<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/NCT02192359</url>
  </required_header>
  <id_info>
    <org_study_id>14108</org_study_id>
    <secondary_id>NCI-2014-01463</secondary_id>
    <secondary_id>14108</secondary_id>
    <secondary_id>P30CA033572</secondary_id>
    <secondary_id>R01CA198076</secondary_id>
    <nct_id>NCT02192359</nct_id>
  </id_info>
  <brief_title>Carboxylesterase-Expressing Allogeneic Neural Stem Cells and Irinotecan Hydrochloride in Treating Patients With Recurrent High-Grade Gliomas</brief_title>
  <official_title>A Phase I Study of Intracranially Administered Carboxylesterase-Expressing Neural Stem Cells in Combination With Intravenous Irinotecan in Patients With Recurrent High-Grade Gliomas</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>City of Hope Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>City of Hope Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This phase I trial studies the side effects and best dose of carboxylesterase-expressing&#xD;
      allogeneic neural stem cells when given together with irinotecan hydrochloride in treating&#xD;
      patients with high-grade gliomas that have come back. Placing genetically modified neural&#xD;
      stem cells into brain tumor cells may make the tumor more sensitive to irinotecan&#xD;
      hydrochloride. Irinotecan hydrochloride may stop the growth of tumor cells by blocking some&#xD;
      of the enzymes needed for cell growth. Giving carboxylesterase-expressing allogeneic neural&#xD;
      stem cells and irinotecan hydrochloride may be a better treatment for high-grade gliomas.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PRIMARY OBJECTIVE:&#xD;
&#xD;
      I. To define the recommended phase II doses (RP2D) of intracranially administered&#xD;
      carboxylesterase-expressing allogeneic neural stem cells (hCE1m6-NSCs) in combination with&#xD;
      intravenous irinotecan in patients with recurrent high grade glioma.&#xD;
&#xD;
      SECONDARY OBJECTIVES:&#xD;
&#xD;
      I. To describe the relationship between hCE1m6-NSC dose and liposomal SN-38 (SN-38)&#xD;
      concentrations in brain interstitium.&#xD;
&#xD;
      II. To characterize the relationship between intracerebral and systemic concentrations of&#xD;
      irinotecan (irinotecan hydrochloride) and SN-38.&#xD;
&#xD;
      III. To investigate the biologic activity of hCE1m6 NSCs by comparing SN-38 concentrations in&#xD;
      the brain after treatment with hCE1m6-NSCs and irinotecan versus irinotecan alone.&#xD;
&#xD;
      IV. To assess for possible development of adenovirally transduced neural stem cell (NSC)&#xD;
      immunogenicity after first exposure and with repeat doses of NSCs.&#xD;
&#xD;
      V. To describe the clinical benefit (defined as stable disease, partial response, or complete&#xD;
      response) in patients who receive treatment with repeat cycles of NSCs and irinotecan.&#xD;
&#xD;
      VI. To determine, at time of autopsy, the fate of the NSCs.&#xD;
&#xD;
      OUTLINE: This is a dose-escalation study of carboxylesterase-expressing allogeneic neural&#xD;
      stem cells.&#xD;
&#xD;
      Patients receive carboxylesterase-expressing allogeneic neural stem cells intracranially over&#xD;
      1.5-4.5 hours on days 1 and 15 (day 1 only for patients at dose level 1) and irinotecan&#xD;
      hydrochloride intravenously (IV) over 90 minutes on days 3 and 17. Cycles repeat every 28&#xD;
      days in the absence of disease progression or unacceptable toxicity.&#xD;
&#xD;
      After completion of study treatment, patients are followed up at 30 days, 3 and 6 months, and&#xD;
      then annually thereafter for a minimum of 15 years.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">March 7, 2016</start_date>
  <completion_date type="Anticipated">December 30, 2023</completion_date>
  <primary_completion_date type="Anticipated">December 30, 2023</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>Incidence of dose limiting toxicities (DLTs) graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0</measure>
    <time_frame>28 days</time_frame>
    <description>Tables will be created to summarize all toxicities and side effects by dose, course, organ severity (by NCI CTCAE version 4.0), and attribution. Rates and associated 95% Clopper Pearson confidence limits will be estimated for DLTs.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Incidence of all attributable toxicities graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0</measure>
    <time_frame>Up to 30 days after completion of study treatment</time_frame>
    <description>Tables will be created to summarize all toxicities and side effects by dose, course, organ severity (by NCI CTCAE version 4.0), and attribution.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetics parameters, including maximum concentration and area under the curve of irinotecan and SN-38 in dialysate and plasma</measure>
    <time_frame>Pre-dose, at 90 minutes (just prior to the end of the infusion), and then at 30 minutes, 1, 2, 4, 8, 24, and 48 hours after the end of the infusion</time_frame>
    <description>Pharmacokinetic data from patients who undergo intracerebral microdialysis will be summarized using descriptive statistics and graphical methods. The biologic activity of the carboxylesterase-expressing allogeneic neural stem cells (hCE1m6-NSCs) will be assessed using a one-sided two-sample t test. Regression analysis will be used to assess the relationship between hCE1m6-NSC dose and liposomal SN-38 concentrations in brain interstitium using microdialysis data from the patients treated with the initial neural stem cells (NSC) dose and from the patients in the expansion cohort treated with the highest NSC dose.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Development of neural stem cells (NSC) immunogenicity after first and repeat exposures</measure>
    <time_frame>Up to 15 years</time_frame>
    <description>Will be summarized using descriptive statistics and graphical methods.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical benefit, defined by tumor response based on magnetic resonance imaging (MRI) results</measure>
    <time_frame>Up to 15 years</time_frame>
    <description>Rates and associated 95% Clopper Pearson confidence limits will be estimated for clinical benefit at the recommended phase II dose.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fate of the neural stem cells (NSCs), defined by NSC persistence</measure>
    <time_frame>Up to 15 years</time_frame>
    <description>Will be summarized using descriptive statistics and graphical methods.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">18</enrollment>
  <condition>Recurrent Anaplastic Astrocytoma</condition>
  <condition>Recurrent Anaplastic Oligoastrocytoma</condition>
  <condition>Recurrent Anaplastic Oligodendroglioma</condition>
  <condition>Recurrent Glioblastoma</condition>
  <condition>Recurrent Gliosarcoma</condition>
  <condition>Recurrent Malignant Glioma</condition>
  <condition>Recurrent WHO Grade III Glioma</condition>
  <arm_group>
    <arm_group_label>Treatment (hCE1m6-NSCs and irinotecan hydrochloride)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients receive carboxylesterase-expressing allogeneic neural stem cells intracranially over 1.5-4.5 hours on days 1 and 15 (day 1 only for patients at dose level 1) and irinotecan hydrochloride IV over 90 minutes on days 3 and 17. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Carboxylesterase-expressing Allogeneic Neural Stem Cells</intervention_name>
    <description>Given intracranially</description>
    <arm_group_label>Treatment (hCE1m6-NSCs and irinotecan hydrochloride)</arm_group_label>
    <other_name>CE-secreting Allogeneic NSCs</other_name>
    <other_name>hCE1m6-NSC</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Irinotecan</intervention_name>
    <description>Given IV</description>
    <arm_group_label>Treatment (hCE1m6-NSCs and irinotecan hydrochloride)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Irinotecan Hydrochloride</intervention_name>
    <description>Given IV</description>
    <arm_group_label>Treatment (hCE1m6-NSCs and irinotecan hydrochloride)</arm_group_label>
    <other_name>Campto</other_name>
    <other_name>Camptosar</other_name>
    <other_name>Camptothecin 11</other_name>
    <other_name>Camptothecin-11</other_name>
    <other_name>CPT 11</other_name>
    <other_name>CPT-11</other_name>
    <other_name>Irinomedac</other_name>
    <other_name>U-101440E</other_name>
    <other_name>Irinotecan Hydrochloride Trihydrate</other_name>
    <other_name>Irinotecan Monohydrochloride Trihydrate</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Laboratory Biomarker Analysis</intervention_name>
    <description>Correlative studies</description>
    <arm_group_label>Treatment (hCE1m6-NSCs and irinotecan hydrochloride)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Pharmacological Study</intervention_name>
