Ignite Creation Date:
2024-05-05 @ 6:40 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00522197
Status:
COMPLETED
Last Update Posted:
2012-03-09
First Post:
2007-08-28
Brief Title:
ACAPHA in Preventing Lung Cancer in Former Smokers With Bronchial Intraepithelial Neoplasia
Sponsor:
British Columbia Cancer Agency
Organization:
British Columbia Cancer Agency
Study Overview
Official Title:
A Phase II Trial of ACAPHA in Former Smokers With Intraepithelial Neoplasia
Status:
COMPLETED
Status Verified Date:
2012-03
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 is the use of certain drugs to keep cancer from forming The use of ACAPHA a combination of six herbs may prevent lung cancer from forming in former smokers with bronchial intraepithelial neoplasia
PURPOSE This randomized phase II trial is studying the side effects and how well ACAPHA works in preventing lung cancer in former smokers with bronchial intraepithelial neoplasia
PURPOSE This randomized phase II trial is studying the side effects and how well ACAPHA works in preventing lung cancer in former smokers with bronchial intraepithelial neoplasia
Detailed Description:
OBJECTIVES
Determine the efficacy and safety of multi-herbal agent ACAPHA in former smokers with bronchial intraepithelial neoplasia
Evaluate whether ACAPHA can modulate other surrogate endpoint biomarkers of aberrant methylation cell cycle regulation apoptosis as well as phase I and II enzyme regulation
Establish a library of in vivo confocal microendoscopy images with corresponding histopathology nuclear morphometry and other biomarker information to assess the potential of confocal microendoscopy as a nonbiopsy method in assessing the effect of chemoprevention agents
OUTLINE Patients are stratified according to gender Patients are randomized to 1 of 2 arms
Arm I Patients receive oral multi-herbal agent ACAPHA twice daily for 6 months Patients achieving a partial response receive an additional 6 months of ACAPHA
Arm II Patients receive oral placebo twice daily for 6 months Patients achieving a partial response receive an additional 6 months of placebo Patients with progressive disease receive ACAPHA twice daily for 6 months
Patients undergo sputum cytology oral and bronchial brushings bronchoalveolar lavage and bronchial tissue biopsies at baseline and at 6 and 12 months Samples are analyzed for histopathological and morphometric cell changes MIB-1 bcl-2 and TUNEL immunostaining methylation biomarkers and gene expression analysis of RNA
After completion of study therapy patients are followed at 1 and 6 months
Determine the efficacy and safety of multi-herbal agent ACAPHA in former smokers with bronchial intraepithelial neoplasia
Evaluate whether ACAPHA can modulate other surrogate endpoint biomarkers of aberrant methylation cell cycle regulation apoptosis as well as phase I and II enzyme regulation
Establish a library of in vivo confocal microendoscopy images with corresponding histopathology nuclear morphometry and other biomarker information to assess the potential of confocal microendoscopy as a nonbiopsy method in assessing the effect of chemoprevention agents
OUTLINE Patients are stratified according to gender Patients are randomized to 1 of 2 arms
Arm I Patients receive oral multi-herbal agent ACAPHA twice daily for 6 months Patients achieving a partial response receive an additional 6 months of ACAPHA
Arm II Patients receive oral placebo twice daily for 6 months Patients achieving a partial response receive an additional 6 months of placebo Patients with progressive disease receive ACAPHA twice daily for 6 months
Patients undergo sputum cytology oral and bronchial brushings bronchoalveolar lavage and bronchial tissue biopsies at baseline and at 6 and 12 months Samples are analyzed for histopathological and morphometric cell changes MIB-1 bcl-2 and TUNEL immunostaining methylation biomarkers and gene expression analysis of RNA
After completion of study therapy patients are followed at 1 and 6 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| BCCA-R02-1177 | US NIH GrantContract | None | httpsreporternihgovquickSearchU01CA096109 |
| U01CA096109 | NIH | None | None |
| BCCA-H02-61177-A002 | None | None | None |