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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03542097
Recruitment Status : Unknown
Verified May 2018 by Istituto Ortopedico Rizzoli.
Recruitment status was:  Recruiting
First Posted : May 31, 2018
Last Update Posted : May 31, 2018
Sponsor:
Collaborator:
Regione Emilia Romagna - Italy within PRU-Liberati project
Information provided by (Responsible Party):
Istituto Ortopedico Rizzoli

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

Condition or disease Intervention/treatment
Ewing Sarcoma Family of Tumors Other: MGMT methylation evaluation

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.

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Study Type : Observational
Estimated Enrollment : 82 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Assessment of MGMT Promoter Methylation and Clinical Benefit From Temozolomide-based Therapy in Ewing Sarcoma Patients
Actual Study Start Date : April 15, 2014
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : June 30, 2019


Group/Cohort Intervention/treatment
Temozolomide and Irinotecan treatment
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
The MGMT methylation will be evaluated by extracting DNA from fresh and Formalin Fixed paraffin Embedded (FFPE) tumor samples




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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


Biospecimen Retention:   Samples With DNA
Fresh and Formaline Fixed Paraffin Embeded tumor samples


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patient with advanced Ewing Sarcoma treated in clinic
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03542097


Contacts
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Contact: Emanuela Palmerini, MD 00390513666 ext 199 emanuela.palmerini@ior.it

Locations
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Italy
Fondazione IRCCS - Istituto Nazionale dei Tumori Completed
Milan, Mi, Italy, 20133
Istituto di Candiolo - Fondazione del Piemonte per l'Oncologia - IRCCS Completed
Candiolo, Turin, Italy, 10060
Orthopedic Rizzoli Institute Recruiting
Bologna, Italy, 40136
Contact: Emanuela Palmerini, MD    00390516366 ext 199    emanuela.palmerini@ior.it   
Principal Investigator: Emanuela Palmerini, MD         
Ospedale infantile Regina Margherita Completed
Turin, Italy, 10126
United Kingdom
The Royal Marsden NHS Foundation Trust Not yet recruiting
London, United Kingdom, SW3 6JJ
Contact: Robin Jones, MD    00442078082200 ext 2590    robin.jones4@nhs.net   
Principal Investigator: Robin Jones, MD         
Sponsors and Collaborators
Istituto Ortopedico Rizzoli
Regione Emilia Romagna - Italy within PRU-Liberati project
Investigators
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Principal Investigator: Emanuela Palmerini, MD Rizzoli Orthopedic Institute
  Study Documents (Full-Text)

Documents provided by Istituto Ortopedico Rizzoli:
Study Protocol  [PDF] January 7, 2014

Publications:
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Responsible Party: Istituto Ortopedico Rizzoli
ClinicalTrials.gov Identifier: NCT03542097    
Other Study ID Numbers: TEMIRI-EW
First Posted: May 31, 2018    Key Record Dates
Last Update Posted: May 31, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No Plan

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Istituto Ortopedico Rizzoli:
Ewing Sarcoma
Additional relevant MeSH terms:
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Sarcoma
Sarcoma, Ewing
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Osteosarcoma
Neoplasms, Bone Tissue
Neoplasms, Connective Tissue