Name of the Trial
Phase II Study of Zileuton for the Prevention of Lung Cancer in Patients with Bronchial Dysplasia (WSU-C-2405). See the protocol summary at http://cancer.gov/clinicaltrials/WSU-C-2405.

Principal Investigator
Dr. Omer Kucuk, Barbara Ann Karmanos Cancer Institute

Why Is This Trial Important?
Lung cancer is a leading killer among cancers in both men and women. A condition known as bronchial dysplasia, which is characterized by abnormal cell growth in the bronchial tubes, may be a precursor of squamous cell lung carcinoma, a type of non-small cell lung cancer.

Zileuton (Zyflo) is a drug used to prevent asthma symptoms, and it is being studied in the prevention of cancer. It belongs to the family of drugs called lipoxygenase inhibitors. Lipoxygenases produce chemical substances called leukotrienes that promote inflammation. Inflammation may be involved in the development of some cancers, including lung cancer. This trial will study the effectiveness of zileuton in eliminating bronchial dysplasia in smokers and former smokers who are at high risk for lung cancer.

"So far there is no effective chemopreventive agent for lung cancer," said Dr. Kucuk. "But we know that in animal studies, lipoxygenase inhibitors like zileuton prevent lung cancer from developing.

"With this study, we hope to see zileuton prevent precancerous lesions from progressing in humans, thus paving the way for larger, more conclusive cancer prevention studies with this class of drugs," Dr. Kucuk added. "It's a proof-of-principle study.

"Who Can Join This Trial?
Researchers seek to enroll current or former smokers who have smoked at least 30 pack years, and who are at high risk for bronchial dysplasia. A pack year equals the number of packs of cigarettes smoked per day multiplied by the number of years a person has smoked. See the list of eligibility criteria at http://cancer.gov/clinicaltrials/WSU-C-2405.

Where Is This Trial Taking Place?
This trial is taking place at the Barbara Ann Karmanos Cancer Institute in Detroit, Michigan.

Who to Contact
Contact the Barbara Ann Karmanos Cancer Institute at 1-800-527-6266 or call NCI's Cancer Information Service at 1-800-4-CANCER (1-800-422-6237). The call is toll free and completely confidential.