ALTE11C2, Health Effects after Anthracycline and Radiation Therapy (HEART): Dexrazoxane and Prevention of Anthracycline-related Cardiomyopathy

Study ID
STU 092013-038

Cancer Related

Healthy Volunteers

Study Sites

  • Clements University Hospital

Beverly Kleiber

Principal Investigator
Daniel Bowers


This is a cross-sectional study designed to provide long-term information about dexrazoxane's interaction with cancer therapies in children. only patients who participated in PoG 9404, 9425, and 9426 in the past will be eligible for this study.

Participants will be separated into two strata based on their vital and health status as outlined in the protocol.

Stratum 1: Researchers would like to collect the following information:

* List of any heart problems and symptoms;
* Height, weight, waist circumference, blood pressure, and heart rate;
* echocardiogram (uses sound waves to create a picture of the heart);
* Measurement how far participants can walk in 6 minutes;
* Blood draw (1 tablespoon) to look for damage to the heart muscle as well as cholesterol, glucose and hemoglobin aiC
* additional 2 teaspoons of blood that will be banked for future research related to how genes influence the risk of early heart disease. (This additional blood is optional).

Participants will be asked to fill out a questionnaire on their symptoms, quality of life, family history, physical activity, and smoking. This questionnaire should take no more than 45 minutes to complete. We hope this information can be collected during one visit and will not require multiple trips to the clinic. Participants will need to fast for about 10 hours prior to the blood draw.

Stratum 2: Participants will be asked a few questions about their current health status, which will include any information on relapse of their original cancer or a new secondary cancer. We will also ask permission to contact their healthcare provider(s) about information on any relapse of their original cancer or any new secondary cancer if applicable.

Participant Eligibility

Please note that eligibility requirements differ for the Primary Aims and the Secondary Aims such that those recruited for the Primary Aims (Stratum 1) represent a subset of those eligible for the Secondary Aims.
1. Previously enrolled and randomized on POG 9404, 9425, or 9426.

For Stratum 1, in addition to #1, participants must satisfy the following:
a. Alive and in continuous first complete remission from their original cancer (T-cell leukemia/lymphoma [POG 9404] or Hodgkin lymphoma [POG 9425/9426])
b. Not have been diagnosed with any subsequent malignancy, with the exception of non-melanomatous skin cancer(s). Patients with history of only subsequent non-melanomatous skin cancers remain eligible.
c. All patients and/or their parents or legal guardians must sign a Stratum 1 written informed consent.

Among patients who have relapsed or have experienced a subsequent malignancy other than non-melanomatous skin cancer since their original diagnosis, the study committee will review the available data (both from 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 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).

If selected for Stratum 2, in addition to #1, participants must satisfy the following:
a. 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.
b. All patients and/or their parents or legal guardians must sign a Stratum 2 written informed consent.

2. For all participants, all institutional, FDA, and NCI requirements for human studies must be met.

Finally, the coordinating center will create a master list using SDC records and those of local institutions of patients to be approached. Patients who otherwise appear to be eligible for Stratum 1 or 2 not identified on this list cannot be enrolled without prior approval from the study chair.