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


Phase 3
8 Years
N/A
Not Enrolling
Both
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:

Interventional

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

Authority:

United States: Federal Government

Study ID:

CDR0000065745

NCT ID:

NCT00003070

Start Date:

August 1997

Completion Date:

Related Keywords:

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

Name

Location

Baylor College of MedicineHouston, Texas  77030
Roswell Park Cancer InstituteBuffalo, New York  14263
Walter Reed Army Medical CenterWashington, District of Columbia  20307-5000
Emory University Hospital - AtlantaAtlanta, Georgia  30322
Johns Hopkins Oncology CenterBaltimore, Maryland  21287
University of Massachusetts Memorial Medical CenterWorcester, Massachusetts  01655
University of Mississippi Medical CenterJackson, Mississippi  39216-4505
Washington University School of MedicineSaint Louis, Missouri  63110
University of Rochester Cancer CenterRochester, New York  14642
Duke Comprehensive Cancer CenterDurham, North Carolina  27710
Medical University of South CarolinaCharleston, South Carolina  29425-0721
Simmons Cancer Center - DallasDallas, Texas  75235-9154
University of California Davis Medical CenterSacramento, California  95817
Shands Hospital and Clinics, University of FloridaGainesville, Florida  32610-100277
Sylvester Cancer Center, University of MiamiMiami, Florida  33136
CCOP - Florida PediatricTampa, Florida  33682-7757
CCOP - WichitaWichita, Kansas  67214-3882
Children's Hospital of MichiganDetroit, Michigan  48201
Mount Sinai School of MedicineNew York, New York  10029
Presbyterian HealthcareCharlotte, North Carolina  28233-3549
East Carolina University School of MedicineGreenville, North Carolina  27858-4354
Oklahoma Memorial HospitalOklahoma City, Oklahoma  73126-0307
University of Texas Health Science Center at San AntonioSan Antonio, Texas  78284-7811
Midwest Children's Cancer CenterMilwaukee, Wisconsin  53226
University of California San Diego Cancer CenterLa Jolla, California  92093-0658
Marlene & Stewart Greenebaum Cancer Center, University of MarylandBaltimore, Maryland  21201
State University of New York - Upstate Medical UniversitySyracuse, New York  13210
CCOP - Northern New JerseyHackensack, New Jersey  07601
Yale Comprehensive Cancer CenterNew Haven, Connecticut  06520-8028
CCOP - OchsnerNew Orleans, Louisiana  70121
University of Alabama at Birmingham Comprehensive Cancer CenterBirmingham, Alabama  35294-3300
Comprehensive Cancer Center at Wake Forest UniversityWinston-Salem, North Carolina  27157-1082
Boston Floating Hospital Infants and ChildrenBoston, Massachusetts  02111
CCOP - Columbia River ProgramPortland, Oregon  97213
Naval Medical Center, PortsmouthPortsmouth, Virginia  23708-2197
Massey Cancer CenterRichmond, Virginia  23298-0037
Dana-Farber Cancer InstituteBoston, Massachusetts  02115
Cancer Research Center of HawaiiHonolulu, Hawaii  96813
MBCCOP - Gulf CoastMobile, Alabama  36688
University of Arkansas for Medical SciencesLittle Rock, Arkansas  72205
University of Kansas Medical CenterKansas City, Kansas  66160-7353
MBCCOP - LSU Health Sciences CenterNew Orleans, Louisiana  70112
Hackensack University Medical CenterHackensack, New Jersey  07601
Miami Children's HospitalMiami, Florida  33155-4069
Cardinal Glennon Children's HospitalSaint Louis, Missouri  63104
Schneider Children's HospitalNew Hyde Park, New York  11042
Carolinas Medical CenterCharlotte, North Carolina  28232-2861
St. Christopher's Hospital for ChildrenPhiladelphia, Pennsylvania  19134-1095
Children's Hospital of Greenville Hospital SystemGreenville, South Carolina  29605
Lucile Packard Children's Hospital at StanfordPalo Alto, California  94304
Ochsner ClinicNew Orleans, Louisiana  70121
Mission Saint Joseph's Health SystemAsheville, North Carolina  28801
Saint Jude Children's Research HospitalMemphis, Tennessee  38105-2794
Children's Memorial Hospital, ChicagoChicago, Illinois  60614
MBCCOP - South Texas PediatricSan Antonio, Texas  78284-7810