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.

ELIGIBILITY

• No myelodysplastic syndrome

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

Further Study Details: 

OBJECTIVES: I. Evaluate the efficacy of fenretinide in patients with oral intraepithelial neoplasia.

II. Assess the toxicity of fenretinide in these patients.

PROTOCOL 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.

Criteria

PROTOCOL ENTRY CRITERIA:

--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

--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

Arizona
      Arizona Cancer Center, Tucson,  Arizona,  85724,  United States
      Veterans Affairs Medical Center - Tucson, Tucson,  Arizona,  85723,  United States
Kansas
      University of Kansas Medical Center, Kansas City,  Kansas,  66160-7357,  United States
Kentucky
      Albert B. Chandler Medical Center, University of Kentucky, Lexington,  Kentucky,  40536-0084,  United States
      Veterans Affairs Medical Center - Lexington, Lexington,  Kentucky,  40511-1093,  United States
Louisiana
      MBCCOP - LSU Medical Center, New Orleans,  Louisiana,  70112,  United States
Michigan
      Barbara Ann Karmanos Cancer Institute, Detroit,  Michigan,  48201,  United States
      University of Michigan Comprehensive Cancer Center, Ann Arbor,  Michigan,  48109-0752,  United States
      Veterans Affairs Medical Center - Detroit, Detroit,  Michigan,  48201-1932,  United States
Missouri
      Veterans Affairs Medical Center - Kansas City, Kansas City,  Missouri,  64128,  United States
Ohio
      Barrett Cancer Center, The University Hospital, Cincinnati,  Ohio,  45219,  United States
      Veterans Affairs Medical Center - Cincinnati, Cincinnati,  Ohio,  45220-2288,  United States
Texas
      University of Texas Health Science Center at San Antonio, San Antonio,  Texas,  78284,  United States
      Veterans Affairs Medical Center - San Antonio (Murphy), San Antonio,  Texas,  78284,  United States
Utah
      Huntsman Cancer Institute, Salt Lake City,  Utah,  84132,  United States

Study chairs or principal investigators

Omer Kucuk,  Study Chair,  Southwest Oncology Group   

Study ID Numbers:  CDR0000066085; SWOG-9507; NCI-P98-0128
Record last reviewed:  October 2004
Last Updated:  October 16, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00003223
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08