Budesonide in Treating Former and Current Smokers With Bronchial Dysplasia

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. The use of budesonide may be an effective way to prevent bronchial dysplasia.

PURPOSE: Randomized double-blinded phase II trial to determine the effectiveness of budesonide in treating former or current smokers who have bronchial dysplasia.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: British Columbia Cancer Agency
• Collaborator: National Cancer Institute (NCI)
• Treatments: Budesonide

Criteria

DISEASE CHARACTERISTICS: Histologically confirmed mild, moderate, or severe bronchial dysplasia More than one suspicious area of abnormal fluorescence on bronchoscopy If only one abnormal area, lesion must be greater than 1.5 mm Current or ex-smokers who have smoked at least 30 pack years (e.g., 1 pack per day for at least 30 years) Sputum cells with morphometric index at least 7 by computer-assisted image analysis No invasive cancer on bronchoscopy or abnormal chest x-ray suspicious of lung cancer

PATIENT CHARACTERISTICS: Age: 40 to 74 Performance status: Not specified Life expectancy:

Not specified Hematopoietic: No bleeding disorder Hepatic: Not specified Renal: Not specified Cardiovascular: No unstable angina or congestive heart failure Pulmonary: No active pulmonary tuberculosis No acute bronchitis or pneumonia No acute or chronic respiratory failure Other: No history of allergy to budesonide or lactose No known reaction to lidocaine Ability to reliably take medication Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified Endocrine therapy: At least 6 months since prior oral glucocorticoids (e.g., prednisone) At least 6 months since prior inhaled glucocorticoids (e.g., budesonide, Beclovent, or Becloforte) Radiotherapy: Not specified Surgery: Not specified