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

Sponsored by Children's Oncology Group

About this 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.

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). SE…

Where this study is enrolling (56)

  • Children's Hospital of Alabama

    Birmingham, Alabama

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  • Phoenix Childrens Hospital

    Phoenix, Arizona

    Call 602-933-1000

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  • Banner University Medical Center - Tucson

    Tucson, Arizona

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  • Arkansas Children's Hospital

    Little Rock, Arkansas

    Call 501-364-7373

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  • City of Hope Comprehensive Cancer Center

    Duarte, California

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Show all 56 locations

  • Rady Children's Hospital - San Diego

    San Diego, California

    Call 858-966-5934

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  • Lucile Packard Children's Hospital Stanford University

    Palo Alto, California

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  • Kaiser Permanente-Oakland

    Oakland, California

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  • Yale University

    New Haven, Connecticut

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

    Tampa, Florida

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  • Golisano Children's Hospital of Southwest Florida

    Fort Myers, Florida

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  • Saint Mary's Hospital

    West Palm Beach, Florida

    Call 561-881-2815

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  • Nemours Children's Clinic-Jacksonville

    Jacksonville, Florida

    Call 904-697-3529

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  • Nemours Children's Hospital

    Orlando, Florida

    Call 407-650-7150

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  • Children's Healthcare of Atlanta - Egleston

    Atlanta, Georgia

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  • Kapiolani Medical Center for Women and Children

    Honolulu, Hawaii

    Call 808-983-6090

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  • Saint Jude Midwest Affiliate

    Peoria, Illinois

    Call 888-226-4343

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  • Lurie Children's Hospital-Chicago

    Chicago, Illinois

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  • Advocate Children's Hospital-Oak Lawn

    Oak Lawn, Illinois

    Call 847-723-7570

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  • Ochsner Medical Center Jefferson

    New Orleans, Louisiana

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  • Maine Children's Cancer Program

    Scarborough, Maine

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  • Sinai Hospital of Baltimore

    Baltimore, Maryland

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  • Johns Hopkins University/Sidney Kimmel Cancer Center

    Baltimore, Maryland

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  • Dana-Farber Cancer Institute

    Boston, Massachusetts

    Call 877-442-3324

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  • Ascension Saint John Hospital

    Detroit, Michigan

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  • University of Mississippi Medical Center

    Jackson, Mississippi

    Call 601-815-6700

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  • Washington University School of Medicine

    St Louis, Missouri

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  • University Medical Center of Southern Nevada

    Las Vegas, Nevada

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  • Alliance for Childhood Diseases/Cure 4 the Kids Foundation

    Las Vegas, Nevada

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  • Summerlin Hospital Medical Center

    Las Vegas, Nevada

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  • Sunrise Hospital and Medical Center

    Las Vegas, Nevada

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  • Hackensack University Medical Center

    Hackensack, New Jersey

    Call 201-996-2879

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  • University of New Mexico Cancer Center

    Albuquerque, New Mexico

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  • State University of New York Upstate Medical University

    Syracuse, New York

    Call 315-464-5476

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  • Stony Brook University Medical Center

    Stony Brook, New York

    Call 800-862-2215

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

    New Hyde Park, New York

    Call 718-470-3460

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  • University of Rochester

    Rochester, New York

    Call 585-275-5830

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  • Mission Hospital

    Asheville, North Carolina

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  • Wake Forest University Health Sciences

    Winston-Salem, North Carolina

    Call 336-713-6771

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  • Children's Hospital Medical Center of Akron

    Akron, Ohio

    Call 330-543-3193

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  • Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohio

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  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma

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  • Legacy Emanuel Children's Hospital

    Portland, Oregon

    Call 503-413-2560

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  • Oregon Health and Science University

    Portland, Oregon

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  • Saint Christopher's Hospital for Children

    Philadelphia, Pennsylvania

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  • Rhode Island Hospital

    Providence, Rhode Island

    Call 401-444-1488

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  • BI-LO Charities Children's Cancer Center

    Greenville, South Carolina

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  • Medical University of South Carolina

    Charleston, South Carolina

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  • University of Texas Health Science Center at San Antonio

    San Antonio, Texas

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  • Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center

    Houston, Texas

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  • UT Southwestern/Simmons Cancer Center-Dallas

    Dallas, Texas

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  • University of Vermont and State Agricultural College

    Burlington, Vermont

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  • Virginia Commonwealth University/Massey Cancer Center

    Richmond, Virginia

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  • Seattle Children's Hospital

    Seattle, Washington

    Call 866-987-2000

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  • Providence Sacred Heart Medical Center and Children's Hospital

    Spokane, Washington

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  • Children's Hospital of Wisconsin

    Milwaukee, Wisconsin

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Who can participate

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

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Trial data sourced from ClinicalTrials.gov.