Inositol in Preventing Lung Cancer in Patients With Bronchial Epithelial Dysplasia Who Are Current or Former Smokers

OBJECTIVES:

• Determine the safety of inositol for the prevention of lung cancer in patients with bronchial epithelial dysplasia who are current or former smokers.
• Determine the potential efficacy of this drug in regression of existing dysplastic lesions or prevention of appearance of new dysplastic lesions in these patients.
• Determine whether intake of this drug can facilitate smoking cessation in patients who are current smokers.

OUTLINE: This is a dose-escalation study.

Patients receive oral inositol twice daily. Treatment continues for 1 or 3 months in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-12 patients receive escalating doses of inositol until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 3 of 12 patients experience dose-limiting toxicity.

Once the MTD is determined, 10 patients are treated with inositol twice daily at the MTD for 3 months in the absence of disease progression or unacceptable toxicity.

Patients are followed at 1 month.

PROJECTED ACCRUAL: A total of 3-28 patients will be accrued for this study.

DISEASE CHARACTERISTICS:

• Diagnosis of persistent bronchial dysplasia despite regular twice-daily treatment with inhaled budesonide for 6 or 12 months on protocol BCCA-CIC-98-37
• Current or former smokers who have smoked at least 30 pack years
• Sputum cells showing AIC atypia by computer-assisted image analysis
• At least 2 abnormal sites on fluorescence bronchoscopy (red/green ratio at least 0.45) suspicious for bronchial dysplasia

• At least 1 site confirmed by bronchial biopsy
• Solitary dysplastic lesion allowed provided the diameter is greater than 1.5 mm
• No invasive cancer on bronchoscopy or abnormal low-dose spiral CT scan suspicious for lung cancer

PATIENT CHARACTERISTICS:

Age

• 40 to 74

Performance status

• ECOG 0-1

Life expectancy

• Not specified

Hematopoietic

• Hematologic function normal
• No bleeding disorder

Hepatic

• Liver function normal
• Liver enzymes no greater than upper limit of normal

Renal

• Renal function normal

Cardiovascular

• No unstable angina
• No congestive heart failure

Pulmonary

• No acute or chronic respiratory failure
• No acute bronchitis or pneumonia within the past month

Other

• Fasting glucose less than 144 mg/dL
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• Willing to have a bronchoscopy
• No schizophrenia
• No bipolar disorder
• No diabetes
• No known reaction to topical xylocaine
• No other medical condition that would jeopardize patient safety during study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Not specified

Chemotherapy

• No prior chemotherapy

Endocrine therapy

• Not specified

Radiotherapy

• No prior radiotherapy

Surgery

• No prior surgery for lung cancer

Other

• No concurrent lithium