<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02233049</url>
  </required_header>
  <id_info>
    <org_study_id>2014-001929-32</org_study_id>
    <secondary_id>2014/2126</secondary_id>
    <nct_id>NCT02233049</nct_id>
  </id_info>
  <brief_title>Biological Medicine for Diffuse Intrinsic Pontine Glioma (DIPG) Eradication</brief_title>
  <acronym>BIOMEDE</acronym>
  <official_title>Biological Medicine for Diffuse Intrinsic Pontine Glioma (DIPG) Eradication</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Gustave Roussy, Cancer Campus, Grand Paris</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Innovative Therapies For Children with Cancer Consortium</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Gustave Roussy, Cancer Campus, Grand Paris</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Diffuse Intrinsic Pontine Gliomas (DIPG) appear almost exclusively in children and&#xD;
      adolescents, representing 15 to 20% of posterior fossa tumours. Even if it is one of the most&#xD;
      common malignant brain tumours, there are only 30 to 40 new cases per year in France. Their&#xD;
      clinical presentation is stereotyped with a short clinical history and a unique MRI&#xD;
      appearance that was usually considered as sufficient to establish the diagnosis. The&#xD;
      prognosis of DIPG is always unfavourable; median overall survival is 9 to 10 months in&#xD;
      general and most patients will die within two years after diagnosis (Kaplan 1996,Hargrave&#xD;
      2006). Malignant gliomas infiltrating the brainstem represent the greatest challenge of&#xD;
      paediatric oncology; despite numerous collaborative studies performed, patients' survival has&#xD;
      not significantly increased in thirty years (Hargrave 2009). There is no validated prognostic&#xD;
      factor. There is currently no validated treatment except radiotherapy.&#xD;
&#xD;
      Several targeted agents have been tested in DIPG (Pollack 2007 Haas-Kogan 2008, Geoerger,&#xD;
      2011), without knowing whether the target was present in the tumour. A critical review of the&#xD;
      paradigms of these trials tells us that there are long term survivors in these studies that&#xD;
      is to say patients who may have benefited from the tested therapy, but they are few. So far,&#xD;
      the new therapies that have been tried were evaluated one after the other in search of a&#xD;
      treatment that would be effective for all patients, measuring the treatment effect on median&#xD;
      survival. They were all rejected as ineffective. However the investigators can challenge the&#xD;
      endpoint to evaluate efficacy in these trials as the existence of long term survivors (&gt; 18&#xD;
      months, for example) and their number should not been ignored, especially if targeted&#xD;
      therapies are considered. The investigators propose a paradigm shift in the choice of&#xD;
      treatment; the issue raised would be to give to each patient the treatment associated with&#xD;
      the highest likelihood of efficacy based on the specific biological tumour profile.&#xD;
&#xD;
      The development of targeted therapies for malignant gliomas infiltrating the brainstem has&#xD;
      been hampered by the absence of biological data. It is therefore crucial to better understand&#xD;
      the biology of these tumours. Despite the safety of the biopsy in brainstem tumours, most&#xD;
      teams of paediatric neurosurgery limit the use of stereotactic biopsy only for clinically or&#xD;
      radiologically unusual forms. Until recently, there has been no systematic genetic study at&#xD;
      diagnosis to date and the few available data were confounded by the inclusion of autopsies or&#xD;
      clinically and radiologically unusual cases (Louis, 1993; Gilbertson 2003; Okada, 2008;&#xD;
      Zarghooni 2010; Broniscer, 2010; Wu, 2012 and Schwartzentruber, 2012).&#xD;
&#xD;
      French teams gathered in the French Society of Paediatric Oncology and the European&#xD;
      consortium &quot;Innovative Therapies in Children with Cancer (ITCC)&quot; decided a few years ago to&#xD;
      perform biopsies of these tumours for diagnostic confirmation and to ensure the presence of&#xD;
      certain therapeutic targets prior to a possible inclusion in a trial evaluating a targeted&#xD;
