<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/NCT01677962</url>
  </required_header>
  <id_info>
    <org_study_id>101778</org_study_id>
    <nct_id>NCT01677962</nct_id>
  </id_info>
  <brief_title>A Study of Vaccination With Poly-ICLC and Dendritic Cells in Patients With Pancreatic Adenocarcinoma</brief_title>
  <official_title>A Feasibility and Safety Study of Vaccination With Poly-ICLC and Dendritic Cells in Patients With Locally Advanced Unresectable Pancreatic Adenocarcinoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medical University of South Carolina</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medical University of South Carolina</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The main purpose of this study is to examine the safety of the study drug in patients with&#xD;
      locally advanced unresectable pancreatic adenocarcinoma. The study team would like to know&#xD;
      about any side effects a patient may have when given the study drug. Another goal of the&#xD;
      study is to determine if combining dendritic cells and the study drug can be possibly used as&#xD;
      a vaccine for this disease. Dendritic cells are cells that are present in the body's immune&#xD;
      system that help your body fight disease.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">May 2016</completion_date>
  <primary_completion_date type="Actual">September 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>Primary Outcome</measure>
    <time_frame>from study consent to last treatment (Day 56)</time_frame>
    <description>Number of Participants With Adverse Events (AEs)&#xD;
Evaluate the frequency of toxicities by type and severity, and dose of study drug according to the Common Toxicity Criteria for Adverse Events (CTCAE) version 4.0.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Primary Objective</measure>
    <time_frame>from study consent to last treatment (Day 56)</time_frame>
    <description>Determining the feasibility of generating dendritic cells and administering these cells as a vaccine to patients</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Secondary Outcome</measure>
    <time_frame>Average three months Per Participant</time_frame>
    <description>Number of Participants With Tumor Response</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Secondary Objective</measure>
    <time_frame>Post treatment</time_frame>
    <description>Measure overall Survival</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">12</enrollment>
  <condition>Pancreatic Adenocarcinoma Non-resectable</condition>
  <arm_group>
    <arm_group_label>dendritic cell and Poly-ICLC vaccination</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Dendritic cell and Poly-ICLC vaccination will be administered directly into the tumor on Day 0 and Day 14 of Treatment Phase. Subjects will then have standard of care procedures along with injections of Poly-ICLC and dendritic cells for the remainder of the study.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Poly-ICLC</intervention_name>
    <arm_group_label>dendritic cell and Poly-ICLC vaccination</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>dendritic cell</intervention_name>
    <arm_group_label>dendritic cell and Poly-ICLC vaccination</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Each of the following criteria must be met in order for a patient to be considered eligible&#xD;
        for enrollment.&#xD;
&#xD;
          -  Patients must have histologically or cytologically confirmed diagnosis of pancreatic&#xD;
             adenocarcinoma that is locally advanced and unresectable. Patients with endocrine or&#xD;
             neuroendocrine tumors, lymphoma of the pancreas, or ampullary cancer are not eligible.&#xD;
&#xD;
          -  Patients must have measurable disease per RECIST 1.1. One or more tumors measurable on&#xD;
             CT scan per RECIST 1.1. (Eisenhauer)&#xD;
&#xD;
          -  Patients may have had prior cancer therapy. Patients do not need to demonstrate&#xD;
             progression to be considered for this trial.&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group (ECOG) performance status ≤2.&#xD;
&#xD;
          -  Age ≥ 18 years.&#xD;
&#xD;
          -  Patient must have an expected life expectancy greater than 3 months.&#xD;
&#xD;
          -  Signed, written IRB-approved informed consent.&#xD;
&#xD;
          -  Bilirubin ≤ 3 times upper limit of normal (CTCAE Grade 2 baseline)&#xD;
&#xD;
          -  AST (SGOT), ALT (SGPT) ≤ 3 x ULN (CTCAE Grade 1 baseline)&#xD;
&#xD;
          -  Serum creatinine ≤1.5 XULN (CTCAE Grade 1 baseline)&#xD;
&#xD;
          -  Acceptable hematologic status, defined as:&#xD;
&#xD;
          -  Absolute neutrophil count ≥ 1000 cells/mm3&#xD;
&#xD;
          -  Platelet count ≥ 75,000 (plt/mm3), (CTCAE Grade 1 baseline)&#xD;
&#xD;
          -  Hemoglobin ≥ 9 g/dL.&#xD;
&#xD;
          -  Urinalysis with no clinically significant abnormalities.&#xD;
&#xD;
          -  PT and PTT ≤ 1.5 X ULN after correction of nutritional deficiencies that may&#xD;
             contribute to prolonged PT/PTT&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Each of the following criteria should not be present in order for the patient to be&#xD;
        considered eligible for enrollment.&#xD;
&#xD;
          -  Patients must not have metastatic disease. Patients with evidence of metastatic&#xD;
             disease at the time of screening or prior to the administration of DC vaccination will&#xD;
             be considered a screen failure and excluded from study.&#xD;
&#xD;
          -  Prior surgery is allowed provided at least 14 days has elapsed between surgery and&#xD;
             registration. Prior radiation/chemo is allowed provided that at least 28 days have&#xD;
