Enalapril in Treating Heart Damage Patients Who Received Anthracycline Chemotherapy for Childhood Cancer
- Conditions
- Unspecified Childhood Solid Tumor, Protocol SpecificCardiac Toxicity
- Interventions
- Procedure: quality-of-life assessment
- Registration Number
- NCT00003070
- Lead Sponsor
- Children's Oncology Group
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 13
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Stratum 1 < 350/mg/m2 anthracycline dose quality-of-life assessment \< 4 years of age at diagnosis \< 4 years since cessation of anthracycline treatment Stratum 2 < 350mg/m2 anthracycline dose quality-of-life assessment \< 4 years of age at diagnosis \>= 4 years since cessation of anthracycline treatment Stratum 5 >= 350mg/m2 anthracycline dose enalapril maleate \< 4 years of age at diagnosis \< 4 years since cessation of anthracycline treatment Stratum 8 >= 350mg/m2 anthracycline dose quality-of-life assessment \>= 4 years of age at diagnosis \>= 4 years since cessation of anthracycline treatment Stratum 2 < 350mg/m2 anthracycline dose enalapril maleate \< 4 years of age at diagnosis \>= 4 years since cessation of anthracycline treatment Stratum 3 < 350mg/m2 anthracycline dose quality-of-life assessment \>= 4 years of age at diagnosis \< 4 years since cessation of anthracycline treatment Stratum 4 < 350mg/m2 anthracycline dose quality-of-life assessment \>= 4 years of age at diagnosis \>= 4 years since cessation of anthracycline treatment Stratum 5 >= 350mg/m2 anthracycline dose quality-of-life assessment \< 4 years of age at diagnosis \< 4 years since cessation of anthracycline treatment Stratum 6 >=350mg/m2 anthracycline dose quality-of-life assessment \< 4 years of age at diagnosis \< 4 years since cessation of anthracycline treatment Stratum 7 >= 350mg/m2 anthracycline dose quality-of-life assessment \>= 4 years of age at diagnosis \< 4 years since cessation of anthracycline treatment Stratum 4 < 350mg/m2 anthracycline dose enalapril maleate \>= 4 years of age at diagnosis \>= 4 years since cessation of anthracycline treatment Stratum 1 < 350/mg/m2 anthracycline dose enalapril maleate \< 4 years of age at diagnosis \< 4 years since cessation of anthracycline treatment Stratum 3 < 350mg/m2 anthracycline dose enalapril maleate \>= 4 years of age at diagnosis \< 4 years since cessation of anthracycline treatment Stratum 6 >=350mg/m2 anthracycline dose enalapril maleate \< 4 years of age at diagnosis \< 4 years since cessation of anthracycline treatment Stratum 7 >= 350mg/m2 anthracycline dose enalapril maleate \>= 4 years of age at diagnosis \< 4 years since cessation of anthracycline treatment Stratum 8 >= 350mg/m2 anthracycline dose enalapril maleate \>= 4 years of age at diagnosis \>= 4 years since cessation of anthracycline treatment
- Primary Outcome Measures
Name Time Method Cardiac functional status and quality of life baseline, two and five years Cardiac functional status (depressed fractional shortening) and quality-of-life, will be assessed at baseline, two and five years into the study.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (61)
Emory University Hospital - Atlanta
🇺🇸Atlanta, Georgia, United States
Hospital for Sick Children
🇨🇦Toronto, Ontario, Canada
Dana-Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
Miami Children's Hospital
🇺🇸Miami, Florida, United States
MBCCOP - Gulf Coast
🇺🇸Mobile, Alabama, United States
University of California San Diego Cancer Center
🇺🇸La Jolla, California, United States
CCOP - Ochsner
🇺🇸New Orleans, Louisiana, United States
Roswell Park Cancer Institute
🇺🇸Buffalo, New York, United States
Carolinas Medical Center
🇺🇸Charlotte, North Carolina, United States
