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    Summary
    EudraCT Number:2017-000801-19
    Sponsor's Protocol Code Number:MBMET_MEYER2017
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2020-12-09
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2017-000801-19
    A.3Full title of the trial
    An interventional, open-label, Phase II study, to evaluate safety and efficacy of standard and high-dose chemotherapy associated with craniospinal irradiation in patients with metastatic medulloblastoma and other embryonal tumours
    Studio interventistico, in aperto, di Fase II, per valutare la sicurezza e l'efficacia di chemioterapia standard e ad alte dosi associata ad irradiamento craniospinale in pazienti affetti da medulloblastoma metastatico e altri tumori embrionali
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical study to evaluate safety and efficacy of standard and high-dose chemotherapy associated with radiotherapy in pediatric and young adults patients with metastatic medulloblastoma and other embryonal tumours
    Studio clinico per valutare la sicurezza e l'efficacia di chemioterapia standard e ad alte dosi associata a radioterapia in pazienti pediatrici e giovani adulti affetti da medulloblastoma metastatico e altri tumori embrionali
    A.3.2Name or abbreviated title of the trial where available
    MBMET_MEYER2017
    MBMET_MEYER2017
    A.4.1Sponsor's protocol code numberMBMET_MEYER2017
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorAZIENDA OSPEDALIERO-UNIVERSITARIA MEYER
    B.1.3.4CountryItaly
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportProgetto Neuro-Oncologia Fondazione Meyer
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAZIENDA OSPEDALIERO-UNIVERSITARIA MEYER
    B.5.2Functional name of contact pointCLINICAL TRIAL OFFICE
    B.5.3 Address:
    B.5.3.1Street AddressVIALE PIERACCINI 24
    B.5.3.2Town/ cityFIRENZE
    B.5.3.3Post code50139
    B.5.3.4CountryItaly
    B.5.4Telephone number0555662425
    B.5.5Fax number0555662425
    B.5.6E-mailclinicaltrialoffice@meyer.it
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name METOTRESSATO TEVA - 100 MG/ML SOLUZIONE INIETTABILE 1 FLACONE DA 50 ML
    D.2.1.1.2Name of the Marketing Authorisation holderTEVA ITALIA S.R.L.
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameMETOTREXATO
    D.3.2Product code [METOTREXATO]
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMETOTREXATO
    D.3.9.2Current sponsor codeHD-MTX
    D.3.9.3Other descriptive nameMETHOTREXATE
    D.3.10 Strength
    D.3.10.1Concentration unit gm/m2 gram(s)/square meter
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number8
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name ETOPOSIDE TEVA - 1 FLACONE 50 ML 20MG/ML
    D.2.1.1.2Name of the Marketing Authorisation holderTEVA PHARMA B.V.
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameETOPOSIDE
    D.3.2Product code [ETOPOSIDE]
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNETOPOSIDE
    D.3.9.2Current sponsor codeVP-16
    D.3.9.3Other descriptive nameETOPOSIDE
    D.3.10 Strength
    D.3.10.1Concentration unit gm/m2 gram(s)/square meter
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 3
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name ENDOXAN BAXTER - 500 MG POLVERE PER SOLUZIONE INIETTABILE 1 FLACONE VETRO TIPO III 500 MG
    D.2.1.1.2Name of the Marketing Authorisation holderBAXTER S.P.A.
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameCICLOFOSFAMIDE
    D.3.2Product code [CICLOFOSFAMIDE]
    D.3.4Pharmaceutical form Powder for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCICLOFOSFAMIDE
    D.3.9.2Current sponsor codeHD-EDX
    D.3.9.3Other descriptive nameCYCLOPHOSPHAMIDE
    D.3.10 Strength
    D.3.10.1Concentration unit mg/m2 milligram(s)/square meter
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number800
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 4
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name CARBOPLATINO ACTAVIS - 10 MG/ML CONCENTRATO PER SOLUZIONE PER INFUSIONE 1 FLACONCINO 50 MG/5 ML
    D.2.1.1.2Name of the Marketing Authorisation holderACTAVIS ITALY S.P.A.
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameCARBOPLATINO
    D.3.2Product code [CARBOPLATINO]
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCARBOPLATINO
    D.3.9.2Current sponsor codeCBCDA
    D.3.9.3Other descriptive nameCARBOPLATIN
    D.3.10 Strength
    D.3.10.1Concentration unit mg/m2 milligram(s)/square meter
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number800
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 5
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name TEPADINA - 100 MG - POLVERE PER CONCENTRATO PER SOLUZIONE PER INFUSIONE - USO ENDOVENOSO - FLACONCINO(VETRO) - 10MG/ML 1 FLACONCINO DA 100 MG
    D.2.1.1.2Name of the Marketing Authorisation holderADIENNE S.R.L.
