Diagnostic Study of Tumor Characteristics in Patients With Ewing's Sarcoma

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Children's Oncology Group
ClinicalTrials.gov Identifier:
NCT00048984
First received: November 12, 2002
Last updated: April 30, 2013
Last verified: April 2013
  Purpose

RATIONALE: Genetic testing may help predict how cancer will respond to treatment and allow doctors to plan more effective therapy.

PURPOSE: Diagnostic trial to study genetic differences in patients who have Ewing's sarcoma.


Condition Intervention
Sarcoma
Other: laboratory biomarker analysis

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: A Groupwide Biology and Banking Study for Ewing Sarcoma

Resource links provided by NLM:


Further study details as provided by Children's Oncology Group:

Primary Outcome Measures:
  • Event Free Survival [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Success rate in which biomarker analyses can be carried out [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
  • Percent of the population on which biomarker analysis could be successfully conducted [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
    Determined by the number of patients on whom a definitive analytic result could be obtained, divided by the total number of patients enrolled after the test became part of the routine battery used by the investigators.

  • Percent of submissions on which biomarker analysis could be successfully conducted [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
    Determined by the number of patients on whom a definitive analytic result could be obtained, divided by the total number of patients for whom a specimen was submitted for the relevant assay.

  • Relation to known prognostic factors including the presence or absence of metastatic disease, the site of disease, and other known risk factors [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
    The prevalence of these risk factors will be determined for the evaluable and nonevaluable samples to ensure the comparability of these two groups.


Enrollment: 637
Study Start Date: January 2003
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Basic science (biomarker analysis)
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. laboratory biomarker analysis
Other: laboratory biomarker analysis
Correlative studies
Other Names:
  • Marker Name
  • BAX
  • BCL2
  • CASP8
  • IGF1var
  • IGFBP3
  • MRD

Detailed Description:

OBJECTIVES:

  • Determine the prognostic significance of chromosomal translocation subtype in patients with Ewing's sarcoma.
  • Determine the prognostic significance of minimal residual disease detection in bone marrow of these patients, using reverse transcriptase-polymerase chain reaction determination of EWS-ETS fusion genes.
  • Determine whether serum levels of IGF1 and IGFBP3 are of significance to outcome of these patients.
  • Establish clinical proteomics for investigating altered signaling molecules in the pathogenesis of Ewing's 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.

PROJECTED ACCRUAL: A total of 470 patients will be accrued for this study within 4 years.

  Eligibility

Ages Eligible for Study:   up to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

Age

  • 50 and under

Performance status

  • Not specified

Life expectancy

  • Not specified

Hematopoietic

  • Not specified

Hepatic

  • Not specified

Renal

  • Not specified

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • Not specified

Endocrine therapy

  • Not specified

Radiotherapy

  • Not specified

Surgery

  • Not specified
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00048984

  Show 163 Study Locations
Sponsors and Collaborators
Children's Oncology Group
Investigators
Study Chair: Daniel C. West, MD University of California, Davis
  More Information

Additional Information:
No publications provided

Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT00048984     History of Changes
Obsolete Identifiers: NCT00063271, NCT00228774
Other Study ID Numbers: AEWS02B1, NCI-03-C-0216, CDR0000257115, COG-AEWS02B1
Study First Received: November 12, 2002
Last Updated: April 30, 2013
Health Authority: United States: Federal Government

Keywords provided by Children's Oncology Group:
localized Ewing sarcoma/peripheral primitive neuroectodermal tumor
metastatic Ewing sarcoma/peripheral primitive neuroectodermal tumor
recurrent Ewing sarcoma/peripheral primitive neuroectodermal tumor

Additional relevant MeSH terms:
Neuroectodermal Tumors, Primitive
Sarcoma, Ewing's
Neuroectodermal Tumors, Primitive, Peripheral
Sarcoma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Osteosarcoma
Neoplasms, Bone Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue

ClinicalTrials.gov processed this record on June 17, 2013