Health Effects After Anthracycline and Radiation Therapy (HEART): Dexrazoxane and Prevention of Anthracycline-Related Cardiomyopathy

Status: Recruiting
Location: See all (79) locations...
Intervention Type: Other
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Healthy Volunteers: f
View:

⁃ Study Strata I, II, and III are closed for further patient entry as of March 31, 2021. The study remains open for existing medical record submission of Stratum IV

• STRATUM I AND STRATUM II: LEUKEMIA AND LYMPHOMA SURVIVORS

• Previously enrolled leukemia and lymphoma survivors, randomized to + or - DRZ on P9404, P9425, P9426, or DFCI 95-01 (high-risk patients only)

• STRATUM I: Alive and in continuous first complete remission from their original cancer (leukemia/lymphoblastic lymphoma \[P9404, high-risk DFCI 95-01\] or Hodgkin lymphoma \[P9425/P9426\])

• STRATUM I: Did not have progressive disease or induction failure requiring off-protocol therapy including hematopoietic cell transplantation

• STRATUM I: Must not have been diagnosed with any subsequent malignancy that required additional cardiotoxic therapies (i.e., radiotherapy to the chest \[also includes fields directed towards the neck, upper abdomen, or spine\], or additional anthracyclines or anthraquinones); patients with history of subsequent malignancy that did not require such therapies remain eligible

• STRATUM I: All patients and/or their parents or legal guardians must sign a written informed consent

• STRATUM II: Among leukemia and lymphoma patients randomized to + or - DRZ on P9404, P9425, P9426, and DFCI 95-01 (high risk patients only) who have relapsed or have experienced a subsequent malignancy that precludes eligibility since their original diagnosis, the study committee will review the available data (both from Children's Oncology Group's \[COG?s\] Statistics and Data Center \[SDC\] and the participating institution) to determine if individual patients are to be selected for Stratum 2; in recognition that local institutions sometimes have more updated relapse/subsequent cancer data than SDC, in cases where local data is more updated, local data will be used preferentially; the study will petition the Institutional Review Board (IRB) specifically for a waiver of consent to include any relapse and subsequent cancer data obtained from existing records for analysis of the secondary aims; patients selected for Stratum 2 will be those for whom late relapse or subsequent cancer is reported but who lack clear confirmation in existing records (either at SDC or at the local institution)

• STRATUM II: Alive, but have experienced relapse of their original cancer and/or have developed a subsequent cancer (other than non-melanomatous skin cancer) since their original diagnosis

• STRATUM II: All patients and/or their parents or legal guardians must sign a written informed consent