      therapy (Geoerger, 2009; Geoerger, 2010). Part of this experiment was reported by the team of&#xD;
      the Necker Hospital in Paris, confirming the low rate of complications of stereotactic biopsy&#xD;
      procedure (Roujeau, 2007). The biopsy specimen analysis allowed practicing&#xD;
      immunohistochemical, genomic (CGHarray), gene expression (transcriptome) and direct&#xD;
      sequencing of candidate genes studies.&#xD;
&#xD;
      In this study, the majority of patients will receive a treatment assumed to specifically&#xD;
      target a biological abnormality identified on the biopsy. More importantly, patients will not&#xD;
      receive a drug for which the identified target is absent.&#xD;
&#xD;
      In this first step of the protocol, the patients will thus be allocated to one of the three&#xD;
      treatment groups as follows:&#xD;
&#xD;
        -  If the tumor overexpresses EGFR without PTEN loss of expression, patients may receive&#xD;
           erlotinib or dasatinib allocated by randomization (R1 randomisation).&#xD;
&#xD;
        -  If the tumor shows loss of PTEN expression without EGFR overexpression, patients may&#xD;
           receive everolimus or dasatinib allocated by randomisation (R2 randomisation).&#xD;
&#xD;
        -  If the tumor shows both EGFR overexpression and loss of PTEN expression, patients may&#xD;
           receive erlotinib, everolimus or dasatinib by randomisation (R3 randomisation).&#xD;
&#xD;
        -  If the tumor shows neither EGFR overexpression nor loss of PTEN expression (a very rare&#xD;
           situation in our experience), patients will receive dasatinib (no randomisation).&#xD;
&#xD;
        -  If the biopsy assessment is not contributive, the treatment will be allocated by&#xD;
           randomisation between erlotinib, everolimus and dasatinib (R3 randomisation).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>October 2014</start_date>
  <completion_date type="Anticipated">October 2018</completion_date>
  <primary_completion_date type="Anticipated">October 2018</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Overall Survival</measure>
    <time_frame>Assessed up two years after randomization</time_frame>
  </primary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">250</enrollment>
  <condition>Diffuse Intrinsic Pontine Glioma</condition>
  <arm_group>
    <arm_group_label>R1: erlotinib versus dasatinib</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>EGFR+ only Tarceva® (erlotinib): 25 mg and 100 mg tablets. The prescribed dose is 125 mg/m²/day orally, once daily. Sprycel® (dasatinib): 20 mg and 50 mg tablets. The prescribed dose is 85 mg/m²/dose, orally, twice daily, i.e. 170 mg/m2/day.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>R2: everolimus versus dasatinib</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>PTEN-loss only Votubia® (everolimus): 2.5 mg tablets. The prescribed dose is 5 mg/m²/day, orally, once daily. Sprycel® (dasatinib): 20 mg and 50 mg tablets. The prescribed dose is 85 mg/m²/dose, orally, twice daily, i.e. 170 mg/m2/day.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>R3: erlotinib versus everolimus versus dasatinib</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>EGFR+ and PTEN-loss or inconclusive biopsy Tarceva® (erlotinib): 25 mg and 100 mg tablets. The prescribed dose is 125 mg/m²/day orally, once daily. Votubia® (everolimus): 2.5 mg tablets. The prescribed dose is 5 mg/m²/day, orally, once daily. Sprycel® (dasatinib): 20 mg and 50 mg tablets. The prescribed dose is 85 mg/m²/dose, orally, twice daily, i.e. 170 mg/m2/day.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort Dasatinib</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Neither EGFR overexpression nor loss of PTEN expression Sprycel® (dasatinib): 20 mg and 50 mg tablets. The prescribed dose is 85 mg/m²/dose, orally, twice daily, i.e. 170 mg/m2/day</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Erlotinib</intervention_name>
    <arm_group_label>R1: erlotinib versus dasatinib</arm_group_label>
    <arm_group_label>R3: erlotinib versus everolimus versus dasatinib</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Everolimus</intervention_name>
