|
Enalapril in Treating Heart Damage Patients Who Received Anthracycline Chemotherapy for Childhood Cancer Clinical Trials Information presented on Clinical Trials Search is not intended to be a substitute for qualified health advice, trips or treatment by using a genuine doctor. We aren't doctors. Always consult your mD on Enalapril in Treating Heart Damage Patients Who Received Anthracycline Chemotherapy for Childhood Cancer conditions. Clinical Trials Search.org is a site committed to listing clinical research studies in human subjects. Enalapril in Treating Heart Damage Patients Who Received Anthracycline Chemotherapy for Childhood Cancer Clinical research trials and Enalapril in Treating Heart Damage Patients Who Received Anthracycline Chemotherapy for Childhood Cancer health trials take place in a lot of of cities across the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the potency of new drugs. The aim of the studies / projects is to answer specific human medical questions. Clinical trials are a popular manner for physicians, government agencies, and private sector corporations to discover remedies for all kinds of circumstances, like Enalapril in Treating Heart Damage Patients Who Received Anthracycline Chemotherapy for Childhood Cancer. Enalapril in Treating Heart Damage Patients Who Received Anthracycline Chemotherapy for Childhood Cancer Clinical Trials and other clinical trials allow for volunteers to have health treatment alternatives before they are available to the general public. Many times the test subjects obtain treatment for without cost, and occasionally they are paid for their time. Sometimes there is a cost for a Enalapril in Treating Heart Damage Patients Who Received Anthracycline Chemotherapy for Childhood Cancer clinical trial. Subjects oftentimes recieve the most effective healthcare possible for their Enalapril in Treating Heart Damage Patients Who Received Anthracycline Chemotherapy for Childhood Cancer condition. Hazards are a reality, however, and could include additional or frequent doctor visits, healthcare dangers (perhaps life-threatening), and/or the treatment being ineffective. Trials are federally governed with exacting guidelines to protect clinical trials subjects.
|
|
|
|
|
|
|
Home > "E" Clinical Trials Conditions > Enalapril in Treating Heart Damage Patients Who Received Anthracycline Chemotherapy for Childhood Cancer  Enalapril in Treating Heart Damage Patients Who Received Anthracycline Chemotherapy for Childhood Cancer
Enalapril in Treating Heart Damage Patients Who Received Anthracycline Chemotherapy for Childhood Cancer
For Condition: unspecified childhood solid tumor, protocol specific,cardiac toxicity
Status: Completed
Sponsor(s): National Cancer Institute (NCI) , Pediatric Oncology Group
Synopsis: 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.
Details: 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. PROTOCOL 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:
Study Type: Interventional, Educational/Counseling/Training
Minimum Age/Maximum Age: 8 Years/
Genders:
Protocol Entry Criteria: PROTOCOL 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
StephenLipshultz, Study Chair, Pediatric Oncology Group
Duke Comprehensive Cancer Center
Durham, North Carolina, 27710
United States
Simmons Cancer Center - Dallas
Dallas, Texas, 75235-9154
United States
University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham, Alabama, 35294-3300
United States
University of California Davis Medical Center
Sacramento, California, 95817
United States
Saint Jude Children's Research Hospital
Memphis, Tennessee, 38105-2794
United States
Washington University School of Medicine
St. Louis, Missouri, 63110
United States
Swiss Pediatric Oncology Group Bern
Bern, , CH 3010
Switzerland
MBCCOP - South Texas Pediatric
San Antonio, Texas, 78229-3900
United States
Massey Cancer Center
Richmond, Virginia, 23298-0037
United States
Midwest Children's Cancer Center
Milwaukee, Wisconsin, 53226
United States
Shands Hospital and Clinics, University of Florida
Gainesville, Florida, 32610-100277
United States
MBCCOP - LSU Health Sciences Center
New Orleans, Louisiana, 70112
United States
Walter Reed Army Medical Center
Washington D.C., District of Columbia, 20307-5000
United States
Children's Memorial Hospital, Chicago
Chicago, Illinois, 60614
United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78284-7811
United States
CCOP - Ochsner
New Orleans, Louisiana, 70121
United States
Medical University of South Carolina
