<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/NCT03027388</url>
  </required_header>
  <id_info>
    <org_study_id>170037</org_study_id>
    <secondary_id>17-C-0037</secondary_id>
    <nct_id>NCT03027388</nct_id>
  </id_info>
  <brief_title>Protein Phosphatase 2A Inhibitor, in Recurrent Glioblastoma</brief_title>
  <official_title>Phase II Trial of LB100, a Protein Phosphatase 2A Inhibitor, in Recurrent Glioblastoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Institutes of Health Clinical Center (CC)</source>
  <oversight_info>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Background:&#xD;
&#xD;
      The brain is separated from the rest of the blood stream by the blood-brain barrier. This is&#xD;
      like a filter that protects the brain. But is also a challenge when medicines need to get&#xD;
      into the brain. Researchers want to give the new drug LB100 to people before brain tumor&#xD;
      surgery. They will measure how much LB100 is in the blood and how much gets into the brain.&#xD;
      This may help with the use of LB100 to treat brain tumors in the future.&#xD;
&#xD;
      Objective:&#xD;
&#xD;
      To see if LB100 can pass into the brain.&#xD;
&#xD;
      Eligibility:&#xD;
&#xD;
      People at least 18 years old with a brain tumor that requires surgery&#xD;
&#xD;
      Design:&#xD;
&#xD;
      Participants will be screened with:&#xD;
&#xD;
      Physical exam&#xD;
&#xD;
      Medical history&#xD;
&#xD;
      Blood tests&#xD;
&#xD;
      Neurosurgery evaluation&#xD;
&#xD;
      Scans&#xD;
&#xD;
      Heart tests&#xD;
&#xD;
      Tumor sample. This can be from a previous procedure.&#xD;
&#xD;
      Participants will have their brain surgery at the Clinical Center.&#xD;
&#xD;
      Participants will get a dose of the study drug through a plastic tube in a vein for 2 hours&#xD;
      during surgery.&#xD;
&#xD;
      Participants will have blood taken 7 times in the 8 hours after getting the study drug.&#xD;
&#xD;
      Tumor samples will be taken during surgery.&#xD;
&#xD;
      Participants will have a heart test after getting the study drug. Sticky pads on the skin&#xD;
      will measure electrical activity of the heart.&#xD;
&#xD;
      Two-three weeks after leaving the hospital, participants will have a follow-up visit. They&#xD;
      will have a physical exam and blood tests.&#xD;
&#xD;
      One month after surgery, they will be contacted in person or by phone to see how they are&#xD;
      doing.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background:&#xD;
&#xD;
        -  Primary gliomas are an incurable disease in spite of aggressive multimodality therapy&#xD;
           consisting of craniotomy, irradiation, and chemotherapy. Therapeutic options for&#xD;
           patients with recurrent glioma are limited, and there is an unmet need to identify more&#xD;
           effective agents.&#xD;
&#xD;
        -  LB100, a water soluble small molecule novel protein phosphatase 2A (PP2A) inhibitor, was&#xD;
           commercially developed through a CRADA based on our previous intramural research. This&#xD;
           compound has shown to be effective in a variety of cancer types in both in vitro and in&#xD;
           vivo models. Preclinical studies indicate LB100 has in vitro and in vivo activity as a&#xD;
           single agent as well as potentiating the effect of cytotoxic agents including&#xD;
           temozolomide, docetaxel, doxorubicin, and ionizing radiation. LB100 is active in&#xD;
           combination with temozolomide or doxorubicin against xenografts of glioblastoma,&#xD;
           neuroblastoma, pheochromocytoma, breast cancer, fibrosarcoma, and melanoma.&#xD;
&#xD;
        -  A complete phase I study of LB100 has established its safety and the recommended phase&#xD;
           II dose (2.33 mg/m^2, daily for three days every 3 weeks).&#xD;
&#xD;
        -  Although it is a polar compound, rodent studies suggest LB100 has activity in the brain.&#xD;
&#xD;
        -  Whether LB100 can across the human blood brain barrier (BBB), and at what concentration&#xD;
           relative to the plasma level is not known. Characterizing these parameters is important&#xD;
           because:&#xD;
&#xD;
             -  1) Our ongoing in vitro studies indicate that LB100 has distinct mechanisms of&#xD;
                action at different drug concentrations (e.g. nM versus uM);&#xD;
&#xD;
             -  2) There are other brain tumors lacking effective medical therapies but without a&#xD;
                BBB. Characterizing the LB100 BBB penetration profile will assist in defining its&#xD;
                optimal clinical indication.&#xD;
&#xD;
      Objective:&#xD;
&#xD;
      -To determine the pharmacokinetic (PK) properties of LB100 in glioma tumor tissues.&#xD;
&#xD;
      Eligibility:&#xD;
&#xD;
        -  Patients with histologically proven glioblastoma and grades II-III astrocytomas and&#xD;
           oligodendrogliomas.&#xD;
&#xD;
        -  A clear clinical indication for another surgical resection must be present.&#xD;
&#xD;
        -  Subjects must be greater than or equal to 18 years old.&#xD;
&#xD;
        -  Karnofsky performance status of greater than or equal to 60%.&#xD;
&#xD;
        -  Patients must have adequate organ function.&#xD;
&#xD;
      Design:&#xD;
&#xD;
        -  This is a two stage Phase II, open label, single institution study to determine the PK&#xD;
           and PD profile of LB100.&#xD;
&#xD;