    <arm_group_label>R2: everolimus versus dasatinib</arm_group_label>
    <arm_group_label>R3: erlotinib versus everolimus versus dasatinib</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dasatinib</intervention_name>
    <arm_group_label>Cohort Dasatinib</arm_group_label>
    <arm_group_label>R1: erlotinib versus dasatinib</arm_group_label>
    <arm_group_label>R2: everolimus versus dasatinib</arm_group_label>
    <arm_group_label>R3: erlotinib versus everolimus versus dasatinib</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Eligibility criteria for the BIOMEDE study (pre-screening for the randomised subtrials)&#xD;
&#xD;
          -  Diagnosis of DIPG (clinical and radiological, or histological in case the biopsy was&#xD;
             performed before study entry)&#xD;
&#xD;
          -  DIPG at diagnosis: no prior chemotherapy for the present cancer;no prior cerebral&#xD;
             radiation therapy&#xD;
&#xD;
          -  NB : Metastatic disease allowed. Patient with metastatic disease are eligible for the&#xD;
             study (including the randomised trial if diagnosis of DIPG confirmed). In this&#xD;
             situation, radiotherapy will have to start within three weeks after the biopsy while&#xD;
             targerted treatment will start at the end of the irradiation.&#xD;
&#xD;
          -  Age &gt; 6 months and &lt; 25 years. For children below the age of 3 years, inclusion in the&#xD;
             study and medical decisions should be discussed with the coordinating investigator.&#xD;
&#xD;
          -  Eligible for a biopsy, or biopsy performed for diagnostic purpose and material&#xD;
             available for the biomarker assessment&#xD;
&#xD;
          -  Eligible for cerebral radiotherapy&#xD;
&#xD;
          -  Patient covered by an health insurance if national requirement&#xD;
&#xD;
          -  Written informed consent given by patient and/or parents/legal representative for&#xD;
             biomarkers assessment and registration in the study.&#xD;
&#xD;
        Non eligibility criteria for the study&#xD;
&#xD;
          -  Massive intratumour bleeding&#xD;
&#xD;
          -  Any other concomitant anti-cancer treatment not foreseen by this protocol&#xD;
&#xD;
          -  Any other cancer during the last 5 years&#xD;
&#xD;
          -  Uncontrolled intercurrent illness or active infection&#xD;
&#xD;
          -  Any other co-morbid condition that in the investigator's opinion would impair study&#xD;
             participation&#xD;
&#xD;
          -  Unable for medical follow-up (geographic, social or mental reasons)&#xD;
&#xD;
          -  Patient not fulfilling one of the previous eligibility criteria.&#xD;
&#xD;
          -  Patient previously treated with irradiation on the brainstem for another neoplasm&#xD;
&#xD;
          -  Patient with congenital galactose intolerance, Lapp lactase deficiency or&#xD;
             glucose-galactose malabsorption.&#xD;
&#xD;
          -  Patient not covered by a social security agreement accepted in the treating country if&#xD;
             national requirement&#xD;
&#xD;
          -  Pregnant or breast feeding women&#xD;
&#xD;
          -  NB: A patient with known hypersensitivity for one the drug or its excipients could&#xD;
             still participate to the study and receive one of the other drug(s)&#xD;
&#xD;
        Common eligibility criteria for the BIOMEDE randomised subtrials&#xD;
&#xD;
          -  Eligibility criteria for the study (see above)&#xD;
&#xD;
          -  Confirmed histological diagnosis of diffuse intrinsic pontine glioma (grade II, III,&#xD;
             IV WHO), confirmed by central pathology review (including the assessment of the loss&#xD;
             of H3K27me3 by immunohistochemistry or the presence of a mutation in the histone H3&#xD;
             variant genes).&#xD;
&#xD;
        Patients without classical clinical and radiological diagnostic criteria who fulfil the&#xD;
        histological and biological criteria of DIPG are eligible for the trial.&#xD;
&#xD;
        Pilocytic astrocytoma and gangliogliomas are not eligible.&#xD;
&#xD;
          -  Life expectancy &gt; 12 weeks after the start of study treatment&#xD;
&#xD;
          -  Karnofsky performance status scale or Lansky Play Scale &gt; 50%. The PS should not take&#xD;
