<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/NCT03250520</url>
  </required_header>
  <id_info>
    <org_study_id>HIM 2017-072</org_study_id>
    <nct_id>NCT03250520</nct_id>
  </id_info>
  <brief_title>Application of Palliative Treatment in Children With Brain Stem Glioma and Recurrent High-grade Tumors in the Central Nervous System With the Nanomaterial NPt-Ca</brief_title>
  <official_title>Pilot Study of the Application of Palliative Treatment in Children With Brain Stem Glioma and Recurrent High-grade Tumors in the Central Nervous System With the Nanomaterial Platinum Acetylacetonate (1% wt) Supported by Sol-gel Technology Functionalized Titania (NPt-Ca)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital Infantil de Mexico Federico Gomez</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospital Infantil de Mexico Federico Gomez</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This Protocol is a pilot, clinical interventional study to selected patients between five and&#xD;
      fourteen years of both sexes, carriers of the diagnosis of glioma brain stem and high grade&#xD;
      recurrent in the central nervous system tumors, in whom there has been no response to&#xD;
      conventional-based surgery/radiation/chemotherapy treatment or whose location does not allow&#xD;
      treatment with conventional measures, and that already have an indication for a neurosurgical&#xD;
      palliative procedure. It will be a close pharmacovigilance on possible adverse effects&#xD;
      related to the nanomaterial based on the profile of cisplatin (chemotherapeutic platinum&#xD;
      derivative), since documented toxicity data are not counted for NPt-Ca. Quality of life will&#xD;
      be documented with PedsQL Cancer Module© and tumor size by magnetic resonance brain images.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 1, 2017</start_date>
  <completion_date type="Actual">June 28, 2022</completion_date>
  <primary_completion_date type="Actual">January 28, 2022</primary_completion_date>
  <phase>Early Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in the quality of life using the PedsQL Cancer Module©</measure>
    <time_frame>Preoperative and at 1.3, 6, 12, 18 and 24 months.</time_frame>
    <description>Measures of the change of quality of life pre and after the administration of NPt-Ca using the questionnaire PedsQL Cancer Module©</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in tumor size</measure>
    <time_frame>Immediate, 1, 2, 3, 6, 8, 10, 12, 18 and 24 months.</time_frame>
    <description>Change in tumor size after the administration of NPt-Ca using volumetric measures on the brain magnetic resonance.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">8</enrollment>
  <condition>Brain Tumor, Pediatric, Brainstem Glioma</condition>
  <condition>Brain Tumor, Pediatric, Recurrent</condition>
  <arm_group>
    <arm_group_label>glioma brain stem</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>high grade recurrent brain tumor in the central nervous system</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Platinum acetylacetonate (1% wt) supported by sol-gel technology functionalized titania</intervention_name>
    <description>Sol-gel process Pt(acac)2- F-TiO2 nanostructured material with antitumoral activity used as an alternative in the treatment of cancer tumors. The biocatalysts were prepared by the sol-gel route using the complex Pt(acac)2.</description>
    <arm_group_label>glioma brain stem</arm_group_label>
    <arm_group_label>high grade recurrent brain tumor in the central nervous system</arm_group_label>
    <other_name>Pt(acac)2/Titanium dioxide (Ti02)</other_name>
    <other_name>Pt(acac)2/F-TiO2</other_name>
    <other_name>NPt</other_name>
    <other_name>NPt-Ca</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Histopathological diagnosis or MRI of the brain stem or tumor of recurrent high-grade&#xD;
             glioma.&#xD;
&#xD;
          -  Indication of palliative surgical treatment by neurosurgery.&#xD;
&#xD;
          -  Good general condition, enabling the realization of surgical treatment.&#xD;
&#xD;
          -  Scale Lansky &gt; 20)&#xD;
&#xD;
          -  conventional treatment (surgery, radiotherapy, and chemotherapy) failed or not&#xD;
             applicable to the patient.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with emerging infectious diseases or fever in the last 72 hours prior to&#xD;
             placement of the NPt-Ca.&#xD;
&#xD;
          -  Patients whose parents/carers do not authorize expressly the realization of procedure&#xD;
