<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/NCT01702792</url>
  </required_header>
  <id_info>
    <org_study_id>W12209</org_study_id>
    <nct_id>NCT01702792</nct_id>
  </id_info>
  <brief_title>Derivation of Tumor Specific Hybridomas</brief_title>
  <official_title>Vaccination of Patients With Newly Diagnosed Glioblastoma Using Autologous Tumor Lysate and Montanide Emulsion for Derivation of Tumor Specific Hybridomas</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Dartmouth-Hitchcock Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Vermont</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Dartmouth-Hitchcock Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a non-randomized, open-label study in patients with newly diagnosed glioblastoma to&#xD;
      determine the ability to generate human hybridomas from lymph nodes draining an autologous&#xD;
      tumor vaccine injection and demonstrate that the hybridomas secrete glioblastoma-specific&#xD;
      antibodies.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The intradermal vaccine will be injected 20cm in the anterior thigh. Vaccination will be done&#xD;
      twice and separated by one week. The first vaccination will be performed approximately 2&#xD;
      weeks after surgery.&#xD;
&#xD;
      Approximately one week after the second vaccination one or two vaccine-draining lymph node(s)&#xD;
      will be removed. The lymph node(s) will be identified using SN technology. One or two lymph&#xD;
      node(s) will be removed.&#xD;
&#xD;
      Lymph nodes will be processed for recovery of B cells and formation of hybridomas.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Investigator is leaving Dartmouth&#xD;
  </why_stopped>
  <start_date>January 2014</start_date>
  <completion_date type="Actual">May 6, 2015</completion_date>
  <primary_completion_date type="Actual">May 6, 2015</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>number of hybridoma clones that produce anti-glioma antibodies</measure>
    <time_frame>6 months</time_frame>
    <description>The primary technical endpoint demonstrating the feasibility of the pilot study will be based upon the total count of the number of generated hybridoma clones sourced from the dermal vaccine draining lymph nodes that are determined to be producing anti-glioma antibodies.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Production of Antibodies</measure>
    <time_frame>6 months</time_frame>
    <description>Secondary outcomes will include:&#xD;
Determining how many hybridoma clones produce glioblastoma-specific antibodies. The initial secondary endpoint will include the counting of the number of hybridoma clones sourced from the dermal vaccine draining lymph nodes that generate specific glioma antibodies.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Toxicity of Vaccine</measure>
    <time_frame>6 months</time_frame>
    <description>• Determining toxicity of vaccine</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clone Production Rate</measure>
    <time_frame>6 months</time_frame>
    <description>Determining whether B cells sourced from the vaccine nodes produce more anti-tumor antibody hybridomas than the non-vaccine node. The rate of producing these clones will be compared according to the source of the B cells. Thus, B cells recovered from vaccine related nodes will be compared to B cells recovered from the non-vaccine node.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lymph Node Biopsy</measure>
    <time_frame>6 months</time_frame>
    <description>Determine the safety and toxicity issues related to the Lymph Node Biopsy</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Tumor Binding Characteristics</measure>
    <time_frame>6 months</time_frame>
    <description>Exploratory objectives will include:&#xD;
Determining the rate of tumor binding antibodies from hybridomas derived from circulating B cells.&#xD;
Determining the tumor-binding profile of antibodies present in the blood.</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">1</enrollment>
  <condition>Glioblastoma</condition>
  <arm_group>
    <arm_group_label>Tumor Vaccine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>1 x 107 TCE tumor lysate in 0.5 ml Lactated Ringers Solution (approximately 1 mg of tumor lysate protein) and equivalent volume of adjuvant will be injected 2 weeks and 3 weeks (2 vaccinations) after surgery in the intradermal skin of the upper thigh. There will be 2 vaccine administrations and patients will be followed for 2 months after inguinal node removal for any possible vaccine/study-related toxicity.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Tumor Vaccine</intervention_name>
    <description>Tumor cells obtained at the time of surgery are irradiated with 10,000 Gy and freeze fractured. Lysate at 1x107 tumor cell equivalent (TCE) will be used for vaccination with adjuvant, Montanide ISA 51 VG.</description>
    <arm_group_label>Tumor Vaccine</arm_group_label>
    <other_name>Autologous Tumor Lysate and Montanide Emulsion</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with confirmed new diagnosis of glioblastoma and who have a yield of at least&#xD;
             8x10(7) tumor cells obtained at the time of surgery&#xD;
&#xD;
          -  Age &gt; 18 years&#xD;
&#xD;
          -  KPS Score of greater than or equal to 70&#xD;
&#xD;
          -  Adequate bone marrow as evidenced by:&#xD;
&#xD;
        Absolute lymphocyte count &gt; 1,000/uL Platelet count &gt; 50,000/uL&#xD;
&#xD;
          -  Adequate renal function as evidenced by serum creatinine &lt; 2.0&#xD;
&#xD;
          -  Patients must be able to read, understand and provide informed consent to participate&#xD;
