<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/NCT01690377</url>
  </required_header>
  <id_info>
    <org_study_id>2004-093</org_study_id>
    <secondary_id>KWF 2004-3127</secondary_id>
    <nct_id>NCT01690377</nct_id>
  </id_info>
  <brief_title>Natural Dendritic Cell Vaccines in Metastatic Melanoma Patients</brief_title>
  <official_title>Plasmacytoid Dendritic Cells in Vaccination of Stage IV Melanoma Patients: a Phase I Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Radboud University Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Radboud University Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Dendritic cells (DCs) are the professional antigen-presenting cells of the immune system. As&#xD;
      such they are currently used in clinical vaccination protocols in cancer patients, and both&#xD;
      immunological and clinical responses have been observed. Several subsets of dendritic cells&#xD;
      have been characterized in the peripheral blood. One such subset is referred to as&#xD;
      plasmacytoid dendritic cells (PDC), another as myeloid dendritic cells (myDC). To date PDC&#xD;
      and myDC have not been evaluated for their capability to induce anti-tumor immune responses&#xD;
      in patients. For this reason the investigators will perform a safety and efficacy study with&#xD;
      PDC and myDC in stage IV melanoma patients.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>February 2008</start_date>
  <completion_date type="Actual">November 2014</completion_date>
  <primary_completion_date type="Actual">November 2014</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>intervention-related toxicity</measure>
    <time_frame>Within the first 6 months</time_frame>
    <description>all adverse events within a time frame of 3 weeks after the last vaccination will be scored according to Common Terminology Criteria for Adverse Events (CTCAE)Version 4.0</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Immunological response</measure>
    <time_frame>Within the first year</time_frame>
    <description>The immunological response will be determined by tetramer sampling of skin-test derived lymphocyte cultures and peripheral blood after vaccination</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Melanoma</condition>
  <arm_group>
    <arm_group_label>1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>PDC or myDC</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>PDC or myDC</intervention_name>
    <description>PDC or myDC; first patient 0.3 * 10E6 PDC; second and third 1 * 10E6 PDC; fourth and fifth 3 * 10E6 PDC.</description>
    <arm_group_label>1</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Stage IV melanoma according to the 2001 AJCC criteria. Limited tumor burden; LDH &lt; 2x&#xD;
             upper limit of normal&#xD;
&#xD;
          -  Histological proof of cutaneous melanoma&#xD;
&#xD;
          -  Melanoma expressing tyrosinase and/or gp100 (approximately 20% of cells or more&#xD;
             determined by immunohistochemistry staining)&#xD;
&#xD;
          -  HLA Type A2&#xD;
&#xD;
          -  WBC &gt; 3.0 * 10E9/l, lymphocytes &gt; 0.8 * 10E9/l, platelets &gt; 100 * 10E9/l, serum&#xD;
             creatinine &lt; 150 umol/l, serum bilirubin &lt; 25 umol/l, normal liver function&#xD;
&#xD;
          -  Expected adequacy of follow up&#xD;
&#xD;
          -  Written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  autoimmune disorders, concomitant use of immunosuppressive drugs&#xD;
&#xD;
          -  serious concomitant disease, serious active infections, other malignancy in the past 5&#xD;
             years with the exception of curatively treated carcinoma in-situ of the&#xD;
             cervix/squamous cell carcinoma of the skin&#xD;
&#xD;
          -  known allergy to shell fish (vaccine contains KLH)&#xD;
&#xD;
          -  pregnancy or lactation&#xD;
&#xD;
          -  clinical signs of CNS metastases, in patients with a clinical suspicion of CNS&#xD;
             metastases, a CT scan of the brain should be performed to exclude this&#xD;
&#xD;
          -  prior chemotherapy, immunotherapy, or radiotherapy within three months before planned&#xD;
             vaccination is allowed&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>C J A Punt, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Radboud University Medical Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>C G Figdor, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Radboud University Nijmegen Medical Centre / Nijmegen Centre for Molecular Life Sciences</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Radboud University Nijmegen Medical Centre</name>
      <address>
        <city>Nijmegen</city>
        <zip>6500 HB</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <verification_date>November 2014</verification_date>
  <study_first_submitted>February 5, 2008</study_first_submitted>
  <study_first_submitted_qc>September 18, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 21, 2012</study_first_posted>
  <last_update_submitted>December 7, 2016</last_update_submitted>
  <last_update_submitted_qc>December 7, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 8, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Dendritic Cells</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Melanoma</mesh_term>
  </condition_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/NCT01690377
org study id: 2004-093
secondary id: KWF 2004-3127
nct id: NCT01690377
lead sponsor: 
has dmc: No
Dendritic cells (DCs) are the professional antigen-presenting cells of the immune system. As
      such they are currently used in clinical vaccination protocols in cancer patients, and both
      immunological and clinical responses have been observed. Several subsets of dendritic cells
      have been characterized in the peripheral blood. One such subset is referred to as
      plasmacytoid dendritic cells (PDC), another as myeloid dendritic cells (myDC). To date PDC
      and myDC have not been evaluated for their capability to induce anti-tumor immune responses
      in patients. For this reason the investigators will perform a safety and efficacy study with
      PDC and myDC in stage IV melanoma patients.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: intervention-related toxicity
time frame: Within the first 6 months
description: all adverse events within a time frame of 3 weeks after the last vaccination will be scored according to Common Terminology Criteria for Adverse Events (CTCAE)Version 4.0
measure: Immunological response
time frame: Within the first year
description: The immunological response will be determined by tetramer sampling of skin-test derived lymphocyte cultures and peripheral blood after vaccination
arm group label: 1
arm group type: Experimental
description: PDC or myDC
intervention type: Biological
intervention name: PDC or myDC
description: PDC or myDC; first patient 0.3 * 10E6 PDC; second and third 1 * 10E6 PDC; fourth and fifth 3 * 10E6 PDC.
arm group label: 1
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: C J A Punt, MD, PhD
role: Principal Investigator
affiliation: Radboud University Medical Center
last name: C G Figdor, PhD
role: Principal Investigator
affiliation: Radboud University Nijmegen Medical Centre / Nijmegen Centre for Molecular Life Sciences
facility: 
country: Netherlands
responsible party type: Sponsor
mesh term: Melanoma