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

Study Overview
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Brief Summary
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RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. Inositol may be effective in preventing the development of lung cancer in patients with bronchial epithelial dysplasia. PURPOSE: This phase I trial is studying the side effects and best dose of inositol in preventing lung cancer in current or former smokers with bronchial epithelial dysplasia.

Detailed Description
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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.

Official Title
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A Phase I Study Of The Safety Of Myo-Inositol As A Chemopreventive Agent

Conditions
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Lung Cancer, Precancerous Condition

Intervention / Treatment
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* Dietary Supplement: inositol


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 74 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention


Arms and Interventions

| Intervention/Treatment |
| --- |
|Dietary Supplement: inositol|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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non-small cell lung cancer, small cell lung cancer, precancerous condition