Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003070
Status:
COMPLETED
Last Update Posted:
2014-08-05
First Post:
1999-11-01
Brief Title:
Enalapril in Treating Heart Damage Patients Who Received Anthracycline Chemotherapy for Childhood Cancer
Sponsor:
Childrens Oncology Group
Organization:
Childrens Oncology Group
Study Overview
Official Title:
Afterload Reduction Therapy for Late Anthracycline Cardiotoxicity A Pediatric Oncology Group Cancer Control Study
Status:
COMPLETED
Status Verified Date:
2014-08
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 Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Chemoprotective drugs such as enalapril may protect normal cells from the toxic effects of chemotherapy It is not known whether enalapril is more effective than a placebo in treating heart damage in patients who received anthracycline chemotherapy for childhood cancer
PURPOSE Randomized double-blinded phase III trial to compare the effectiveness of enalapril with a placebo in treating heart damage in patients who received anthracycline chemotherapy for childhood cancer
PURPOSE Randomized double-blinded phase III trial to compare the effectiveness of enalapril with a placebo in treating heart damage in patients who received anthracycline chemotherapy for childhood cancer
Detailed Description:
OBJECTIVES I Determine whether enalapril treatment results in a reduction in body surface area-adjusted left ventricular mass in anthracycline-treated survivors of childhood cancer II Determine whether improvement in ventricular function achieved by enalapril is sustained and alters the course of late cardiotoxicity III Determine the impact of enalapril therapy on quality of life
OUTLINE This is a double blind placebo controlled randomized study Patients are stratified based on the cumulative anthracycline dose age at cancer diagnosis and the duration of time since cessation of anthracycline therapy Patients are administered enalapril or placebo by mouth bid Patients undergo a series of cardiac tests after administration of drug Follow-up occurs at 2 6 and 12 months and every year thereafter
PROJECTED ACCRUAL 75 patients in each treatment arm will be accrued
OUTLINE This is a double blind placebo controlled randomized study Patients are stratified based on the cumulative anthracycline dose age at cancer diagnosis and the duration of time since cessation of anthracycline therapy Patients are administered enalapril or placebo by mouth bid Patients undergo a series of cardiac tests after administration of drug Follow-up occurs at 2 6 and 12 months and every year thereafter
PROJECTED ACCRUAL 75 patients in each treatment arm will be accrued
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 |
|---|---|---|---|
| CDR0000065745 | OTHER | Clinical Trialsgov | None |
| POG-9480 | OTHER | None | None |
| NCI-P97-0086 | OTHER | None | None |