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.
Interventional
Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Supportive Care
Stephen Lipshultz, MD
Study Chair
James P. Wilmot Cancer Center
United States: Federal Government
CDR0000065745
NCT00003070
August 1997
Name | Location |
---|---|
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 |