Dexrazoxane Hydrochloride and Heart Health After Cancer Treatment
This observational study is looking at how dexrazoxane hydrochloride affects heart health in people who have had certain cancers like Hodgkin lymphoma, leukemia, and osteosarcoma. Researchers are studying blood samples to understand the effects of dexrazoxane hydrochloride on cells and how well patients respond to treatment. The main goals are to see if patients who received dexrazoxane hydrochloride have fewer signs of heart problems (cardiomyopathy and heart failure) compared to those who didn't. They are also looking at how factors like the dose of other cancer drugs (anthracycline) and radiation might change these effects. The study is currently open for existing medical record submission for Stratum IV, but other groups are closed to new participants.
- Study design
- This is an observational study with a planned enrollment of 420 participants. It compares heart health markers in cancer survivors who did or did not receive dexrazoxane hydrochloride.
- What's involved
- Participants will have assessments of therapy complications, laboratory biomarker analysis, quality-of-life assessments, and questionnaire administration.
- Compensation
- Not stated in the trial record.
- Follow-up
- Left ventricular function and serum biomarkers will be measured at baseline.
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NCT01790152
Effects of Dexrazoxane Hydrochloride on Biomarkers Associated With Cardiomyopathy and Heart Failure After Cancer Treatment
Recruiting
Not specifiedAll AgesObservationalChildren's Oncology GroupGovernment-funded
~420 participants
Updated 2026-05-18 on ClinicalTrials.gov
What's tested:Assessment of Therapy ComplicationsLaboratory Biomarker AnalysisQuality-of-Life AssessmentQuestionnaire Administration
At a glance
Recruiting sites
62 of 79 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Left ventricular function and measures of pathologic remodeling (i.e., thickness-to-dimension ratio) assessed using standard 2-dimensional, M-mode, and Doppler echocardiogram
Measured over Baseline
+1 more outcome measured
Conditions
Where it's being run
79 sites across 39 statesFlorida8
California5
New York5
Texas5
Illinois4
Nevada4
Michigan3
Ontario3
Study leadership
- Eric J Chow · PRINCIPAL_INVESTIGATOR · Children's Oncology Group
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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
Exclusion
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
What this trial measures
- Left ventricular function and measures of pathologic remodeling (i.e., thickness-to-dimension ratio) assessed using standard 2-dimensional, M-mode, and Doppler echocardiogramBaseline
Univariate tests will be used as well as examination of the entire cohort via multivariable regression adjusting for all a priori covariates of interest.
- Differences in serum biomarkers (particularly cardiac troponins and natriuretic peptides)Baseline
Univariate tests will be used as well as examination of the entire cohort via multivariable regression adjusting for all a priori covariates of interest.