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A Groupwide Biology and Banking Study for Ewing Sarcoma


N/A
N/A
50 Years
Not Enrolling
Both
Localized Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor, Metastatic Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor, Recurrent Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor

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Trial Information

A Groupwide Biology and Banking Study for Ewing Sarcoma


PRIMARY OBJECTIVES:

I. To develop a mechanism to collect and distribute tumor specimens to various
investigators, and a system to prioritize and develop quality-control measures for central
data reporting of studies undertaken.

II. To determine the prognostic significance of translocation subtype in Ewing sarcoma; to
determine the prognostic significance of translocation negative Ewing sarcoma.

III. To determine the prognostic significance of MRD detection in bone marrow specimens by
RT-PCR determination of EWS-ETS fusion genes.

IV. To determine whether serum levels of IGF1, IGFBP3 are of significance in the outcome of
patients with Ewing sarcoma.

V. To determine whether RNA expression profiles performed on diagnostic specimens will allow
for the identification of newer prognostic categories and potentially new molecular targets
for treatment in Ewing sarcoma.

VI. To identify new treatment targets for therapy. Further testing of these potential
targets will be carried out in hopes of expediting translation of these findings to the
clinic.

VII. To establish a bank of Ewing sarcoma xenografts in SCID/Beige mice. VIII. To establish
clinical proteomics as a resource for investigations of altered signaling molecules in the
pathogenesis of Ewing sarcoma.

OUTLINE: This is a multicenter study.

Patients undergo various specimen collections, including bone marrow aspirate,
paraffin-embedded blocks of tumor tissue or slides of tumor tissue, and blood specimens.
These specimens are collected before, during, and after any chemotherapy regimens, during
follow-up, and at time of recurrence. Translocation studies are performed on specimens to
identify fusion genes, specifically EWS-ETS. Serum IGF1 and IFGBP3 levels are determined.
Bone marrow is assessed for minimal residual disease using reverse-transcriptase polymerase
chain reaction.


Inclusion Criteria:



- Newly diagnosed or recurrent Ewing's sarcoma

- Availability of the following specimens:

- Paraffin-embedded block or 20 unstained slides and 1-3 thick (50 micron)
sections from initial biopsy

- Pretreatment serum and whole blood

- Concurrent therapy is not required

Type of Study:

Observational

Study Design:

Time Perspective: Prospective

Outcome Measure:

Event-free survival

Outcome Description:

Univariate analysis using the proportional-hazards regression model will be used to formally assess the prognostic significance of each biological characteristic as it relates to risk for adverse event. Methods such as recursive partitioning adapted to survival analysis will be used to explore possible interactions between the presence of various markers and risk for adverse event.

Outcome Time Frame:

1 year

Safety Issue:

No

Principal Investigator

Daniel West

Investigator Role:

Principal Investigator

Investigator Affiliation:

Children's Oncology Group

Authority:

United States: Institutional Review Board

Study ID:

AEWS02B1

NCT ID:

NCT00048984

Start Date:

January 2003

Completion Date:

Related Keywords:

  • Localized Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor
  • Metastatic Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor
  • Recurrent Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor
  • Neuroectodermal Tumors
  • Neuroectodermal Tumors, Primitive
  • Sarcoma, Ewing's
  • Neuroectodermal Tumors, Primitive, Peripheral
  • Sarcoma

Name

Location

Children's Oncology GroupArcadia, California  91006-3776