        -  The dose (established from a Phase I study) will be 2.33 mg/m^2 delivered intravenously&#xD;
           over 2 hours.&#xD;
&#xD;
        -  PK and PD effect of LB100 treated tissues will only be evaluated with pathologic&#xD;
           confirmation of recurrent tumor. Resected material demonstrating chemoradiation&#xD;
           treatment effect or inflammatory response will not be included in the analysis.&#xD;
&#xD;
        -  PK will be determined by quantitating LB100 in tumor tissues removed at various time&#xD;
           points.&#xD;
&#xD;
        -  The primary endpoint is PK response, defined as a binary variable indicating the&#xD;
           presence/absence of LB100 in tumor tissues.&#xD;
&#xD;
        -  PD effect is defined as statistically significant elevation of phospho-proteins in&#xD;
           treated tumor tissues compared to untreated glioma specimens. Untreated inter-patient&#xD;
           baseline variance and standard deviation (SD) will be calculated. Post-treatment PD&#xD;
           effect difference greater than 2.5 times the baseline SD is statistically significant at&#xD;
           the .05 significance level. Due to relatively small sample size, t-distribution is to be&#xD;
           used to calculate the cutoff defining the PD response.&#xD;
&#xD;
        -  Up to 25 patients may be enrolled to obtain 8 evaluable subjects. A two-stage design&#xD;
           will be used. Five patients will be initially treated. If at least one of five&#xD;
           demonstrates PK activity, 3 additional subjects will be enrolled. PK effect will be&#xD;
           declared to be significant if at least 2 of the 8 patients demonstrate a PK response&#xD;
           (presence of LB100 in tumor tissue).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 9, 2019</start_date>
  <completion_date type="Actual">August 31, 2022</completion_date>
  <primary_completion_date type="Actual">August 15, 2022</primary_completion_date>
  <phase>Phase 2</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>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Drug Level in tumor tissue</measure>
    <time_frame>Post Surgery</time_frame>
    <description>To determine the pharmacokinetic properties of LB100 in glioblastoma tumor tissues</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Relationship between drug concentration at the site of action and the resulting effect and the presence of correlation to identify predictive markers.</measure>
    <time_frame>8 hours post infusion</time_frame>
    <description>Intra-patient PD effect in PBMC and tumor tissue will be evaluated in all subjects for presence of correlation to identify potential predictive markers</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plasma concentration and calculated LB100</measure>
    <time_frame>8 hours post infusion</time_frame>
    <description>determine the plasma concentration and calculated PK parameters of LB100 and LB100M (endothall).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Concentration of LG100 and its major metabolite LB100 in glioblastoma tumor tissue</measure>
    <time_frame>8 hours post infusion</time_frame>
    <description>determine the concentration LB100 and its major metabolite, 7-oxabicyclo [2.2.1] heptanes-2,3-dicarboxylic acid (LB100M) in glioma tumor tissue when a known non-toxic dose of LB100 is delivered intravenously over 2 hours</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in phospho-protein expression in circulating PBMC</measure>
    <time_frame>8 hours post infusion</time_frame>
    <description>determine changes in phospho-protein expression in circulating PBMC</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">7</enrollment>
  <condition>Astrocytoma, Grades II, III and IV</condition>
  <condition>Glioblastoma Multiforme</condition>
  <condition>Giant Cell Glioblastoma</condition>
  <condition>Glioma</condition>
  <condition>Oligodendrogliomas</condition>
  <arm_group>
    <arm_group_label>1/LB100</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Treatment with LB100</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>LB-100</intervention_name>
    <description>LB-100 will be infused over 2 hours via IV infusion 2 to 4 hours before surgery. The dose established from a Phase I study will be 2.33 mg/m2.</description>
    <arm_group_label>1/LB100</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        -  INCLUSION CRITERIA:&#xD;
&#xD;
          -  Patients must have histologically confirmed glioblastoma/gliosarcoma, grades II-III&#xD;
             astrocytoma and oligodendroglioma.&#xD;
&#xD;
          -  Patients must have recurrent disease for which there is a clinical indication for&#xD;
             resection.&#xD;
&#xD;
          -  Age greater than or equal to18 years.&#xD;
&#xD;
          -  Karnofsky greater than or equal to 60%.&#xD;
&#xD;
          -  Patients must have adequate bone marrow function (WBC greater than or equal to&#xD;
             3,000/uL ANC greater than or equal to 1,500/mm^3, platelet count of greater than or&#xD;
             equal to 100,000/mm^3, and hemoglobin greater than or equal to 10 gm/dL), adequate&#xD;
             liver function (SGOT and bilirubin &lt; 2 times ULN). These tests must be performed&#xD;
             within 28 days prior to receiving drug. Eligibility level for hemoglobin may be&#xD;
             reached by transfusion.&#xD;
&#xD;
          -  Patients must have a serum creatinine of &lt;=1.7 mg/dL. If the serum creatinine is&#xD;
