Inositol in Preventing Lung Cancer in Patients With Bronchial Epithelial Dysplasia Who Are Current or Former Smokers
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|ClinicalTrials.gov Identifier: NCT00061997|
Recruitment Status : Completed
First Posted : June 6, 2003
Last Update Posted : February 2, 2010
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.
|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer Precancerous Condition||Dietary Supplement: inositol||Phase 1|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||A Phase I Study Of The Safety Of Myo-Inositol As A Chemopreventive Agent|
|Study Start Date :||May 2003|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00061997
|Canada, British Columbia|
|British Columbia Cancer Agency - Vancouver Cancer Centre|
|Vancouver, British Columbia, Canada, V5Z 4E6|
|Study Chair:||Stephen Lam, MD||British Columbia Cancer Agency|