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A Randomized, Double Blind, Placebo-Controlled Phase II Clinical Trial of N(4-Hydroxy-phenyl)Retinamide (Fenretinide, 4HPR) in Oral Leukoplakia


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

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Trial Information

A Randomized, Double Blind, Placebo-Controlled Phase II Clinical Trial of N(4-Hydroxy-phenyl)Retinamide (Fenretinide, 4HPR) in Oral Leukoplakia


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.

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.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically proven dysplastic leukoplakia greater than 1 cm in
diameter

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

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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Outcome Measure:

Determine modulation by fenretinide of surrogate endpoint markers of oral mucosal carcinogenesis in patients with oral dysplastic leukoplakia.

Outcome Time Frame:

baseline to 6 months

Safety Issue:

No

Principal Investigator

Samuel W. Beenken, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Alabama at Birmingham

Authority:

United States: Federal Government

Study ID:

CDR0000067401

NCT ID:

NCT00004161

Start Date:

June 1997

Completion Date:

January 2004

Related Keywords:

  • Head and Neck Cancer
  • lip and oral cavity cancer
  • Head and Neck Neoplasms
  • Leukoplakia
  • Leukoplakia, Oral

Name

Location

University of Alabama Comprehensive Cancer CenterBirmingham, Alabama  35294