             with knowledge of its experimental nature, are not agreed or established their&#xD;
             commitment to meet follow-up parameters established by this Protocol.&#xD;
&#xD;
          -  Patients with surgical complications prior to placement of the NPt-Ca.&#xD;
&#xD;
          -  Patients in which the size and location of the lesion do not allow their surgical&#xD;
             approach or an increase in volume by infiltration of the lesion with 3 ml of volume of&#xD;
             NPt-Ca.&#xD;
&#xD;
          -  Patient whose neurological condition do not allow the implementation of MRI without&#xD;
             anesthesia.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>5 Years</minimum_age>
    <maximum_age>14 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Hospital Infantil de Mexico Federico Gomez</name>
      <address>
        <city>DF</city>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Mexico</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>June 10, 2017</study_first_submitted>
  <study_first_submitted_qc>August 11, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 15, 2017</study_first_posted>
  <last_update_submitted>February 27, 2023</last_update_submitted>
  <last_update_submitted_qc>February 27, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 28, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hospital Infantil de Mexico Federico Gomez</investigator_affiliation>
    <investigator_full_name>Daniel Eduardo Alvarez Amado</investigator_full_name>
    <investigator_title>Researcher in the Neurology Department</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neoplasms</mesh_term>
    <mesh_term>Glioma</mesh_term>
    <mesh_term>Brain Neoplasms</mesh_term>
    <mesh_term>Recurrence</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Titanium dioxide</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03250520
org study id: HIM 2017-072
nct id: NCT03250520
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This Protocol is a pilot, clinical interventional study to selected patients between five and
      fourteen years of both sexes, carriers of the diagnosis of glioma brain stem and high grade
      recurrent in the central nervous system tumors, in whom there has been no response to
      conventional-based surgery/radiation/chemotherapy treatment or whose location does not allow
      treatment with conventional measures, and that already have an indication for a neurosurgical
      palliative procedure. It will be a close pharmacovigilance on possible adverse effects
      related to the nanomaterial based on the profile of cisplatin (chemotherapeutic platinum
      derivative), since documented toxicity data are not counted for NPt-Ca. Quality of life will
      be documented with PedsQL Cancer Module© and tumor size by magnetic resonance brain images.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Change in the quality of life using the PedsQL Cancer Module©
time frame: Preoperative and at 1.3, 6, 12, 18 and 24 months.
description: Measures of the change of quality of life pre and after the administration of NPt-Ca using the questionnaire PedsQL Cancer Module©
measure: Change in tumor size
time frame: Immediate, 1, 2, 3, 6, 8, 10, 12, 18 and 24 months.
description: Change in tumor size after the administration of NPt-Ca using volumetric measures on the brain magnetic resonance.
arm group label: glioma brain stem
arm group type: Experimental
arm group label: high grade recurrent brain tumor in the central nervous system
arm group type: Experimental
intervention type: Drug
intervention name: Platinum acetylacetonate (1% wt) supported by sol-gel technology functionalized titania
description: Sol-gel process Pt(acac)2- F-TiO2 nanostructured material with antitumoral activity used as an alternative in the treatment of cancer tumors. The biocatalysts were prepared by the sol-gel route using the complex Pt(acac)2.
arm group label: glioma brain stem
arm group label: high grade recurrent brain tumor in the central nervous system
other name: Pt(acac)2/Titanium dioxide (Ti02)
other name: Pt(acac)2/F-TiO2
other name: NPt
other name: NPt-Ca
criteria: 
gender: All
minimum age: 5 Years
maximum age: 14 Years
healthy volunteers: No
facility: 
country: Mexico
responsible party type: Principal Investigator
investigator affiliation: Hospital Infantil de Mexico Federico Gomez
investigator full name: Daniel Eduardo Alvarez Amado
investigator title: Researcher in the Neurology Department
mesh term: Neoplasms
mesh term: Glioma
mesh term: Brain Neoplasms
mesh term: Recurrence
mesh term: Titanium dioxide
sharing ipd: Undecided