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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03542097

Acronym

MGMTLiberati

Enrollment

Registered

2018-05-31

Start date

2014-04-15

Completion date

2019-06-30

Last updated

2023-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ewing Sarcoma Family of Tumors

Keywords

Ewing Sarcoma

Brief summary

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

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.

Interventions

OTHERMGMT methylation evaluation

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

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Assessment of MGMT promoter methylation	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

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

Countries

Italy, United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 18, 2026