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