Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Related Publications
Trial Contact Information
Registry Information

Alternate Title

Enalapril in Treating Heart Damage Patients Who Received Anthracycline Chemotherapy for Childhood Cancer

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase III Supportive care Completed 8 to 120 NCI POG-9480 NCI-P97-0086, NCT00003070

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.

Entry 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

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

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 

Expected Enrollment

75 patients in each treatment arm will be accrued.

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.

Krischer JP, Epstein S, Cuthbertson DD, et al.: Clinical cardiotoxicity following anthracycline treatment for childhood cancer: the Pediatric Oncology Group experience. J Clin Oncol 15 (4): 1544-52, 1997.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

Pediatric Oncology Group

Stephen Lipshultz, MD, Protocol chair		Ph: 716-275-6096

Registry Information
Official Title		Afterload Reduction Therapy for Late Anthracycline Cardiotoxicity: A Pediatric Oncology Group Cancer Control Study
Trial Start Date		1997-08-15
Registered in ClinicalTrials.gov		NCT00003070
Date Submitted to PDQ		1997-09-02
Information Last Verified		2007-05-14
NCI Grant/Contract Number		CA30969

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