<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/NCT01695733</url>
  </required_header>
  <id_info>
    <org_study_id>201010722</org_study_id>
    <nct_id>NCT01695733</nct_id>
  </id_info>
  <brief_title>Response to Influenza Vaccine in Patients With Non-Hematologic Malignancies Receiving Chemotherapy</brief_title>
  <official_title>Influenza Vaccination Response in Patients With Non-Hematological Malignancies</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Washington University School of Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Washington University School of Medicine</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This clinical trial studies the best time to administer the influenza vaccine to patients&#xD;
      with non-hematologic malignancies receiving chemotherapy. Giving the vaccine at different&#xD;
      times relative to chemotherapy may affect how well it works to help the body build an immune&#xD;
      response and prevent influenza in these patients.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    no longer had funding to continue&#xD;
  </why_stopped>
  <start_date>September 2011</start_date>
  <completion_date type="Actual">September 2013</completion_date>
  <primary_completion_date type="Actual">September 2013</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>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>Optimal timing of seasonal influenza vaccination with regard to chemotherapy administration schedule.</measure>
    <time_frame>4 weeks from the influenza vaccine</time_frame>
    <description>We will assess co-primary endpoints of serologic response to the H3N2 and H1N1 strains in the 2011-2012 and 2012-2013 seasonal influenza vaccine.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Report the presence of post-vaccination adverse events</measure>
    <time_frame>4 weeks from the influenza vaccine</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">21</enrollment>
  <condition>Neoplasms</condition>
  <arm_group>
    <arm_group_label>Schedule A</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Influenza vaccination on the first day of chemotherapy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Schedule B</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Influenza vaccination 1 week (+/- 1 day) prior to chemotherapy</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>trivalent influenza vaccine</intervention_name>
    <arm_group_label>Schedule A</arm_group_label>
    <arm_group_label>Schedule B</arm_group_label>
    <other_name>Flushield, Fluvirin, Fluzone, Influenza Vaccine</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients must have biopsy-confirmed non-hematological malignancy&#xD;
&#xD;
          -  Patients must be scheduled to receive cytotoxic chemotherapy (adjuvant or metastatic&#xD;
             setting), excluding immunotherapy&#xD;
&#xD;
          -  Patients must be of age &gt;=18 years.&#xD;
&#xD;
          -  Patients must have an absolute lymphocyte count &gt;= 1,000/mcL immediately prior to&#xD;
             influenza vaccination&#xD;
&#xD;
          -  Ability of the patient (or legally authorized representative if applicable) to&#xD;
             understand and the willingness to sign a written informed consent document&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who have already received the influenza vaccine during the season in which&#xD;
             they are considered for eligibility will be excluded&#xD;
&#xD;
          -  History of allergic reactions attributed to compounds of similar chemical or biologic&#xD;
             composition to the influenza vaccine or egg allergies&#xD;
&#xD;
          -  Previous history of Guillian-Barre syndrome within the previous 6 weeks to influenza&#xD;
             vaccination&#xD;
&#xD;
          -  Patients must not be receiving chronic steroid therapy, defined as &gt;= 14 days, unless&#xD;
             used as part of a chemotherapy regimen&#xD;
&#xD;
          -  Patients must not be on any other agents that can suppress the immune system&#xD;
&#xD;
          -  Planned concurrent therapy with radiation&#xD;
&#xD;
          -  Uncontrolled illness at time of enrollment or influenza vaccination including, but not&#xD;
             limited to, ongoing or active febrile illness&#xD;
&#xD;
          -  Psychiatric illness/social situations that would limit compliance with study&#xD;
             requirements&#xD;
&#xD;
          -  Known immunosuppression eg. history of organ transplantation or known human&#xD;
             immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy&#xD;
             are ineligible because they may not be able to mount an appropriate immune response&#xD;
&#xD;
          -  History of influenza-like illness, defined as a temperature &gt; 37.8 degree C with cough&#xD;
             or sore throat starting October 1, 2011 throughout the duration of the study&#xD;
&#xD;
          -  Patient may not be scheduled to receive chemotherapy on a weekly basis.&#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>Saiama Waqar, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Washington University School of Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Washington University School of Medicine</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.siteman.wustl.edu</url>
    <description>Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine</description>
  </link>
  <verification_date>August 2018</verification_date>
  <study_first_submitted>September 26, 2012</study_first_submitted>
  <study_first_submitted_qc>September 26, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 28, 2012</study_first_posted>
  <last_update_submitted>August 29, 2018</last_update_submitted>
  <last_update_submitted_qc>August 29, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">August 31, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Influenza, Human</mesh_term>
    <mesh_term>Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vaccines</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/NCT01695733
org study id: 201010722
nct id: NCT01695733
lead sponsor: 
collaborator: 
has dmc: No
This clinical trial studies the best time to administer the influenza vaccine to patients
      with non-hematologic malignancies receiving chemotherapy. Giving the vaccine at different
      times relative to chemotherapy may affect how well it works to help the body build an immune
      response and prevent influenza in these patients.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Optimal timing of seasonal influenza vaccination with regard to chemotherapy administration schedule.
time frame: 4 weeks from the influenza vaccine
description: We will assess co-primary endpoints of serologic response to the H3N2 and H1N1 strains in the 2011-2012 and 2012-2013 seasonal influenza vaccine.
measure: Report the presence of post-vaccination adverse events
time frame: 4 weeks from the influenza vaccine
arm group label: Schedule A
arm group type: Experimental
description: Influenza vaccination on the first day of chemotherapy
arm group label: Schedule B
arm group type: Experimental
description: Influenza vaccination 1 week (+/- 1 day) prior to chemotherapy
intervention type: Biological
intervention name: trivalent influenza vaccine
arm group label: Schedule A
arm group label: Schedule B
other name: Flushield, Fluvirin, Fluzone, Influenza Vaccine
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Saiama Waqar, M.D.
role: Principal Investigator
affiliation: Washington University School of Medicine
facility: 
country: United States
url: http://www.siteman.wustl.edu
description: Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine
responsible party type: Sponsor
mesh term: Influenza, Human
mesh term: Neoplasms
mesh term: Vaccines