<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/NCT04477200</url>
  </required_header>
  <id_info>
    <org_study_id>UMCC 2019.192</org_study_id>
    <secondary_id>HUM00175785</secondary_id>
    <secondary_id>R37CA258346</secondary_id>
    <nct_id>NCT04477200</nct_id>
  </id_info>
  <brief_title>Mycophenolate Mofetil Combined With Radiation Therapy in Glioblastoma</brief_title>
  <official_title>Phase 0/I Dose Escalation Study of Mycophenolate Mofetil Combined With Radiation Therapy in Glioblastoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Michigan Rogel Cancer Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Michigan Rogel Cancer Center</source>
  <oversight_info>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a phase 0/1 dose-escalation trial to determine the maximum tolerated dose of&#xD;
      Mycophenolate Mofetil (MMF) when administered with radiation, in patients with glioblastoma&#xD;
      or gliosarcoma.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The goal of the Phase 0 component is to determine if MMF achieves active concentrations in&#xD;
      brain tumors. Eight participants in Phase 0 will receive MMF for one week before undergoing&#xD;
      an already planned biopsy or re-resection (surgical removal) of glioblastoma or gliosarcoma&#xD;
      (GBM/GS). A small portion of the tumor, removed as part of clinical care, will be used for&#xD;
      testing in this study. Sixty additional participants will be enrolled in the Phase 1&#xD;
      component of the trial (30 with recurrent GBM/GS and 30 with newly diagnosed GBM/GS). The&#xD;
      goal of the Phase 1 component is to find the dose of MMF that works best without causing&#xD;
      severe side effects (the maximum tolerated dose) when combined with radiation in recurrent&#xD;
      GBM/GS and with radiation and chemotherapy in newly diagnosed GBM/GS. Participants in Phase 0&#xD;
      who meet the eligibility criteria for the Phase 1 component may participate in both phases.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">August 5, 2020</start_date>
  <completion_date type="Anticipated">October 2027</completion_date>
  <primary_completion_date type="Anticipated">October 2024</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Sequential Assignment</intervention_model>
    <intervention_model_description>Phase 0 will include 8 participants; eligible participants from phase 0 may continue on to phase 1.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Concentration of mycophenolic acid (MPA) in tumor tissue in Phase 0 participants</measure>
    <time_frame>At 1 week</time_frame>
    <description>The concentration of MPA (the active metabolite of mycophenolate mofetil [MMF]) in tumor tissue, measured by mass spectrometry on a continuous scale after one week of MMF administration.&#xD;
This measure includes all phase 0 participants.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of recurrent phase 1 participants who experience dose-limiting toxicities (DLTs) at each dose level</measure>
    <time_frame>Up to 28 days following completion of MMF + RT (up to ~9 weeks)</time_frame>
    <description>DLT will be defined based on the rate of drug related grade 3-5 adverse events experienced from the start of treatment with MMF and for up to 4 weeks after completion of MMF + radiation therapy (RT). Assessed using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0.&#xD;
This measure includes only phase 1 participants with recurrent GBM/GS.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of newly diagnosed phase 1 participants who experience dose-limiting toxicities (DLTs) at each dose level -- DLT1 period</measure>
    <time_frame>Up to 28 days following completion of MMF + RT + TMZ (up to ~11 weeks)</time_frame>
    <description>DLT will be defined based on the rate of drug related grade 3-5 adverse events experienced from the start of treatment with MMF and for up to 4 weeks after completion of MMF + RT + TMZ. Assessed using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0.&#xD;
This measure includes only newly diagnosed phase 1 participants.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of newly diagnosed phase 1 participants who experience dose-limiting toxicities (DLTs) at each dose level -- DLT2 period</measure>
    <time_frame>During the first 2 cycles (8 weeks) of MMF with adjuvant TMZ (up to ~19 weeks)</time_frame>
    <description>DLT will be defined based on the rate of drug related grade 3-5 adverse events experienced during the first 2 cycles (8 weeks) of MMF with adjuvant TMZ. (The first cycle of MMF with adjuvant TMZ begins 28 days post-RT.) These will be assessed using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0.&#xD;
This measure includes only newly diagnosed phase 1 participants.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Concentrations of guanosine triphosphate (GTP) in tumor tissue in Phase 0 participants</measure>
    <time_frame>After one week of MMF administration</time_frame>
    <description>The concentrations of GTP in tumor tissue, measured by mass spectrometry on a continuous scale.&#xD;
This measure includes all phase 0 participants.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse events associated with treatment in all Phase 1 Participants</measure>
    <time_frame>Up to 28 days following completion of MMF + RT (up to ~9 weeks)</time_frame>
    <description>Toxicities at each dose level will be tabulated, categorized by grade and attribution.&#xD;
This measure includes all phase 1 participants.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse events associated with treatment in newly diagnosed phase 1 participants</measure>
    <time_frame>Up to 28 days following completion of MMF with adjuvant temozolomide (up to ~15 months)</time_frame>
    <description>Toxicities at each dose level will be tabulated, categorized by grade and attribution.&#xD;
This measure includes only newly diagnosed phase 1 participants.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Response Rate in phase 1 participants with recurrent GBM/GS</measure>
    <time_frame>Until study stops or death; up to approximately 3 years.</time_frame>
    <description>Determined by modified Response Assessment for Neuro-Oncology (mRANO) criteria. The number and proportion of patients with progressive disease, stable disease, partial and complete response will be calculated for each dose level and overall.&#xD;
This measure includes only phase 1 participants with recurrent GBM/GS.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Median Progression Free Survival (PFS) in phase 1 participants with recurrent GBM/GS</measure>
    <time_frame>Until study stops or death; up to approximately 3 years.</time_frame>
    <description>PFS defined as time from date of registration to the date of documented progressive disease, other disease related therapy or death. Determined by mRANO criteria.&#xD;
This measure includes only phase 1 participants with recurrent GBM/GS.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Median Freedom from Local Progression (FFLP) in phase 1 participants with recurrent GBM/GS</measure>
    <time_frame>Until study stops or death; up to approximately 3 years.</time_frame>
    <description>FFLP defined as time from date of registration to the date of documented local progressive disease. Determined by mRANO criteria.&#xD;
This measure includes only phase 1 participants with recurrent GBM/GS.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Median Overall Survival (OS) in phase 1 participants with recurrent GBM/GS</measure>
    <time_frame>Until study stops or death; up to approximately 3 years.</time_frame>
    <description>OS defined as time from date of registration to date of death or last follow up. Determined by Kaplan Meier method.&#xD;
This measure includes only phase 1 participants with recurrent GBM/GS.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">68</enrollment>
  <condition>Recurrent Glioblastoma</condition>
  <condition>Recurrent Gliosarcoma</condition>
  <condition>Recurrent Astrocytoma, Grade IV</condition>
  <condition>Newly Diagnosed Glioblastoma</condition>
  <condition>Newly Diagnosed Gliosarcoma</condition>
  <condition>Newly Diagnosed Astrocytoma, Grade IV</condition>
  <arm_group>
    <arm_group_label>Phase 0 - Recurrent glioblastoma (GBM) / gliosarcoma (GS)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Mycophenolate mofetil</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Phase 1 - Recurrent GBM / GS</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Mycophenolate mofetil; radiation therapy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Phase 1 - Newly Diagnosed GBM / GS</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Mycophenolate mofetil; radiation therapy; temozolomide</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Mycophenolate Mofetil</intervention_name>
    <description>500-2000mg orally twice daily, one week prior to re-resection (2 participants at each of 4 dose levels: 500mg, 1000mg, 1500mg and 2000mg)</description>
    <arm_group_label>Phase 0 - Recurrent glioblastoma (GBM) / gliosarcoma (GS)</arm_group_label>
    <other_name>MMF</other_name>
  </intervention>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Radiation Therapy</intervention_name>
    <description>40.5 Gy in 15 fractions</description>
    <arm_group_label>Phase 1 - Recurrent GBM / GS</arm_group_label>
    <other_name>RT</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Re-resection (as part of standard of care)</intervention_name>
    <description>Re-resection or biopsy of tumor as part of standard of care</description>
    <arm_group_label>Phase 0 - Recurrent glioblastoma (GBM) / gliosarcoma (GS)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Temozolomide</intervention_name>
    <description>Temozolomide capsules are an approved oral chemotherapeutic drug for the treatment of adult patients with newly diagnosed GBM/GS concomitantly with radiotherapy and then as adjuvant treatment. The dosing and timing of temozolomide therapy will be determined as per standard-of-care for the individual patient by the treating oncologist.</description>
    <arm_group_label>Phase 1 - Newly Diagnosed GBM / GS</arm_group_label>
    <other_name>TMZ</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Mycophenolate Mofetil</intervention_name>
    <description>250-2000mg orally twice daily, one week prior to and concurrent with RT.</description>
    <arm_group_label>Phase 1 - Recurrent GBM / GS</arm_group_label>
    <other_name>MMF</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Mycophenolate Mofetil</intervention_name>
    <description>250-2000mg orally twice daily, one week prior to and concurrent with RT and cyclic chemotherapy with temozolomide.</description>
    <arm_group_label>Phase 1 - Newly Diagnosed GBM / GS</arm_group_label>
    <other_name>MMF</other_name>
  </intervention>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Radiation Therapy</intervention_name>
    <description>60 Gy in 30 fractions</description>
    <arm_group_label>Phase 1 - Newly Diagnosed GBM / GS</arm_group_label>
    <other_name>RT</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Glioblastoma or gliosarcoma (recurrent or newly diagnosed).&#xD;
&#xD;
          -  Karnofsky Performance Status 60 or greater.&#xD;
&#xD;
          -  Phase 0: Candidate for clinically indicated re-resection or biopsy of glioblastoma or&#xD;
             gliosarcoma per treating physician(s).&#xD;
&#xD;
          -  Phase 1, Recurrent: Candidate for clinically indicated re-irradiation of glioblastoma&#xD;
             or gliosarcoma per treating physician(s) (No more than one prior course of radiation&#xD;
             for GBM).&#xD;
&#xD;
          -  Phase 1, Newly Diagnosed: Candidate for upfront standard of care chemoradiation for&#xD;
             glioblastoma or gliosarcoma per treating physician(s), to start no earlier than 14&#xD;
             days post- operatively from last definitive surgery for glioblastoma or gliosarcoma&#xD;
             (if more than one surgery done. Ex. biopsy prior to resection).&#xD;
&#xD;
          -  ANC &gt;=1,500 cells/mm^3 within 14 days prior to enrollment.&#xD;
&#xD;
          -  Patient (men and childbearing age women) agrees to the use of highly effective&#xD;
             contraception during study participation and for at least 6 weeks for female patients&#xD;
             and 90 days for male patients after final MMF administration.&#xD;
&#xD;
          -  Ability to understand and the willingness to sign a written informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Lack of histopathological diagnosis of the tumor.&#xD;
&#xD;
          -  Gliomatosis cerebri pattern (tumor involving 3 or more lobes) of disease.&#xD;
&#xD;
          -  Leptomeningeal disease.&#xD;
&#xD;
          -  Use of bevacizumab within 8 weeks of study enrollment.&#xD;
&#xD;
          -  Known history of HIV.&#xD;
&#xD;
          -  Active hepatitis B or C infection.&#xD;
&#xD;
          -  Active systemic or central nervous system (CNS) infection.&#xD;
&#xD;
          -  Grade 4 lymphopenia (if ALC &lt;0.5, patient must be on Pneumocystis jirovecii&#xD;
             prophylaxis).&#xD;
&#xD;
          -  Estimated CrCl &lt; 25 ml/min.&#xD;
&#xD;
          -  History of organ transplantation.&#xD;
&#xD;
          -  Patients with known hypoxanthine-guanine phosphoribosyl-transferase deficiency.&#xD;
&#xD;
          -  Serious intercurrent disease.&#xD;
&#xD;
          -  History of allergic reaction or hypersensitivity to mycophenolate mofetil or&#xD;
             mycophenolic acid or any component of the drug product; or medical contraindication&#xD;
             for MMF per treating physician(s).&#xD;
&#xD;
          -  Known immunosuppressive condition from autoimmune disease, immune deficiency syndrome,&#xD;
             or chronic immunosuppressive therapy.&#xD;
&#xD;
          -  Inability to undergo MRI brain with and without contrast.&#xD;
&#xD;
          -  Pregnant or lactating women.&#xD;
&#xD;
          -  Patients with known phenylketonuria.&#xD;
&#xD;
          -  Phase 0: Patients undergoing biopsy who are deemed unlikely to have sufficient tissue&#xD;
             to spare for research purposes (e.g., those whose tumors are in an eloquent brain&#xD;
             location where all tissue taken must be used for diagnostic purposes).&#xD;
&#xD;
          -  Phase I: Increase in steroid requirement within 7 days of study enrollment (stable or&#xD;
             decreasing dose allowed).&#xD;
&#xD;
          -  Phase I, Recurrent: Radiation within 6 months prior to study enrollment.&#xD;
&#xD;
          -  Phase I, Recurrent: Surgery within 4 weeks of re-irradiation.&#xD;
&#xD;
          -  Phase I, Newly Diagnosed: History of hypersensitivity reactions to temozolomide or any&#xD;
             other ingredients in temozolomide and dacarbazine.&#xD;
&#xD;
          -  Phase I, Newly Diagnosed: Prior chemotherapy or radiation therapy for glioblastoma or&#xD;
             gliosarcoma.&#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>Nathan Clarke, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Michigan Rogel Cancer Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Michigan Rogel Cancer Center</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48109</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Cancer AnswerLine</last_name>
      <phone>800-865-1125</phone>
      <email>CancerAnswerLine@med.umich.edu</email>
    </contact>
    <investigator>
      <last_name>Nathan Clarke, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>July 14, 2020</study_first_submitted>
  <study_first_submitted_qc>July 14, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 20, 2020</study_first_posted>
  <last_update_submitted>June 20, 2023</last_update_submitted>
  <last_update_submitted_qc>June 20, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 22, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>recurrent Glioblastoma</keyword>
  <keyword>recurrent Gliosarcoma</keyword>
  <keyword>newly diagnosed Glioblastoma</keyword>
  <keyword>newly diagnosed Gliosarcooma</keyword>
  <keyword>Recurrent Astrocytoma, Grade IV</keyword>
  <keyword>Newly Diagnosed Astrocytoma, Grade IV</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>Gliosarcoma</mesh_term>
    <mesh_term>Recurrence</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Mycophenolic Acid</mesh_term>
    <mesh_term>Temozolomide</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04477200
org study id: UMCC 2019.192
secondary id: HUM00175785
secondary id: R37CA258346
nct id: NCT04477200
lead sponsor: 
collaborator: 
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
This is a phase 0/1 dose-escalation trial to determine the maximum tolerated dose of
      Mycophenolate Mofetil (MMF) when administered with radiation, in patients with glioblastoma
      or gliosarcoma.
