Effects of Dexrazoxane Hydrochloride on Biomarkers Associated With Cardiomyopathy and Heart Failure After Cancer Treatment
Recruiting · NCT01790152 · Observational (researchers observe without assigning treatment) · Lead sponsor: Children's Oncology Group
View the official record on ClinicalTrials.gov →Interventions studied
Assessment of Therapy ComplicationsLaboratory Biomarker AnalysisQuality-of-Life AssessmentQuestionnaire Administration
What this trial is about
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.
Who can take part
Age range
No age limits stated
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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
Where it is running
60 locations listed across 33 US states.
- Children's Hospital of Alabama - Birmingham, Alabama, United States
- Phoenix Childrens Hospital - Phoenix, Arizona, United States
- Banner University Medical Center - Tucson - Tucson, Arizona, United States
- Arkansas Children's Hospital - Little Rock, Arkansas, United States
- City of Hope Comprehensive Cancer Center - Duarte, California, United States
- Valley Children's Hospital - Madera, California, United States
- Kaiser Permanente-Oakland - Oakland, California, United States
- Lucile Packard Children's Hospital Stanford University - Palo Alto, California, United States
- Rady Children's Hospital - San Diego - San Diego, California, United States
- Yale University - New Haven, Connecticut, United States
- Golisano Children's Hospital of Southwest Florida - Fort Myers, Florida, United States
- University of Florida Health Science Center - Gainesville - Gainesville, Florida, United States
- Memorial Regional Hospital/Joe DiMaggio Children's Hospital - Hollywood, Florida, United States
- Nemours Children's Clinic-Jacksonville - Jacksonville, Florida, United States
- Nemours Children's Hospital - Orlando, Florida, United States
- Johns Hopkins All Children's Hospital - St. Petersburg, Florida, United States
- Saint Joseph's Hospital/Children's Hospital-Tampa - Tampa, Florida, United States
- Saint Mary's Hospital - West Palm Beach, Florida, United States
- Children's Healthcare of Atlanta - Egleston - Atlanta, Georgia, United States
- University of Hawaii Cancer Center - Honolulu, Hawaii, United States
- Kapiolani Medical Center for Women and Children - Honolulu, Hawaii, United States
- Lurie Children's Hospital-Chicago - Chicago, Illinois, United States
- University of Illinois - Chicago, Illinois, United States
- Advocate Children's Hospital-Oak Lawn - Oak Lawn, Illinois, United States
- Saint Jude Midwest Affiliate - Peoria, Illinois, United States
- Ochsner Medical Center Jefferson - New Orleans, Louisiana, United States
- Maine Children's Cancer Program - Scarborough, Maine, United States
- Sinai Hospital of Baltimore - Baltimore, Maryland, United States
- Johns Hopkins University/Sidney Kimmel Cancer Center - Baltimore, Maryland, United States
- Dana-Farber Cancer Institute - Boston, Massachusetts, United States
- Wayne State University/Karmanos Cancer Institute - Detroit, Michigan, United States
- Ascension Saint John Hospital - Detroit, Michigan, United States
- Hurley Medical Center - Flint, Michigan, United States
- University of Mississippi Medical Center - Jackson, Mississippi, United States
- Columbia Regional - Columbia, Missouri, United States
- Washington University School of Medicine - St Louis, Missouri, United States
- University Medical Center of Southern Nevada - Las Vegas, Nevada, United States
- Sunrise Hospital and Medical Center - Las Vegas, Nevada, United States
- Alliance for Childhood Diseases/Cure 4 the Kids Foundation - Las Vegas, Nevada, United States
- Summerlin Hospital Medical Center - Las Vegas, Nevada, United States
- Dartmouth Hitchcock Medical Center - Lebanon, New Hampshire, United States
- Hackensack University Medical Center - Hackensack, New Jersey, United States
- University of New Mexico Cancer Center - Albuquerque, New Mexico, United States
- Roswell Park Cancer Institute - Buffalo, New York, United States
- The Steven and Alexandra Cohen Children's Medical Center of New York - New Hyde Park, New York, United States
- University of Rochester - Rochester, New York, United States
- Stony Brook University Medical Center - Stony Brook, New York, United States
- State University of New York Upstate Medical University - Syracuse, New York, United States
- Mission Hospital - Asheville, North Carolina, United States
- Wake Forest University Health Sciences - Winston-Salem, North Carolina, United States
- Children's Hospital Medical Center of Akron - Akron, Ohio, United States
- Cincinnati Children's Hospital Medical Center - Cincinnati, Ohio, United States
- University of Oklahoma Health Sciences Center - Oklahoma City, Oklahoma, United States
- Legacy Emanuel Children's Hospital - Portland, Oregon, United States
- Oregon Health and Science University - Portland, Oregon, United States
- Saint Christopher's Hospital for Children - Philadelphia, Pennsylvania, United States
- Rhode Island Hospital - Providence, Rhode Island, United States
- Medical University of South Carolina - Charleston, South Carolina, United States
- BI-LO Charities Children's Cancer Center - Greenville, South Carolina, United States
- Medical City Dallas Hospital - Dallas, Texas, United States
Showing 60 of 79 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →