NCT01790152Recruiting
Effects of Dexrazoxane Hydrochloride on Biomarkers Associated With Cardiomyopathy and Heart Failure After Cancer Treatment
Health Effects After Anthracycline and Radiation Therapy (HEART): Dexrazoxane and Prevention of Anthracycline-Related Cardiomyopathy
Source: ClinicalTrials.gov · Last updated 18 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 420 (estimated)
- First submitted
- 11 Feb 2013
- Start date
- 5 Mar 2014
- Primary completion date
- 31 Dec 2022
- Lead sponsor
- Children's Oncology Group
- NCT number
- NCT01790152
What you commit to
- Study type: Observational
- Planned participants: 420
- From 5 Mar 2014 to the primary completion date, 31 Dec 2022
- 79 sites in 4 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Who the study is looking for
- 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
- Previously enrolled osteosarcoma survivors treated on P9754 who are alive and able (themselves and/or parents/legal guardian) to provide written informed consent; note that relapse and subsequent malignancy are not exclusion criteria for P9754 survivors
- Comparison subjects for P9754 survivors will be eligible to be enrolled from any ALTE11C2 participating COG site (even if that institution did not participate on P9754), according to the following criteria:
- Newly diagnosed, previously untreated biopsy-proven moderate or high grade osteosarcoma without metastasis; patients with low grade osteosarcoma, parosteal or periosteal sarcoma are ineligible
- \< 31 years of age at time of initial osteosarcoma diagnosis
- Diagnosis occurred between January 1, 1999 through December 31, 2002; duration of therapy can extend beyond 2002
- No evidence of poor or low cardiac function at time of initial osteosarcoma diagnosis; if reports from the time are available: shortening fraction \>= 28% by echocardiogram and within the institutional normative range for age, or radionuclide angiogram ejection fraction \>= 50%; if imaging reports from the time are no longer available, there must be no documentation within available medical records that suggest poor or low cardiac function at time of diagnosis
- Comparison subject must have institutional records (e.g., clinic note, treatment summary, chemotherapy roadmap) documenting lifetime receipt of 450 to 600 mg/m\^2 of doxorubicin (doses within 10% are acceptable); this includes initial therapy as well as any subsequent therapy for relapse or second cancer, if relevant; as such, comparison subjects who have had osteosarcoma relapse or subsequent malignancies remain eligible so long as they meet all other eligibility criteria
- No anthracycline or anthraquinone aside from doxorubicin was ever given as part of initial or subsequent therapies
- No exposure to DRZ at any point in time
- All patients and/or their parents or legal guardians must sign a written informed consent
- STRATUM IV: CARDIOMYOPATHY CASES, NOT OTHERWISE ELIGIBLE FOR STRATUMS 1, 2, AND 3
- Individuals diagnosed with cancer prior to age 21 years, who required treatment with chemotherapy and/or radiotherapy, achieved initial remission, and remained alive after completing anti-cancer-therapy for at least 1 year
- Must have screening echocardiograms for heart function as part of cancer therapy and off-therapy evaluations available (Digital Imaging and Communications in Medicine \[DICOM\] format). Images from Video Home System (VHS) tapes and reports only (without images) are not suitable
- Cannot have a known history of congenital heart disease (patent foramen ovale remain eligible) or underlying genetic syndrome associated with abnormal cardiovascular development or health (e.g., down syndrome)
- Based on echocardiography, must have either left ventricular fractional shortening =\< 28.0% or ejection fraction =\< 50.0% on at least two occasions, with at least one of these measurements occurring after cancer therapy completion and be in the absence of sepsis or any uncontrolled infection
- If the fractional shortening or ejection fraction criteria is only met on one occasion, this must be after cancer therapy completion, be in the absence of sepsis or any uncontrolled infection, and the patient must have subsequently started on chronic medical therapy for cardiomyopathy (e.g., beta-blocker, angiotensin-converting enzyme \[ACE\]-inhibitor, angiotensin receptor blocker) lasting at least 6 months
- For all participants (stratums 1, 2, 3, and 4), all institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met
Sex: All · Does not accept healthy volunteers
Sites (79)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Princess Margaret Hospital for Children Coordinator of this site? Confirm its status | Perth | Australia | Active, not recruiting |
| Perth Children's Hospital Coordinator of this site? Confirm its status | Perth | Australia | Recruiting |
| Alberta Children's Hospital Coordinator of this site? Confirm its status | Calgary | Canada | Recruiting |
