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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2016 by Children's Oncology Group
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group
ClinicalTrials.gov Identifier:
NCT01790152
First received: February 11, 2013
Last updated: April 5, 2016
Last verified: April 2016

February 11, 2013
April 5, 2016
August 2013
January 2019   (final data collection date for primary outcome measure)
  • Left ventricular thickness-to-dimension ratio assessed using standard 2-dimensional. [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Univariate tests will be used as well as examination of the entire cohort via multivariable regression adjusting for all a priori covariates of interest.
  • Left ventricular thickness-to-dimension ratio assessed using M-mode. [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Univariate tests will be used as well as examination of the entire cohort via multivariable regression adjusting for all a priori covariates of interest.
  • Left ventricular thickness-to-dimension ratio assessed using Doppler echocardiogram. [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Univariate tests will be used as well as examination of the entire cohort via multivariable regression adjusting for all a priori covariates of interest.
Left ventricular (LV) thickness-to-dimension ratio [ Time Frame: 2 years ] [ Designated as safety issue: No ]
A decrease in echocardiographically derived measure of pathologic left ventricle (LV) remodeling which has been shown to be an important earlier surrogate measure of subsequent heart failure in both anthracycline-exposed pediatric cancer survivors5 and in the general pediatric and adult cardiomyopathy/heart failure population. This ratio can be derived from standard measurements.
Complete list of historical versions of study NCT01790152 on ClinicalTrials.gov Archive Site
  • Differences in serum biomarkers (particularly cardiac troponins and natriuretic peptides) [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Primary disease relapse [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    An analytic Markov model will be created and used.
  • Quality of life based on self-report instruments [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    An analytic Markov model will be created and used. Estimates and their 95% confidence will be included to explore the sensitivity of any QALY estimates.
  • Second cancer rates [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    An analytic Markov model will be created and used.
  • Differences in serum biomarkers [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Particularly cardiac troponins and natriuretic peptides associated with acute changes following anthracycline exposure will be examined. Analyses involving markers of inflammation (hs-CRP, TNF, IL6) and more novel markers associated with heart failure in the general population (galectin-3, ST2, growth differentiation factor-15) are exploratory.
  • Quality of life [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Based on self-report instruments will be factored into QALY estimates to answer the secondary aims.
  • Update primary disease relapse and second cancer rates [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Given additional elapsed time since last follow-up used in the prior published analyses,11-13 primary disease relapse and second cancer rates will be updated.
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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.

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.

Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Probability Sample
Patients with T-cell leukemia/lymphoma or Hodgkin lymphoma enrolled on Pediatric Oncology Group (POG) 9404, 9425, 9426.
  • Recurrent Adult Hodgkin Lymphoma
  • Recurrent Adult T-Cell Leukemia/Lymphoma
  • Refractory Childhood Hodgkin Lymphoma
  • Stage I Adult Hodgkin Lymphoma
  • Stage I Adult T-Cell Leukemia/Lymphoma
  • Stage I Childhood Hodgkin Lymphoma
  • Stage II Adult Hodgkin Lymphoma
  • Stage II Adult T-Cell Leukemia/Lymphoma
  • Stage II Childhood Hodgkin Lymphoma
  • Stage III Adult Hodgkin Lymphoma
  • Stage III Adult T-Cell Leukemia/Lymphoma
  • Stage III Childhood Hodgkin Lymphoma
  • Stage IV Adult Hodgkin Lymphoma
  • Stage IV Adult T-Cell Leukemia/Lymphoma
  • Stage IV Childhood Hodgkin Lymphoma
  • Other: Assessment of Therapy Complications
    Ancillary studies
  • Other: Laboratory Biomarker Analysis
    Correlative studies
  • Other: Quality-of-Life Assessment
    Ancillary studies
    Other Name: Quality of Life Assessment
  • Other: Questionnaire Administration
    Ancillary studies
Ancillary-Correlative (laboratory biomarker analysis)
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.
Interventions:
  • Other: Assessment of Therapy Complications
  • Other: Laboratory Biomarker Analysis
  • Other: Quality-of-Life Assessment
  • Other: Questionnaire Administration
Chow EJ, Asselin BL, Schwartz CL, Doody DR, Leisenring WM, Aggarwal S, Baker KS, Bhatia S, Constine LS, Freyer DR, Lipshultz SE, Armenian SH. Late Mortality After Dexrazoxane Treatment: A Report From the Children's Oncology Group. J Clin Oncol. 2015 Aug 20;33(24):2639-45. doi: 10.1200/JCO.2014.59.4473. Epub 2015 May 26.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
420
Not Provided
January 2019   (final data collection date for primary outcome measure)

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
Both
Child, Adult, Senior
No
United States,   Canada
 
NCT01790152
ALTE11C2, NCI-2012-03196, S0004187, ALTE11C2, ALTE11C2, ALTE11C2, U10CA095861, UG1CA189955
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Not Provided
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Children's Oncology Group
Children's Oncology Group
National Cancer Institute (NCI)
Principal Investigator: Eric Chow Children's Oncology Group
Children's Oncology Group
April 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP