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Dexrazoxane

Razoxane

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.

Assessment of Therapy Complications

Laboratory Biomarker Analysis

Quality-of-Life Assessment

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Site Public Contact

Smita Bhatia

Alexandra M. Walsh

Holly E. Pariury

David L. Becton

Saro H. Armenian

Laura A. Campbell

Jay Michael S. Balagtas

William D. Roberts

Nina S. Kadan-Lottick

Emad K. Salman

Ramamoorthy Nagasubramanian

Dana A. Obzut

Narayana Gowda

Lillian R. Meacham

Wade T. Kyono

Jennifer L. Reichek

Rebecca E. McFall

Jaime M. Libes

Craig Lotterman

Eric C. Larsen

Jason M. Fixler

Kenneth J. Cohen

Lynda M. Vrooman

Adonis N. Lorenzana

Anderson (Andy) B. Collier

Robert J. Hayashi

Alan K. Ikeda

Michael B. Harris

John F. Kuttesch

Jonathan D. Fish

Angela R. Girvin

Laura E. Hogan

Philip M. Monteleone

Douglas J. Scothorn

Thomas B. Russell

Steven J. Kuerbitz

Rajaram Nagarajan

Rene Y. McNall-Knapp

Janice F. Olson

Susan J. Lindemulder

Gregory E. Halligan

Jennifer J. Greene Welch

Jacqueline M. Kraveka

Nichole L. Bryant

Daniel C. Bowers

Julienne Brackett

Anne-Marie R. Langevin

Jessica L. Heath

Madhu S. Gowda

Douglas S. Hawkins

Judy L. Felgenhauer

Richard L. Tower

Marianne B. Phillips

Douglas R. Strother

Sharon B. Abish

Yvan Samson

Bruno Michon

Luis A. Clavell

Eric J Chow

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.

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

Health Effects After Anthracycline and Radiation Therapy (HEART): Dexrazoxane and Prevention of Anthracycline-Related Cardiomyopathy

Univariate tests will be used as well as examination of the entire cohort via multivariable regression adjusting for all a priori covariates of interest.

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.

An analytic Markov model will be created and used.

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.

National Cancer Institute (NCI)

Children's Oncology Group

Spots Global Cancer Trial Database for hodgkin lymphoma in remission