Zileuton in Preventing Lung Cancer in Patients With Bronchial Dysplasia
|ClinicalTrials.gov Identifier: NCT00056004|
Recruitment Status : Completed
First Posted : March 7, 2003
Last Update Posted : April 29, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Head and Neck Cancer Lung Cancer||Drug: zileuton||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||38 participants|
|Official Title:||Phase II Trial Of Zileuton In Persons With Bronchial Dysplasia|
|Study Start Date :||June 2003|
|Primary Completion Date :||September 2006|
|Study Completion Date :||March 2009|
- Bronchial dysplasia number and grade at 6 months
- Biomarkers (Ki-67, Cyclin D1, bcl-2, bax, caspase-3) by immunohistochemistry at 6 and 12 months
- Biomarkers (5-HETE, LTB-4) by blood and BAL levels at 6 and 12 months
- Adverse events as measured by number and severity monthly
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00056004
|United States, Michigan|
|Barbara Ann Karmanos Cancer Institute|
|Detroit, Michigan, United States, 48201-1379|
|Study Chair:||Omer Kucuk, MD||Barbara Ann Karmanos Cancer Institute|