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Markers of Anthracycline-Related Cardiac Muscle Injury


N/A
N/A
21 Years
Not Enrolling
Both
Osteosarcoma, Ewing's Sarcoma Family of Tumors, Rhabdomyosarcoma, Non-rhabdomyosarcoma Soft Tissue Sarcomas

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Trial Information

Markers of Anthracycline-Related Cardiac Muscle Injury


The primary aim of this proposal is to serially evaluate imaging tests in previously
untreated patients with osteosarcoma, Ewing's Sarcoma Family of Tumors(ESFT),
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.

The secondary aim of the study is to estimate the proportion of patients with decreased
(evaluation j - evaluation j+1) peak longitudinal systolic strain (ε) or strain rate (SR),
peak radial systolic ε or SR, peak radial systolic myocardial velocity or peak longitudinal
systolic myocardial velocity among those who have a shortening fraction (SF) ≥ 29% prior to
each infusion of anthracycline. This study will evaluate whether the serum levels of cTn-T
and/or NT-BNP will increase following doxorubicin administration. The study will evaluate
whether the serum levels of cTn-T and/or NT-BNP will increase with increasing cumulative
doxorubicin dose.


Inclusion Criteria:



- 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

Exclusion Criteria:

- 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

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

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

Outcome Description:

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.

Outcome Time Frame:

3 years

Safety Issue:

Yes

Principal Investigator

Daniel Green, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

St. Jude Children's Research Hospital

Authority:

United States: Institutional Review Board

Study ID:

MARCI

NCT ID:

NCT01112800

Start Date:

May 2010

Completion Date:

January 2013

Related Keywords:

  • Osteosarcoma
  • Ewing's Sarcoma Family of Tumors
  • Rhabdomyosarcoma
  • Non-rhabdomyosarcoma Soft Tissue Sarcomas
  • Anthracycline
  • Cardiac Muscle Injury
  • Doxorubicin
  • Doppler Imaging
  • Intermediate non-rhabdomyosarcoma soft tissue sarcomas
  • High-risk non-rhabdomyosarcoma soft tissue sarcomas
  • Osteosarcoma
  • Rhabdomyosarcoma
  • Sarcoma, Ewing's
  • Neuroectodermal Tumors, Primitive, Peripheral
  • Sarcoma

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