             greater than 1.7 mg/dl, a 24-hour urine creatinine clearance will be obtained and if&#xD;
             the result of this study is within normal limits*, the patient would be eligible to&#xD;
             enroll onto study. This test must be performed within 28 days prior to&#xD;
             registrationreceiving drug. (*Normal Creatinine Clearance Range: Male: 90 - 130&#xD;
             ml/min; Female: 80 - 125 ml/min)&#xD;
&#xD;
          -  Patients must be in adequate general medical health to safely tolerate a craniotomy.&#xD;
&#xD;
          -  At the time of registration, all subjects must be removed greater than or equal to 28&#xD;
             days from any investigational agents.&#xD;
&#xD;
          -  The effects of LB100 on the developing human fetus are unknown. For this reason, women&#xD;
             of child-bearing potential and men must agree to use adequate contraception (hormonal&#xD;
             or barrier method of birth control; abstinence) prior to study entry and for the&#xD;
             duration of study participation. Should a woman become pregnant or suspect she is&#xD;
             pregnant while she or her partner is participating in this study, she should inform&#xD;
             her treating physician immediately.&#xD;
&#xD;
          -  Ability of subject to understand and the willingness to sign a written informed&#xD;
             consent document indicating that they are aware of the investigational nature of this&#xD;
             study, and that this is not a therapeutic clinical trial.&#xD;
&#xD;
        EXCLUSION CRITERIA:&#xD;
&#xD;
          -  Patients who are receiving any other investigational agents.&#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;
          -  Patients unwilling to undergo craniotomy.&#xD;
&#xD;
          -  Pregnant women are excluded from this study because the safety of PP2A inhibition on a&#xD;
             developing fetus has not been established. Because there is an unknown but potential&#xD;
             risk for adverse events in nursing infants secondary to treatment of the mother with&#xD;
             LB100, breastfeeding should be discontinued if the mother is treated with LB100.&#xD;
&#xD;
          -  Patients may not have had prior chemotherapy or biologic therapy in the 4 weeks prior&#xD;
             to study entry. For patients who have been treated with targeted therapy, 5 half-lives&#xD;
             of that therapy (or 28 days, whichever is shorter) must have passed prior to&#xD;
             enrollment in the study.&#xD;
&#xD;
          -  Known HIV-positive patients on combination antiretroviral therapy are ineligible&#xD;
             because of the potential for pharmacokinetic interactions with LB100. Appropriate&#xD;
             studies will be undertaken in patients receiving combination antiretroviral therapy&#xD;
             when indicated.&#xD;
&#xD;
          -  Patients who are receiving strong CYP450 inducers or inhibitors are ineligible&#xD;
&#xD;
          -  Recruitment Strategies&#xD;
&#xD;
        Patients with recurrent disease will be identified by the Neuro-Oncology Branch, Clinical&#xD;
        Center. This study will be posted on NIH websites and on NIH Social media forums.&#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>Eric C Burton, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>National Cancer Institute (NCI)</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>National Institutes of Health Clinical Center</name>
      <address>
        <city>Bethesda</city>
        <state>Maryland</state>
        <zip>20892</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://clinicalstudies.info.nih.gov/cgi/detail.cgi?B_2017-C-0037.html</url>
    <description>NIH Clinical Center Detailed Web Page</description>
  </link>
  <verification_date>July 6, 2023</verification_date>
  <study_first_submitted>January 18, 2017</study_first_submitted>
  <study_first_submitted_qc>January 20, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 23, 2017</study_first_posted>
  <last_update_submitted>July 12, 2023</last_update_submitted>
  <last_update_submitted_qc>July 12, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 13, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Brain Tumor</keyword>
  <keyword>Blood Brain Barrier</keyword>
  <keyword>Pharmacokinetics</keyword>
  <keyword>Pharmacodynamics</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Glioblastoma</mesh_term>
    <mesh_term>Astrocytoma</mesh_term>
    <mesh_term>Oligodendroglioma</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>LB100</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>.BTRIS: All IPD recorded in the medical record will be shared with intramural investigators upon request.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_time_frame>BTRIS: Clinical data available during the study and indefinitely.</ipd_time_frame>
    <ipd_access_criteria>BTRIS: Clinical data will be made available via subscription to BTRIS and with the permission of the study PI.</ipd_access_criteria>
  </patient_data>
  <pending_results>
    <submitted>August 11, 2023</submitted>
    <returned>September 5, 2023</returned>
  </pending_results>
  <!-- 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/NCT03027388
org study id: 170037
secondary id: 17-C-0037
nct id: NCT03027388
lead sponsor: 
is fda regulated drug: Yes
is fda regulated device: No
Background:

