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.

Condition	Treatment or Intervention	Phase
prevention of oral cancer	Drug: fenretinide	Phase II

Further Study Details: 

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.

PROTOCOL 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.

Ages Eligible for Study:  18 Years and above

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

• Histologically proven dysplastic leukoplakia greater than 1 cm in diameter

--Prior/Concurrent Therapy--

• Biologic therapy: Not specified
• Chemotherapy: Not specified
• Endocrine therapy: Not specified
• Radiotherapy: Not specified
• Surgery: Not specified
• Other: At least 3 months since prior chronic high dose (greater than 30,000 IU/day) vitamin A (retinol); At least 1 month since other prior retinoids

--Patient Characteristics--

• Age: 18 and over
• Performance status: ECOG 0-2
• Life expectancy: Not specified
• Hematopoietic: WBC at least 3,500/mm3; Platelet count at least 125,000/mm3; Hemoglobin at least 12.0 g/dL
• Hepatic: Bilirubin less than 1.5 mg/dL; SGOT less than 2 times upper limit of normal (ULN)
• Renal: Creatinine less than 1.7 mg/dL
• Cardiovascular: No symptomatic coronary artery disease; No uncontrolled hypertension; No prior coronary artery bypass; No acute myocardial infarction in the past year
• Other: Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective barrier contraception for 1 month prior, during, and for 12 months after study; Fasting serum triglyceride less than 2 times ULN; Cholesterol less than 350 mg/dL; No hypersensitivity to vitamin A or retinoids; No active malignancy; No concurrent acute or chronic medical or psychiatric condition that would preclude compliance or toxicity assessment; No concurrent and severe night blindness

Alabama
      University of Alabama Comprehensive Cancer Center, Birmingham,  Alabama,  35294,  United States

Study chairs or principal investigators

Samuel W. Beenken,  Study Chair,  UAB Comprehensive Cancer Center   

Study ID Numbers:  CDR0000067401; UAB-9713; NCI-G99-1626
Record last reviewed:  June 2004
Last Updated:  October 13, 2004
Record first received:  December 10, 1999
ClinicalTrials.gov Identifier:  NCT00004161
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08