About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Assessment of Therapy Complications
- Laboratory Biomarker Analysis
- Quality-of-Life Assessment
- Questionnaire Administration
Treatment groups
Sponsors and collaborators
Children's Oncology Group
Lead sponsor
National Cancer Institute (NCI)
Collaborator