|
|
Home
Search
Study Topics
Glossary
|
 |
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||||||||||||||||||||||||
| Sponsor: | Pediatric Oncology Group |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00003070 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Cardiac Toxicity Unspecified Childhood Solid Tumor, Protocol Specific |
Drug: enalapril maleate Procedure: quality-of-life assessment |
Phase III |
| Study Type: | Interventional |
| Study Design: | Supportive Care, Randomized, Double-Blind, Placebo Control |
| Official Title: | Afterload Reduction Therapy for Late Anthracycline Cardiotoxicity: A Pediatric Oncology Group Cancer Control Study |
| Study Start Date: | August 1997 |
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.
Eligibility| Ages Eligible for Study: | 8 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Hide Study Locations| United States, Alabama | |
| MBCCOP - Gulf Coast | |
| Mobile, Alabama, United States, 36688 | |
| University of Alabama at Birmingham Comprehensive Cancer Center | |
| Birmingham, Alabama, United States, 35294-3300 | |
| United States, Arkansas | |
| University of Arkansas for Medical Sciences | |
| Little Rock, Arkansas, United States, 72205 | |
| United States, California | |
| Lucile Packard Children's Hospital at Stanford | |
| Palo Alto, California, United States, 94304 | |
| University of California Davis Medical Center | |
| Sacramento, California, United States, 95817 | |
| University of California San Diego Cancer Center | |
| La Jolla, California, United States, 92093-0658 | |
| United States, Connecticut | |
| Yale Comprehensive Cancer Center | |
| New Haven, Connecticut, United States, 06520-8028 | |
| United States, District of Columbia | |
| Walter Reed Army Medical Center | |
| Washington, District of Columbia, United States, 20307-5000 | |
| United States, Florida | |
| CCOP - Florida Pediatric | |
| Tampa, Florida, United States, 33682-7757 | |
| Miami Children's Hospital | |
| Miami, Florida, United States, 33155 | |
| Shands Hospital and Clinics, University of Florida | |
| Gainesville, Florida, United States, 32610-100277 | |
| Sylvester Cancer Center, University of Miami | |
| Miami, Florida, United States, 33136 | |
| United States, Georgia | |
| Emory University Hospital - Atlanta | |
| Atlanta, Georgia, United States, 30322 | |
| United States, Hawaii | |
| Cancer Research Center of Hawaii | |
| Honolulu, Hawaii, United States, 96813 | |
| United States, Illinois | |
| Children's Memorial Hospital, Chicago | |
| Chicago, Illinois, United States, 60614 | |
| United States, Kansas | |
| CCOP - Wichita | |
| Wichita, Kansas, United States, 67214-3882 | |
| University of Kansas Medical Center | |
| Kansas City, Kansas, United States, 66160-7357 | |
| United States, Louisiana | |
| CCOP - Ochsner | |
| New Orleans, Louisiana, United States, 70121 | |
| MBCCOP - LSU Health Sciences Center | |
| New Orleans, Louisiana, United States, 70112 | |
| Ochsner Clinic | |
| New Orleans, Louisiana, United States, 70121 | |
| United States, Maryland | |
| Johns Hopkins Oncology Center | |
| Baltimore, Maryland, United States, 21231-2410 | |
| Marlene & Stewart Greenebaum Cancer Center, University of Maryland | |
| Baltimore, Maryland, United States, 21201 | |
| United States, Massachusetts | |
| Boston Floating Hospital Infants and Children | |
| Boston, Massachusetts, United States, 02111 | |
| Dana-Farber Cancer Institute | |
| Boston, Massachusetts, United States, 02115 | |
| University of Massachusetts Memorial Medical Center | |
| Worcester, Massachusetts, United States, 01655 | |
| United States, Michigan | |
| Children's Hospital of Michigan | |
| Detroit, Michigan, United States, 48201 | |
| United States, Mississippi | |
| University of Mississippi Medical Center | |
| Jackson, Mississippi, United States, 39216-4505 | |
| United States, Missouri | |
| Cardinal Glennon Children's Hospital | |
| Saint Louis, Missouri, United States, 63104 | |
| Washington University School of Medicine | |
