Unspecified Childhood Solid Tumor, Protocol Specific Clinical Trial
Official title:
Afterload Reduction Therapy for Late Anthracycline Cardiotoxicity: A Pediatric Oncology Group Cancer Control Study
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Supportive Care
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