NCT00056004

Zileuton in Preventing Lung Cancer in Patients With Bronchial Dysplasia

Phase II Trial Of Zileuton In Persons With Bronchial Dysplasia

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: Barbara Ann Karmanos Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Head and Neck Cancer
• Lung Cancer

Interventions

Type	Name	Description
DRUG	zileuton

Timeline

• Start date: 2003-06-01
• Primary completion: 2006-09-01
• Completion: 2009-03-01
• First posted: 2003-03-07
• Last updated: 2013-04-29

Locations

1 site across 1 country: United States