| Saint Louis, Missouri, United States, 63110 | |
| United States, New Jersey | |
| CCOP - Northern New Jersey | |
| Hackensack, New Jersey, United States, 07601 | |
| Hackensack University Medical Center | |
| Hackensack, New Jersey, United States, 07601 | |
| United States, New York | |
| Mount Sinai School of Medicine | |
| New York, New York, United States, 10029 | |
| Roswell Park Cancer Institute | |
| Buffalo, New York, United States, 14263-0001 | |
| Schneider Children's Hospital | |
| New Hyde Park, New York, United States, 11042 | |
| State University of New York - Upstate Medical University | |
| Syracuse, New York, United States, 13210 | |
| University of Rochester Cancer Center | |
| Rochester, New York, United States, 14642 | |
| United States, North Carolina | |
| Carolinas Medical Center | |
| Charlotte, North Carolina, United States, 28232-2861 | |
| Comprehensive Cancer Center at Wake Forest University | |
| Winston-Salem, North Carolina, United States, 27157-1082 | |
| Duke Comprehensive Cancer Center | |
| Durham, North Carolina, United States, 27710 | |
| East Carolina University School of Medicine | |
| Greenville, North Carolina, United States, 27858-4354 | |
| Mission Saint Joseph's Health System | |
| Asheville, North Carolina, United States, 28801 | |
| Presbyterian Healthcare | |
| Charlotte, North Carolina, United States, 28233-3549 | |
| United States, Oklahoma | |
| Oklahoma Memorial Hospital | |
| Oklahoma City, Oklahoma, United States, 73126-0307 | |
| United States, Oregon | |
| CCOP - Columbia River Program | |
| Portland, Oregon, United States, 97213 | |
| United States, Pennsylvania | |
| St. Christopher's Hospital for Children | |
| Philadelphia, Pennsylvania, United States, 19134-1095 | |
| United States, South Carolina | |
| Children's Hospital of Greenville Hospital System | |
| Greenville, South Carolina, United States, 29605 | |
| Medical University of South Carolina | |
| Charleston, South Carolina, United States, 29425-0721 | |
| United States, Tennessee | |
| Saint Jude Children's Research Hospital | |
| Memphis, Tennessee, United States, 38105-2794 | |
| United States, Texas | |
| Baylor College of Medicine | |
| Houston, Texas, United States, 77030 | |
| MBCCOP - South Texas Pediatric | |
| San Antonio, Texas, United States, 78229-3900 | |
| Simmons Cancer Center - Dallas | |
| Dallas, Texas, United States, 75235-9154 | |
| University of Texas Health Science Center at San Antonio | |
| San Antonio, Texas, United States, 78284-7811 | |
| United States, Virginia | |
| Massey Cancer Center | |
| Richmond, Virginia, United States, 23298-0037 | |
| Naval Medical Center, Portsmouth | |
| Portsmouth, Virginia, United States, 23708-2197 | |
| United States, Wisconsin | |
| Midwest Children's Cancer Center | |
| Milwaukee, Wisconsin, United States, 53226 | |
| Canada, Alberta | |
| Cross Cancer Institute | |
| Edmonton, Alberta, Canada, T6G 1Z2 | |
| Canada, Ontario | |
| Children's Hospital | |
| Hamilton, Ontario, Canada, L8N 3Z5 | |
| Hospital for Sick Children | |
| Toronto, Ontario, Canada, M5G 1X8 | |
| Canada, Quebec | |
| Hopital Sainte Justine | |
| Montreal, Quebec, Canada, H3T 1C5 | |
| Montreal Children's Hospital | |
| Montreal, Quebec, Canada, H3H 1P3 | |
| Switzerland | |
| Swiss Pediatric Oncology Group Bern | |
| Bern, Switzerland, CH 3010 | |
| Study Chair: | Stephen Lipshultz, MD | James P. Wilmot Cancer Center |
More Information
| Study ID Numbers: | CDR0000065745, POG-9480, NCI-P97-0086 |
| Study First Received: | November 1, 1999 |
| Last Updated: | May 9, 2009 |
| ClinicalTrials.gov Identifier: | NCT00003070 History of Changes |
| Health Authority: | United States: Federal Government |
|
unspecified childhood solid tumor, protocol specific cardiac toxicity |
|
Enalapril Molecular Mechanisms of Pharmacological Action Enalaprilat Therapeutic Uses Angiotensin-Converting Enzyme Inhibitors |
Enzyme Inhibitors Cardiovascular Agents Antihypertensive Agents Pharmacologic Actions Protease Inhibitors |