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameTIOTEPA
    D.3.2Product code [TIOTEPA]
    D.3.4Pharmaceutical form Powder for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTIOTEPA
    D.3.9.2Current sponsor codeHD-TT
    D.3.9.3Other descriptive nameTHIOTEPA
    D.3.10 Strength
    D.3.10.1Concentration unit mg/m2 milligram(s)/square meter
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number300
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 6
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name NAVELBINE - 10 MG/ML CONCENTRATO PER SOLUZIONE PER INFUSIONE 1 FLACONE 1 ML
    D.2.1.1.2Name of the Marketing Authorisation holderPIERRE FABRE PHARMA S.R.L.
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameVINORELBINA
    D.3.2Product code [VINORELBINA]
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNVINORELBINA
    D.3.9.2Current sponsor codeVINORELBINA
    D.3.9.3Other descriptive nameVINORELBINE
    D.3.10 Strength
    D.3.10.1Concentration unit mg/m2 milligram(s)/square meter
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 7
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name CECENU
    D.2.1.1.2Name of the Marketing Authorisation holderMedac
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameLOMUSTINA
    D.3.2Product code [LOMUSTINA]
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLOMUSTINA
    D.3.9.2Current sponsor codeCCNU
    D.3.9.3Other descriptive nameLOMUSTINE
    D.3.10 Strength
    D.3.10.1Concentration unit mg/m2 milligram(s)/square meter
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number80
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Metastatic medulloblastoma and other embryonal tumours
    Medulloblastoma metastatico e altri tumori embrionali (classificazione WHO 2007)
    E.1.1.1Medical condition in easily understood language
    Brain tumours
    Neoplasie cerebrali
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10027107
    E.1.2Term Medulloblastoma
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate safety of standard and high-dose chemotherapy associated with craniospinal irradiation in pediatric and young adult patients with metastatic MB or other embryonal tumours.
    Valutare la sicurezza della somministrazione di chemioterapia standard e ad alte dosi associata ad irradiamento craniospinale con boost sul letto chirurgico nella terapia di prima linea in pazienti pediatrici e giovani adulti affetti da MB metastatico e altri tumori embrionali
    E.2.2Secondary objectives of the trial
    To evaluate the effectiveness of treatment in terms of progression-free survival, overall survival and responses to therapy.
    To evaluate neuropsychological and psychological aspects, endocrinological and visual sequelae.
    Valutare l'efficacia del trattamento mediante determinazione della sopravvivenza libera da progressione di malattia, della sopravvivenza globale e delle risposte al trattamento.
    Valutare gli aspetti neuropsicologici e psicologici e l'incidenza di eventuali complicanze endocrinologiche e visive
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Histologically confirmed, newly diagnosed, no previously treated patients with metastatic MB and other embryonal tumours (supratentorial primitive neuro-ectodermal tumors (sPNET) and pinealoblastoma, anaplastic large cell or partial resecate medulloblastoma (residue volume > 1,5 cm2), according to WHO 2007 classification. Patients underwent surgery
    2. Males and females aged >3 years and <21 years;
    3. Life expectancy = 4 weeks
    4. Karnofsky / Lansky = 40%
    5. Adequate hematological function (leucocyte = 2.0 x 10^9/l - Hemoglobin = 10 g/dl - platelet = 50 x 10^9 /l);
    6. Adequate liver function (total bilirubin = 2.5 x ULN - ALT/AST = 5.0 x ULN);
    7. Adequate renal function (serum creatinine = 1.5 x ULN);
    8. Written informed consent obtained from the patient/parents or legal representative;
    9. Availability to trial treatment and ability to be compliant with the protocol
    1. Pazienti con MB metastatico e altri tumori embrionali (PNET sovratentoriali (sPNET) e pinealoblastomi, , medulloblastomi anaplastici/a grandi cellule o parzialmente resecati (volume residuo >1,5cm2), secondo classificazione WHO 2007, di prima diagnosi non precedentemente trattati (con chemio e radioterapia) e trattati solo chirurgicamente
    2. Maschi e femmine di età compresa fra i 3 e i 21 anni
    3. Aspettativa di vita = 4 settimane
    4. Karnofsky/Lansky = 40 %
    5. Funzione ematologica adeguata (Conta assoluta dei leucociti = 2.0 x 10^9/l, Emoglobina = 10 g/dl, Conta delle piastrine = 50 x 10^9 /l)
    6. Funzione epatica adeguata (Bilirubina totale = 2.5 x ULN, ALT/AST = 5.0 x ULN)
    7. Funzione renale adeguata (Creatinina sierica = 1.5 x ULN)
    8. Consenso informato scritto da parte del paziente se maggiorenne, dei genitori o dei tutori legali
    9. Disponibilità del paziente durante il trattamento e capacità di attenersi al protocollo
    E.4Principal exclusion criteria
    1. Any disease or condition that contraindicates the use of the study treatment (es. serious mental retardation, brain palsy, congenital syndrome, cardiomyopathy)
    2. Administration of anti-cancer therapy concomitantly to the study enrolment
    3. Concomitant partecipation to other clinical trial
