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


Phase 2
18 Years
N/A
Not Enrolling
Both
Head and Neck Cancer

Thank you

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 CenterTucson, Arizona  85724
University of Michigan Comprehensive Cancer CenterAnn Arbor, Michigan  48109-0752
Albert B. Chandler Medical Center, University of KentuckyLexington, Kentucky  40536-0084
Barbara Ann Karmanos Cancer InstituteDetroit, Michigan  48201
Barrett Cancer Center, The University HospitalCincinnati, Ohio  45219
MBCCOP - LSU Medical CenterNew Orleans, Louisiana  70112
University of Texas Health Science Center at San AntonioSan Antonio, Texas  78284-7811
Huntsman Cancer InstituteSalt Lake City, Utah  84112
Veterans Affairs Medical Center - LexingtonLexington, Kentucky  40511-1093
Veterans Affairs Medical Center - TucsonTucson, Arizona  85723
University of Kansas Medical CenterKansas City, Kansas  66160-7353
Veterans Affairs Medical Center - DetroitDetroit, Michigan  48201-1932
Veterans Affairs Medical Center - Kansas CityKansas City, Missouri  64128
Veterans Affairs Medical Center - CincinnatiCincinnati, Ohio  45220-2288
Veterans Affairs Medical Center - San Antonio (Murphy)San Antonio, Texas  78284