             the neurologic deficit per se into account. NB: Children and young adults with a worse&#xD;
             performance status due to glioma-related motor paresis can be included.&#xD;
&#xD;
          -  Absolute neutrophil count &gt; 1.5 x 109/l, Platelets &gt; 100 x 109/l&#xD;
&#xD;
          -  Total bilirubin &lt; 1,5 x ULN, AST and ALT&lt; 2,5 x ULN&#xD;
&#xD;
          -  Serum creatinine &lt; 1,5 X ULN for age. If serum creatinine &gt; 1,5 ULN, creatinine&#xD;
             clearance must be &gt; 70 ml/min/1,73 m² (EDTA radioisotope GFR or 24 hours urines&#xD;
             collection)&#xD;
&#xD;
          -  Normal coagulation tests: prothrombin rate (prothrombin time = PT), TCA (PTT),&#xD;
             fibrinogen&#xD;
&#xD;
          -  No current organ toxicity &gt; grade 2 according to the NCI-CTCAE version 4.0 especially&#xD;
             cardiovascular, pulmonary or renal disease (,including but not limited to: congenital&#xD;
             long QT syndrome, nephrotic syndrome, glomerulopathy, uncontrolled high blood pressure&#xD;
             despite adequate treatment, interstitial lung disease, pulmonary arterial&#xD;
             hypertension). In case of known or possible cardiac disease, a cardiological advice&#xD;
             will be required prior to the inclusion in the randomized trial as a preexisting&#xD;
             cardiopathy represents a contra-indication to dasatinib.&#xD;
&#xD;
          -  Effective contraception for patients (male and female) of reproductive potential&#xD;
             during their entire participation in the study and during 6 months after the end of&#xD;
             treatment&#xD;
&#xD;
          -  Negative pregnancy test (serum beta-HCG) evaluated in the last week in females of&#xD;
             reproductive potential&#xD;
&#xD;
          -  Written informed consent given by patient and/or parents/legal representative for&#xD;
             treatment and randomization&#xD;
&#xD;
        Eligibility criteria for the subtrials Eligibility criteria for the different subtrials&#xD;
        will be mainly based on biomarkers assessment as detailed in the table above. In addition,&#xD;
        contra-indication and precautions for use to specific drugs will be considered.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Months</minimum_age>
    <maximum_age>25 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jacques GRILL, MD, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Gustave Roussy, Cancer Campus, Grand Paris</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jacques GRILL, MD, PhD</last_name>
    <phone>0142116209</phone>
    <phone_ext>+33</phone_ext>
    <email>jacques.grill@gustaveroussy.fr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Perrine CAPOLINO</last_name>
    <phone>0142114211</phone>
    <phone_ext>+33</phone_ext>
    <email>perrine.capolino@gustaveroussy.fr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Gustave Roussy</name>
      <address>
        <city>Villejuif</city>
        <state>Val De Marne</state>
        <zip>94805</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jacques GRILL, MD, PhD</last_name>
      <phone>0142116209</phone>
      <phone_ext>+33</phone_ext>
      <email>jacques.grill@gustaveroussy.fr</email>
    </contact>
    <contact_backup>
      <last_name>Perrine CAPOLINO</last_name>
      <phone>0142114211</phone>
      <phone_ext>+33</phone_ext>
      <email>perrine.capolino@gustaveroussy.fr</email>
    </contact_backup>
    <investigator>
      <last_name>Jacques GRILL, MD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>July 2018</verification_date>
  <study_first_submitted>August 29, 2014</study_first_submitted>
  <study_first_submitted_qc>September 5, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 8, 2014</study_first_posted>
  <last_update_submitted>July 20, 2018</last_update_submitted>
  <last_update_submitted_qc>July 20, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">July 23, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Children</keyword>
  <keyword>adolescents</keyword>
  <keyword>young adults</keyword>
  <keyword>newly diagnosed</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Glioma</mesh_term>
    <mesh_term>Diffuse Intrinsic Pontine Glioma</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Everolimus</mesh_term>
