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
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.
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).
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
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.
- Previously enrolled and randomized on POG 9404, 9425, or 9426
- Alive and in continuous first complete remission from their original cancer (T-cell
leukemia/lymphoma [POG 9404] or Hodgkin lymphoma [POG 9425/9426])
- 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.
- All patients and/or their parents or legal guardians must sign a written informed
consent (see Stratum 1 sample 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 COG's Statistics and Data Center (SDC) and
the participating institution) to determine if individual patients are to be selected
for secondary aim arm only. The study will petition the 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).