Zileuton in Preventing Lung Cancer in Patients With Bronchial Dysplasia

You may be eligible if

• DISEASE CHARACTERISTICS:
• At high risk for dysplasia, defined by 1 of the following criteria:
• * Current or former smokers who have smoked at least 30 pack-years
• * Former smokers must be enrolled within 20 years of complete smoking cessation
• * Patients with curatively treated stage I non-small cell lung cancer\*
• * Patients with curatively treated stage I or II squamous cell carcinoma of the head and neck (limited to oral cavity, pharynx, or larynx)\* NOTE: \*At least 12 months post-curative therapy
• Histologic confirmation of mild to severe bronchial dysplasia on bronchoscopic biopsy required
• * Moderate or severe atypia on sputum cytology required before bronchoscopy (not required for patients with prior lung or head and neck cancer)
• No evidence of malignancy by chest x-ray
• PATIENT CHARACTERISTICS:
• Age
• 18 and over (for patients with prior lung or head and neck malignancy)
• 35 and over (for all other patients)
• Performance status
• SWOG 0-1
• Life expectancy
• Not specified
• Hematopoietic
• WBC at least 3,000/mm\^3
• Platelet count at least 100,000/mm\^3
• Hemoglobin at least 10.0 g/dL
• No bleeding disorder
• Hepatic
• Bilirubin no greater than upper limit of normal (ULN)
• Liver enzymes no greater than ULN
• PT/PTT no greater than ULN
• No active or chronic liver disease (even if transaminases have normalized)
• Renal
• Creatinine no greater than ULN
• Cardiovascular
• No unstable angina
• No uncontrolled heart failure
• Pulmonary
• No significant asthma or chronic obstructive pulmonary disease requiring chronic or periodic (at least once per year) steroids for flares
• No acute or chronic respiratory failure
• Other
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• Willing and able to undergo serial bronchoscopic examinations
• No ongoing alcohol use (i.e., at least 1 glass of wine, beer, or a mixed drink per day on a regular basis)
• No other medical condition that would preclude safety during study participation
• No other active or invasive malignancy within the past 5 years except basal cell skin cancer or carcinoma in situ of the cervix
• No hypersensitivity to study drug or any of its inactive ingredients
• PRIOR CONCURRENT THERAPY:
• Biologic therapy
• Not specified
• Chemotherapy
• Not specified
• Endocrine therapy
• More than 3 months since prior corticosteroids\*
• No concurrent corticosteroids\*
• No concurrent anticancer hormonal agents NOTE: \*Systemic or inhaled, including chronic administration
• Radiotherapy
• No concurrent radiotherapy
• Surgery
• Not specified
• Other
• More than 3 months since prior lipoxygenase inhibitors\*
• More than 3 months since prior investigational agents
• More than 3 months since prior nutritional supplements (except 1 daily multivitamin)
• No concurrent nutritional supplements (except 1 daily multivitamin)
• No other concurrent lipoxygenase inhibitors\*
• No other concurrent investigational agents
• No concurrent warfarin, beta-blockers, or theophylline
• No other concurrent antineoplastic agents
• No concurrent or chronic daily use of non-steroidal anti-inflammatory agents (NSAIDS) (except cardioprotective doses of aspirin less than 100 mg/day)
• * Periodic use of NSAIDS allowed
• Concurrent participation in a smoking cessation program (including use of bupropion or nicotine gum or patch) allowed NOTE: \*Systemic or inhaled, including chronic administration