Unspecified Childhood Solid Tumor, Protocol Specific Clinical Trial
Official title:
Afterload Reduction Therapy for Late Anthracycline Cardiotoxicity: A Pediatric Oncology Group Cancer Control Study
Verified date | August 2014 |
Source | Children's Oncology Group |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 13 |
Est. completion date | March 2007 |
Est. primary completion date | July 2003 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 8 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Supportive Care
Country | Name | City | State |
---|---|---|---|
Canada | Cross Cancer Institute | Edmonton | Alberta |
Canada | Children's Hospital | Hamilton | Ontario |
Canada | Hopital Sainte Justine | Montreal | Quebec |
Canada | Montreal Children's Hospital | Montreal | Quebec |
Canada | Hospital for Sick Children | Toronto | Ontario |
Switzerland | Swiss Pediatric Oncology Group Bern | Bern | |
United States | Mission Saint Joseph's Health System | Asheville | North Carolina |
United States | Emory University Hospital - Atlanta | Atlanta | Georgia |
United States | Johns Hopkins Oncology Center | Baltimore | Maryland |
United States | Marlene & Stewart Greenebaum Cancer Center, University of Maryland | Baltimore | Maryland |
United States | University of Alabama at Birmingham Comprehensive Cancer Center | Birmingham | Alabama |
United States | Boston Floating Hospital Infants and Children | Boston | Massachusetts |
United States | Dana-Farber Cancer Institute | Boston | Massachusetts |
United States | Roswell Park Cancer Institute | Buffalo | New York |
United States | Medical University of South Carolina | Charleston | South Carolina |
United States | Carolinas Medical Center | Charlotte | North Carolina |
United States | Presbyterian Healthcare | Charlotte | North Carolina |
United States | Children's Memorial Hospital, Chicago | Chicago | Illinois |
United States | Simmons Cancer Center - Dallas | Dallas | Texas |
United States | Children's Hospital of Michigan | Detroit | Michigan |
United States | Duke Comprehensive Cancer Center | Durham | North Carolina |
United States | Shands Hospital and Clinics, University of Florida | Gainesville | Florida |
United States | Children's Hospital of Greenville Hospital System | Greenville | South Carolina |
United States | East Carolina University School of Medicine | Greenville | North Carolina |
United States | CCOP - Northern New Jersey | Hackensack | New Jersey |
United States | Hackensack University Medical Center | Hackensack | New Jersey |
United States | Cancer Research Center of Hawaii | Honolulu | Hawaii |
United States | Baylor College of Medicine | Houston | Texas |
United States | University of Mississippi Medical Center | Jackson | Mississippi |
United States | University of Kansas Medical Center | Kansas City | Kansas |
United States | University of California San Diego Cancer Center | La Jolla | California |
United States | University of Arkansas for Medical Sciences | Little Rock | Arkansas |
United States | Saint Jude Children's Research Hospital | Memphis | Tennessee |
United States | Miami Children's Hospital | Miami | Florida |
United States | Sylvester Cancer Center, University of Miami | Miami | Florida |
United States | Midwest Children's Cancer Center | Milwaukee | Wisconsin |
United States | MBCCOP - Gulf Coast | Mobile | Alabama |
United States | Yale Comprehensive Cancer Center | New Haven | Connecticut |
United States | Schneider Children's Hospital | New Hyde Park | New York |
United States | CCOP - Ochsner | New Orleans | Louisiana |
United States | MBCCOP - LSU Health Sciences Center | New Orleans | Louisiana |
United States | Ochsner Clinic | New Orleans | Louisiana |
United States | Mount Sinai School of Medicine | New York | New York |
United States | Oklahoma Memorial Hospital | Oklahoma City | Oklahoma |
United States | Lucile Packard Children's Hospital at Stanford | Palo Alto | California |
United States | St. Christopher's Hospital for Children | Philadelphia | Pennsylvania |
United States | CCOP - Columbia River Program | Portland | Oregon |
United States | Naval Medical Center, Portsmouth | Portsmouth | Virginia |
United States | Massey Cancer Center | Richmond | Virginia |
United States | University of Rochester Cancer Center | Rochester | New York |
United States | University of California Davis Medical Center | Sacramento | California |
United States | Cardinal Glennon Children's Hospital | Saint Louis | Missouri |
United States | Washington University School of Medicine | Saint Louis | Missouri |
United States | MBCCOP - South Texas Pediatric | San Antonio | Texas |
United States | University of Texas Health Science Center at San Antonio | San Antonio | Texas |
United States | State University of New York - Upstate Medical University | Syracuse | New York |
United States | CCOP - Florida Pediatric | Tampa | Florida |
United States | Walter Reed Army Medical Center | Washington | District of Columbia |
United States | CCOP - Wichita | Wichita | Kansas |
United States | Comprehensive Cancer Center at Wake Forest University | Winston-Salem | North Carolina |
United States | University of Massachusetts Memorial Medical Center | Worcester | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Children's Oncology Group | National Cancer Institute (NCI) |
United States, Canada, Switzerland,
Krischer JP, Epstein S, Cuthbertson DD, Goorin AM, Epstein ML, Lipshultz SE. Clinical cardiotoxicity following anthracycline treatment for childhood cancer: the Pediatric Oncology Group experience. J Clin Oncol. 1997 Apr;15(4):1544-52. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Cardiac functional status and quality of life | Cardiac functional status (depressed fractional shortening) and quality-of-life, will be assessed at baseline, two and five years into the study. | baseline, two and five years | No |
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