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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorChildren's Oncology Group

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

420 Participants
are divided into 1 treatment group

Sponsors and collaborators

Children's Oncology Group

Lead sponsor

National Cancer Institute (NCI)

Collaborator