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 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.
Study Type
OBSERVATIONAL
Enrollment
420
Ancillary studies
Correlative studies
Ancillary studies
Ancillary studies
Children's Hospital of Alabama
Birmingham, Alabama, United States
RECRUITINGPhoenix Childrens Hospital
Phoenix, Arizona, United States
RECRUITINGBanner University Medical Center - Tucson
Tucson, Arizona, United States
RECRUITINGArkansas Children's Hospital
Little Rock, Arkansas, United States
Left ventricular function and measures of pathologic remodeling (i.e., thickness-to-dimension ratio) assessed using standard 2-dimensional, M-mode, and Doppler echocardiogram
Univariate tests will be used as well as examination of the entire cohort via multivariable regression adjusting for all a priori covariates of interest.
Time frame: Baseline
Differences in serum biomarkers (particularly cardiac troponins and natriuretic peptides)
Univariate tests will be used as well as examination of the entire cohort via multivariable regression adjusting for all a priori covariates of interest.
Time frame: Baseline
Quality of life based on self-report instruments
An analytic Markov model will be created and used. Estimates and their 95% confidence will be included to explore the sensitivity of any quality-adjusted life years estimates.
Time frame: Baseline
Primary disease relapse
An analytic Markov model will be created and used.
Time frame: Baseline
Second cancer rates
An analytic Markov model will be created and used.
Time frame: Baseline
Longitudinal trajectory of 2-dimensional echocardiographic parameters
Will utilize generalized linear model-general estimation equation to model the trajectories of echocardiographic biomarker estimates (continuous outcomes) across time. Relevant model shapes will be evaluated, beginning with linear models, but also testing more flexible shapes (e.g., quadratic, cubic, or cubic spline functions with varying numbers of knots) to determine whether non-linear components are needed for fit. Will also examine interactions of dexrazoxane (DRZ) status with the selected functions of time to evaluate for differences in trajectories over time by DRZ status.
Time frame: From time of cancer treatment to subsequent follow-up
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City of Hope Comprehensive Cancer Center
Duarte, California, United States
RECRUITINGValley Children's Hospital
Madera, California, United States
ACTIVE_NOT_RECRUITINGKaiser Permanente-Oakland
Oakland, California, United States
RECRUITINGLucile Packard Children's Hospital Stanford University
Palo Alto, California, United States
RECRUITINGRady Children's Hospital - San Diego
San Diego, California, United States
RECRUITINGYale University
New Haven, Connecticut, United States
RECRUITING...and 69 more locations