             in the trial.&#xD;
&#xD;
          -  Patients of childbearing potential must agree to use an effective form of&#xD;
             contraception during the study and for 90 days following vaccination (an effective&#xD;
             form of contraception is an oral contraceptive or a double barrier method)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        A patient may not be enrolled in the trial if any of the following criteria are met:&#xD;
&#xD;
          -  Patients receiving dexamethasone &gt; 8 mg/day during the week before vaccination.&#xD;
&#xD;
          -  Patients who are pregnant or lactating&#xD;
&#xD;
          -  Patients with active second malignancy.&#xD;
&#xD;
          -  Any other medical conditions, including mental illness or substance abuse, deemed by&#xD;
             the Investigator to be likely to interfere with a patient's ability to sign informed&#xD;
             consent, cooperate and participate in the study, or interfere with the interpretation&#xD;
             of the results.&#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>Camilo Fadul, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Dartmouth-Hitchcock Medical Center</affiliation>
  </overall_official>
  <removed_countries>
    <country>United States</country>
  </removed_countries>
  <verification_date>April 2018</verification_date>
  <study_first_submitted>October 3, 2012</study_first_submitted>
  <study_first_submitted_qc>October 5, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 8, 2012</study_first_posted>
  <last_update_submitted>April 2, 2018</last_update_submitted>
  <last_update_submitted_qc>April 2, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">April 4, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Immunotherapy, cancer vaccine, glioblastoma, hybridoma</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Glioblastoma</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Monatide (IMS 3015)</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/NCT01702792
org study id: W12209
nct id: NCT01702792
lead sponsor: 
collaborator: 
has dmc: Yes
This is a non-randomized, open-label study in patients with newly diagnosed glioblastoma to
      determine the ability to generate human hybridomas from lymph nodes draining an autologous
      tumor vaccine injection and demonstrate that the hybridomas secrete glioblastoma-specific
      antibodies.
The intradermal vaccine will be injected 20cm in the anterior thigh. Vaccination will be done
      twice and separated by one week. The first vaccination will be performed approximately 2
      weeks after surgery.

      Approximately one week after the second vaccination one or two vaccine-draining lymph node(s)
      will be removed. The lymph node(s) will be identified using SN technology. One or two lymph
      node(s) will be removed.

      Lymph nodes will be processed for recovery of B cells and formation of hybridomas.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: number of hybridoma clones that produce anti-glioma antibodies
time frame: 6 months
description: The primary technical endpoint demonstrating the feasibility of the pilot study will be based upon the total count of the number of generated hybridoma clones sourced from the dermal vaccine draining lymph nodes that are determined to be producing anti-glioma antibodies.
measure: Production of Antibodies
time frame: 6 months
description: Secondary outcomes will include:
Determining how many hybridoma clones produce glioblastoma-specific antibodies. The initial secondary endpoint will include the counting of the number of hybridoma clones sourced from the dermal vaccine draining lymph nodes that generate specific glioma antibodies.
measure: Toxicity of Vaccine
time frame: 6 months
description: • Determining toxicity of vaccine
measure: Clone Production Rate
time frame: 6 months
description: Determining whether B cells sourced from the vaccine nodes produce more anti-tumor antibody hybridomas than the non-vaccine node. The rate of producing these clones will be compared according to the source of the B cells. Thus, B cells recovered from vaccine related nodes will be compared to B cells recovered from the non-vaccine node.
measure: Lymph Node Biopsy
time frame: 6 months
description: Determine the safety and toxicity issues related to the Lymph Node Biopsy
measure: Tumor Binding Characteristics
time frame: 6 months
description: Exploratory objectives will include:
Determining the rate of tumor binding antibodies from hybridomas derived from circulating B cells.
Determining the tumor-binding profile of antibodies present in the blood.
arm group label: Tumor Vaccine
arm group type: Experimental
description: 1 x 107 TCE tumor lysate in 0.5 ml Lactated Ringers Solution (approximately 1 mg of tumor lysate protein) and equivalent volume of adjuvant will be injected 2 weeks and 3 weeks (2 vaccinations) after surgery in the intradermal skin of the upper thigh. There will be 2 vaccine administrations and patients will be followed for 2 months after inguinal node removal for any possible vaccine/study-related toxicity.
intervention type: Biological
intervention name: Tumor Vaccine
description: Tumor cells obtained at the time of surgery are irradiated with 10,000 Gy and freeze fractured. Lysate at 1x107 tumor cell equivalent (TCE) will be used for vaccination with adjuvant, Montanide ISA 51 VG.
arm group label: Tumor Vaccine
other name: Autologous Tumor Lysate and Montanide Emulsion
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Camilo Fadul, MD
role: Principal Investigator
affiliation: Dartmouth-Hitchcock Medical Center
country: United States
responsible party type: Sponsor
mesh term: Glioblastoma
mesh term: Monatide (IMS 3015)