Effects of Dexrazoxane Hydrochloride on Biomarkers Associated With Cardiomyopathy and Heart Failure After Cancer Treatment
Start Date
3/5/2014
Completion Date
12/31/2026
Summary
This clinical trial studies the effects of dexrazoxane hydrochloride on biomarkers associated with cardiomyopathy and heart failure after cancer treatment. Studying samples of blood in the laboratory from patients receiving dexrazoxane hydrochloride may help doctors learn more about the effects of dexrazoxane hydrochloride on cells. It may also help doctors understand how well patients respond to treatment.
Detailed Description
PRIMARY OBJECTIVES: I. To determine whether leukemia and lymphoma patients from P9404, P9425, P9426, and Dana Farber Cancer Institute (DFCI) 95-01 randomized to the experimental dexrazoxane hydrochloride (DRZ) arms have decreased markers of cardiomyopathy/heart failure (CHF) compared with patients on the standard arm. II. To determine whether osteosarcoma patients from P9754 (all received DRZ) have decreased markers of cardiomyopathy/heart failure (CHF) compared with similarly treated osteosarcoma patients diagnosed during the same time period, but who did not receive DRZ. III. To evaluate whether the cardioprotective effect of DRZ is modified by anthracycline (anthracycline analogue GPX-150) dose, chest radiation, and demographic factors (age at cancer diagnosis, current age, sex). SECONDARY OBJECTIVES: I. To determine whether leukemia and lymphoma patients from P9404, P9425, P9426, and DFCI 95-01 on the DRZ arms experienced differential rates of overall-survival and event-free survival compared with the standard therapy arms. II. To determine whether projected quality-adjusted life years (QALY) differed by DRZ status, accounting for premature cardiac disease, primary disease relapse, and second cancers. III. Determine the longitudinal trajectory of 2-dimensional echocardiographic parameters (focusing on left ventricular \[LV\] function and remodeling/geometric changes that can be reliably re-measured) among patients from time of cancer treatment through subsequent follow-up. OUTLINE: Patients complete a diagnostic symptom checklist, undergo a physical exam, echocardiogram, collection of serum for biomarker testing, and a 6 minute walk test, and complete quality of life, family history, physical activity, and smoking questionnaires.
Eligibility Criteria
Age Range: No minimum to No maximum
Interventions
Assessment of Therapy Complications
Laboratory Biomarker Analysis
Quality-of-Life Assessment
Questionnaire Administration
Conditions
Locations
Children's Hospital of Alabama
Birmingham, Alabama 35233
United States
Phoenix Childrens Hospital
Phoenix, Arizona 85016
United States
Banner University Medical Center - Tucson
Tucson, Arizona 85719
United States
Arkansas Children's Hospital
Little Rock, Arkansas 72202-3591
United States
City of Hope Comprehensive Cancer Center
Duarte, California 91010
United States
Valley Children's Hospital
Madera, California 93636
United States
Kaiser Permanente-Oakland
Oakland, California 94611
United States
Lucile Packard Children's Hospital Stanford University
Palo Alto, California 94304
United States
Rady Children's Hospital - San Diego
San Diego, California 92123
United States
Yale University
New Haven, Connecticut 06520
United States
Golisano Children's Hospital of Southwest Florida
Fort Myers, Florida 33908
United States
University of Florida Health Science Center - Gainesville
Gainesville, Florida 32610
United States
Memorial Regional Hospital/Joe DiMaggio Children's Hospital
Hollywood, Florida 33021
United States
Nemours Children's Clinic-Jacksonville
Jacksonville, Florida 32207
United States
Nemours Children's Hospital
Orlando, Florida 32827
United States
Johns Hopkins All Children's Hospital
St. Petersburg, Florida 33701
United States
Saint Joseph's Hospital/Children's Hospital-Tampa
Tampa, Florida 33607
United States
Saint Mary's Hospital
West Palm Beach, Florida 33407
United States
Children's Healthcare of Atlanta - Egleston
Atlanta, Georgia 30322
United States
University of Hawaii Cancer Center
Honolulu, Hawaii 96813
United States
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii 96826
United States
Lurie Children's Hospital-Chicago
Chicago, Illinois 60611
United States
