RECRUITING

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

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Conditions

Hodgkin Lymphoma in RemissionLeukemia in RemissionLymphoblastic LymphomaOsteosarcomaRecurrent LeukemiaRecurrent LymphomaRecurrent Malignant Neoplasm

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2014-03-05
Study Completion:2025-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT01790152

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:Not specified
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * STRATUM I AND STRATUM II: LEUKEMIA AND LYMPHOMA SURVIVORS
  2. * Previously enrolled leukemia and lymphoma survivors, randomized to + or - DRZ on P9404, P9425, P9426, or DFCI 95-01 (high-risk patients only)
  3. * 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 \[P9425/P9426\])
  4. * STRATUM I: Did not have progressive disease or induction failure requiring off-protocol therapy including hematopoietic cell transplantation
  5. * 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
  6. * STRATUM I: All patients and/or their parents or legal guardians must sign a written informed consent
  7. * 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)
  8. * 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
  9. * STRATUM II: All patients and/or their parents or legal guardians must sign a written informed consent
  10. * STRATUM III: OSTEOSARCOMA SURVIVORS
  11. * 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
  12. * 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:
  13. * Newly diagnosed, previously untreated biopsy-proven moderate or high grade osteosarcoma without metastasis; patients with low grade osteosarcoma, parosteal or periosteal sarcoma are ineligible
  14. * \< 31 years of age at time of initial osteosarcoma diagnosis
  15. * Diagnosis occurred between January 1, 1999 through December 31, 2002; duration of therapy can extend beyond 2002
  16. * 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
  17. * 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
  18. * No anthracycline or anthraquinone aside from doxorubicin was ever given as part of initial or subsequent therapies
  19. * No exposure to DRZ at any point in time
  20. * All patients and/or their parents or legal guardians must sign a written informed consent
  21. * STRATUM IV: CARDIOMYOPATHY CASES, NOT OTHERWISE ELIGIBLE FOR STRATUMS 1, 2, AND 3
  22. * 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
  23. * 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
  24. * 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)
  25. * 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
  26. * 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
  27. * 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
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Principal Investigator

Eric J Chow
PRINCIPAL_INVESTIGATOR
Children's Oncology Group

Study Locations (Sites)

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
Saint 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
Saint 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

Collaborators and Investigators

Sponsor: Children's Oncology Group

  • Eric J Chow, PRINCIPAL_INVESTIGATOR, Children's Oncology Group

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2014-03-05
Study Completion Date2025-12-31

Study Record Updates

Study Start Date2014-03-05
Study Completion Date2025-12-31

Terms related to this study

Additional Relevant MeSH Terms

  • Hodgkin Lymphoma in Remission
  • Leukemia in Remission
  • Lymphoblastic Lymphoma
  • Osteosarcoma
  • Recurrent Leukemia
  • Recurrent Lymphoma
  • Recurrent Malignant Neoplasm