<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/NCT02976441</url>
  </required_header>
  <id_info>
    <org_study_id>15-x135</org_study_id>
    <nct_id>NCT02976441</nct_id>
  </id_info>
  <brief_title>Autologous Stem Cell Collection and Reinfusion in Newly Diagnosed High Grade Gliomas</brief_title>
  <official_title>Feasibility of Autologous Stem Cell Collection and Reinfusion in Newly Diagnosed High Grade Gliomas</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Washington University School of Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Washington University School of Medicine</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators hypothesize that this study will show that sufficient lymphocyte stem cell&#xD;
      can be harvested prior chemoradiation and be reinfused back after treatment, and at least 5&#xD;
      of the 10 patients (50%) will achieve an absolute increase of lymphocyte counts of 300&#xD;
      cells/mm^3 four weeks after stem cell reinfusion in high grade glioma patients.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Physician decided not to go through with study&#xD;
  </why_stopped>
  <start_date>January 2017</start_date>
  <completion_date type="Anticipated">February 2018</completion_date>
  <primary_completion_date type="Anticipated">February 2018</primary_completion_date>
  <phase>Early 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>Efficacy of lymphocyte stem cell harvesting and reinfusion in patients as measured by the number of patients from whom 1-5x10e6 lymphocyte stem cells are collected and successfully reinfused without an adverse event</measure>
    <time_frame>Completion of follow-up of all patients who received stem cell reinfusions (estimated to be 15 months)</time_frame>
    <description>The study will provide preliminary evidence of efficacy if ≥5 of 10 patients (50%) achieve an increase over baseline in absolute lymphocyte counts (ALC) ≥300 cells/mm3 at 4 weeks after reinfusion from their baseline lymphocyte counts.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of lymphocyte stem cells that can be harvested from this patient population</measure>
    <time_frame>Completion of follow-up of all patients who received stem cell reinfusions (estimated to be 15 months)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of patients who have an increase in lymphocyte of ≥300 cells/mm^3 after autologous stem cell reinfusion.</measure>
    <time_frame>4 weeks after stem cell reinfusion</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of lymphocyte rise following stem cell reinfusion</measure>
    <time_frame>Up to 6 months after stem cell reinfusion (approximately 9 months)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in lymphocyte subtypes following collection and reinfusion</measure>
    <time_frame>Up to 6 months after stem cell reinfusion (approximately 9 months)</time_frame>
    <description>Lymphocyte subtypes will be monitored by flow cytometry at the time of stem cell collection, prior to autologous stem cell reinfusion, and then monthly for 6 months.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in series of cytokine levels following collection and reinfusion</measure>
    <time_frame>Up to 6 months after stem cell reinfusion (approximately 9 months)</time_frame>
    <description>Cytokine levels will be checked by ELISPOT at the time of stem cell collection, weekly during radiation therapy/temozolomide (up to 6 weeks), prior to autologous stem cell reinfusion, and then monthly for 6 months.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety and toxicities with stem cell collection and reinfusion as measured by grade and frequency of adverse events</measure>
    <time_frame>Up to 6 months after stem cell reinfusion (approximately 9 months)</time_frame>
    <description>the descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for all adverse event/toxicity reporting.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Astrocytoma</condition>
  <condition>Brainstem Glioma</condition>
  <condition>Ependymoma</condition>
  <condition>Mixed Glioma</condition>
  <condition>Oligodendroglioma</condition>
  <condition>Optic Nerve Glioma</condition>
  <arm_group>
    <arm_group_label>Focal RT, Temozolomide, Stem Cell Collection/Reinfusion</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Autologous stem cell collection will be performed 1-4 days prior to initiating radiation therapy and temozolomide&#xD;
Focal radiation therapy: standard of care dose daily for approximately 6 weeks&#xD;
Temozolomide: standard of care dose by mouth daily for 6 weeks with radiation&#xD;
2-7 days after the end of the radiation therapy and temozolomide the stem cells will be reinfused into the patient&#xD;
Temozolomide: standard of care dose by mouth on days 1-5 every 28 days for 6 months following a 4-6 week rest period after the initial radiation and temozolomide</description>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Radiation therapy</intervention_name>
    <arm_group_label>Focal RT, Temozolomide, Stem Cell Collection/Reinfusion</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Temozolomide</intervention_name>
    <arm_group_label>Focal RT, Temozolomide, Stem Cell Collection/Reinfusion</arm_group_label>
    <other_name>Temodar®</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Stem cell collection</intervention_name>
    <arm_group_label>Focal RT, Temozolomide, Stem Cell Collection/Reinfusion</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Stem cell infusion</intervention_name>
    <arm_group_label>Focal RT, Temozolomide, Stem Cell Collection/Reinfusion</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Histologically confirmed newly diagnosed high grade glioma by pathology (WHO grade III&#xD;
             or IV).&#xD;
&#xD;
          -  At least 18 years of age.&#xD;
&#xD;
          -  Karnofsky performance status ≥ 60%&#xD;
&#xD;
          -  Normal bone marrow and organ function as defined below:&#xD;
&#xD;
               -  Absolute neutrophil count ≥ 1,500/mcl&#xD;
&#xD;
               -  Platelets ≥ 100,000/mcl&#xD;
&#xD;
               -  Hematocrit ≥ 30%&#xD;
&#xD;
               -  Absolute lymphocyte count ≥ 1000/mcl Blood transfusions are permitted to allow&#xD;
                  potential participant to meet these criteria.&#xD;
&#xD;
          -  Post-operative treatment plan must include standard radiation and temozolomide.&#xD;
&#xD;
          -  Women of childbearing potential and men must agree to use adequate contraception&#xD;
             (hormonal or barrier method of birth control, abstinence) prior to study entry and for&#xD;
             the duration of study participation. Should a woman become pregnant or suspect she is&#xD;
             pregnant while participating in this study, she must inform her treating physician&#xD;
             immediately.&#xD;
&#xD;
          -  Ability to understand and willingness to sign an IRB approved written informed consent&#xD;
             document (or that of legally authorized representative, if applicable).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Prior treatment with radiation therapy, chemotherapy, immunotherapy, biologic agents&#xD;
             (including immunotoxins, immunoconjugates, antisense, peptide receptor antagonists,&#xD;
             interferons, interleukins, TIL, LAK, or gene therapy), or hormonal therapy.&#xD;
             Glucocorticoid therapy is allowed.&#xD;
&#xD;
          -  Anti-VEGF therapy within 6 weeks of registration.&#xD;
&#xD;
          -  A history of other malignancy ≤ 5 years previous with the exception of basal cell or&#xD;
             squamous cell carcinoma of the skin which were treated with local resection only or&#xD;
             carcinoma in situ of the cervix.&#xD;
&#xD;
          -  Currently receiving any investigational agents that might affect lymphocytes. Patients&#xD;
             receiving Novocure are allowed on study.&#xD;
&#xD;
          -  A history of allergic reactions attributed to compounds of similar chemical or&#xD;
             biologic composition to filgrastim or plerixafor or other agents used in the study.&#xD;
&#xD;
          -  Fresh CNS bleed as evident by MRI or CT.&#xD;
&#xD;
          -  Contraindicated for anticoagulation.&#xD;
&#xD;
          -  Uncontrolled intercurrent illness including, but not limited to, ongoing or active&#xD;
             infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac&#xD;
             arrhythmia, or psychiatric illness/social situations that would limit compliance with&#xD;
             study requirements.&#xD;
&#xD;
          -  Pregnant and/or breastfeeding. Women of childbearing potential must have a negative&#xD;
             pregnancy test within 14 days of study entry.&#xD;
&#xD;
          -  Known HIV-positivity.&#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>Jian Li Campian, M.D., Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Washington University School of Medicine</affiliation>
  </overall_official>
  <removed_countries>
    <country>United States</country>
  </removed_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>February 2017</verification_date>
  <study_first_submitted>November 23, 2016</study_first_submitted>
  <study_first_submitted_qc>November 23, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 29, 2016</study_first_posted>
  <last_update_submitted>February 16, 2017</last_update_submitted>
  <last_update_submitted_qc>February 16, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">February 20, 2017</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>Glioma</mesh_term>
    <mesh_term>Astrocytoma</mesh_term>
    <mesh_term>Ependymoma</mesh_term>
    <mesh_term>Oligodendroglioma</mesh_term>
    <mesh_term>Optic Nerve Glioma</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Temozolomide</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/NCT02976441
org study id: 15-x135
nct id: NCT02976441
lead sponsor: 
has dmc: No
The investigators hypothesize that this study will show that sufficient lymphocyte stem cell
      can be harvested prior chemoradiation and be reinfused back after treatment, and at least 5
      of the 10 patients (50%) will achieve an absolute increase of lymphocyte counts of 300
      cells/mm^3 four weeks after stem cell reinfusion in high grade glioma patients.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Efficacy of lymphocyte stem cell harvesting and reinfusion in patients as measured by the number of patients from whom 1-5x10e6 lymphocyte stem cells are collected and successfully reinfused without an adverse event
time frame: Completion of follow-up of all patients who received stem cell reinfusions (estimated to be 15 months)
description: The study will provide preliminary evidence of efficacy if ≥5 of 10 patients (50%) achieve an increase over baseline in absolute lymphocyte counts (ALC) ≥300 cells/mm3 at 4 weeks after reinfusion from their baseline lymphocyte counts.