    <mesh_term>Erlotinib Hydrochloride</mesh_term>
    <mesh_term>Dasatinib</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02233049
org study id: 2014-001929-32
secondary id: 2014/2126
nct id: NCT02233049
lead sponsor: 
collaborator: 
has dmc: Yes
Diffuse Intrinsic Pontine Gliomas (DIPG) appear almost exclusively in children and
      adolescents, representing 15 to 20% of posterior fossa tumours. Even if it is one of the most
      common malignant brain tumours, there are only 30 to 40 new cases per year in France. Their
      clinical presentation is stereotyped with a short clinical history and a unique MRI
      appearance that was usually considered as sufficient to establish the diagnosis. The
      prognosis of DIPG is always unfavourable; median overall survival is 9 to 10 months in
      general and most patients will die within two years after diagnosis (Kaplan 1996,Hargrave
      2006). Malignant gliomas infiltrating the brainstem represent the greatest challenge of
      paediatric oncology; despite numerous collaborative studies performed, patients' survival has
      not significantly increased in thirty years (Hargrave 2009). There is no validated prognostic
      factor. There is currently no validated treatment except radiotherapy.

      Several targeted agents have been tested in DIPG (Pollack 2007 Haas-Kogan 2008, Geoerger,
      2011), without knowing whether the target was present in the tumour. A critical review of the
      paradigms of these trials tells us that there are long term survivors in these studies that
      is to say patients who may have benefited from the tested therapy, but they are few. So far,
      the new therapies that have been tried were evaluated one after the other in search of a
      treatment that would be effective for all patients, measuring the treatment effect on median
      survival. They were all rejected as ineffective. However the investigators can challenge the
      endpoint to evaluate efficacy in these trials as the existence of long term survivors (> 18
      months, for example) and their number should not been ignored, especially if targeted
      therapies are considered. The investigators propose a paradigm shift in the choice of
      treatment; the issue raised would be to give to each patient the treatment associated with
      the highest likelihood of efficacy based on the specific biological tumour profile.

      The development of targeted therapies for malignant gliomas infiltrating the brainstem has
      been hampered by the absence of biological data. It is therefore crucial to better understand
      the biology of these tumours. Despite the safety of the biopsy in brainstem tumours, most
      teams of paediatric neurosurgery limit the use of stereotactic biopsy only for clinically or
      radiologically unusual forms. Until recently, there has been no systematic genetic study at
      diagnosis to date and the few available data were confounded by the inclusion of autopsies or
      clinically and radiologically unusual cases (Louis, 1993; Gilbertson 2003; Okada, 2008;
      Zarghooni 2010; Broniscer, 2010; Wu, 2012 and Schwartzentruber, 2012).

      French teams gathered in the French Society of Paediatric Oncology and the European
      consortium "Innovative Therapies in Children with Cancer (ITCC)" decided a few years ago to
      perform biopsies of these tumours for diagnostic confirmation and to ensure the presence of
      certain therapeutic targets prior to a possible inclusion in a trial evaluating a targeted
      therapy (Geoerger, 2009; Geoerger, 2010). Part of this experiment was reported by the team of
      the Necker Hospital in Paris, confirming the low rate of complications of stereotactic biopsy
      procedure (Roujeau, 2007). The biopsy specimen analysis allowed practicing
      immunohistochemical, genomic (CGHarray), gene expression (transcriptome) and direct
      sequencing of candidate genes studies.

      In this study, the majority of patients will receive a treatment assumed to specifically
      target a biological abnormality identified on the biopsy. More importantly, patients will not
      receive a drug for which the identified target is absent.

