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

NCT03542097 | Completed

• 1 other identifier: TEMIRI-EW
• Study Type: observational
• Target: 82
• Locations: 2 countries
• Sites: 5

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

Conditions

Ewing Sarcoma Family of Tumors

Keywords

Ewing Sarcoma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

  at month 2, 4, 6, 8, 10 and 12

Study Arms (1)

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

Interventions

MGMT methylation evaluation OTHER

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

Temozolomide and Irinotecan treatment

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patient with advanced Ewing Sarcoma treated in clinic

You may qualify if:

• Histological confirmed diagnosis of Ewing Sarcoma
• Chemotherapic treatment with temozolomide and irinotecan
• Written informed consent prior to any study related activities

You may not qualify if:

• 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

Sponsors & Collaborators

• Istituto Ortopedico Rizzoli: lead
• Regione Emilia-Romagna: collaborator

Study Sites (5)

Fondazione IRCCS - Istituto Nazionale dei Tumori

Milan, Mi, 20133, Italy

Location

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

Candiolo, Turin, 10060, Italy

Location

Orthopedic Rizzoli Institute

Bologna, 40136, Italy

Location

Ospedale infantile Regina Margherita

Turin, 10126, Italy

Location

The Royal Marsden NHS Foundation Trust

London, SW3 6JJ, United Kingdom

Location

Related Publications (5)

• Kushner BH, Meyers PA. How effective is dose-intensive/myeloablative therapy against Ewing's sarcoma/primitive neuroectodermal tumor metastatic to bone or bone marrow? The Memorial Sloan-Kettering experience and a literature review. J Clin Oncol. 2001 Feb 1;19(3):870-80. doi: 10.1200/JCO.2001.19.3.870.

  PMID: 11157041 BACKGROUND

• Bacci G, Ferrari S, Longhi A, Donati D, De Paolis M, Forni C, Versari M, Setola E, Briccoli A, Barbieri E. Therapy and survival after recurrence of Ewing's tumors: the Rizzoli experience in 195 patients treated with adjuvant and neoadjuvant chemotherapy from 1979 to 1997. Ann Oncol. 2003 Nov;14(11):1654-9. doi: 10.1093/annonc/mdg457.

  PMID: 14581274 BACKGROUND

• Casey DA, Wexler LH, Merchant MS, Chou AJ, Merola PR, Price AP, Meyers PA. Irinotecan and temozolomide for Ewing sarcoma: the Memorial Sloan-Kettering experience. Pediatr Blood Cancer. 2009 Dec;53(6):1029-34. doi: 10.1002/pbc.22206.

  PMID: 19637327 BACKGROUND

• Donson AM, Addo-Yobo SO, Handler MH, Gore L, Foreman NK. MGMT promoter methylation correlates with survival benefit and sensitivity to temozolomide in pediatric glioblastoma. Pediatr Blood Cancer. 2007 Apr;48(4):403-7. doi: 10.1002/pbc.20803.

  PMID: 16609952 BACKGROUND

• Hegi ME, Diserens AC, Gorlia T, Hamou MF, de Tribolet N, Weller M, Kros JM, Hainfellner JA, Mason W, Mariani L, Bromberg JE, Hau P, Mirimanoff RO, Cairncross JG, Janzer RC, Stupp R. MGMT gene silencing and benefit from temozolomide in glioblastoma. N Engl J Med. 2005 Mar 10;352(10):997-1003. doi: 10.1056/NEJMoa043331.

  PMID: 15758010 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Fresh and Formaline Fixed Paraffin Embeded tumor samples

MeSH Terms

Conditions

Neuroectodermal Tumors, Primitive, Peripheral; Sarcoma, Ewing

Condition Hierarchy (Ancestors)

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

Study Officials

• Emanuela Palmerini, MD

  Rizzoli Orthopedic Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2018
• First Posted: May 31, 2018
• Study Start: April 15, 2014
• Primary Completion: December 31, 2018
• Study Completion: June 30, 2019
• Last Updated: May 15, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1); IT (4)