measure: Number of lymphocyte stem cells that can be harvested from this patient population
time frame: Completion of follow-up of all patients who received stem cell reinfusions (estimated to be 15 months)
measure: Proportion of patients who have an increase in lymphocyte of ≥300 cells/mm^3 after autologous stem cell reinfusion.
time frame: 4 weeks after stem cell reinfusion
measure: Duration of lymphocyte rise following stem cell reinfusion
time frame: Up to 6 months after stem cell reinfusion (approximately 9 months)
measure: Changes in lymphocyte subtypes following collection and reinfusion
time frame: Up to 6 months after stem cell reinfusion (approximately 9 months)
description: Lymphocyte subtypes will be monitored by flow cytometry at the time of stem cell collection, prior to autologous stem cell reinfusion, and then monthly for 6 months.
measure: Changes in series of cytokine levels following collection and reinfusion
time frame: Up to 6 months after stem cell reinfusion (approximately 9 months)
description: Cytokine levels will be checked by ELISPOT at the time of stem cell collection, weekly during radiation therapy/temozolomide (up to 6 weeks), prior to autologous stem cell reinfusion, and then monthly for 6 months.
measure: Safety and toxicities with stem cell collection and reinfusion as measured by grade and frequency of adverse events
time frame: Up to 6 months after stem cell reinfusion (approximately 9 months)
description: the descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for all adverse event/toxicity reporting.
arm group label: Focal RT, Temozolomide, Stem Cell Collection/Reinfusion
arm group type: Experimental
description: Autologous stem cell collection will be performed 1-4 days prior to initiating radiation therapy and temozolomide
Focal radiation therapy: standard of care dose daily for approximately 6 weeks
Temozolomide: standard of care dose by mouth daily for 6 weeks with radiation
2-7 days after the end of the radiation therapy and temozolomide the stem cells will be reinfused into the patient
Temozolomide: standard of care dose by mouth on days 1-5 every 28 days for 6 months following a 4-6 week rest period after the initial radiation and temozolomide
intervention type: Radiation
intervention name: Radiation therapy
arm group label: Focal RT, Temozolomide, Stem Cell Collection/Reinfusion
intervention type: Drug
intervention name: Temozolomide
arm group label: Focal RT, Temozolomide, Stem Cell Collection/Reinfusion
other name: Temodar®
intervention type: Procedure
intervention name: Stem cell collection
arm group label: Focal RT, Temozolomide, Stem Cell Collection/Reinfusion
intervention type: Procedure
intervention name: Stem cell infusion
arm group label: Focal RT, Temozolomide, Stem Cell Collection/Reinfusion
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jian Li Campian, M.D., Ph.D.
role: Principal Investigator
affiliation: Washington University School of Medicine
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: Glioma
mesh term: Astrocytoma
mesh term: Ependymoma
mesh term: Oligodendroglioma
mesh term: Optic Nerve Glioma
mesh term: Temozolomide