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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.

Principal Investigator

Dr. Omer Kucuk, Barbara Ann Karmanos Cancer Institute.

Dr. Omer Kucuk Principal Investigator

Why This Trial Is Important

Lung cancer is a leading cancer killer among 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."

Contact Information

This trial is no longer open to new patients. To locate other lung cancer clinical trials, search the NCI's database of clinical trials or call the NCI's Cancer Information Service at 1-800-4-CANCER (1-800-422-6237). The call is toll free and completely confidential.

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