Effects of Dexrazoxane Hydrochloride on Biomarkers Associated With Cardiomyopathy and Heart Failure After Cancer Treatment

Status: Recruiting
Phase:
DFCI Protocol ID: 16-725

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.

Conducting Institutions:

Dana-Farber Cancer Institute, Children's Hospital Boston

Overall PI:

Lynda Vrooman, MD, Dana Farber Cancer Institute

Site-responsible Investigators:

Contacts:

Dana-Farber Cancer Institute: Childrens Hospital Pediatric Clinical Translation Investigation Program CTIP, ctip@partners.org

Eligibility Criteria

Inclusion Criteria:

  -  Previously enrolled and randomized on POG 9404, 9425, or 9426

  -  STRATUM I: Alive and in continuous first complete remission from their original
     cancer (T-cell leukemia/lymphoma [POG 9404] or Hodgkin lymphoma [POG 9425/9426])

  -  STRATUM I: Not have been diagnosed with any subsequent malignancy, with the exception
     of non-melanomatous skin cancer(s); patients with history of only subsequent
     non-melanomatous skin cancers remain eligible

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

  -  Among patients who have relapsed or have experienced a subsequent malignancy other
     than non-melanomatous skin cancer 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

  -  For all participants, all institutional, Food and Drug Administration (FDA), and
     National Cancer Institute (NCI) requirements for human studies must be met; finally,
     the coordinating center will create a master list using SDC records and those of
     local institutions of patients to be approached; patients who otherwise appear to be
     eligible for Stratum 1 or 2 not identified on this list cannot be enrolled without
     prior approval from the study chair

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