Saint Jude Children's Research Hospital
🇺🇸Memphis, Tennessee, United States
Simmons Cancer Center - Dallas
🇺🇸Dallas, Texas, United States
University of Massachusetts Memorial Medical Center
🇺🇸Worcester, Massachusetts, United States
Hopital Sainte Justine
🇨🇦Montreal, Quebec, Canada
Montreal Children's Hospital
🇨🇦Montreal, Quebec, Canada
MBCCOP - LSU Health Sciences Center
🇺🇸New Orleans, Louisiana, United States
Sylvester Cancer Center, University of Miami
🇺🇸Miami, Florida, United States
University of Arkansas for Medical Sciences
🇺🇸Little Rock, Arkansas, United States
Children's Hospital
🇨🇦Hamilton, Ontario, Canada
Shands Hospital and Clinics, University of Florida
🇺🇸Gainesville, Florida, United States
Ochsner Clinic
🇺🇸New Orleans, Louisiana, United States
Swiss Pediatric Oncology Group Bern
🇨🇭Bern, Switzerland
Baylor College of Medicine
🇺🇸Houston, Texas, United States
Cross Cancer Institute
🇨🇦Edmonton, Alberta, Canada
CCOP - Columbia River Program
🇺🇸Portland, Oregon, United States
MBCCOP - South Texas Pediatric
🇺🇸San Antonio, Texas, United States
Oklahoma Memorial Hospital
🇺🇸Oklahoma City, Oklahoma, United States
CCOP - Florida Pediatric
🇺🇸Tampa, Florida, United States
University of Alabama at Birmingham Comprehensive Cancer Center
🇺🇸Birmingham, Alabama, United States
Children's Hospital of Michigan
🇺🇸Detroit, Michigan, United States
Midwest Children's Cancer Center
🇺🇸Milwaukee, Wisconsin, United States
Duke Comprehensive Cancer Center
🇺🇸Durham, North Carolina, United States
University of Texas Health Science Center at San Antonio
🇺🇸San Antonio, Texas, United States
Washington University School of Medicine
🇺🇸Saint Louis, Missouri, United States
Lucile Packard Children's Hospital at Stanford
🇺🇸Palo Alto, California, United States
CCOP - Wichita
🇺🇸Wichita, Kansas, United States
Cancer Research Center of Hawaii
🇺🇸Honolulu, Hawaii, United States
Walter Reed Army Medical Center
🇺🇸Washington, District of Columbia, United States
Children's Memorial Hospital, Chicago
🇺🇸Chicago, Illinois, United States
Boston Floating Hospital Infants and Children
🇺🇸Boston, Massachusetts, United States
Cardinal Glennon Children's Hospital
🇺🇸Saint Louis, Missouri, United States
Johns Hopkins Oncology Center
🇺🇸Baltimore, Maryland, United States
University of Mississippi Medical Center
🇺🇸Jackson, Mississippi, United States
Marlene & Stewart Greenebaum Cancer Center, University of Maryland
🇺🇸Baltimore, Maryland, United States
CCOP - Northern New Jersey
🇺🇸Hackensack, New Jersey, United States
Hackensack University Medical Center
🇺🇸Hackensack, New Jersey, United States
Mount Sinai School of Medicine
🇺🇸New York, New York, United States
State University of New York - Upstate Medical University
🇺🇸Syracuse, New York, United States
Presbyterian Healthcare
🇺🇸Charlotte, North Carolina, United States
Massey Cancer Center
🇺🇸Richmond, Virginia, United States
Children's Hospital of Greenville Hospital System
🇺🇸Greenville, South Carolina, United States
Schneider Children's Hospital
🇺🇸New Hyde Park, New York, United States
Mission Saint Joseph's Health System
🇺🇸Asheville, North Carolina, United States
East Carolina University School of Medicine
🇺🇸Greenville, North Carolina, United States
Naval Medical Center, Portsmouth
🇺🇸Portsmouth, Virginia, United States
University of Rochester Cancer Center
🇺🇸Rochester, New York, United States
St. Christopher's Hospital for Children
🇺🇸Philadelphia, Pennsylvania, United States
University of California Davis Medical Center
🇺🇸Sacramento, California, United States
Yale Comprehensive Cancer Center
🇺🇸New Haven, Connecticut, United States
Comprehensive Cancer Center at Wake Forest University
🇺🇸Winston-Salem, North Carolina, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States