Last updated on July 2019

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


Brief description of study

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 Study 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.

Clinical Study Identifier: NCT01790152

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Sinai Hospital of Baltimore

Baltimore, MD United States
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Children's Hospital of Alabama

Birmingham, AL United States
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Saint Mary's Hospital

West Palm Beach, FL United States
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Ochsner Medical Center Jefferson

New Orleans, LA United States
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Kaiser Permanente-Oakland

Oakland, CA United States
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Yale University

New Haven, CT United States
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Maine Children's Cancer Program

Scarborough, ME United States
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Cook Children's Medical Center

Fort Worth, TX United States
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Arkansas Children's Hospital

Little Rock, AR United States
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Hurley Medical Center

Flint, MI United States
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Columbia Regional

Columbia, MO United States
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University of Rochester

Rochester, NY United States
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Rhode Island Hospital

Providence, RI United States
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Seattle Children's Hospital

Seattle, WA United States
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Johns Hopkins All Children's Hospital

Saint Petersburg, FL United States
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University of Illinois

Chicago, IL United States
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Phoenix Childrens Hospital

Phoenix, AZ United States
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Recruitment Status: Open


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