| McMaster Children's Hospital at Hamilton Health Sciences Coordinator of this site? Confirm its status | Hamilton | Canada | Suspended |
| The Montreal Children's Hospital of the MUHC Coordinator of this site? Confirm its status | Montreal | Canada | Recruiting |
| Centre Hospitalier Universitaire Sainte-Justine Coordinator of this site? Confirm its status | Montreal | Canada | Recruiting |
| Children'S Hospital Of Eastern Ontario Coordinator of this site? Confirm its status | Ottawa | Canada | Active, not recruiting |
| Centre hospitalier universitaire de Québec Coordinator of this site? Confirm its status | Québec | Canada | Recruiting |
| Hospital for Sick Children Coordinator of this site? Confirm its status | Toronto | Canada | Suspended |
| San Jorge Children's Hospital Coordinator of this site? Confirm its status | San Juan | Puerto Rico | Recruiting |
| Children's Hospital Medical Center of Akron Coordinator of this site? Confirm its status | Akron | United States | Recruiting |
| University of New Mexico Cancer Center Coordinator of this site? Confirm its status | Albuquerque | United States | Recruiting |
| Mission Hospital Coordinator of this site? Confirm its status | Asheville | United States | Recruiting |
| Children's Healthcare of Atlanta-Egleston Coordinator of this site? Confirm its status | Atlanta | United States | Recruiting |
| Sinai Hospital of Baltimore Coordinator of this site? Confirm its status | Baltimore | United States | Recruiting |
| Johns Hopkins University/Sidney Kimmel Cancer Center Coordinator of this site? Confirm its status | Baltimore | United States | Recruiting |
| Children's Hospital of Alabama Coordinator of this site? Confirm its status | Birmingham | United States | Recruiting |
| Dana-Farber Cancer Institute Coordinator of this site? Confirm its status | Boston | United States | Recruiting |
| Roswell Park Cancer Institute Coordinator of this site? Confirm its status | Buffalo | United States | Suspended |
| University of Vermont and State Agricultural College Coordinator of this site? Confirm its status | Burlington | United States | Recruiting |
| Medical University of South Carolina Coordinator of this site? Confirm its status | Charleston | United States | Recruiting |
| University of Illinois Coordinator of this site? Confirm its status | Chicago | United States | Active, not recruiting |
| Lurie Children's Hospital-Chicago Coordinator of this site? Confirm its status | Chicago | United States | Recruiting |
| Cincinnati Children's Hospital Medical Center Coordinator of this site? Confirm its status | Cincinnati | United States | Recruiting |
| Columbia Regional Coordinator of this site? Confirm its status | Columbia | United States | Active, not recruiting |
| Medical City Dallas Hospital Coordinator of this site? Confirm its status | Dallas | United States | Active, not recruiting |
| UT Southwestern/Simmons Cancer Center-Dallas Coordinator of this site? Confirm its status | Dallas | United States | Recruiting |
| Ascension Saint John Hospital Coordinator of this site? Confirm its status | Detroit | United States | Recruiting |
| Wayne State University/Karmanos Cancer Institute Coordinator of this site? Confirm its status | Detroit | United States | Active, not recruiting |
| City of Hope Comprehensive Cancer Center Coordinator of this site? Confirm its status | Duarte | United States | Recruiting |
| Hurley Medical Center Coordinator of this site? Confirm its status | Flint | United States | Active, not recruiting |
| Golisano Children's Hospital of Southwest Florida Coordinator of this site? Confirm its status | Fort Myers | United States | Recruiting |
| Cook Children's Medical Center Coordinator of this site? Confirm its status | Fort Worth | United States | Suspended |
| University of Florida Health Science Center - Gainesville Coordinator of this site? Confirm its status | Gainesville | United States | Suspended |
| BI-LO Charities Children's Cancer Center Coordinator of this site? Confirm its status | Greenville | United States | Recruiting |
| Hackensack University Medical Center Coordinator of this site? Confirm its status | Hackensack | United States | Recruiting |
| Memorial Regional Hospital/Joe DiMaggio Children's Hospital Coordinator of this site? Confirm its status | Hollywood | United States | Active, not recruiting |
| University of Hawaii Cancer Center Coordinator of this site? Confirm its status | Honolulu | United States | Active, not recruiting |
| Kapiolani Medical Center for Women and Children Coordinator of this site? Confirm its status | Honolulu | United States | Recruiting |
| Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center Coordinator of this site? Confirm its status | Houston | United States | Recruiting |
| University of Mississippi Medical Center Coordinator of this site? Confirm its status | Jackson | United States | Recruiting |
| Nemours Children's Clinic-Jacksonville Coordinator of this site? Confirm its status | Jacksonville | United States | Recruiting |
