Recruiting

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

Sponsor:

Children's Oncology Group

Code:

NCT01790152

Conditions

Hodgkin Lymphoma in Remission

Leukemia in Remission

Lymphoblastic Lymphoma

Osteosarcoma

Recurrent Leukemia

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Assessment of Therapy Complications

Laboratory Biomarker Analysis

Quality-of-Life Assessment

Questionnaire Administration

Study Details

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.

Conditions

Hodgkin Lymphoma in Remission

Leukemia in Remission

Lymphoblastic Lymphoma

Osteosarcoma

Recurrent Leukemia

Study ID

NCT01790152

Start date

Mar 5, 2014

Status verified date

May, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2022

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Inclusion Criteria:

Study Strata I, II, and III are closed for further patient entry as of March 31, 2021. The study remains open for existing medical record submission of Stratum IV

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
STRATUM I: Must not have been diagnosed with any subsequent malignancy that required additional cardiotoxic therapies (i.e., radiotherapy to the chest \[also includes fields directed towards the neck, upper abdomen, or spine\], or additional anthracyclines or anthraquinones); patients with history of subsequent malignancy that did not require such therapies remain eligible
STRATUM I: All patients and/or their parents or legal guardians must sign a written informed consent
STRATUM II: Among leukemia and lymphoma patients randomized to + or - DRZ on P9404, P9425, P9426, and DFCI 95-01 (high risk patients only) who have relapsed or have experienced a subsequent malignancy that precludes eligibility since their original diagnosis, the study committee will review the available data (both from Children's Oncology Group's \[COG?s\] Statistics and Data Center \[SDC\] and the participating institution) to determine if individual patients are to be selected for Stratum 2; in recognition that local institutions sometimes have more updated relapse/subsequent cancer data than SDC, in cases where local data is more updated, local data will be used preferentially; the study will petition the Institutional Review Board (IRB) specifically for a waiver of consent to include any relapse and subsequent cancer data obtained from existing records for analysis of the secondary aims; patients selected for Stratum 2 will be those for whom late relapse or subsequent cancer is reported but who lack clear confirmation in existing records (either at SDC or at the local institution)
STRATUM II: Alive, but have experienced relapse of their original cancer and/or have developed a subsequent cancer (other than non-melanomatous skin cancer) since their original diagnosis
STRATUM II: All patients and/or their parents or legal guardians must sign a written informed consent
STRATUM III: OSTEOSARCOMA SURVIVORS
Previously enrolled osteosarcoma survivors treated on P9754 who are alive and able (themselves and/or parents/legal guardian) to provide written informed consent; note that relapse and subsequent malignancy are not exclusion criteria for P9754 survivors
Comparison subjects for P9754 survivors will be eligible to be enrolled from any ALTE11C2 participating COG site (even if that institution did not participate on P9754), according to the following criteria:

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
Comparison subject must have institutional records (e.g., clinic note, treatment summary, chemotherapy roadmap) documenting lifetime receipt of 450 to 600 mg/m\^2 of doxorubicin (doses within 10% are acceptable); this includes initial therapy as well as any subsequent therapy for relapse or second cancer, if relevant; as such, comparison subjects who have had osteosarcoma relapse or subsequent malignancies remain eligible so long as they meet all other eligibility criteria
No anthracycline or anthraquinone aside from doxorubicin was ever given as part of initial or subsequent therapies
No exposure to DRZ at any point in time
All patients and/or their parents or legal guardians must sign a written informed consent
STRATUM IV: CARDIOMYOPATHY CASES, NOT OTHERWISE ELIGIBLE FOR STRATUMS 1, 2, AND 3
Individuals diagnosed with cancer prior to age 21 years, who required treatment with chemotherapy and/or radiotherapy, achieved initial remission, and remained alive after completing anti-cancer-therapy for at least 1 year
Must have screening echocardiograms for heart function as part of cancer therapy and off-therapy evaluations available (Digital Imaging and Communications in Medicine \[DICOM\] format). Images from Video Home System (VHS) tapes and reports only (without images) are not suitable
Cannot have a known history of congenital heart disease (patent foramen ovale remain eligible) or underlying genetic syndrome associated with abnormal cardiovascular development or health (e.g., down syndrome)
Based on echocardiography, must have either left ventricular fractional shortening =< 28.0% or ejection fraction =< 50.0% on at least two occasions, with at least one of these measurements occurring after cancer therapy completion and be in the absence of sepsis or any uncontrolled infection
If the fractional shortening or ejection fraction criteria is only met on one occasion, this must be after cancer therapy completion, be in the absence of sepsis or any uncontrolled infection, and the patient must have subsequently started on chronic medical therapy for cardiomyopathy (e.g., beta-blocker, angiotensin-converting enzyme \[ACE\]-inhibitor, angiotensin receptor blocker) lasting at least 6 months
For all participants (stratums 1, 2, 3, and 4), all institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met

