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出境医 / 临床实验 / Assessment of MGMT Promoter Methylation in Advanced Ewing Sarcoma Treated With Temozolomide and Irinotecan (MGMTLiberati)

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

Study Description
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.

Study Design
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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
Arms and Interventions
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
Outcome Measures
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

Eligibility Criteria
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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
Contacts and Locations

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
Tracking Information
First Submitted Date May 17, 2018
First Posted Date May 31, 2018
Last Update Posted Date May 31, 2018
Actual Study Start Date April 15, 2014
Estimated Primary Completion Date December 31, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 30, 2018) 		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
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: May 30, 2018) 		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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Assessment of MGMT Promoter Methylation in Advanced Ewing Sarcoma Treated With Temozolomide and Irinotecan
Official Title Assessment of MGMT Promoter Methylation and Clinical Benefit From Temozolomide-based Therapy in Ewing Sarcoma Patients
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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Fresh and Formaline Fixed Paraffin Embeded tumor samples
Sampling Method Probability Sample
Study Population Patient with advanced Ewing Sarcoma treated in clinic
Condition Ewing Sarcoma Family of Tumors
Intervention Other: MGMT methylation evaluation
The MGMT methylation will be evaluated by extracting DNA from fresh and Formalin Fixed paraffin Embedded (FFPE) tumor samples
Study Groups/Cohorts 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
Intervention: Other: MGMT methylation evaluation
Publications *
  • 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. Review.
  • 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.
  • 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.
  • 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: May 30, 2018) 		82
Original Estimated Enrollment Same as current
Estimated Study Completion Date June 30, 2019
Estimated Primary Completion Date December 31, 2018   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Italy,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number NCT03542097
Other Study ID Numbers TEMIRI-EW
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Plan Description: No Plan
Responsible Party Istituto Ortopedico Rizzoli
Study Sponsor Istituto Ortopedico Rizzoli
Collaborators Regione Emilia Romagna - Italy within PRU-Liberati project
Investigators
Principal Investigator: Emanuela Palmerini, MD Rizzoli Orthopedic Institute
PRS Account Istituto Ortopedico Rizzoli
Verification Date May 2018

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