• STRATUM III: OSTEOSARCOMA SURVIVORS

Locations
United States
Alabama
Children's Hospital of Alabama
RECRUITING
Birmingham
Arkansas
Arkansas Children's Hospital
RECRUITING
Little Rock
Arizona
Phoenix Childrens Hospital
RECRUITING
Phoenix
Banner University Medical Center - Tucson
RECRUITING
Tucson
California
City of Hope Comprehensive Cancer Center
RECRUITING
Duarte
Valley Children's Hospital
ACTIVE_NOT_RECRUITING
Madera
Kaiser Permanente-Oakland
RECRUITING
Oakland
Lucile Packard Children's Hospital Stanford University
RECRUITING
Palo Alto
Rady Children's Hospital - San Diego
RECRUITING
San Diego
Connecticut
Yale University
RECRUITING
New Haven
Florida
Golisano Children's Hospital of Southwest Florida
RECRUITING
Fort Myers
University of Florida Health Science Center - Gainesville
SUSPENDED
Gainesville
Memorial Regional Hospital/Joe DiMaggio Children's Hospital
ACTIVE_NOT_RECRUITING
Hollywood
Nemours Children's Clinic-Jacksonville
RECRUITING
Jacksonville
Nemours Children's Hospital
RECRUITING
Orlando
Johns Hopkins All Children's Hospital
ACTIVE_NOT_RECRUITING
St. Petersburg
Saint Joseph's Hospital/Children's Hospital-Tampa
RECRUITING
Tampa
Saint Mary's Hospital
RECRUITING
West Palm Beach
Georgia
Children's Healthcare of Atlanta - Egleston
RECRUITING
Atlanta
Hawaii
Kapiolani Medical Center for Women and Children
RECRUITING
Honolulu
University of Hawaii Cancer Center
ACTIVE_NOT_RECRUITING
Honolulu
Illinois
Lurie Children's Hospital-Chicago
RECRUITING
Chicago
University of Illinois
ACTIVE_NOT_RECRUITING
Chicago
Advocate Children's Hospital-Oak Lawn
RECRUITING
Oak Lawn
Saint Jude Midwest Affiliate
RECRUITING
Peoria
Louisiana
Ochsner Medical Center Jefferson
RECRUITING
New Orleans
Massachusetts
Dana-Farber Cancer Institute
RECRUITING
Boston
Maryland
Johns Hopkins University/Sidney Kimmel Cancer Center
RECRUITING
Baltimore
Sinai Hospital of Baltimore
RECRUITING
Baltimore
Maine
Maine Children's Cancer Program
RECRUITING
Scarborough
Michigan
Ascension Saint John Hospital
RECRUITING
Detroit
Wayne State University/Karmanos Cancer Institute
ACTIVE_NOT_RECRUITING
Detroit
Hurley Medical Center
ACTIVE_NOT_RECRUITING
Flint
Missouri
Columbia Regional
ACTIVE_NOT_RECRUITING
Columbia
Washington University School of Medicine
RECRUITING
St Louis
Mississippi
University of Mississippi Medical Center
RECRUITING
Jackson
North Carolina
Mission Hospital
RECRUITING
Asheville
Wake Forest University Health Sciences
RECRUITING
Winston-salem
New Hampshire
Dartmouth Hitchcock Medical Center
ACTIVE_NOT_RECRUITING
Lebanon
New Jersey
Hackensack University Medical Center
RECRUITING
Hackensack
New Mexico
University of New Mexico Cancer Center
RECRUITING
Albuquerque
Nevada
Alliance for Childhood Diseases/Cure 4 the Kids Foundation
RECRUITING
Las Vegas
Summerlin Hospital Medical Center
RECRUITING
Las Vegas
Sunrise Hospital and Medical Center
RECRUITING
Las Vegas
University Medical Center of Southern Nevada
RECRUITING
Las Vegas
New York
Roswell Park Cancer Institute
SUSPENDED
Buffalo
The Steven and Alexandra Cohen Children's Medical Center of New York
RECRUITING
New Hyde Park
University of Rochester
RECRUITING
Rochester
Stony Brook University Medical Center
RECRUITING
Stony Brook
State University of New York Upstate Medical University
RECRUITING
Syracuse
Ohio
Children's Hospital Medical Center of Akron
RECRUITING
Akron
Cincinnati Children's Hospital Medical Center
RECRUITING
Cincinnati
Oklahoma
University of Oklahoma Health Sciences Center
RECRUITING
Oklahoma City
Oregon
Legacy Emanuel Children's Hospital
RECRUITING
Portland
Oregon Health and Science University
RECRUITING
Portland
Pennsylvania
Saint Christopher's Hospital for Children
RECRUITING
Philadelphia
Rhode Island
Rhode Island Hospital
RECRUITING
Providence
South Carolina
Medical University of South Carolina
RECRUITING
Charleston
BI-LO Charities Children's Cancer Center
RECRUITING
Greenville
Texas
Medical City Dallas Hospital
ACTIVE_NOT_RECRUITING
Dallas
UT Southwestern/Simmons Cancer Center-Dallas
RECRUITING
Dallas
Cook Children's Medical Center
SUSPENDED
Fort Worth
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
RECRUITING
Houston
University of Texas Health Science Center at San Antonio
RECRUITING
San Antonio
Virginia
Virginia Commonwealth University/Massey Cancer Center
RECRUITING
Richmond
Vermont
University of Vermont and State Agricultural College
RECRUITING
Burlington
Washington
Seattle Children's Hospital
RECRUITING
Seattle
Providence Sacred Heart Medical Center and Children's Hospital
RECRUITING
Spokane
Wisconsin
Children's Hospital of Wisconsin
RECRUITING
Milwaukee
Other Locations
Australia
Perth Children's Hospital
RECRUITING
Perth
Princess Margaret Hospital for Children
ACTIVE_NOT_RECRUITING
Perth
Canada
Alberta Children's Hospital
RECRUITING
Calgary
McMaster Children's Hospital at Hamilton Health Sciences
SUSPENDED
Hamilton
Centre Hospitalier Universitaire Sainte-Justine
RECRUITING
Montreal
The Montreal Children's Hospital of the MUHC
RECRUITING
Montreal
Children's Hospital of Eastern Ontario
ACTIVE_NOT_RECRUITING
Ottawa
Centre Hospitalier Universitaire de Quebec
RECRUITING
Québec
Hospital for Sick Children
SUSPENDED
Toronto
Puerto Rico
San Jorge Children's Hospital
RECRUITING
San Juan
Time Frame
Start Date: 2014-03-05
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 420
Treatments
Ancillary-Correlative (laboratory biomarker analysis)
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.
Sponsors
Leads: Children's Oncology Group
Collaborators: National Cancer Institute (NCI)

This content was sourced from clinicaltrials.gov