Overview

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

Inclusion Criteria:

        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