Lung Cancer Clinical Trial
Official title:
Phase II Trial Of Zileuton In Persons With Bronchial Dysplasia
RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the
development or recurrence of cancer. The use of zileuton may be an effective way to prevent
lung cancer in patients who have bronchial dysplasia.
PURPOSE: Randomized phase II trial to study the effectiveness of zileuton in preventing lung
cancer in patients who have 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.
;
Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Prevention
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