      In this first step of the protocol, the patients will thus be allocated to one of the three
      treatment groups as follows:

        -  If the tumor overexpresses EGFR without PTEN loss of expression, patients may receive
           erlotinib or dasatinib allocated by randomization (R1 randomisation).

        -  If the tumor shows loss of PTEN expression without EGFR overexpression, patients may
           receive everolimus or dasatinib allocated by randomisation (R2 randomisation).

        -  If the tumor shows both EGFR overexpression and loss of PTEN expression, patients may
           receive erlotinib, everolimus or dasatinib by randomisation (R3 randomisation).

        -  If the tumor shows neither EGFR overexpression nor loss of PTEN expression (a very rare
           situation in our experience), patients will receive dasatinib (no randomisation).

        -  If the biopsy assessment is not contributive, the treatment will be allocated by
           randomisation between erlotinib, everolimus and dasatinib (R3 randomisation).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Overall Survival
time frame: Assessed up two years after randomization
arm group label: R1: erlotinib versus dasatinib
arm group type: Experimental
description: EGFR+ only Tarceva® (erlotinib): 25 mg and 100 mg tablets. The prescribed dose is 125 mg/m²/day orally, once daily. Sprycel® (dasatinib): 20 mg and 50 mg tablets. The prescribed dose is 85 mg/m²/dose, orally, twice daily, i.e. 170 mg/m2/day.
arm group label: R2: everolimus versus dasatinib
arm group type: Experimental
description: PTEN-loss only Votubia® (everolimus): 2.5 mg tablets. The prescribed dose is 5 mg/m²/day, orally, once daily. Sprycel® (dasatinib): 20 mg and 50 mg tablets. The prescribed dose is 85 mg/m²/dose, orally, twice daily, i.e. 170 mg/m2/day.
arm group label: R3: erlotinib versus everolimus versus dasatinib
arm group type: Experimental
description: EGFR+ and PTEN-loss or inconclusive biopsy Tarceva® (erlotinib): 25 mg and 100 mg tablets. The prescribed dose is 125 mg/m²/day orally, once daily. Votubia® (everolimus): 2.5 mg tablets. The prescribed dose is 5 mg/m²/day, orally, once daily. Sprycel® (dasatinib): 20 mg and 50 mg tablets. The prescribed dose is 85 mg/m²/dose, orally, twice daily, i.e. 170 mg/m2/day.
arm group label: Cohort Dasatinib
arm group type: Experimental
description: Neither EGFR overexpression nor loss of PTEN expression Sprycel® (dasatinib): 20 mg and 50 mg tablets. The prescribed dose is 85 mg/m²/dose, orally, twice daily, i.e. 170 mg/m2/day
intervention type: Drug
intervention name: Erlotinib
arm group label: R1: erlotinib versus dasatinib
arm group label: R3: erlotinib versus everolimus versus dasatinib
intervention type: Drug
intervention name: Everolimus
arm group label: R2: everolimus versus dasatinib
arm group label: R3: erlotinib versus everolimus versus dasatinib
intervention type: Drug
intervention name: Dasatinib
arm group label: Cohort Dasatinib
arm group label: R1: erlotinib versus dasatinib
arm group label: R2: everolimus versus dasatinib
arm group label: R3: erlotinib versus everolimus versus dasatinib
criteria: 
gender: All
minimum age: 6 Months
maximum age: 25 Years
healthy volunteers: No
last name: Jacques GRILL, MD, PhD
role: Study Chair
affiliation: Gustave Roussy, Cancer Campus, Grand Paris
last name: Jacques GRILL, MD, PhD
phone: 0142116209
phone ext: +33
email: jacques.grill@gustaveroussy.fr
last name: Perrine CAPOLINO
phone: 0142114211
phone ext: +33
email: perrine.capolino@gustaveroussy.fr
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: France
responsible party type: Sponsor
mesh term: Glioma
mesh term: Diffuse Intrinsic Pontine Glioma
mesh term: Everolimus
mesh term: Erlotinib Hydrochloride
mesh term: Dasatinib