Assessment of MGMT Promoter Methylation in Advanced Ewing Sarcoma Treated With Temozolomide and Irinotecan
NCT ID: NCT03542097
Last Updated: 2023-05-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
82 participants
OBSERVATIONAL
2014-04-15
2019-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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
MGMT methylation evaluation
The MGMT methylation will be evaluated by extracting DNA from fresh and Formalin Fixed paraffin Embedded (FFPE) tumor samples
Interventions
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MGMT methylation evaluation
The MGMT methylation will be evaluated by extracting DNA from fresh and Formalin Fixed paraffin Embedded (FFPE) tumor samples
Eligibility Criteria
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Inclusion Criteria
2. Chemotherapic treatment with temozolomide and irinotecan
3. Written informed consent prior to any study related activities
Exclusion Criteria
2. Any situation that could interfere with the complete data collection of the clinical data related to the temozolomide and irinotecan treatment
ALL
No
Sponsors
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Regione Emilia-Romagna
OTHER
Istituto Ortopedico Rizzoli
OTHER
Responsible Party
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Principal Investigators
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Emanuela Palmerini, MD
Role: PRINCIPAL_INVESTIGATOR
Rizzoli Orthopedic Institute
Locations
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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
The Royal Marsden NHS Foundation Trust
London, , United Kingdom
Countries
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References
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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.
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.
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.
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.
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.
Provided Documents
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Document Type: Study Protocol
Other Identifiers
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TEMIRI-EW
Identifier Type: -
Identifier Source: org_study_id
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