Markers of Anthracycline-Related Cardiac Muscle Injury

NCT01112800 | Withdrawn

• 1 other identifier: MARCI
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

Anthracycline antibiotics are included in the chemotherapy regimens of approximately 82% of patients with bone cancer and 44% of those with soft tissue sarcoma diagnosed in childhood or adolescence. Impaired cardiac function occurs after treatment with anthracyclines. The frequency of impairment increases with increasing cumulative dose. There are inadequate data regarding the relationship between doxorubicin administration and changes in serum levels of cardiac troponin T (cTn-T) or I (cTn-I), N-terminal (NT) brain natriuretic peptide (BNP), or tissue Doppler imaging parameters. This non-therapeutic study proposes a prospective, single arm study of serial changes in tissue Doppler imaging parameters, cTn-T and NT-BNP in children and adolescents with malignant bone and soft tissue tumors whose planned chemotherapy includes treatment with ≥ 375 mg/m2 of doxorubicin. The proposed study will rigorously evaluate the usefulness of serial determinations of tissue Doppler imaging, cTn-T and NT-BNP for very early identification of anthracycline-related myocardial injury. Demonstration that one or more of these markers identifies subclinical myocardial damage and that biomarker or tissue Doppler imaging parameters exhibit a dose-response relationship with cumulative doxorubicin dose would facilitate intervention trials in patients at risk for anthracycline cardiomyopathy.

Conditions

Osteosarcoma; Ewing's Sarcoma Family of Tumors; Rhabdomyosarcoma; Non-rhabdomyosarcoma Soft Tissue Sarcomas

Keywords

Anthracycline; Cardiac Muscle Injury; Doxorubicin; Doppler Imaging; Intermediate non-rhabdomyosarcoma soft tissue sarcomas; High-risk non-rhabdomyosarcoma soft tissue sarcomas

Outcome Measures

Primary Outcomes (1)

• Imaging measurement of potential cardiac muscle injury markers before and after cumulative anthracycline exposure.

  This study will serially evaluate imaging tests in previously untreated patients with osteosarcoma, Ewing's sarcoma family of tumors, rhabdomyosarcoma and intermediate and high-risk non-rhabdomyosarcoma soft tissue sarcomas whose planned treatment includes a cumulative doxorubicin dose ≥ 375 mg/m2 to determine if serial levels of one or more of these potential markers of cardiac muscle injury obtained prior to each infusion of doxorubicin and at the completion of chemotherapy correlate with increasing cumulative anthracycline exposure.

  3 years

Study Arms (1)

Participants

Previously untreated patients referred to St. Jude Children's Research Hospital (SJCRH) between the ages of 0 and 21 years with a diagnosis of osteosarcoma, ESFT, rhabdomyosarcoma and intermediate and high-risk non-rhabdomyosarcoma soft tissue sarcomas whose planned treatment includes administration of a cumulative anthracycline dose ≥ 375 mg/m2.

Eligibility Criteria

• Age: Up to 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Previously untreated patients referred to St. Jude Children's Research Hospital (SJCRH) between the ages of 0 and 21 years with a diagnosis of osteosarcoma, ESFT, rhabdomyosarcoma and intermediate and high-risk non-rhabdomyosarcoma soft tissue sarcomas whose planned treatment includes administration of a cumulative anthracycline dose ≥ 375 mg/m2.

You may qualify if:

• Between 0 and 21 years of age
• Diagnosis of osteosarcoma, Ewing Sarcoma Family of Tumors, rhabdomyosarcoma, or intermediate or high-risk non-rhabdomyosarcoma soft tissue sarcoma
• Planned treatment includes administration of a cumulative anthracycline dose ≥ 375 mg/m2

You may not qualify if:

• Pregnant Females
• Patients with a history of cancer prior to the current malignancy
• Patients whose treatment will include radiation therapy to a volume that will include the heart

Sponsors & Collaborators

• St. Jude Children's Research Hospital: lead

Related Links

• St. Jude Children's Research Hospital

Biospecimen

Retention: SAMPLES WITHOUT DNA

A blood sample will be collected at baseline, prior to and at the end of each doxorubicin infusion (48- or 72-hour) and following completion of chemotherapy for osteosarcoma, ESFT, rhabdomyosarcoma or intermediate and high-risk non-rhabdomyosarcoma soft tissue sarcomas.cTn-T and NT-BNP will be measured at baseline, prior to and at the end of each doxorubicin infusion (48- or 72-hour) and following completion of chemotherapy for osteosarcoma, ESFT, rhabdomyosarcoma or intermediate and high-risk non-rhabdomyosarcoma soft tissue sarcomas.

MeSH Terms

Conditions

Osteosarcoma; Rhabdomyosarcoma

Condition Hierarchy (Ancestors)

Neoplasms, Bone Tissue; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Sarcoma; Myosarcoma; Neoplasms, Muscle Tissue

Study Officials

• Daniel Green, MD

  St. Jude Children's Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2010
• First Posted: April 28, 2010
• Study Start: May 1, 2010
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: June 19, 2013

Record last verified: 2013-06