A Single Arm, Phase II Study to Determine the Safety and Efficacy of 4-HPRN-(4-Hydroxyphenyl) Retinamide for Treating Oral Intraepithelial Neoplasia
18 Years
N/A
Both
Head and Neck Cancer
Trial Information
A Single Arm, Phase II Study to Determine the Safety and Efficacy of 4-HPRN-(4-Hydroxyphenyl) Retinamide for Treating Oral Intraepithelial Neoplasia
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.
Inclusion 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
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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Principal Investigator
Omer Kucuk, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Barbara Ann Karmanos Cancer Institute
Authority:
United States: Federal Government
Study ID:
CDR0000066085
NCT ID:
NCT00003223
Start Date:
December 1997
Completion Date:
March 2000
Related Keywords:
- Head and Neck Cancer
- lip and oral cavity cancer
- Neoplasms
- Head and Neck Neoplasms
Name | Location |
|---|---|
| Arizona Cancer Center | Tucson, Arizona 85724 |
| University of Michigan Comprehensive Cancer Center | Ann Arbor, Michigan 48109-0752 |
| Albert B. Chandler Medical Center, University of Kentucky | Lexington, Kentucky 40536-0084 |
| Barbara Ann Karmanos Cancer Institute | Detroit, Michigan 48201 |
| Barrett Cancer Center, The University Hospital | Cincinnati, Ohio 45219 |
| MBCCOP - LSU Medical Center | New Orleans, Louisiana 70112 |
| University of Texas Health Science Center at San Antonio | San Antonio, Texas 78284-7811 |
| Huntsman Cancer Institute | Salt Lake City, Utah 84112 |
| Veterans Affairs Medical Center - Lexington | Lexington, Kentucky 40511-1093 |
| Veterans Affairs Medical Center - Tucson | Tucson, Arizona 85723 |
| University of Kansas Medical Center | Kansas City, Kansas 66160-7353 |
| Veterans Affairs Medical Center - Detroit | Detroit, Michigan 48201-1932 |
| Veterans Affairs Medical Center - Kansas City | Kansas City, Missouri 64128 |
| Veterans Affairs Medical Center - Cincinnati | Cincinnati, Ohio 45220-2288 |
| Veterans Affairs Medical Center - San Antonio (Murphy) | San Antonio, Texas 78284 |
