Lung Cancer Clinical Trial
Official title:
A Phase I Study Of The Safety Of Myo-Inositol As A Chemopreventive Agent
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.
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.
;
Primary Purpose: Prevention
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