      The brain is separated from the rest of the blood stream by the blood-brain barrier. This is
      like a filter that protects the brain. But is also a challenge when medicines need to get
      into the brain. Researchers want to give the new drug LB100 to people before brain tumor
      surgery. They will measure how much LB100 is in the blood and how much gets into the brain.
      This may help with the use of LB100 to treat brain tumors in the future.

      Objective:

      To see if LB100 can pass into the brain.

      Eligibility:

      People at least 18 years old with a brain tumor that requires surgery

      Design:

      Participants will be screened with:

      Physical exam

      Medical history

      Blood tests

      Neurosurgery evaluation

      Scans

      Heart tests

      Tumor sample. This can be from a previous procedure.

      Participants will have their brain surgery at the Clinical Center.

      Participants will get a dose of the study drug through a plastic tube in a vein for 2 hours
      during surgery.

      Participants will have blood taken 7 times in the 8 hours after getting the study drug.

      Tumor samples will be taken during surgery.

      Participants will have a heart test after getting the study drug. Sticky pads on the skin
      will measure electrical activity of the heart.

      Two-three weeks after leaving the hospital, participants will have a follow-up visit. They
      will have a physical exam and blood tests.

      One month after surgery, they will be contacted in person or by phone to see how they are
      doing.
Background:

        -  Primary gliomas are an incurable disease in spite of aggressive multimodality therapy
           consisting of craniotomy, irradiation, and chemotherapy. Therapeutic options for
           patients with recurrent glioma are limited, and there is an unmet need to identify more
           effective agents.

        -  LB100, a water soluble small molecule novel protein phosphatase 2A (PP2A) inhibitor, was
           commercially developed through a CRADA based on our previous intramural research. This
           compound has shown to be effective in a variety of cancer types in both in vitro and in
           vivo models. Preclinical studies indicate LB100 has in vitro and in vivo activity as a
           single agent as well as potentiating the effect of cytotoxic agents including
           temozolomide, docetaxel, doxorubicin, and ionizing radiation. LB100 is active in
           combination with temozolomide or doxorubicin against xenografts of glioblastoma,
           neuroblastoma, pheochromocytoma, breast cancer, fibrosarcoma, and melanoma.

        -  A complete phase I study of LB100 has established its safety and the recommended phase
           II dose (2.33 mg/m^2, daily for three days every 3 weeks).

        -  Although it is a polar compound, rodent studies suggest LB100 has activity in the brain.

