Zileuton in Preventing Lung Cancer in Patients With Bronchial Dysplasia (NCT00056004) | Clinical Trial Compass
CompletedPhase 2
Zileuton in Preventing Lung Cancer in Patients With Bronchial Dysplasia
United States38 participantsStarted 2003-06
Plain-language summary
RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. The use of zileuton may be an effective way to prevent lung cancer in patients who have bronchial dysplasia.
PURPOSE: Randomized phase II trial to study the effectiveness of zileuton in preventing lung cancer in patients who have bronchial dysplasia.
Who can participate
Age range18 Years
SexALL
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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 …