intraepithelial neoplasia Stage II: moderate dysplasia, keratosis with atypia Stage III: severe keratinizing or nonkeratinizing dysplasia No myelodysplastic syndrome No retinopathies PATIENT CHARACTERISTICS: See General Eligibility Criteria PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent biologic therapy Chemotherapy: No concurrent chemotherapy Endocrine therapy: No concurrent endocrine therapy Radiotherapy: No concurrent radiotherapy Surgery: Prior surgical ablation of prior dysplastic sites allowed Other: At least 2 months since prior therapy toxicities Patient Characteristics– Age: Not specified Performance Status: SWOG 0-1 Life Expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception at least 1 month before, during, and at least 2 months after study

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • SWOG Cancer Research Network
  • Collaborator
    • National Cancer Institute (NCI)
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Omer Kucuk, MD, Study Chair, Barbara Ann Karmanos Cancer Institute

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