Ignite Creation Date:
2024-05-05 @ 11:30 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00061997
Status:
COMPLETED
Last Update Posted:
2010-02-02
First Post:
2003-06-05
Brief Title:
Inositol in Preventing Lung Cancer in Patients With Bronchial Epithelial Dysplasia Who Are Current or Former Smokers
Sponsor:
British Columbia Cancer Agency
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase I Study Of The Safety Of Myo-Inositol As A Chemopreventive Agent
Status:
COMPLETED
Status Verified Date:
2005-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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:
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
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 Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| BCCA-C02-0298 | None | None | None |
| BCCA-U98-0411 | None | None | None |