Protocol Summary

Protocol No.: OCR13168

Sponsor Protocol No.: ALTE11C2

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

Principal Investigator(s)
Slayton, William

Objective
This study looks at 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.

Description
We propose to ascertain echocardiographic and serum biomarkers of cardiac injury and CHF in a cohort of long-term pediatric cancer survivors (>10 years since diagnosis) of 3 pediatric cooperative groups trials (POG 9404, 9425, 9426) that featured upfront dexrazoxane randomization. The primary study end-point will be an echocardiographic index of pathologic left ventricle remodeling (decreased left ventricle thickness-to-dimension ratio) which has been shown to be an important earlier surrogate measure/predictor of subsequent heart failure in both anthracycline-exposed pediatric cancer survivors.

Phase: NA

Age Group: Children

Scope: National

Treatment
Stratum 1 with diagnostic interventions:
- Diagnostic/symptom checklist
- Anthropometry
- Echocardiogram
- Serum biomarkers
- Troponins (cTnT, cTnI)
- Natriuretic peptides (BNP, NT-ProBNP)
- Inflammation (hs-CRP, IL-6 TNF, Galectin-3, ST2, GDF15)
- Fasting glucose lipid profile
- Insulin hemoglobin AIC DNA
- 6 minute walk test
- Participant Questionnaires: Quality of life, family history, physical activity, and smoking
- Fasting for at least 10 hours prior to the study blood draw.

Stratum 2 Relapse and subsequent malignancy status:
- Patients not eligible for Stratum 1 may still contribute data to the Secondary Aims: Relapse and subsequent malignancy status.

Detailed Eligibility
Inclusion criteria:
1. Previously enrolled and randomized on POG 9404, 9425, or 9426
2. Alive and in continuous first complete remission from their original cancer (T-cell leukemia/lymphoma [POG 9404] or Hodgkin lymphoma [POG 9425/9426])
3. 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.
4. All patients and/or their parents or legal guardians must sign a written informed consent (see Stratum 1 sample consent).
5. 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 secondary aim arm only. 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).

Applicable Disease Sites
Pediatric (Childhood) Cancer

Participating Institutions
UF Gainesville : Beate Oltman Greer

Contact
Beate Oltman Greer
Phone: +1 352-294-8744

Email: bgreer01@ufl.edu

More Information:
View study listing on ClinicialTrials.gov
http://www.clinicaltrials.gov/ct2/show/
NCT01790152