Effects of Dexrazoxane Hydrochloride on Biomarkers Associated With Cardiomyopathy and Heart Failure After Cancer Treatment
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ClinicalTrials.gov Identifier: NCT01790152 |
Recruitment Status :
Recruiting
First Posted : February 13, 2013
Last Update Posted : August 4, 2020
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Tracking Information | ||||
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First Submitted Date | February 11, 2013 | |||
First Posted Date | February 13, 2013 | |||
Last Update Posted Date | August 4, 2020 | |||
Actual Study Start Date | August 5, 2013 | |||
Estimated Primary Completion Date | March 30, 2022 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures |
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Original Primary Outcome Measures |
Left ventricular (LV) thickness-to-dimension ratio [ Time Frame: 2 years ] 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.
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Change History | ||||
Current Secondary Outcome Measures |
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Original Secondary Outcome Measures |
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Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title | Effects of Dexrazoxane Hydrochloride on Biomarkers Associated With Cardiomyopathy and Heart Failure After Cancer Treatment | |||
Official Title | Health Effects After Anthracycline and Radiation Therapy (HEART): Dexrazoxane and Prevention of Anthracycline-Related Cardiomyopathy | |||
Brief Summary | 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. | |||
Detailed Description | PRIMARY OBJECTIVES: I. To determine whether leukemia and lymphoma patients from P9404, P9425, P9426, and Dana Farber Cancer Institute (DFCI) 95-01 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 determine whether osteosarcoma patients from P9754 (all received DRZ) have decreased markers of cardiomyopathy/heart failure (CHF) compared with similarly treated osteosarcoma patients diagnosed during the same time period, but who did not receive DRZ. III. 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 leukemia and lymphoma patients from P9404, P9425, P9426, and DFCI 95-01 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 DRZ status, accounting for premature cardiac disease, primary disease relapse, and second cancers. III. Determine the longitudinal trajectory of 2-dimensional echocardiographic parameters (focusing on left ventricular [LV] function and remodeling/geometric changes that can be reliably re-measured) among patients from time of cancer treatment through subsequent follow-up. 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. |
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Study Type | Observational | |||
Study Design | Observational Model: Case-Only Time Perspective: Prospective |
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Target Follow-Up Duration | Not Provided | |||
Biospecimen | Retention: Samples With DNA Description: Serum
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Sampling Method | Non-Probability Sample | |||
Study Population | Patients with leukemia or lymphoma enrolled on Pediatric Oncology Group (POG) P9404, P9425, P9426, and DFCI 95-01 or osteosarcoma enrolled on P9754 | |||
Condition |
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Intervention |
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Study Groups/Cohorts | 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:
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Publications * | 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. |
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Recruitment Information | ||||
Recruitment Status | Recruiting | |||
Estimated Enrollment |
420 | |||
Original Estimated Enrollment | Same as current | |||
Estimated Study Completion Date | March 30, 2022 | |||
Estimated Primary Completion Date | March 30, 2022 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria | Inclusion Criteria:
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Sex/Gender |
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Ages | Child, Adult, Older Adult | |||
Accepts Healthy Volunteers | No | |||
Contacts | ||||
Listed Location Countries | Australia, Canada, Puerto Rico, United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number | NCT01790152 | |||
Other Study ID Numbers | ALTE11C2 NCI-2012-03196 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ) S0004187 ALTE11C2 ( Other Identifier: Childrens Oncology Group ) COG-ALTE11C2 ( Other Identifier: DCP ) ALTE11C2 ( Other Identifier: CTEP ) R01CA211996 ( U.S. NIH Grant/Contract ) U10CA095861 ( U.S. NIH Grant/Contract ) UG1CA189955 ( U.S. NIH Grant/Contract ) |
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Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Children's Oncology Group | |||
Study Sponsor | Children's Oncology Group | |||
Collaborators | National Cancer Institute (NCI) | |||
Investigators |
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PRS Account | Children's Oncology Group | |||
Verification Date | July 2020 |