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