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Afterload Reduction Therapy for Late Anthracycline Cardiotoxicity: A Pediatric Oncology Group Cancer Control Study

Phase 3
8 Years
Not Enrolling
Cardiac Toxicity, Unspecified Childhood Solid Tumor, Protocol Specific

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Trial Information

Afterload Reduction Therapy for Late Anthracycline Cardiotoxicity: A Pediatric Oncology Group Cancer Control Study

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.

Inclusion Criteria

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

Type of Study:


Study Design:

Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Supportive Care

Principal Investigator

Stephen Lipshultz, MD

Investigator Role:

Study Chair

Investigator Affiliation:

James P. Wilmot Cancer Center


United States: Federal Government

Study ID:




Start Date:

August 1997

Completion Date:

Related Keywords:

  • Cardiac Toxicity
  • Unspecified Childhood Solid Tumor, Protocol Specific
  • unspecified childhood solid tumor, protocol specific
  • cardiac toxicity



Baylor College of Medicine Houston, Texas  77030
Roswell Park Cancer Institute Buffalo, New York  14263
Walter Reed Army Medical Center Washington, District of Columbia  20307-5000
Emory University Hospital - Atlanta Atlanta, Georgia  30322
Johns Hopkins Oncology Center Baltimore, Maryland  21287
University of Massachusetts Memorial Medical Center Worcester, Massachusetts  01655
University of Mississippi Medical Center Jackson, Mississippi  39216-4505
Washington University School of Medicine Saint Louis, Missouri  63110
University of Rochester Cancer Center Rochester, New York  14642
Duke Comprehensive Cancer Center Durham, North Carolina  27710
Medical University of South Carolina Charleston, South Carolina  29425-0721
Simmons Cancer Center - Dallas Dallas, Texas  75235-9154
University of California Davis Medical Center Sacramento, California  95817
Shands Hospital and Clinics, University of Florida Gainesville, Florida  32610-100277
Sylvester Cancer Center, University of Miami Miami, Florida  33136
CCOP - Florida Pediatric Tampa, Florida  33682-7757
CCOP - Wichita Wichita, Kansas  67214-3882
Children's Hospital of Michigan Detroit, Michigan  48201
Mount Sinai School of Medicine New York, New York  10029
Presbyterian Healthcare Charlotte, North Carolina  28233-3549
East Carolina University School of Medicine Greenville, North Carolina  27858-4354
Oklahoma Memorial Hospital Oklahoma City, Oklahoma  73126-0307
University of Texas Health Science Center at San Antonio San Antonio, Texas  78284-7811
Midwest Children's Cancer Center Milwaukee, Wisconsin  53226
University of California San Diego Cancer Center La Jolla, California  92093-0658
Marlene & Stewart Greenebaum Cancer Center, University of Maryland Baltimore, Maryland  21201
State University of New York - Upstate Medical University Syracuse, New York  13210
CCOP - Northern New Jersey Hackensack, New Jersey  07601
Yale Comprehensive Cancer Center New Haven, Connecticut  06520-8028
CCOP - Ochsner New Orleans, Louisiana  70121
University of Alabama at Birmingham Comprehensive Cancer Center Birmingham, Alabama  35294-3300
Comprehensive Cancer Center at Wake Forest University Winston-Salem, North Carolina  27157-1082
Boston Floating Hospital Infants and Children Boston, Massachusetts  02111
CCOP - Columbia River Program Portland, Oregon  97213
Naval Medical Center, Portsmouth Portsmouth, Virginia  23708-2197
Massey Cancer Center Richmond, Virginia  23298-0037
Dana-Farber Cancer Institute Boston, Massachusetts  02115
Cancer Research Center of Hawaii Honolulu, Hawaii  96813
MBCCOP - Gulf Coast Mobile, Alabama  36688
University of Arkansas for Medical Sciences Little Rock, Arkansas  72205
University of Kansas Medical Center Kansas City, Kansas  66160-7353
MBCCOP - LSU Health Sciences Center New Orleans, Louisiana  70112
Hackensack University Medical Center Hackensack, New Jersey  07601
Miami Children's Hospital Miami, Florida  33155-4069
Cardinal Glennon Children's Hospital Saint Louis, Missouri  63104
Schneider Children's Hospital New Hyde Park, New York  11042
Carolinas Medical Center Charlotte, North Carolina  28232-2861
St. Christopher's Hospital for Children Philadelphia, Pennsylvania  19134-1095
Children's Hospital of Greenville Hospital System Greenville, South Carolina  29605
Lucile Packard Children's Hospital at Stanford Palo Alto, California  94304
Ochsner Clinic New Orleans, Louisiana  70121
Mission Saint Joseph's Health System Asheville, North Carolina  28801
Saint Jude Children's Research Hospital Memphis, Tennessee  38105-2794
Children's Memorial Hospital, Chicago Chicago, Illinois  60614
MBCCOP - South Texas Pediatric San Antonio, Texas  78284-7810