Phase II Trial Of Zileuton In Persons With Bronchial Dysplasia
OBJECTIVES:
- Determine the efficacy of zileuton, in terms of number of sites and grade of dysplastic
lesions in the bronchial epithelium, in patients with documented bronchial dysplasia.
- Correlate the regression of bronchial dysplasia (number and grade) and improvement in
sputum cytology with the modulation of molecular biomarkers in patients treated with
this drug.
- Determine the overall toxicity of this drug in these patients.
- Determine the 6-month natural history of bronchial dysplasia in patients who are
randomized to receive treatment with a placebo.
OUTLINE: This is a randomized, double-blind, placebo-controlled study. Patients are
stratified according to smoking status (current vs recently quit smoker), and prior cancer
(none vs lung or head and neck). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive oral zileuton 4 times daily for 6 months in the absence of
disease progression or unacceptable toxicity.
- Arm II: Patients receive oral placebo 4 times daily for 6 months in the absence of
disease progression or unacceptable toxicity.
Patients are followed at 4 weeks.
PROJECTED ACCRUAL: Approximately 134 patients will be accrued for this study.
Interventional
Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Prevention
Bronchial dysplasia number and grade at 6 months
No
Omer Kucuk, MD
Study Chair
Barbara Ann Karmanos Cancer Institute
United States: Federal Government
CDR0000271915
NCT00056004
June 2003
March 2009
Name | Location |
---|---|
Barbara Ann Karmanos Cancer Institute | Detroit, Michigan 48201 |