NIH Clinical Research Studies

Protocol Number: 03-C-0216

Active Accrual, Protocols Recruiting New Patients

Title:
A Groupwide Biology and Banking Study for Ewing Sarcoma: Children's Oncology Group
Number:
03-C-0216
Summary:
Background:

It is clear that improved understanding of the basic biology of Ewing sarcoma will ultimately lead to improved treatment approaches to this disease. With the identification of the invariant EWS-ETS fusion gene in these tumors, the search for new downstream target genes is ongoing with hopes of identifying new molecular treatment targets for drug development. Many important questions remain to be resolved, including the effect of translocation type on prognosis, the effect of submicroscopic molecular-only disease on long-term outcome and the identification of molecular targets and molecular determinants of prognosis.

Objectives:

-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.

-To determine the prognostic significance of translocation subtype in Ewing sarcoma.

-To determine the prognostic significance of MRD detection in bone marrow specimens by RT-PCR

-To determine if serum levels of IGF are of significance in the outcome of patients with Ewing sarcoma.

-To determine if 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.

-To identify new targets for therapy.

-To identify a bank of Ewing sarcoma xenografts in SCID mice.

-To establish clinical proteomics as a resource for investigations of altered signaling molecules in the pathogenesis of Ewing sarcoma.

Eligibility:

-Newly diagnosed or recurrent Ewing sarcoma patients, prior to treatment.

-Specimen requirements consisting of paraffin embedded block or 20 unstained slides and pretreatment blood and tissue specimens.

-For patients who enroll on a Ewing sarcoma therapeutic trial : Agreement to obtain specimens at additional designated time-points during therapy, at the time of surgery, at the completion of therapy and at relapse.

Design:

This study is designed to analyze biological factors of Ewing tumors, and for those patients enrolled on the local and metastatic Ewing sarcoma protocols, to relate the tumor characteristics and treatment outcomes. With this information it will be possible to further refine the aims of the next biology study. This study will also establish a bank for Ewing sarcoma tumors.

Sponsoring Institute:
National Cancer Institute (NCI)
Recruitment Detail
Type: Participants currently recruited/enrolled
Gender: Male & Female
Referral Letter Required: No
Population Exclusion(s): None

Eligibility Criteria:
INCLUSION CRITERIA:

All newly-diagnosed Ewing sarcoma patients are eligible for this study.

Minimum specimen requirements to enroll a patient on AEWS02B1:

a) Parafin-embedded block or, alternatively, at least 10 (20 are preferred) unstained slides and 1-3 thick (50 micron) sections(s) from the initial biopsy.

b) Pretreatment blood consisting of at least 5 mL (14 mL preferred) of serum and at least 5 mL (10 mL preferred) of whole blood in EDTA (purple top tube).

Additional blood and bone specimens will be required from patients enrolled on a Ewing sarcoma therapeutic trial .

Signed informed consent for AEWS02B1 according to institutional guidelines is required.

Special Instructions:
Currently Not Provided
Keywords:
Tissue Banking
Tumor Studies
Recruitment Keyword(s):
Ewing Sarcoma
Condition(s):
Ewing's Sarcoma
Investigational Drug(s):
None
Investigational Device(s):
None
Intervention(s):
None
Supporting Site:
National Cancer Institute

Contact(s):
NCI Referral Office
National Institute of Health Clinical Center (CC), 9000 Rockville Pike, Bethesda, Maryland 20892, United States: NCI Clinical Trials Referral Office
Phone: 1-888-NCI-1937
Fax: Not Listed
Electronic Address: ncicssc@mail.nih.gov

Citation(s):
Patricio MB, Vilhena M, Neves M, Raposo S, Catita J, De Sousa V, Martins AG. Ewing's sarcoma in children: twenty-five years of experience at the Instituto Portuges de Oncologia de Francisco Gentil (I.P.O.F.G.). J Surg Oncol. 1991 May;47(1):37-40.

Kinsella TJ, Miser JS, Waller B, Venzon D, Glatstein E, Weaver-McClure L, Horowitz ME. Long-term follow-up of Ewing's sarcoma of bone treated with combined modality therapy. Int J Radiat Oncol Biol Phys. 1991 Mar;20(3):389-95.

Gasparini M, Lombardi F, Ballerini E, Gandola L, Gianni MC, Massimino M, Rottoli L, Fossati-Bellani F. Long-term outcome of patients with monostotic Ewing's sarcoma treated with combined modality. Med Pediatr Oncol. 1994;23(5):406-12.

Active Accrual, Protocols Recruiting New Patients

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