A Phase I Study Of The Safety Of Myo-Inositol As A Chemopreventive Agent
- 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
Stephen Lam, MD
British Columbia Cancer Agency
United States: Federal Government