| University Medical Center of Southern Nevada Coordinator of this site? Confirm its status | Las Vegas | United States | Recruiting |
| Alliance for Childhood Diseases/Cure 4 the Kids Foundation Coordinator of this site? Confirm its status | Las Vegas | United States | Recruiting |
| Summerlin Hospital Medical Center Coordinator of this site? Confirm its status | Las Vegas | United States | Recruiting |
| Sunrise Hospital and Medical Center Coordinator of this site? Confirm its status | Las Vegas | United States | Recruiting |
| Dartmouth Hitchcock Medical Center Coordinator of this site? Confirm its status | Lebanon | United States | Active, not recruiting |
| Arkansas Children's Hospital Coordinator of this site? Confirm its status | Little Rock | United States | Recruiting |
| Valley Children's Hospital Coordinator of this site? Confirm its status | Madera | United States | Active, not recruiting |
| Children's Hospital of Wisconsin Coordinator of this site? Confirm its status | Milwaukee | United States | Recruiting |
| Yale University Coordinator of this site? Confirm its status | New Haven | United States | Recruiting |
| The Steven and Alexandra Cohen Children's Medical Center of New York Coordinator of this site? Confirm its status | New Hyde Park | United States | Recruiting |
| Ochsner Medical Center Jefferson Coordinator of this site? Confirm its status | New Orleans | United States | Recruiting |
| Kaiser Permanente-Oakland Coordinator of this site? Confirm its status | Oakland | United States | Recruiting |
| Advocate Children's Hospital-Oak Lawn Coordinator of this site? Confirm its status | Oak Lawn | United States | Recruiting |
| University of Oklahoma Health Sciences Center Coordinator of this site? Confirm its status | Oklahoma City | United States | Recruiting |
| Nemours Children's Hospital Coordinator of this site? Confirm its status | Orlando | United States | Recruiting |
| Lucile Packard Children's Hospital Stanford University Coordinator of this site? Confirm its status | Palo Alto | United States | Recruiting |
| Saint Jude Midwest Affiliate Coordinator of this site? Confirm its status | Peoria | United States | Recruiting |
| Saint Christopher's Hospital for Children Coordinator of this site? Confirm its status | Philadelphia | United States | Recruiting |
| Phoenix Childrens Hospital Coordinator of this site? Confirm its status | Phoenix | United States | Recruiting |
| Legacy Emanuel Children's Hospital Coordinator of this site? Confirm its status | Portland | United States | Recruiting |
| Oregon Health and Science University Coordinator of this site? Confirm its status | Portland | United States | Recruiting |
| Rhode Island Hospital Coordinator of this site? Confirm its status | Providence | United States | Recruiting |
| Virginia Commonwealth University/Massey Cancer Center Coordinator of this site? Confirm its status | Richmond | United States | Recruiting |
| University of Rochester Coordinator of this site? Confirm its status | Rochester | United States | Recruiting |
| University of Texas Health Science Center at San Antonio Coordinator of this site? Confirm its status | San Antonio | United States | Recruiting |
| Rady Children's Hospital - San Diego Coordinator of this site? Confirm its status | San Diego | United States | Recruiting |
| Maine Children's Cancer Program Coordinator of this site? Confirm its status | Scarborough | United States | Recruiting |
| Seattle Children's Hospital Coordinator of this site? Confirm its status | Seattle | United States | Recruiting |
| Providence Sacred Heart Medical Center and Children's Hospital Coordinator of this site? Confirm its status | Spokane | United States | Recruiting |
| Washington University School of Medicine Coordinator of this site? Confirm its status | St Louis | United States | Recruiting |
| Stony Brook University Medical Center Coordinator of this site? Confirm its status | Stony Brook | United States | Recruiting |
| Johns Hopkins All Children's Hospital Coordinator of this site? Confirm its status | St. Petersburg | United States | Active, not recruiting |
| State University of New York Upstate Medical University Coordinator of this site? Confirm its status | Syracuse | United States | Recruiting |
| Saint Joseph's Hospital/Children's Hospital-Tampa Coordinator of this site? Confirm its status | Tampa | United States | Recruiting |
| Banner University Medical Center - Tucson Coordinator of this site? Confirm its status | Tucson | United States | Recruiting |
| Saint Mary's Hospital Coordinator of this site? Confirm its status | West Palm Beach | United States | Recruiting |
| Wake Forest University Health Sciences Coordinator of this site? Confirm its status | Winston-Salem | United States | Recruiting |
Related publications
- Longitudinal Change in Cardiac Function After Doxorubicin and Dexrazoxane: A Report From Children's Oncology Group ALTE11C2.J Clin Oncol · 2026 · PMID 42561216
This page is information, not medical advice. Discuss any trial with your doctor.