    4. Pregnancy or breastfeeding
    5. Non adequate contraception
    6. Hypersensibility to active principles or excipients
    7. Severe bone-marrow depression
    8. Concomitant use of yellow fever vaccine or other live vaccines
    9. Other contraindications reported in the SmPC
    1. Evidenza di qualsiasi altra malattia o condizioni gravi che rappresentino una controindicazione alla terapia in studio (e.g. grave ritardo mentale, grave paralisi cerebrale, gravi sindromi congenite, cardiopatie)
    2. Esecuzione di un ciclo di chemioterapia di 1° linea contemporaneamente all’inizio dello studio
    3. Concomitante partecipazione ad altre sperimentazioni
    4. Stato di gravidanza o allattamento
    5. Utilizzo di metodi contraccettivi inadeguati sia da parte di pazienti di sesso femminile che maschile
    6. Ipersensibilità al principio attivo o ad uno qualsiasi degli eccipienti
    7. Grave mielodepressione
    8. Uso concomitante di vaccino per la febbre gialla o di altri vaccini vivi
    9. Altre controindicazioni riportate nel RCP dei vari farmaci
    E.5 End points
    E.5.1Primary end point(s)
    - Percentage of subjects with neurological symptoms >=G3, evaluated according to CTCAE 4.0, not present at the beginning of postoperative chemoradiotherapy and not related to the recurrence / progression of the disease - Percentage of subjects with SAE - Percentage of subjects with SAE leading to withdrawal from the study - Mortality due to adverse events
    - Proporzione di soggetti con sintomatologia neurologica >=G3, valutata secondo la CTCAE 4.0, non presente all’inizio del trattamento chemioradioterapico postoperatorio e non riconducibile a recidiva/progressione di malattia - Proporzione di soggetti con SAE e relativa tipologia - Proporzione di soggetti con SAE che determinano il ritiro dallo studio - Mortalità per eventi avversi
    E.5.1.1Timepoint(s) of evaluation of this end point
    24 months from the end of the treatment (end of follow-up)
    24 mesi dalla fine del trattamento (fine follow-up).

    E.5.2Secondary end point(s)
    - Progression free survival (PFS) defined as time frame between the date of the enrolment and the date tumour progression ; Overall survival (OS) defined as time frame between the date of the enrolment and the death to any cause; Difference in scoring for neuropsychological (Griffiths, Rey, BVN tests, educational learning) and psycological (PedsQL, CBCL) scales; Rate of treatment response:
    - CR, complete response the complete disappearance of all radiographic and/or cytological evidence of tumor;
    - PR, partial response >= 50% reduction in the product of the perpendicular diameters of the tumor with negative cytology
    - SD, stable disease <= 25%reduction in tumor size
    - PD, progressive disease >= 25% increase in tumor size or the appearance of tumor in previously uninvolved areas; Incidence of endocrinological and visual sequelae
    - PFS definita come il tempo tra la data di arruolamento e la data di progressione o la data di morte; OS definita come il tempo tra la data di arruolamento e la data di decesso per qualsiasi causa ; Differenze nei punteggi alle scale per le valutazioni neuropsicologiche (test di Griffiths, Rey, BVN, apprendimento scolastico) e psicologiche (PedsQL, CBCL); Proporzione di risposta al trattamento:
    - CR, risposta completa: completa scomparsa di segni evidenti di malattia all'esame citologico e/o radiologico
    - PR, risposta parziale: riduzione >= 50% dell¿area neoplastica, misurata come prodotto dei diametri perpendicolari maggiori, con esame citologico negativo
    - SD, malattia stabile: riduzione <= 25% della massa tumorale
    - PD, progressione malattia: aumento >= 25% della massa tumorale o comparsa di nuove lesioni di malattia; Incidenza delle complicanze endocrinologiche e visive
    E.5.2.1Timepoint(s) of evaluation of this end point
    MRI scan assessment; MRI scan assessment; Before radiotherapy, at the end of the chemioterapy and at the end of the follow-up; After induction phase and at the end of the treatment; 24 months from the end of the treatment (end of follow-up)
    Ad ogni rivalutazione con RMN; Ad ogni rivalutazione RMN; Prima della radioterapia, alla fine del trattamento e alla fine del follow-up; Dopo la fase di induzione e a fine trattamento; 24 mesi dalla fine del trattamento (fine follow-up).
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Singolo braccio
    Single arm
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months84
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months84
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 13
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 3
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 2
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state18
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 18
    F.4.2.2In the whole clinical trial 18
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Patients will carry out regular clinical follow-up
    I pazienti effettueranno controlli regolari secondo pratica clinica
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2017-02-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-11-28
    P. End of Trial
    P.End of Trial StatusOngoing
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