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

N/ACompletedNCT03542097

Istituto Ortopedico Rizzoli82 enrolled

Overview

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

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Ewing Sarcoma Family of Tumors

Interventions

MGMT methylation evaluationOTHER

The MGMT methylation will be evaluated by extracting DNA from fresh and Formalin Fixed paraffin Embedded (FFPE) tumor samples

Eligibility

Sex: ALL

Medical Language ↔ Plain English

Inclusion Criteria: 1. Histological confirmed diagnosis of Ewing Sarcoma 2. Chemotherapic treatment with temozolomide and irinotecan 3. Written informed consent prior to any study related activities Exclusion Criteria: 1. Lack of written informed consent for the study 2. Any situation that could interfere with the complete data collection of the clinical data related to the temozolomide and irinotecan treatment

Locations (5)

Fondazione IRCCS - Istituto Nazionale dei Tumori

Milan, Mi, Italy

Istituto di Candiolo - Fondazione del Piemonte per l'Oncologia - IRCCS

Candiolo, Turin, Italy

Orthopedic Rizzoli Institute

Bologna, Italy

Ospedale infantile Regina Margherita

Turin, Italy

Outcomes

Primary Outcomes

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

Time frame: at day 1

Secondary Outcomes

Correlation of the MGMT promoter methylation to the activity of the temozolomide irinotecan combination

Correlation with level of MGMT methylation with tumor response

Time frame: at month 2, 4, 6, 8, 10 and 12

Data from ClinicalTrials.gov

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