    <description>Correlative studies</description>
    <arm_group_label>Treatment (hCE1m6-NSCs and irinotecan hydrochloride)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient must be able to understand and be willing to sign a written informed consent&#xD;
             document&#xD;
&#xD;
          -  Participant must be willing to comply with study and/or follow-up procedures&#xD;
&#xD;
          -  Karnofsky performance status &gt;= 70%&#xD;
&#xD;
          -  Life expectancy of &gt;= 3 months&#xD;
&#xD;
          -  Histologically-confirmed diagnosis of a grade III or IV glioma (including&#xD;
             glioblastoma, anaplastic astrocytoma, gliosarcoma, anaplastic oligodendroglioma, or&#xD;
             anaplastic oligoastrocytoma), or has a prior, histologically-confirmed, diagnosis of a&#xD;
             grade II glioma and now has radiographic findings consistent with a high-grade glioma&#xD;
             (grade III or IV)&#xD;
&#xD;
          -  Imaging studies show evidence of recurrent tumor(s); if a patient is going to be&#xD;
             enrolled to dose level two or higher, the patient must have a component of&#xD;
             supratentorial disease (so as to enable placement of a Rickham reservoir/catheter)&#xD;
             that is amenable to resection or biopsy&#xD;
&#xD;
          -  High-grade glioma has recurred or progressed after prior treatment with brain&#xD;
             radiation and temozolomide&#xD;
&#xD;
          -  Participant must be in need of a craniotomy for tumor resection or a stereotactic&#xD;
             brain biopsy for the purpose of diagnosis or differentiating between tumor progression&#xD;
             versus treatment-induced effects following radiation therapy +/- chemotherapy&#xD;
&#xD;
          -  Based on the neurosurgeon?s judgment, there is no anticipated physical connection&#xD;
             between the post-resection tumor cavity and the cerebral ventricles&#xD;
&#xD;
          -  Neurosurgeon finds the prospective participant is able to undergo neurosurgery&#xD;
&#xD;
          -  Any number of prior therapies is permitted; from the start of study treatment, the&#xD;
             following time periods must have elapsed: 6 weeks from nitrosourea-containing&#xD;
             chemotherapy, 4 weeks from non-nitrosourea-containing cytotoxic chemotherapy (except&#xD;
             23 days from last daily dose of temozolomide taken in a 5 of 28 day regimen), and 2&#xD;
             weeks from last dose of a targeted agent (except 4 weeks for bevacizumab); there is no&#xD;
             time period requirement for prior radiation therapy&#xD;
&#xD;
          -  Any clinically significant toxicity from prior therapy must have improved to grade 0&#xD;
             or grade 1&#xD;
&#xD;
          -  Absolute neutrophil count (ANC) &gt;= 1,500 cells/ul&#xD;
&#xD;
          -  Platelets &gt; 100,000 cells/ul&#xD;
&#xD;
          -  Total bilirubin =&lt; 2.0 mg/dl&#xD;
&#xD;
          -  Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) =&lt; 4&#xD;
             times institutional upper limit of normal&#xD;
&#xD;
          -  Serum creatinine =&lt; 1.5 x the institutional upper limit of normal&#xD;
&#xD;
          -  Homozygous negative for the UDP glucuronosyltransferase 1 family, polypeptide A1 (UGT&#xD;
             1A1)*28 allele&#xD;
&#xD;
          -  Absence anti-human leukocyte antigen (HLA) antibodies specific for HLA class I&#xD;
             antigens expressed by the coagulation factor III (thromboplastin, tissue factor)&#xD;
             (F3).cytosine deaminase (CD).carboxylesterase (CE) NSCs&#xD;
&#xD;
          -  Negative serum pregnancy test (women of childbearing potential only)&#xD;
&#xD;
          -  Agreement by females of childbearing potential and sexually active males to use an&#xD;
             effective method of contraception while participating in this study; women of&#xD;
             childbearing potential must have a negative pregnancy test &lt; 2 weeks prior to&#xD;
             registration&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Prior therapy with neural stem cells&#xD;
&#xD;
          -  Use of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) inducers&#xD;
             including hepatic enzyme-inducing anticonvulsants (phenytoin, fosphenytoin,&#xD;
             carbamazepine, phenobarbital, primidone, oxcarbazepine) within 2 weeks prior to start&#xD;
             of study treatment&#xD;
&#xD;
