Assessment of MGMT Promoter Methylation in Advanced Ewing Sarcoma Treated With Temozolomide and Irinotecan

Study Overview
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Brief Summary
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This is a biological study in patients with advanced Ewing Sarcoma who received, according, clinical practice, temozolomide and irinotecan The O6-methylguanine-DNA methyltransferase (MGMT) methylation status, will be correlated with the disease clinical data and with the disease response

Detailed Description
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This is a biological study in patients with advanced Ewing Sarcoma who received, according, clinical practice, temozolomide and irinotecan. The MGMT methylation status will be correlated with the disease clinical data and with the disease response also in term of metabolic activity (if data will be available) The MGMT methylation analysis will be performed extracting from fresh tumor sample, the DNA on the basis of the standard protocols.

Official Title
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Assessment of MGMT Promoter Methylation and Clinical Benefit From Temozolomide-based Therapy in Ewing Sarcoma Patients

Conditions
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Ewing Sarcoma Family of Tumors

Intervention / Treatment
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* Other: MGMT methylation evaluation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histological confirmed diagnosis of Ewing Sarcoma Chemotherapic treatment with temozolomide and irinotecan Written informed consent prior to any study related activities Exclusion Criteria: Lack of written informed consent for the study Any situation that could interfere with the complete data collection of the clinical data related to the temozolomide and irinotecan treatment
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Temozolomide and Irinotecan treatment<br>The group include all the patients with histological confirmed diagnosis of Ewing's Sarcoma who received chemotherapic treatment with temozolomide and irinotecan. In this group the MGMT methylation evaluation will be done | Other: MGMT methylation evaluation<br>* The MGMT methylation will be evaluated by extracting DNA from fresh and Formalin Fixed paraffin Embedded (FFPE) tumor samples<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of MGMT promoter methylation | Amplification the methylation-specific Polymerase Chain Reaction products will be electrophoresed on a 2% agarose gel and will visualized with UV light | at day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation of the MGMT promoter methylation to the activity of the temozolomide irinotecan combination | Correlation with level of MGMT methylation with tumor response | at month 2, 4, 6, 8, 10 and 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ewing Sarcoma