Study Design

Enrollment

420 participants

Anticipated

Interventions and Outcome Measures

Arms

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

Assessment of Therapy Complications

Ancillary studies

Laboratory Biomarker Analysis

Correlative studies

Quality-of-Life Assessment

Ancillary studies

Questionnaire Administration

Ancillary studies

Primary outcome measure

Left ventricular function and measures of pathologic remodeling (i.e., thickness-to-dimension ratio) assessed using standard 2-dimensional, M-mode, and Doppler echocardiogram [ Time Frame: Baseline ]
Differences in serum biomarkers (particularly cardiac troponins and natriuretic peptides) [ Time Frame: Baseline ]

Central Contacts and Locations

Locations

Children's Hospital of Alabama

Recruiting

Birmingham, Alabama, United States, 35233

Contacts

Site Public Contact

205-638-9285 oncologyresearch@peds.uab.edu

Principal Investigator:

Smita Bhatia

Phoenix Childrens Hospital

Recruiting

Phoenix, Arizona, United States, 85016

Contacts

Site Public Contact

602-546-0920

Principal Investigator:

Alexandra M. Walsh

Banner University Medical Center - Tucson

Recruiting

Tucson, Arizona, United States, 85719

Contacts

Site Public Contact

aselegue@email.arizona.edu

Principal Investigator:

Holly E. Pariury

Arkansas Children's Hospital

Recruiting

Little Rock, Arkansas, United States, 72202-3591

Contacts

Site Public Contact

501-364-7373

Principal Investigator:

David L. Becton

City of Hope Comprehensive Cancer Center

Recruiting

Duarte, California, United States, 91010

Contacts

Site Public Contact

800-826-4673 becomingapatient@coh.org

Principal Investigator:

Saro H. Armenian

Kaiser Permanente-Oakland

Recruiting

Oakland, California, United States, 94611

Contacts

Site Public Contact

877-642-4691 Kpoct@kp.org

Principal Investigator:

Laura A. Campbell

Lucile Packard Children's Hospital Stanford University

Recruiting

Palo Alto, California, United States, 94304

Contacts

Site Public Contact

800-694-0012 ccto-office@stanford.edu

Principal Investigator:

Jay Michael S. Balagtas

Rady Children's Hospital - San Diego

Recruiting

San Diego, California, United States, 92123

Contacts

Site Public Contact

858-966-5934

Principal Investigator:

William D. Roberts

Yale University

Recruiting

New Haven, Connecticut, United States, 06520

Contacts

Site Public Contact

203-785-5702 canceranswers@yale.edu

Principal Investigator:

Nina S. Kadan-Lottick

Golisano Children's Hospital of Southwest Florida

Recruiting

Fort Myers, Florida, United States, 33908

Contacts

Site Public Contact

239-343-5333 molly.arnstrom@leehealth.org

Principal Investigator:

Emad K. Salman

Nemours Children's Clinic-Jacksonville

Recruiting

Jacksonville, Florida, United States, 32207

Contacts

Site Public Contact

904-697-3529

Principal Investigator:

Ramamoorthy Nagasubramanian

Nemours Children's Hospital

Recruiting

Orlando, Florida, United States, 32827

Contacts

Site Public Contact

407-650-7150

Principal Investigator:

Ramamoorthy Nagasubramanian

Saint Joseph's Hospital/Children's Hospital-Tampa

Recruiting

Tampa, Florida, United States, 33607

Contacts

Site Public Contact

813-356-7168 Katelynn.Colgain@baycare.org

Principal Investigator:

Dana A. Obzut

Saint Mary's Hospital

Recruiting

West Palm Beach, Florida, United States, 33407

Contacts

Site Public Contact

561-881-2815

Principal Investigator:

Narayana Gowda

Children's Healthcare of Atlanta - Egleston

Recruiting

Atlanta, Georgia, United States, 30322

Contacts

Site Public Contact

404-785-2025 Leann.Schilling@choa.org

Principal Investigator:

Lillian R. Meacham

Kapiolani Medical Center for Women and Children

Recruiting

Honolulu, Hawaii, United States, 96826

Contacts

Site Public Contact

808-983-6090

Principal Investigator:

Wade T. Kyono

Lurie Children's Hospital-Chicago

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Site Public Contact

773-880-4562

Principal Investigator:

Jennifer L. Reichek

Advocate Children's Hospital-Oak Lawn

Recruiting

Oak Lawn, Illinois, United States, 60453

Contacts

Site Public Contact

847-723-7570

Principal Investigator:

Rebecca E. McFall

Saint Jude Midwest Affiliate

Recruiting

Peoria, Illinois, United States, 61637

Contacts

Site Public Contact

888-226-4343

Principal Investigator:

Jaime M. Libes

Ochsner Medical Center Jefferson

Recruiting

New Orleans, Louisiana, United States, 70121

Contacts

Site Public Contact

504-703-8712 Gregory.Johnstone@ochsner.org

Principal Investigator:

Craig Lotterman

Maine Children's Cancer Program

Recruiting

Scarborough, Maine, United States, 04074

Contacts

Site Public Contact

207-396-7581 sverwys@mmc.org

Principal Investigator:

Eric C. Larsen

Sinai Hospital of Baltimore

Recruiting

Baltimore, Maryland, United States, 21215

Contacts

Site Public Contact

410-601-6120 pridgely@lifebridgehealth.org

Principal Investigator:

Jason M. Fixler

Johns Hopkins University/Sidney Kimmel Cancer Center

Recruiting

Baltimore, Maryland, United States, 21287

Contacts

Site Public Contact

410-955-8804 jhcccro@jhmi.edu

Principal Investigator:

Kenneth J. Cohen

Dana-Farber Cancer Institute

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Site Public Contact

877-442-3324

Principal Investigator:

Lynda M. Vrooman

Ascension Saint John Hospital

Recruiting

Detroit, Michigan, United States, 48236

Contacts

Site Public Contact

734-712-3671 stephanie.couch@stjoeshealth.org

Principal Investigator:

Adonis N. Lorenzana

University of Mississippi Medical Center

Recruiting

Jackson, Mississippi, United States, 39216

Contacts

Site Public Contact

601-815-6700

Principal Investigator:

Anderson (Andy) B. Collier

Washington University School of Medicine

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Site Public Contact

800-600-3606 info@siteman.wustl.edu

Principal Investigator:

Robert J. Hayashi

University Medical Center of Southern Nevada

Recruiting

Las Vegas, Nevada, United States, 89102

Contacts

Site Public Contact

702-384-0013 research@sncrf.org

Principal Investigator:

Alan K. Ikeda

Sunrise Hospital and Medical Center

Recruiting

Las Vegas, Nevada, United States, 89109

Contacts

Site Public Contact

702-384-0013 research@sncrf.org

Principal Investigator:

Alan K. Ikeda

Alliance for Childhood Diseases/Cure 4 the Kids Foundation

Recruiting

Las Vegas, Nevada, United States, 89135

Contacts

Site Public Contact

702-384-0013 research@sncrf.org

Principal Investigator:

Alan K. Ikeda

Summerlin Hospital Medical Center

Recruiting

Las Vegas, Nevada, United States, 89144

Contacts

Site Public Contact

702-384-0013 research@sncrf.org

Principal Investigator:

Alan K. Ikeda

Hackensack University Medical Center

Recruiting

Hackensack, New Jersey, United States, 07601

Contacts

Site Public Contact

201-996-2879

Principal Investigator:

Michael B. Harris

University of New Mexico Cancer Center

Recruiting

Albuquerque, New Mexico, United States, 87102

Contacts

Site Public Contact

505-925-0366 LByatt@nmcca.org

Principal Investigator:

John F. Kuttesch

The Steven and Alexandra Cohen Children's Medical Center of New York

Recruiting

New Hyde Park, New York, United States, 11040

Contacts

Site Public Contact

718-470-3460

Principal Investigator:

Jonathan D. Fish

University of Rochester

Recruiting

Rochester, New York, United States, 14642

Contacts

Site Public Contact

585-275-5830

Principal Investigator:

Angela R. Girvin

Stony Brook University Medical Center

Recruiting

Stony Brook, New York, United States, 11794

Contacts

Site Public Contact

800-862-2215

Principal Investigator:

Laura E. Hogan

State University of New York Upstate Medical University

Recruiting

Syracuse, New York, United States, 13210

Contacts

Site Public Contact

315-464-5476

Principal Investigator:

Philip M. Monteleone

Mission Hospital

Recruiting

Asheville, North Carolina, United States, 28801

Contacts

Site Public Contact

828-213-2539 Karen.Smith3@HCAHealthcare.com

Principal Investigator:

Douglas J. Scothorn

Wake Forest University Health Sciences

Recruiting

Winston-Salem, North Carolina, United States, 27157

Contacts

Site Public Contact

336-713-6771

Principal Investigator:

Thomas B. Russell

Children's Hospital Medical Center of Akron

Recruiting

Akron, Ohio, United States, 44308

Contacts

Site Public Contact

330-543-3193

Principal Investigator:

Steven J. Kuerbitz

Cincinnati Children's Hospital Medical Center

Recruiting

Cincinnati, Ohio, United States, 45229

Contacts

Site Public Contact

513-636-2799 cancer@cchmc.org

Principal Investigator:

Rajaram Nagarajan

University of Oklahoma Health Sciences Center

Recruiting

Oklahoma City, Oklahoma, United States, 73104

Contacts

Site Public Contact

405-271-8777 ou-clinical-trials@ouhsc.edu

Principal Investigator:

Rene Y. McNall-Knapp

Legacy Emanuel Children's Hospital

Recruiting

Portland, Oregon, United States, 97227

Contacts

Site Public Contact

503-413-2560

Principal Investigator:

Janice F. Olson

Oregon Health and Science University

Recruiting

Portland, Oregon, United States, 97239

Contacts

Site Public Contact

503-494-1080 trials@ohsu.edu

Principal Investigator:

Susan J. Lindemulder

Saint Christopher's Hospital for Children

Recruiting

Philadelphia, Pennsylvania, United States, 19134

Contacts

Site Public Contact

215-427-8991

Principal Investigator:

Gregory E. Halligan

Rhode Island Hospital

Recruiting

Providence, Rhode Island, United States, 02903

Contacts

Site Public Contact

401-444-1488

Principal Investigator:

Jennifer J. Greene Welch

Medical University of South Carolina

Recruiting

Charleston, South Carolina, United States, 29425

Contacts

Site Public Contact

843-792-9321 hcc-clinical-trials@musc.edu

Principal Investigator:

Jacqueline M. Kraveka

BI-LO Charities Children's Cancer Center

Recruiting

Greenville, South Carolina, United States, 29605

Contacts

Site Public Contact

864-522-2066 kim.williams3@prismahealth.org

Principal Investigator:

Nichole L. Bryant

UT Southwestern/Simmons Cancer Center-Dallas

Recruiting

Dallas, Texas, United States, 75390

Contacts

Site Public Contact

214-648-7097 canceranswerline@UTSouthwestern.edu

Principal Investigator:

Daniel C. Bowers

Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Site Public Contact

713-798-1354 burton@bcm.edu

Principal Investigator:

Julienne Brackett

University of Texas Health Science Center at San Antonio

Recruiting

San Antonio, Texas, United States, 78229

Contacts

Site Public Contact

210-450-3800 phoresearchoffice@uthscsa.edu

Principal Investigator:

Anne-Marie R. Langevin

University of Vermont and State Agricultural College

Recruiting

Burlington, Vermont, United States, 05405

Contacts

Site Public Contact

802-656-8990 rpo@uvm.edu

Principal Investigator:

Jessica L. Heath

Virginia Commonwealth University/Massey Cancer Center

Recruiting

Richmond, Virginia, United States, 23298

Contacts

Site Public Contact

804-628-1914 klcampbell@vcu.edu

Principal Investigator:

Madhu S. Gowda

Seattle Children's Hospital

Recruiting

Seattle, Washington, United States, 98105

Contacts

Site Public Contact

866-987-2000

Principal Investigator:

Douglas S. Hawkins

Providence Sacred Heart Medical Center and Children's Hospital

Recruiting

Spokane, Washington, United States, 99204

Contacts

Site Public Contact

800-228-6618 HopeBeginsHere@providence.org

Principal Investigator:

Judy L. Felgenhauer

Children's Hospital of Wisconsin

Recruiting

Milwaukee, Wisconsin, United States, 53226

Contacts

Site Public Contact

414-955-4727 MACCCTO@mcw.edu

Principal Investigator:

Richard L. Tower

Alberta Children's Hospital

Recruiting

Calgary, Alberta, Canada, T3B 6A8

Contacts

Site Public Contact

403-220-6898 research4kids@ucalgary.ca

Principal Investigator:

Douglas R. Strother

The Montreal Children's Hospital of the MUHC

Recruiting

Montreal, Quebec, Canada, H3H 1P3

Contacts

Site Public Contact

514-412-4445 info@thechildren.com

Principal Investigator:

Sharon B. Abish

Centre Hospitalier Universitaire Sainte-Justine

Recruiting

Montreal, Quebec, Canada, H3T 1C5

Contacts

Site Public Contact

514-345-4931

Principal Investigator:

Yvan Samson

Centre Hospitalier Universitaire de Quebec

Recruiting

Québec, Canada, G1V 4G2

Contacts

Site Public Contact

418-525-4444

Principal Investigator:

Bruno Michon

More Information

Sponsor

Children's Oncology Group

Last update posted

May 18, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Children's Oncology Group on 2026-05-18.