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Keep this study
Lead
SWOG Cancer Research Network
With
National Cancer Institute (NCI)
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.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