          -  Use of moderate to strong CYP3A4 inhibitors within 2 weeks prior to start of study&#xD;
             treatment&#xD;
&#xD;
          -  Use of drugs known to inhibit UGT1A1, such as atazanir, gemfibrozil, indinavir, or&#xD;
             ketoconazole, within 2 weeks prior to start of study treatment&#xD;
&#xD;
          -  Co-medication that may interfere with study results; e.g. immuno-suppressive agents&#xD;
             other than corticosteroids, such as systemic cyclosporine and tacrolimus; consult&#xD;
             principal investigator for questions, including necessary washout period for the&#xD;
             specific drug&#xD;
&#xD;
          -  Flucytosine within 2 weeks prior to start of study treatment&#xD;
&#xD;
          -  Use of herbal medications&#xD;
&#xD;
          -  Current use (or planned use during the treatment period) of other investigational&#xD;
             agents, or biological, chemotherapy, radiation or other anti-tumor therapy&#xD;
&#xD;
          -  Patient has known human immunodeficiency virus (HIV) or hepatitis C infection;&#xD;
             baseline testing for HIV or hepatitis C is not required&#xD;
&#xD;
          -  Prospective participant is unable to undergo a magnetic resonance imaging (MRI) with&#xD;
             contrast agent&#xD;
&#xD;
          -  Known chronic or active viral infections of the central nervous system (CNS)&#xD;
&#xD;
          -  Clinically significant uncontrolled illness&#xD;
&#xD;
          -  Active infection requiring antibiotics&#xD;
&#xD;
          -  Diagnosis of Gilbert?s disease&#xD;
&#xD;
          -  History of allergic reactions attributed to compounds of similar chemical or biologic&#xD;
             composition to irinotecan&#xD;
&#xD;
          -  Known sensitivity to any of the products to be administered during dosing&#xD;
&#xD;
          -  Any other active malignancy&#xD;
&#xD;
          -  Pregnant women and women who are lactating&#xD;
&#xD;
          -  Serious medical or psychiatric illness that could, in the investigator?s opinion,&#xD;
             potentially interfere with the safety monitoring requirements and completion of&#xD;
             treatment according to this protocol&#xD;
&#xD;
          -  Prospective participants who, in the opinion of the investigator, may not be able to&#xD;
             comply with all study procedures (including compliance issues related to&#xD;
             feasibility/logistics)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>69 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jana L Portnow</last_name>
    <role>Principal Investigator</role>
    <affiliation>City of Hope Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>City of Hope Medical Center</name>
      <address>
        <city>Duarte</city>
        <state>California</state>
        <zip>91010</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>July 15, 2014</study_first_submitted>
  <study_first_submitted_qc>July 15, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 16, 2014</study_first_posted>
  <last_update_submitted>June 14, 2023</last_update_submitted>
  <last_update_submitted_qc>June 14, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 15, 2023</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>Glioblastoma</mesh_term>
    <mesh_term>Glioma</mesh_term>
    <mesh_term>Astrocytoma</mesh_term>
    <mesh_term>Gliosarcoma</mesh_term>
    <mesh_term>Oligodendroglioma</mesh_term>
    <mesh_term>Recurrence</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Irinotecan</mesh_term>
    <mesh_term>Camptothecin</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/NCT02192359
org study id: 14108
secondary id: NCI-2014-01463
secondary id: 14108
secondary id: P30CA033572
secondary id: R01CA198076
nct id: NCT02192359
lead sponsor: 
collaborator: 
has dmc: Yes
This phase I trial studies the side effects and best dose of carboxylesterase-expressing
      allogeneic neural stem cells when given together with irinotecan hydrochloride in treating
      patients with high-grade gliomas that have come back. Placing genetically modified neural
      stem cells into brain tumor cells may make the tumor more sensitive to irinotecan
      hydrochloride. Irinotecan hydrochloride may stop the growth of tumor cells by blocking some
      of the enzymes needed for cell growth. Giving carboxylesterase-expressing allogeneic neural
      stem cells and irinotecan hydrochloride may be a better treatment for high-grade gliomas.
PRIMARY OBJECTIVE:

      I. To define the recommended phase II doses (RP2D) of intracranially administered
      carboxylesterase-expressing allogeneic neural stem cells (hCE1m6-NSCs) in combination with
      intravenous irinotecan in patients with recurrent high grade glioma.

      SECONDARY OBJECTIVES:

      I. To describe the relationship between hCE1m6-NSC dose and liposomal SN-38 (SN-38)
      concentrations in brain interstitium.

      II. To characterize the relationship between intracerebral and systemic concentrations of
      irinotecan (irinotecan hydrochloride) and SN-38.

      III. To investigate the biologic activity of hCE1m6 NSCs by comparing SN-38 concentrations in
      the brain after treatment with hCE1m6-NSCs and irinotecan versus irinotecan alone.

      IV. To assess for possible development of adenovirally transduced neural stem cell (NSC)
      immunogenicity after first exposure and with repeat doses of NSCs.

      V. To describe the clinical benefit (defined as stable disease, partial response, or complete
      response) in patients who receive treatment with repeat cycles of NSCs and irinotecan.

      VI. To determine, at time of autopsy, the fate of the NSCs.

      OUTLINE: This is a dose-escalation study of carboxylesterase-expressing allogeneic neural
      stem cells.

      Patients receive carboxylesterase-expressing allogeneic neural stem cells intracranially over
      1.5-4.5 hours on days 1 and 15 (day 1 only for patients at dose level 1) and irinotecan
      hydrochloride intravenously (IV) over 90 minutes on days 3 and 17. Cycles repeat every 28
      days in the absence of disease progression or unacceptable toxicity.

      After completion of study treatment, patients are followed up at 30 days, 3 and 6 months, and
      then annually thereafter for a minimum of 15 years.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Incidence of dose limiting toxicities (DLTs) graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
time frame: 28 days
description: Tables will be created to summarize all toxicities and side effects by dose, course, organ severity (by NCI CTCAE version 4.0), and attribution. Rates and associated 95% Clopper Pearson confidence limits will be estimated for DLTs.
measure: Incidence of all attributable toxicities graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
time frame: Up to 30 days after completion of study treatment
description: Tables will be created to summarize all toxicities and side effects by dose, course, organ severity (by NCI CTCAE version 4.0), and attribution.
measure: Pharmacokinetics parameters, including maximum concentration and area under the curve of irinotecan and SN-38 in dialysate and plasma
time frame: Pre-dose, at 90 minutes (just prior to the end of the infusion), and then at 30 minutes, 1, 2, 4, 8, 24, and 48 hours after the end of the infusion
description: Pharmacokinetic data from patients who undergo intracerebral microdialysis will be summarized using descriptive statistics and graphical methods. The biologic activity of the carboxylesterase-expressing allogeneic neural stem cells (hCE1m6-NSCs) will be assessed using a one-sided two-sample t test. Regression analysis will be used to assess the relationship between hCE1m6-NSC dose and liposomal SN-38 concentrations in brain interstitium using microdialysis data from the patients treated with the initial neural stem cells (NSC) dose and from the patients in the expansion cohort treated with the highest NSC dose.
measure: Development of neural stem cells (NSC) immunogenicity after first and repeat exposures
time frame: Up to 15 years
description: Will be summarized using descriptive statistics and graphical methods.
measure: Clinical benefit, defined by tumor response based on magnetic resonance imaging (MRI) results
time frame: Up to 15 years
description: Rates and associated 95% Clopper Pearson confidence limits will be estimated for clinical benefit at the recommended phase II dose.
measure: Fate of the neural stem cells (NSCs), defined by NSC persistence
time frame: Up to 15 years
description: Will be summarized using descriptive statistics and graphical methods.
arm group label: Treatment (hCE1m6-NSCs and irinotecan hydrochloride)
arm group type: Experimental
description: Patients receive carboxylesterase-expressing allogeneic neural stem cells intracranially over 1.5-4.5 hours on days 1 and 15 (day 1 only for patients at dose level 1) and irinotecan hydrochloride IV over 90 minutes on days 3 and 17. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
intervention type: Biological
intervention name: Carboxylesterase-expressing Allogeneic Neural Stem Cells
description: Given intracranially
arm group label: Treatment (hCE1m6-NSCs and irinotecan hydrochloride)
other name: CE-secreting Allogeneic NSCs
other name: hCE1m6-NSC
intervention type: Drug
intervention name: Irinotecan
description: Given IV
arm group label: Treatment (hCE1m6-NSCs and irinotecan hydrochloride)
intervention type: Drug
intervention name: Irinotecan Hydrochloride
description: Given IV
arm group label: Treatment (hCE1m6-NSCs and irinotecan hydrochloride)
other name: Campto
other name: Camptosar
other name: Camptothecin 11
other name: Camptothecin-11
other name: CPT 11
other name: CPT-11
other name: Irinomedac
other name: U-101440E
other name: Irinotecan Hydrochloride Trihydrate
other name: Irinotecan Monohydrochloride Trihydrate
intervention type: Other
intervention name: Laboratory Biomarker Analysis
description: Correlative studies
arm group label: Treatment (hCE1m6-NSCs and irinotecan hydrochloride)
intervention type: Other
intervention name: Pharmacological Study
description: Correlative studies
arm group label: Treatment (hCE1m6-NSCs and irinotecan hydrochloride)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 69 Years
healthy volunteers: No
last name: Jana L Portnow
role: Principal Investigator
affiliation: City of Hope Medical Center
facility: 
country: United States
responsible party type: Sponsor
mesh term: Glioblastoma
mesh term: Glioma
mesh term: Astrocytoma
mesh term: Gliosarcoma
mesh term: Oligodendroglioma
mesh term: Recurrence
mesh term: Irinotecan
mesh term: Camptothecin