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.
STRATUM I AND STRATUM II: LEUKEMIA AND LYMPHOMA SURVIVORS
Previously enrolled leukemia and lymphoma survivors, randomized to + or - DRZ on P9404, P9425, P9426, or DFCI 95-01 (high-risk patients only)
STRATUM I: Alive and in continuous first complete remission from their original cancer (leukemia/lymphoblastic lymphoma [P9404, high-risk DFCI 95-01] or Hodgkin lymphoma [P9425/P9426])
STRATUM I: Did not have progressive disease or induction failure requiring off-protocol therapy including hematopoietic cell transplantation
Newly diagnosed, previously untreated biopsy-proven moderate or high grade osteosarcoma without metastasis; patients with low grade osteosarcoma, parosteal or periosteal sarcoma are ineligible
< 31 years of age at time of initial osteosarcoma diagnosis
Diagnosis occurred between January 1, 1999 through December 31, 2002; duration of therapy can extend beyond 2002
No evidence of poor or low cardiac function at time of initial osteosarcoma diagnosis; if reports from the time are available: shortening fraction >= 28% by echocardiogram and within the institutional normative range for age, or radionuclide angiogram ejection fraction >= 50%; if imaging reports from the time are no longer available, there must be no documentation within available medical records that suggest poor or low cardiac function at time of diagnosis
Patients with leukemia or lymphoma enrolled on Pediatric Oncology Group (POG) P9404, P9425, P9426, and DFCI 95-01 or osteosarcoma enrolled on P9754
Case-only
Prospective
Assessment of Therapy Complications
Other interventionAncillary studies
Laboratory Biomarker Analysis
Other interventionCorrelative studies
Quality-of-Life Assessment
Other interventionAncillary studies
Questionnaire Administration
Other interventionAncillary studies
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.
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.
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.
Primary disease relapse
An analytic Markov model will be created and used.
Second cancer rates
An analytic Markov model will be created and used.
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.
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Children's Oncology Group
Lead sponsor
National Cancer Institute (NCI)
Collaborator
