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:
Children's Oncology Group
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
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Purpose
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.
| Condition | Intervention |
|---|---|
|
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 Other: Laboratory Biomarker Analysis Other: Quality-of-Life Assessment Other: Questionnaire Administration |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Prospective |
| Official Title: | Health Effects After Anthracycline and Radiation Therapy (HEART): Dexrazoxane and Prevention of Anthracycline-Related Cardiomyopathy |
Resource links provided by NLM:
Genetic and Rare Diseases Information Center resources:
Lymphosarcoma
Hodgkin Lymphoma
Leukemia, T-cell, Chronic
Hodgkin Lymphoma, Childhood
U.S. FDA Resources
Further study details as provided by Children's Oncology Group:
Primary Outcome Measures:
- 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.
Secondary Outcome Measures:
- 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.
| Estimated Enrollment: | 420 |
| Study Start Date: | August 2013 |
| Estimated Primary Completion Date: | January 2019 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
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.
|
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
|
Detailed 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| Ages Eligible for Study: | Child, Adult, Senior |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Study Population
Patients with T-cell leukemia/lymphoma or Hodgkin lymphoma enrolled on Pediatric Oncology Group (POG) 9404, 9425, 9426.
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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01790152
Show 55 Study Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01790152
Show 55 Study Locations
Sponsors and Collaborators
Children's Oncology Group
National Cancer Institute (NCI)
Investigators
| Principal Investigator: | Eric Chow | Children's Oncology Group |
More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Children's Oncology Group |
| ClinicalTrials.gov Identifier: | NCT01790152 History of Changes |
| Other Study ID Numbers: | ALTE11C2 NCI-2012-03196 S0004187 ALTE11C2 ALTE11C2 ALTE11C2 U10CA095861 UG1CA189955 |
| Study First Received: | February 11, 2013 |
| Last Updated: | April 5, 2016 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Lymphoma Leukemia Hodgkin Disease Cardiomyopathies Leukemia, T-Cell Leukemia-Lymphoma, Adult T-Cell Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Heart Diseases Cardiovascular Diseases |
Leukemia, Lymphoid Dexrazoxane Razoxane Antineoplastic Agents Cardiotonic Agents Topoisomerase II Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Protective Agents Physiological Effects of Drugs Antimitotic Agents Mitosis Modulators |
ClinicalTrials.gov processed this record on September 27, 2016