Zileuton in Preventing Lung Cancer in Patients 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.
|Study Design:||Allocation: Randomized
Primary Purpose: Prevention
|Official Title:||Phase II Trial Of Zileuton In Persons With Bronchial Dysplasia|
- Bronchial dysplasia number and grade at 6 months [ Designated as safety issue: No ]
- Biomarkers (Ki-67, Cyclin D1, bcl-2, bax, caspase-3) by immunohistochemistry at 6 and 12 months [ Designated as safety issue: No ]
- Biomarkers (5-HETE, LTB-4) by blood and BAL levels at 6 and 12 months [ Designated as safety issue: No ]
- Adverse events as measured by number and severity monthly [ Designated as safety issue: Yes ]
|Study Start Date:||June 2003|
|Study Completion Date:||March 2009|
|Primary Completion Date:||September 2006 (Final data collection date for primary outcome measure)|
- 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.
|United States, Michigan|
|Barbara Ann Karmanos Cancer Institute|
|Detroit, Michigan, United States, 48201-1379|
|Study Chair:||Omer Kucuk, MD||Barbara Ann Karmanos Cancer Institute|