Celecoxib in Preventing Cancer in Patients With Oral Leukoplakia and/or Head and Neck Dysplasia

2014-08-26 22:55:34 | BioPortfolio

Summary

RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. Celecoxib may be effective in preventing head and neck cancer in patients who have oral leukoplakia or head and neck dysplasia.

PURPOSE: Phase II trial to study the effectiveness of celecoxib in preventing cancer in patients who have oral leukoplakia and/or head and neck dysplasia.

Description

OBJECTIVES:

- Determine the response rate, in terms of prostaglandin E2 expression, in patients with oral leukoplakia and/or dysplasia treated with celecoxib.

- Determine the change in other biomarkers including COX-2, Ak+, Ki-67, BCL2, BAX, VEGF, and CD31, in patients treated with this drug.

- Determine the efficacy of this drug, in terms of reducing the size of oral leukoplakia lesions and presence of dysplasia, in these patients.

- Correlate change in biomarker expression with response of oral leukoplakia lesions and/or dysplasia in patients treated with this drug.

- Determine the toxic effects of this drug in these patients.

OUTLINE: This is an open-label, multicenter study.

Patients receive oral celecoxib twice daily for 3 months. After 3 months, patients undergo a repeat biopsy. Patients with a positive response receive celecoxib for an additional 9 months.

Patients are followed every 3-6 months for 1 year.

PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study within 30 months.

Study Design

Allocation: Non-Randomized, Control: Active Control, Masking: Open Label, Primary Purpose: Prevention

Conditions

Head and Neck Cancer

Intervention

celecoxib

Location

Brigham and Women's Hospital
Boston
Massachusetts
United States
02115

Status

Active, not recruiting

Source

National Cancer Institute (NCI)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-26T22:55:34-0400

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