Zileuton in Preventing Lung Cancer in Patients With Bronchial Dysplasia

Inclusion criteria

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