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NCT01790152Recruiting

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

Children's Oncology Group

Start Date

3/5/2014

Completion Date

12/31/2026

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.

Detailed Description

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.

Eligibility Criteria

Age Range: No minimum to No maximum

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

Interventions

OTHER

Assessment of Therapy Complications

OTHER

Laboratory Biomarker Analysis

OTHER

Quality-of-Life Assessment

OTHER

Questionnaire Administration

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Conditions

Hodgkin Lymphoma in RemissionLeukemia in RemissionLymphoblastic LymphomaOsteosarcomaRecurrent LeukemiaRecurrent LymphomaRecurrent Malignant Neoplasm

Locations

Children's Hospital of Alabama

Birmingham, Alabama 35233

United States

Phoenix Childrens Hospital

Phoenix, Arizona 85016

United States

Banner University Medical Center - Tucson

Tucson, Arizona 85719

United States

Arkansas Children's Hospital

Little Rock, Arkansas 72202-3591

United States

City of Hope Comprehensive Cancer Center

Duarte, California 91010

United States

Valley Children's Hospital

Madera, California 93636

United States

Kaiser Permanente-Oakland

Oakland, California 94611

United States

Lucile Packard Children's Hospital Stanford University

Palo Alto, California 94304

United States

Rady Children's Hospital - San Diego

San Diego, California 92123

United States

Yale University

New Haven, Connecticut 06520

United States

Golisano Children's Hospital of Southwest Florida

Fort Myers, Florida 33908

United States

University of Florida Health Science Center - Gainesville

Gainesville, Florida 32610

United States

Memorial Regional Hospital/Joe DiMaggio Children's Hospital

Hollywood, Florida 33021

United States

Nemours Children's Clinic-Jacksonville

Jacksonville, Florida 32207

United States

Nemours Children's Hospital

Orlando, Florida 32827

United States

Johns Hopkins All Children's Hospital

St. Petersburg, Florida 33701

United States

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

Tampa, Florida 33607

United States

Saint Mary's Hospital

West Palm Beach, Florida 33407

United States

Children's Healthcare of Atlanta - Egleston

Atlanta, Georgia 30322

United States

University of Hawaii Cancer Center

Honolulu, Hawaii 96813

United States

Kapiolani Medical Center for Women and Children

Honolulu, Hawaii 96826

United States

Lurie Children's Hospital-Chicago

Chicago, Illinois 60611

United States

University of Illinois

Chicago, Illinois 60612

United States

Advocate Children's Hospital-Oak Lawn

Oak Lawn, Illinois 60453

United States

Saint Jude Midwest Affiliate

Peoria, Illinois 61637

United States

Ochsner Medical Center Jefferson

New Orleans, Louisiana 70121

United States

Maine Children's Cancer Program

Scarborough, Maine 04074

United States

Sinai Hospital of Baltimore

Baltimore, Maryland 21215

United States

Johns Hopkins University/Sidney Kimmel Cancer Center

Baltimore, Maryland 21287

United States

Dana-Farber Cancer Institute

Boston, Massachusetts 02215

United States

Wayne State University/Karmanos Cancer Institute

Detroit, Michigan 48201

United States

Ascension Saint John Hospital

Detroit, Michigan 48236

United States

Hurley Medical Center

Flint, Michigan 48503

United States

University of Mississippi Medical Center

Jackson, Mississippi 39216

United States

Columbia Regional

Columbia, Missouri 65201

United States

Washington University School of Medicine

St Louis, Missouri 63110

United States

University Medical Center of Southern Nevada

Las Vegas, Nevada 89102

United States

Sunrise Hospital and Medical Center

Las Vegas, Nevada 89109

United States

Alliance for Childhood Diseases/Cure 4 the Kids Foundation

Las Vegas, Nevada 89135

United States

Summerlin Hospital Medical Center

Las Vegas, Nevada 89144

United States

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire 03756

United States

Hackensack University Medical Center

Hackensack, New Jersey 07601

United States

University of New Mexico Cancer Center

Albuquerque, New Mexico 87102

United States

Roswell Park Cancer Institute

Buffalo, New York 14263

United States

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

New Hyde Park, New York 11040

United States

University of Rochester

Rochester, New York 14642

United States

Stony Brook University Medical Center

Stony Brook, New York 11794

United States

State University of New York Upstate Medical University

Syracuse, New York 13210

United States

Mission Hospital

Asheville, North Carolina 28801

United States

Wake Forest University Health Sciences

Winston-Salem, North Carolina 27157

United States

Children's Hospital Medical Center of Akron

Akron, Ohio 44308

United States

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio 45229

United States

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma 73104

United States

Legacy Emanuel Children's Hospital

Portland, Oregon 97227

United States

Oregon Health and Science University

Portland, Oregon 97239

United States

Saint Christopher's Hospital for Children

Philadelphia, Pennsylvania 19134

United States

Rhode Island Hospital

Providence, Rhode Island 02903

United States

Medical University of South Carolina

Charleston, South Carolina 29425

United States

BI-LO Charities Children's Cancer Center

Greenville, South Carolina 29605

United States

Medical City Dallas Hospital

Dallas, Texas 75230

United States

UT Southwestern/Simmons Cancer Center-Dallas

Dallas, Texas 75390

United States

Cook Children's Medical Center

Fort Worth, Texas 76104

United States

Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center

Houston, Texas 77030

United States

University of Texas Health Science Center at San Antonio

San Antonio, Texas 78229

United States

University of Vermont and State Agricultural College

Burlington, Vermont 05405

United States

Virginia Commonwealth University/Massey Cancer Center

Richmond, Virginia 23298

United States

Seattle Children's Hospital

Seattle, Washington 98105

United States

Providence Sacred Heart Medical Center and Children's Hospital

Spokane, Washington 99204

United States

Children's Hospital of Wisconsin

Milwaukee, Wisconsin 53226

United States

Princess Margaret Hospital for Children

Perth, Western Australia 6008

Australia

Perth Children's Hospital

Perth, Western Australia 6009

Australia

Alberta Children's Hospital

Calgary, Alberta T3B 6A8

Canada

McMaster Children's Hospital at Hamilton Health Sciences

Hamilton, Ontario L8N 3Z5

Canada

Children's Hospital of Eastern Ontario

Ottawa, Ontario K1H 8L1

Canada

Hospital for Sick Children

Toronto, Ontario M5G 1X8

Canada

The Montreal Children's Hospital of the MUHC

Montreal, Quebec H3H 1P3

Canada

Centre Hospitalier Universitaire Sainte-Justine

Montreal, Quebec H3T 1C5

Canada

Centre Hospitalier Universitaire de Quebec

Québec, G1V 4G2

Canada

San Jorge Children's Hospital

San Juan, 00912

Puerto Rico