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

Study ID
STU 092013-038

Study Sites

  • Children’s Medical Center (Dallas, Plano, Southlake)

Contact
Beverly Kleiber
2144566484
beverly.kleiber@childrens.com

Principal Investigator
Daniel Bowers, M.D.

Official Title

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

Brief 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.

Description

PRIMARY OBJECTIVES:
I. To determine whether patients randomized to the experimental dexrazoxane hydrochloride (DRZ) arms have decreased markers of cardiomyopathy/heart failure (CHF) compared with patients on the standard arm.
II. To evaluate whether the cardioprotective effect of DRZ is modified by anthracycline (anthracycline analogue GPX-150) dose, chest radiation, and demographic factors (age at cancer diagnosis, current age, sex).
SECONDARY OBJECTIVES:
I. To determine whether patients on the DRZ arms experienced differential rates of overall-survival and event-free survival compared with the standard therapy arms.
II. To determine whether projected quality-adjusted life years (QALY) differed by randomization status, accounting for premature cardiac disease, primary disease relapse, and second cancers.
OUTLINE:
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.

Eligibility

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