        -  Whether LB100 can across the human blood brain barrier (BBB), and at what concentration
           relative to the plasma level is not known. Characterizing these parameters is important
           because:

             -  1) Our ongoing in vitro studies indicate that LB100 has distinct mechanisms of
                action at different drug concentrations (e.g. nM versus uM);

             -  2) There are other brain tumors lacking effective medical therapies but without a
                BBB. Characterizing the LB100 BBB penetration profile will assist in defining its
                optimal clinical indication.

      Objective:

      -To determine the pharmacokinetic (PK) properties of LB100 in glioma tumor tissues.

      Eligibility:

        -  Patients with histologically proven glioblastoma and grades II-III astrocytomas and
           oligodendrogliomas.

        -  A clear clinical indication for another surgical resection must be present.

        -  Subjects must be greater than or equal to 18 years old.

        -  Karnofsky performance status of greater than or equal to 60%.

        -  Patients must have adequate organ function.

      Design:

        -  This is a two stage Phase II, open label, single institution study to determine the PK
           and PD profile of LB100.

        -  The dose (established from a Phase I study) will be 2.33 mg/m^2 delivered intravenously
           over 2 hours.

        -  PK and PD effect of LB100 treated tissues will only be evaluated with pathologic
           confirmation of recurrent tumor. Resected material demonstrating chemoradiation
           treatment effect or inflammatory response will not be included in the analysis.

        -  PK will be determined by quantitating LB100 in tumor tissues removed at various time
           points.

        -  The primary endpoint is PK response, defined as a binary variable indicating the
           presence/absence of LB100 in tumor tissues.

        -  PD effect is defined as statistically significant elevation of phospho-proteins in
           treated tumor tissues compared to untreated glioma specimens. Untreated inter-patient
           baseline variance and standard deviation (SD) will be calculated. Post-treatment PD
           effect difference greater than 2.5 times the baseline SD is statistically significant at
           the .05 significance level. Due to relatively small sample size, t-distribution is to be
           used to calculate the cutoff defining the PD response.

        -  Up to 25 patients may be enrolled to obtain 8 evaluable subjects. A two-stage design
           will be used. Five patients will be initially treated. If at least one of five
           demonstrates PK activity, 3 additional subjects will be enrolled. PK effect will be
           declared to be significant if at least 2 of the 8 patients demonstrate a PK response
           (presence of LB100 in tumor tissue).
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Drug Level in tumor tissue
time frame: Post Surgery
description: To determine the pharmacokinetic properties of LB100 in glioblastoma tumor tissues
measure: Relationship between drug concentration at the site of action and the resulting effect and the presence of correlation to identify predictive markers.
time frame: 8 hours post infusion
description: Intra-patient PD effect in PBMC and tumor tissue will be evaluated in all subjects for presence of correlation to identify potential predictive markers
measure: Plasma concentration and calculated LB100
time frame: 8 hours post infusion
description: determine the plasma concentration and calculated PK parameters of LB100 and LB100M (endothall).
measure: Concentration of LG100 and its major metabolite LB100 in glioblastoma tumor tissue
time frame: 8 hours post infusion
description: determine the concentration LB100 and its major metabolite, 7-oxabicyclo [2.2.1] heptanes-2,3-dicarboxylic acid (LB100M) in glioma tumor tissue when a known non-toxic dose of LB100 is delivered intravenously over 2 hours
measure: Changes in phospho-protein expression in circulating PBMC
time frame: 8 hours post infusion
description: determine changes in phospho-protein expression in circulating PBMC
arm group label: 1/LB100
arm group type: Experimental
description: Treatment with LB100
intervention type: Drug
intervention name: LB-100
description: LB-100 will be infused over 2 hours via IV infusion 2 to 4 hours before surgery. The dose established from a Phase I study will be 2.33 mg/m2.
arm group label: 1/LB100
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Eric C Burton, M.D.
role: Principal Investigator
affiliation: National Cancer Institute (NCI)
facility: 
country: United States
url: https://clinicalstudies.info.nih.gov/cgi/detail.cgi?B_2017-C-0037.html
description: NIH Clinical Center Detailed Web Page
responsible party type: Sponsor
mesh term: Glioblastoma
mesh term: Astrocytoma
mesh term: Oligodendroglioma
mesh term: LB100
sharing ipd: Yes
ipd description: .BTRIS: All IPD recorded in the medical record will be shared with intramural investigators upon request.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd time frame: BTRIS: Clinical data available during the study and indefinitely.
ipd access criteria: BTRIS: Clinical data will be made available via subscription to BTRIS and with the permission of the study PI.
submitted: August 11, 2023
returned: September 5, 2023