<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/NCT01734564</url>
  </required_header>
  <id_info>
    <org_study_id>CD-2010-01</org_study_id>
    <nct_id>NCT01734564</nct_id>
  </id_info>
  <brief_title>Phase II Study With Hiltonol and Dendritic Cells in Solid Tumors</brief_title>
  <official_title>Phase II Study With Hiltonol and Dendritic Cells in Solid Tumors</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Clinica Universidad de Navarra, Universidad de Navarra</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Clinica Universidad de Navarra, Universidad de Navarra</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      In this phase II study, patients with solid tumors will receive treatment with hiltonol and&#xD;
      autologous dendritic cells.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In this phase II study, patients with solid tumors will receive treatment with intratumoral&#xD;
      hiltonol and two cycles of autologous dendritic cells loaded with autologous tumor and&#xD;
      administered subcutaneously. A new cohort will explore the role of radiation therapy, looking&#xD;
      for an abscopal effect.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">December 2016</completion_date>
  <primary_completion_date type="Actual">December 2016</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Response rate</measure>
    <time_frame>8-10 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Safety (Common Toxicity Criteria 4.0)</measure>
    <time_frame>8-10 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">15</enrollment>
  <condition>Neoplasms</condition>
  <arm_group>
    <arm_group_label>Hiltonol and autologous dendritic cells</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Hiltonol and autologous dendritic cells</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Hiltonol, dendritic cells and radiation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Hiltonol, dendritic cells and radiation.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Hiltonol and autologous dendritic cells</intervention_name>
    <description>Hiltonol and autologous dendritic cells</description>
    <arm_group_label>Hiltonol and autologous dendritic cells</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Hiltonol, dendritic cells and radiation</intervention_name>
    <description>Hiltonol, autologous dendritic cells and radiation therapy. Radiation therapy will pursue an abscopal effect.</description>
    <arm_group_label>Hiltonol, dendritic cells and radiation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Confirmed diagnosis of advanced solid tumors&#xD;
&#xD;
          -  Measurable disease&#xD;
&#xD;
          -  Performance status 0, 1 or 2.&#xD;
&#xD;
          -  Adequate renal, hepatic and bone marrow function&#xD;
&#xD;
          -  Availability of tumor tissue, for maturing dendritic cells&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Clinically relevant diseases or infections.&#xD;
&#xD;
          -  concurrent participation in other clinical trial or administration or other&#xD;
             antitumoral treatment&#xD;
&#xD;
          -  Concurrent cancer, with the exceptions allowed by the PI.&#xD;
&#xD;
          -  Pregnant or breast feeding women&#xD;
&#xD;
          -  immunosuppressant treatment&#xD;
&#xD;
          -  known uncontrolled central nervous system metastasis&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jose Luis Perez Gracia, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Clinica Universidad de Navarra</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Clinica Universidad de Navarra</name>
      <address>
        <city>Pamplona</city>
        <state>Navarra</state>
        <zip>31008</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>May 2016</verification_date>
  <study_first_submitted>November 21, 2012</study_first_submitted>
  <study_first_submitted_qc>November 21, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 27, 2012</study_first_posted>
  <last_update_submitted>April 10, 2017</last_update_submitted>
  <last_update_submitted_qc>April 10, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">April 11, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Poly I-C</mesh_term>
    <mesh_term>Carboxymethylcellulose Sodium</mesh_term>
    <mesh_term>Poly ICLC</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/NCT01734564
org study id: CD-2010-01
nct id: NCT01734564
lead sponsor: 
has dmc: Yes
In this phase II study, patients with solid tumors will receive treatment with hiltonol and
      autologous dendritic cells.
In this phase II study, patients with solid tumors will receive treatment with intratumoral
      hiltonol and two cycles of autologous dendritic cells loaded with autologous tumor and
      administered subcutaneously. A new cohort will explore the role of radiation therapy, looking
      for an abscopal effect.
allocation: Non-Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Response rate
time frame: 8-10 weeks
measure: Safety (Common Toxicity Criteria 4.0)
time frame: 8-10 weeks
arm group label: Hiltonol and autologous dendritic cells
arm group type: Experimental
description: Hiltonol and autologous dendritic cells
arm group label: Hiltonol, dendritic cells and radiation
arm group type: Experimental
description: Hiltonol, dendritic cells and radiation.
intervention type: Biological
intervention name: Hiltonol and autologous dendritic cells
description: Hiltonol and autologous dendritic cells
arm group label: Hiltonol and autologous dendritic cells
intervention type: Radiation
intervention name: Hiltonol, dendritic cells and radiation
description: Hiltonol, autologous dendritic cells and radiation therapy. Radiation therapy will pursue an abscopal effect.
arm group label: Hiltonol, dendritic cells and radiation
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jose Luis Perez Gracia, MD, PhD
role: Principal Investigator
affiliation: Clinica Universidad de Navarra
facility: 
country: Spain
responsible party type: Sponsor
mesh term: Poly I-C
mesh term: Carboxymethylcellulose Sodium
mesh term: Poly ICLC