Charleston, South Carolina, 29425-0721
United States
Johns Hopkins Oncology Center
Baltimore, Maryland, 21231-2410
United States
University of California San Diego Cancer Center
La Jolla, California, 92093-0658
United States
Miami Children's Hospital
Miami, Florida, 33155
United States
Cancer Research Center of Hawaii
Honolulu, Hawaii, 96813
United States
University of Massachusetts Memorial Medical Center
Worcester, Massachusetts, 01655
United States
Children's Hospital
Hamilton, Ontario, L8N 3Z5
Canada
CCOP - Wichita
Wichita, Kansas, 67214-3882
United States
MBCCOP - Gulf Coast
Mobile, Alabama, 36688
United States
Carolinas Medical Center
Charlotte, North Carolina, 28232-2861
United States
Emory University Hospital - Atlanta
Atlanta, Georgia, 30322
United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
United States
CCOP - Florida Pediatric
Tampa, Florida, 33682-7757
United States
Ochsner Clinic
New Orleans, Louisiana, 70121
United States
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2
Canada
Marlene & Stewart Greenebaum Cancer Center, University of Maryland
Baltimore, Maryland, 21201
United States
Boston Floating Hospital Infants and Children
Boston, Massachusetts, 02111
United States
Montreal Children's Hospital
Montreal, Quebec, H3H 1P3
Canada
Roswell Park Cancer Institute
Buffalo, New York, 14263-0001
United States
Mission Saint Joseph's Health System
Asheville, North Carolina, 28801
United States
Comprehensive Cancer Center at Wake Forest University
Winston Salem, North Carolina, 27157-1082
United States
CCOP - Columbia River Program
Portland, Oregon, 97213
United States
State University of New York - Upstate Medical University
Syracuse, New York, 13210
United States
Mount Sinai School of Medicine
New York City, New York, 10029
United States
Cardinal Glennon Children's Hospital
St. Louis, Missouri, 63104
United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216-4505
United States
East Carolina University School of Medicine
Greenville, North Carolina, 27858-4354
United States
Children's Hospital of Michigan
Detroit, Michigan, 48201
United States
CCOP - Northern New Jersey
Hackensack, New Jersey, 07601
United States
Oklahoma Memorial Hospital
Oklahoma City, Oklahoma, 73126-0307
United States
University of Kansas Medical Center
Kansas City, Kansas, 66160-7357
United States
Presbyterian Healthcare
Charlotte, North Carolina, 28233-3549
United States
Yale Comprehensive Cancer Center
New Haven, Connecticut, 06520-8028
United States
Children's Hospital of Greenville Hospital System
Greenville, South Carolina, 29605
United States
Schneider Children's Hospital
New Hyde Park, New York, 11042
United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
United States
Hospital for Sick Children
Toronto, Ontario, M5G 1X8
Canada
St. Christopher's Hospital for Children
Philadelphia, Pennsylvania, 19134-1095
United States
Sylvester Cancer Center, University of Miami
Miami, Florida, 33136
United States
Hackensack University Medical Center
Hackensack, New Jersey, 07601
United States
Naval Medical Center, Portsmouth
Portsmouth, Virginia, 23708-2197
United States
Hopital Sainte Justine
Montreal, Quebec, H3T 1C5
Canada
University of Rochester Cancer Center
Rochester, New York, 14642
United States
Baylor College of Medicine
Houston, Texas, 77030
United States
Lucile Packard Children's Hospital at Stanford
Palo Alto, California, 94304
United States
Additional Information:
Study ID Numbers: CDR0000065745; POG-9480,NCI-P97-0086
Study Start Date: April 1999
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003070
Other Unspecified Childhood Solid Tumor, Protocol Specific Studies:
1. Combination Chemotherapy, Surgery, and Radiation Therapy With or Without Dexrazoxane and Trastuzumab in Treating Women With Stage III or Stage IV Breast Cancer
2. Combination Chemotherapy With or Without Dexrazoxane in Treating Children With Hodgkin's Disease
3. Oblimersen Plus Combination Chemotherapy and Dexrazoxane in Treating Children and Adolescents With Relapsed or Refractory Solid Tumors
4. Combination Chemotherapy Plus Dexrazoxane in Treating Patients With Newly Diagnosed Nonmetastatic Osteosarcoma
5. Chemotherapy Followed by Radiation Therapy in Treating Young Patients With Newly Diagnosed Hodgkin's Disease
Related Studies:
Other unspecified childhood solid tumor, protocol specific Clinical Trials
Other Ontario Clinical Trials
Other Hamilton Clinical Trials
Enalapril in Treating Heart Damage Patients Who Received Anthracycline Chemotherapy for Childhood Cancer
|
|
|
|
|
|
|
|
