Fenretinide in Treating Patients With Leukoplakia of the Mouth
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Head and Neck Cancer |
Drug: fenretinide Drug: Placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Prevention |
| Official Title: | A Randomized, Double Blind, Placebo-Controlled Phase II Clinical Trial of N(4-Hydroxy-phenyl)Retinamide (Fenretinide, 4HPR) in Oral Leukoplakia |
- Determine modulation by fenretinide of surrogate endpoint markers of oral mucosal carcinogenesis in patients with oral dysplastic leukoplakia. [ Time Frame: baseline to 6 months ] [ Designated as safety issue: No ]
- Determine whether fenretinide will cause significant modulation of intermediate endpoint markers and significant regression of oral dysplastic leukoplakia in this patient population. [ Time Frame: baseline to 6 months ] [ Designated as safety issue: No ]
- Compare the ability of fenretinide and placebo to modulate surrogate endpoint biomarkers in this patient population. [ Time Frame: baseline to 6 months ] [ Designated as safety issue: No ]
- Document the degree of recurrence of oral dysplastic leukoplakia after the administration of fenretinide, both at the same site and at new sites. [ Time Frame: baseline to 6 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 30 |
| Study Start Date: | June 1997 |
| Study Completion Date: | January 2004 |
| Primary Completion Date: | January 2004 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Arm I
Patients receive oral fenretinide 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.
|
Drug: fenretinide |
|
Experimental: 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.
|
Drug: Placebo |
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, Alabama | |
| University of Alabama Comprehensive Cancer Center | |
| Birmingham, Alabama, United States, 35294 | |
| Study Chair: | Samuel W. Beenken, MD | University of Alabama at Birmingham |
More Information
Additional Information:
No publications provided
| Responsible Party: | University of Alabama at Birmingham |
| ClinicalTrials.gov Identifier: | NCT00004161 History of Changes |
| Other Study ID Numbers: | CDR0000067401, UAB-9713, NCI-G99-1626 |
| Study First Received: | December 10, 1999 |
| Last Updated: | April 10, 2013 |
| Health Authority: | United States: Federal Government |
Keywords provided by University of Alabama at Birmingham:
|
lip and oral cavity cancer |
Additional relevant MeSH terms:
|
Head and Neck Neoplasms Leukoplakia Leukoplakia, Oral Neoplasms by Site Neoplasms Precancerous Conditions Pathological Conditions, Anatomical Mouth Neoplasms Mouth Diseases |
Stomatognathic Diseases Fenretinide Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Anticarcinogenic Agents Protective Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 16, 2013