Enalapril in Treating Heart Damage Patients Who Received Anthracycline Chemotherapy for Childhood Cancer
NCT ID: NCT00003070
Last Updated: 2014-08-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
13 participants
INTERVENTIONAL
2000-09-30
2007-03-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
SUPPORTIVE_CARE
DOUBLE
Study Groups
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Stratum 1 < 350/mg/m2 anthracycline dose
\< 4 years of age at diagnosis \< 4 years since cessation of anthracycline treatment
enalapril maleate
quality-of-life assessment
Stratum 2 < 350mg/m2 anthracycline dose
\< 4 years of age at diagnosis \>= 4 years since cessation of anthracycline treatment
enalapril maleate
quality-of-life assessment
Stratum 3 < 350mg/m2 anthracycline dose
\>= 4 years of age at diagnosis \< 4 years since cessation of anthracycline treatment
enalapril maleate
quality-of-life assessment
Stratum 4 < 350mg/m2 anthracycline dose
\>= 4 years of age at diagnosis \>= 4 years since cessation of anthracycline treatment
enalapril maleate
quality-of-life assessment
Stratum 5 >= 350mg/m2 anthracycline dose
\< 4 years of age at diagnosis \< 4 years since cessation of anthracycline treatment
enalapril maleate
quality-of-life assessment
Stratum 6 >=350mg/m2 anthracycline dose
\< 4 years of age at diagnosis \< 4 years since cessation of anthracycline treatment
enalapril maleate
quality-of-life assessment
Stratum 7 >= 350mg/m2 anthracycline dose
\>= 4 years of age at diagnosis \< 4 years since cessation of anthracycline treatment
enalapril maleate
quality-of-life assessment
Stratum 8 >= 350mg/m2 anthracycline dose
\>= 4 years of age at diagnosis \>= 4 years since cessation of anthracycline treatment
enalapril maleate
quality-of-life assessment
Interventions
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enalapril maleate
quality-of-life assessment
Eligibility Criteria
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Inclusion Criteria
PATIENT CHARACTERISTICS: Age: At least 8 at study entry and less than 22 at diagnosis Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: No history of renal disease No known renal artery stenosis Cardiovascular: No congenital cardiovascular malformations No active congestive heart failure not attributable to sepsis or renal failure No medication for heart condition No history of symptomatic arrhythmia antedating anthracycline therapy No constrictive pericarditis No uncontrolled hypertension Pulmonary: No primary valvular or outflow tract obstruction Other: Not pregnant or lactating Must use adequate contraception No reaction or intolerance to ACE inhibitors
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 1 year since prior cumulative anthracycline therapy of at least 200 mg/m2 No prior amsacrine therapy Endocrine therapy: Not specified Radiotherapy: No prior mediastinal, spinal, or total body irradiation that included the heart Surgery: Not specified Other: No concurrent angiotensin converting enzyme (ACE)inhibitor treatment No concurrent treatment with other investigational drug No oncologic therapy within past 6 months
8 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Children's Oncology Group
NETWORK
Responsible Party
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Principal Investigators
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Stephen Lipshultz, MD
Role: STUDY_CHAIR
James P. Wilmot Cancer Center
Locations
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University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham, Alabama, United States
MBCCOP - Gulf Coast
Mobile, Alabama, United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
University of California San Diego Cancer Center
La Jolla, California, United States
Lucile Packard Children's Hospital at Stanford
Palo Alto, California, United States
University of California Davis Medical Center
Sacramento, California, United States
Yale Comprehensive Cancer Center
New Haven, Connecticut, United States
Walter Reed Army Medical Center
Washington D.C., District of Columbia, United States
Shands Hospital and Clinics, University of Florida
Gainesville, Florida, United States
Sylvester Cancer Center, University of Miami
Miami, Florida, United States
Miami Children's Hospital
Miami, Florida, United States
CCOP - Florida Pediatric
Tampa, Florida, United States
Emory University Hospital - Atlanta
Atlanta, Georgia, United States
Cancer Research Center of Hawaii
Honolulu, Hawaii, United States
Children's Memorial Hospital, Chicago
Chicago, Illinois, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
CCOP - Wichita
Wichita, Kansas, United States
MBCCOP - LSU Health Sciences Center
New Orleans, Louisiana, United States
CCOP - Ochsner
New Orleans, Louisiana, United States
Ochsner Clinic
New Orleans, Louisiana, United States
Marlene & Stewart Greenebaum Cancer Center, University of Maryland
Baltimore, Maryland, United States
Johns Hopkins Oncology Center
Baltimore, Maryland, United States
Boston Floating Hospital Infants and Children
Boston, Massachusetts, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
University of Massachusetts Memorial Medical Center
Worcester, Massachusetts, United States
Children's Hospital of Michigan
Detroit, Michigan, United States
University of Mississippi Medical Center
Jackson, Mississippi, United States
Cardinal Glennon Children's Hospital
St Louis, Missouri, United States
Washington University School of Medicine
St Louis, Missouri, United States
CCOP - Northern New Jersey
Hackensack, New Jersey, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
Schneider Children's Hospital
New Hyde Park, New York, United States
Mount Sinai School of Medicine
New York, New York, United States
University of Rochester Cancer Center
Rochester, New York, United States
State University of New York - Upstate Medical University
Syracuse, New York, United States
Mission Saint Joseph's Health System
Asheville, North Carolina, United States
Carolinas Medical Center
Charlotte, North Carolina, United States
Presbyterian Healthcare
Charlotte, North Carolina, United States
Duke Comprehensive Cancer Center
Durham, North Carolina, United States
East Carolina University School of Medicine
Greenville, North Carolina, United States
Comprehensive Cancer Center at Wake Forest University
Winston-Salem, North Carolina, United States
Oklahoma Memorial Hospital
Oklahoma City, Oklahoma, United States
CCOP - Columbia River Program
Portland, Oregon, United States
St. Christopher's Hospital for Children
Philadelphia, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Children's Hospital of Greenville Hospital System
Greenville, South Carolina, United States
Saint Jude Children's Research Hospital
Memphis, Tennessee, United States
Simmons Cancer Center - Dallas
Dallas, Texas, United States
Baylor College of Medicine
Houston, Texas, United States
MBCCOP - South Texas Pediatric
San Antonio, Texas, United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States
Naval Medical Center, Portsmouth
Portsmouth, Virginia, United States
Massey Cancer Center
Richmond, Virginia, United States
Midwest Children's Cancer Center
Milwaukee, Wisconsin, United States
Cross Cancer Institute
Edmonton, Alberta, Canada
Children's Hospital
Hamilton, Ontario, Canada
Hospital for Sick Children
Toronto, Ontario, Canada
Montreal Children's Hospital
Montreal, Quebec, Canada
Hopital Sainte Justine
Montreal, Quebec, Canada
Swiss Pediatric Oncology Group Bern
Bern, , Switzerland
Countries
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References
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Krischer JP, Epstein S, Cuthbertson DD, Goorin AM, Epstein ML, Lipshultz SE. Clinical cardiotoxicity following anthracycline treatment for childhood cancer: the Pediatric Oncology Group experience. J Clin Oncol. 1997 Apr;15(4):1544-52. doi: 10.1200/JCO.1997.15.4.1544.
Other Identifiers
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POG-9480
Identifier Type: OTHER
Identifier Source: secondary_id
NCI-P97-0086
Identifier Type: OTHER
Identifier Source: secondary_id
CDR0000065745
Identifier Type: OTHER
Identifier Source: secondary_id
P9480
Identifier Type: -
Identifier Source: org_study_id
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