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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00003070
Other study ID # P9480
Secondary ID POG-9480NCI-P97-
Status Completed
Phase Phase 3
First received November 1, 1999
Last updated August 4, 2014
Start date September 2000
Est. completion date March 2007

Study information

Verified date August 2014
Source Children's Oncology Group
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial 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.


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 information / eligibility

Status Completed
Enrollment 13
Est. completion date March 2007
Est. primary completion date July 2003
Accepts healthy volunteers No
Gender Both
Age group 8 Years and older
Eligibility DISEASE CHARACTERISTICS: Histologically diagnosed childhood malignancy that had prior anthracycline therapy Echocardiographic evidence of reduced fractional shortening, reduced contractility, or increased afterload, or any combination At least 6 months oncologic disease free

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Supportive Care


Related Conditions & MeSH terms


Intervention

Drug:
enalapril maleate

Procedure:
quality-of-life assessment


Locations

Country Name City State
Canada Cross Cancer Institute Edmonton Alberta
Canada Children's Hospital Hamilton Ontario
Canada Hopital Sainte Justine Montreal Quebec
Canada Montreal Children's Hospital Montreal Quebec
Canada Hospital for Sick Children Toronto Ontario
Switzerland Swiss Pediatric Oncology Group Bern Bern
United States Mission Saint Joseph's Health System Asheville North Carolina
United States Emory University Hospital - Atlanta Atlanta Georgia
United States Johns Hopkins Oncology Center Baltimore Maryland
United States Marlene & Stewart Greenebaum Cancer Center, University of Maryland Baltimore Maryland
United States University of Alabama at Birmingham Comprehensive Cancer Center Birmingham Alabama
United States Boston Floating Hospital Infants and Children Boston Massachusetts
United States Dana-Farber Cancer Institute Boston Massachusetts
United States Roswell Park Cancer Institute Buffalo New York
United States Medical University of South Carolina Charleston South Carolina
United States Carolinas Medical Center Charlotte North Carolina
United States Presbyterian Healthcare Charlotte North Carolina
United States Children's Memorial Hospital, Chicago Chicago Illinois
United States Simmons Cancer Center - Dallas Dallas Texas
United States Children's Hospital of Michigan Detroit Michigan
United States Duke Comprehensive Cancer Center Durham North Carolina
United States Shands Hospital and Clinics, University of Florida Gainesville Florida
United States Children's Hospital of Greenville Hospital System Greenville South Carolina
United States East Carolina University School of Medicine Greenville North Carolina
United States CCOP - Northern New Jersey Hackensack New Jersey
United States Hackensack University Medical Center Hackensack New Jersey
United States Cancer Research Center of Hawaii Honolulu Hawaii
United States Baylor College of Medicine Houston Texas
United States University of Mississippi Medical Center Jackson Mississippi
United States University of Kansas Medical Center Kansas City Kansas
United States University of California San Diego Cancer Center La Jolla California
United States University of Arkansas for Medical Sciences Little Rock Arkansas
United States Saint Jude Children's Research Hospital Memphis Tennessee
United States Miami Children's Hospital Miami Florida
United States Sylvester Cancer Center, University of Miami Miami Florida
United States Midwest Children's Cancer Center Milwaukee Wisconsin
United States MBCCOP - Gulf Coast Mobile Alabama
United States Yale Comprehensive Cancer Center New Haven Connecticut
United States Schneider Children's Hospital New Hyde Park New York
United States CCOP - Ochsner New Orleans Louisiana
United States MBCCOP - LSU Health Sciences Center New Orleans Louisiana
United States Ochsner Clinic New Orleans Louisiana
United States Mount Sinai School of Medicine New York New York
United States Oklahoma Memorial Hospital Oklahoma City Oklahoma
United States Lucile Packard Children's Hospital at Stanford Palo Alto California
United States St. Christopher's Hospital for Children Philadelphia Pennsylvania
United States CCOP - Columbia River Program Portland Oregon
United States Naval Medical Center, Portsmouth Portsmouth Virginia
United States Massey Cancer Center Richmond Virginia
United States University of Rochester Cancer Center Rochester New York
United States University of California Davis Medical Center Sacramento California
United States Cardinal Glennon Children's Hospital Saint Louis Missouri
United States Washington University School of Medicine Saint Louis Missouri
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 State University of New York - Upstate Medical University Syracuse New York
United States CCOP - Florida Pediatric Tampa Florida
United States Walter Reed Army Medical Center Washington District of Columbia
United States CCOP - Wichita Wichita Kansas
United States Comprehensive Cancer Center at Wake Forest University Winston-Salem North Carolina
United States University of Massachusetts Memorial Medical Center Worcester Massachusetts

Sponsors (2)

Lead Sponsor Collaborator
Children's Oncology Group National Cancer Institute (NCI)

Countries where clinical trial is conducted

United States,  Canada,  Switzerland, 

References & Publications (1)

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Cardiac functional status and quality of life Cardiac functional status (depressed fractional shortening) and quality-of-life, will be assessed at baseline, two and five years into the study. baseline, two and five years No
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