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

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

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Key information

Conditions

Ewing Sarcoma Family of Tumors Neoplasms Neoplasms by Histologic Type Neoplasms, Bone Tissue Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Neuroectodermal Tumors Neuroectodermal Tumors, Primitive Neuroectodermal Tumors, Primitive, Peripheral Osteosarcoma Sarcoma Sarcoma, Ewing

Sex eligibility

All sexes

Study type

Observational

Primary location

Fondazione IRCCS - Istituto Nazionale dei Tumori, Milan, Mi, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MGMT methylation evaluation

Other

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

Primary outcomes

Assessment of MGMT promoter methylation

Time frame: at day 1

Amplification the methylation-specific Polymerase Chain Reaction products will be electrophoresed on a 2% agarose gel and will visualized with UV light

Secondary outcomes

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

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

Correlation with level of MGMT methylation with tumor response

Sponsors and collaborators

Lead sponsor

Istituto Ortopedico Rizzoli

Other

Collaborators

Regione Emilia-Romagna

Registry information

Official study title

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

Acronym: MGMTLiberati

Important dates

Study start: 2014
Primary completion: 2018
Study completion: 2019
First posted: May 31, 2018
Registry last updated: May 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed