Zileuton in Preventing Lung Cancer in Patients With Bronchial Dysplasia

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