University of Illinois
Chicago, Illinois 60612
United States
Advocate Children's Hospital-Oak Lawn
Oak Lawn, Illinois 60453
United States
Saint Jude Midwest Affiliate
Peoria, Illinois 61637
United States
Ochsner Medical Center Jefferson
New Orleans, Louisiana 70121
United States
Maine Children's Cancer Program
Scarborough, Maine 04074
United States
Sinai Hospital of Baltimore
Baltimore, Maryland 21215
United States
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore, Maryland 21287
United States
Dana-Farber Cancer Institute
Boston, Massachusetts 02215
United States
Wayne State University/Karmanos Cancer Institute
Detroit, Michigan 48201
United States
Ascension Saint John Hospital
Detroit, Michigan 48236
United States
Hurley Medical Center
Flint, Michigan 48503
United States
University of Mississippi Medical Center
Jackson, Mississippi 39216
United States
Columbia Regional
Columbia, Missouri 65201
United States
Washington University School of Medicine
St Louis, Missouri 63110
United States
University Medical Center of Southern Nevada
Las Vegas, Nevada 89102
United States
Sunrise Hospital and Medical Center
Las Vegas, Nevada 89109
United States
Alliance for Childhood Diseases/Cure 4 the Kids Foundation
Las Vegas, Nevada 89135
United States
Summerlin Hospital Medical Center
Las Vegas, Nevada 89144
United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire 03756
United States
Hackensack University Medical Center
Hackensack, New Jersey 07601
United States
University of New Mexico Cancer Center
Albuquerque, New Mexico 87102
United States
Roswell Park Cancer Institute
Buffalo, New York 14263
United States
The Steven and Alexandra Cohen Children's Medical Center of New York
New Hyde Park, New York 11040
United States
University of Rochester
Rochester, New York 14642
United States
Stony Brook University Medical Center
Stony Brook, New York 11794
United States
State University of New York Upstate Medical University
Syracuse, New York 13210
United States
Mission Hospital
Asheville, North Carolina 28801
United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina 27157
United States
Children's Hospital Medical Center of Akron
Akron, Ohio 44308
United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio 45229
United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma 73104
United States
Legacy Emanuel Children's Hospital
Portland, Oregon 97227
United States
Oregon Health and Science University
Portland, Oregon 97239
United States
Saint Christopher's Hospital for Children
Philadelphia, Pennsylvania 19134
United States
Rhode Island Hospital
Providence, Rhode Island 02903
United States
Medical University of South Carolina
Charleston, South Carolina 29425
United States
BI-LO Charities Children's Cancer Center
Greenville, South Carolina 29605
United States
Medical City Dallas Hospital
Dallas, Texas 75230
United States
UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas 75390
United States
Cook Children's Medical Center
Fort Worth, Texas 76104
United States
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
Houston, Texas 77030
United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas 78229
United States
University of Vermont and State Agricultural College
Burlington, Vermont 05405
United States
Virginia Commonwealth University/Massey Cancer Center
Richmond, Virginia 23298
United States
Seattle Children's Hospital
Seattle, Washington 98105
United States
Providence Sacred Heart Medical Center and Children's Hospital
Spokane, Washington 99204
United States
Children's Hospital of Wisconsin
Milwaukee, Wisconsin 53226
United States
Princess Margaret Hospital for Children
Perth, Western Australia 6008
Australia
Perth Children's Hospital
Perth, Western Australia 6009
Australia
Alberta Children's Hospital
Calgary, Alberta T3B 6A8
Canada
McMaster Children's Hospital at Hamilton Health Sciences
Hamilton, Ontario L8N 3Z5
Canada
Children's Hospital of Eastern Ontario
Ottawa, Ontario K1H 8L1
Canada
Hospital for Sick Children
Toronto, Ontario M5G 1X8
Canada
The Montreal Children's Hospital of the MUHC
Montreal, Quebec H3H 1P3
Canada
Centre Hospitalier Universitaire Sainte-Justine
Montreal, Quebec H3T 1C5
Canada
Centre Hospitalier Universitaire de Quebec
Québec, G1V 4G2
Canada
San Jorge Children's Hospital
San Juan, 00912
Puerto Rico