             elapsed since the last treatment.&#xD;
&#xD;
          -  Patients must not have any serious uncontrolled acute or chronic medical condition&#xD;
             that would interfere with this treatment. Examples would include active acute or&#xD;
             chronic infection requiring antibiotics, uncontrolled cardiovascular, endocrine, or&#xD;
             infectious disease.&#xD;
&#xD;
          -  Patient must not have clinically significant ascites.&#xD;
&#xD;
          -  Patients must not have significant ongoing cardiac problems, myocardial infarction&#xD;
             within the last six months, uncontrolled hypertension, unstable angina, uncontrolled&#xD;
             arrhythmia or congestive heart failure.&#xD;
&#xD;
          -  Patients with known brain metastases are not eligible. However, brain-imaging studies&#xD;
             are not required for eligibility if the patient has no neurologic signs or symptoms.&#xD;
             If brainimaging studies are performed, they must be negative for disease. Patients&#xD;
             must have no plans to receive concurrent chemotherapy, hormonal therapy, radiotherapy,&#xD;
             immunotherapy or any other type of therapy for treatment of cancer while on this&#xD;
             protocol treatment.&#xD;
&#xD;
          -  Due to the undetermined effect of this treatment regimen in patients with HIV-1&#xD;
             infection and the potential for serious interaction with anti-HIV medications,&#xD;
             patients known to be infected with HIV are not eligible for this study.&#xD;
&#xD;
          -  Due to the possibility of harm to a fetus or nursing infant from this treatment&#xD;
             regimen, patients must not be pregnant or nursing. Women of child bearing potential&#xD;
             must have a negative pregnancy test completed during study screening. Women and men of&#xD;
             reproductive potential must have agreed to use an effective contraceptive method.&#xD;
&#xD;
          -  No other prior malignancy is allowed except for the following: adequately treated&#xD;
             basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated&#xD;
             Stage I or II cancer from which the patient is currently in complete remission, or any&#xD;
             other cancer from which the patient has been disease free for five years.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Medical University of South Carolina</name>
      <address>
        <city>Charleston</city>
        <state>South Carolina</state>
        <zip>29425</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>August 17, 2012</study_first_submitted>
  <study_first_submitted_qc>August 29, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 3, 2012</study_first_posted>
  <last_update_submitted>December 13, 2016</last_update_submitted>
  <last_update_submitted_qc>December 13, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 15, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Medical University of South Carolina</investigator_affiliation>
    <investigator_full_name>Carolyn Britten</investigator_full_name>
    <investigator_title>Chief, Hematology/Oncology Division</investigator_title>
  </responsible_party>
  <keyword>locally advanced, unresectable pancreatic adenocarcinoma</keyword>
  <keyword>Poly ICLC</keyword>
  <keyword>dendritic cells</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Adenocarcinoma</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <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/NCT01677962
org study id: 101778
nct id: NCT01677962
lead sponsor: 
has dmc: Yes
The main purpose of this study is to examine the safety of the study drug in patients with
      locally advanced unresectable pancreatic adenocarcinoma. The study team would like to know
      about any side effects a patient may have when given the study drug. Another goal of the
      study is to determine if combining dendritic cells and the study drug can be possibly used as
      a vaccine for this disease. Dendritic cells are cells that are present in the body's immune
      system that help your body fight disease.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Primary Outcome
time frame: from study consent to last treatment (Day 56)
description: Number of Participants With Adverse Events (AEs)
Evaluate the frequency of toxicities by type and severity, and dose of study drug according to the Common Toxicity Criteria for Adverse Events (CTCAE) version 4.0.
measure: Primary Objective
time frame: from study consent to last treatment (Day 56)
description: Determining the feasibility of generating dendritic cells and administering these cells as a vaccine to patients
measure: Secondary Outcome
time frame: Average three months Per Participant
description: Number of Participants With Tumor Response
measure: Secondary Objective
time frame: Post treatment
description: Measure overall Survival
arm group label: dendritic cell and Poly-ICLC vaccination
arm group type: Experimental
description: Dendritic cell and Poly-ICLC vaccination will be administered directly into the tumor on Day 0 and Day 14 of Treatment Phase. Subjects will then have standard of care procedures along with injections of Poly-ICLC and dendritic cells for the remainder of the study.
intervention type: Biological
intervention name: Poly-ICLC
arm group label: dendritic cell and Poly-ICLC vaccination
intervention type: Biological
intervention name: dendritic cell
arm group label: dendritic cell and Poly-ICLC vaccination
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Medical University of South Carolina
investigator full name: Carolyn Britten
investigator title: Chief, Hematology/Oncology Division
mesh term: Adenocarcinoma
mesh term: Poly ICLC