The objectives of this study are: 1) To determine the efficacy of the lipoxygenase inhibitor zileuton in reducing dysplasia of the bronchial epithelium in subjects at increased risk of lung cancer by virtue of pre-existing dysplasia. Participants with confirmed bronchial dysplasia will be randomized to zileuton or placebo for 6 months, followed by cross-over to the other arm of the study for an additional 6 months. 2) To determine the efficacy of zileuton in modulating intermediate biomarkers. 3) To evaluate the correlation between regression of bronchial dysplasia and modulation of biomarkers. 4) To evaluate the stability of a chemopreventive effect over 6 months following cessation of treatment and to evaluate the natural history of bronchial dysplasia over 6 months while participants are on placebo. 5) To evaluate the safety of zileuton in this cohort.

Agency
National Institute of Health (NIH)
Institute
Division of Cancer Prevention And Control (NCI)
Type
Research and Development Contracts (N01)
Project #
N01CN005022-000
Application #
6357835
Study Section
Project Start
2000-09-30
Project End
2003-03-31
Budget Start
2000-09-30
Budget End
2001-09-29
Support Year
Fiscal Year
2000
Total Cost
$758,959
Indirect Cost
Name
Wayne State University
Department
Type
Schools of Medicine
DUNS #
City
Detroit
State
MI
Country
United States
Zip Code
48202