The goal of the Phase 0 component is to determine if MMF achieves active concentrations in
      brain tumors. Eight participants in Phase 0 will receive MMF for one week before undergoing
      an already planned biopsy or re-resection (surgical removal) of glioblastoma or gliosarcoma
      (GBM/GS). A small portion of the tumor, removed as part of clinical care, will be used for
      testing in this study. Sixty additional participants will be enrolled in the Phase 1
      component of the trial (30 with recurrent GBM/GS and 30 with newly diagnosed GBM/GS). The
      goal of the Phase 1 component is to find the dose of MMF that works best without causing
      severe side effects (the maximum tolerated dose) when combined with radiation in recurrent
      GBM/GS and with radiation and chemotherapy in newly diagnosed GBM/GS. Participants in Phase 0
      who meet the eligibility criteria for the Phase 1 component may participate in both phases.
allocation: Non-Randomized
intervention model: Sequential Assignment
intervention model description: Phase 0 will include 8 participants; eligible participants from phase 0 may continue on to phase 1.
primary purpose: Treatment
masking: None (Open Label)
measure: Concentration of mycophenolic acid (MPA) in tumor tissue in Phase 0 participants
time frame: At 1 week
description: The concentration of MPA (the active metabolite of mycophenolate mofetil [MMF]) in tumor tissue, measured by mass spectrometry on a continuous scale after one week of MMF administration.
This measure includes all phase 0 participants.
measure: Number of recurrent phase 1 participants who experience dose-limiting toxicities (DLTs) at each dose level
time frame: Up to 28 days following completion of MMF + RT (up to ~9 weeks)
description: DLT will be defined based on the rate of drug related grade 3-5 adverse events experienced from the start of treatment with MMF and for up to 4 weeks after completion of MMF + radiation therapy (RT). Assessed using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0.
This measure includes only phase 1 participants with recurrent GBM/GS.
measure: Number of newly diagnosed phase 1 participants who experience dose-limiting toxicities (DLTs) at each dose level -- DLT1 period
time frame: Up to 28 days following completion of MMF + RT + TMZ (up to ~11 weeks)
description: DLT will be defined based on the rate of drug related grade 3-5 adverse events experienced from the start of treatment with MMF and for up to 4 weeks after completion of MMF + RT + TMZ. Assessed using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0.
This measure includes only newly diagnosed phase 1 participants.
measure: Number of newly diagnosed phase 1 participants who experience dose-limiting toxicities (DLTs) at each dose level -- DLT2 period
time frame: During the first 2 cycles (8 weeks) of MMF with adjuvant TMZ (up to ~19 weeks)
description: DLT will be defined based on the rate of drug related grade 3-5 adverse events experienced during the first 2 cycles (8 weeks) of MMF with adjuvant TMZ. (The first cycle of MMF with adjuvant TMZ begins 28 days post-RT.) These will be assessed using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0.
This measure includes only newly diagnosed phase 1 participants.
measure: Concentrations of guanosine triphosphate (GTP) in tumor tissue in Phase 0 participants
time frame: After one week of MMF administration
description: The concentrations of GTP in tumor tissue, measured by mass spectrometry on a continuous scale.
This measure includes all phase 0 participants.
measure: Adverse events associated with treatment in all Phase 1 Participants
time frame: Up to 28 days following completion of MMF + RT (up to ~9 weeks)
description: Toxicities at each dose level will be tabulated, categorized by grade and attribution.
This measure includes all phase 1 participants.
measure: Adverse events associated with treatment in newly diagnosed phase 1 participants
time frame: Up to 28 days following completion of MMF with adjuvant temozolomide (up to ~15 months)
description: Toxicities at each dose level will be tabulated, categorized by grade and attribution.
This measure includes only newly diagnosed phase 1 participants.
measure: Overall Response Rate in phase 1 participants with recurrent GBM/GS
time frame: Until study stops or death; up to approximately 3 years.
description: Determined by modified Response Assessment for Neuro-Oncology (mRANO) criteria. The number and proportion of patients with progressive disease, stable disease, partial and complete response will be calculated for each dose level and overall.
This measure includes only phase 1 participants with recurrent GBM/GS.
measure: Median Progression Free Survival (PFS) in phase 1 participants with recurrent GBM/GS
time frame: Until study stops or death; up to approximately 3 years.
description: PFS defined as time from date of registration to the date of documented progressive disease, other disease related therapy or death. Determined by mRANO criteria.
This measure includes only phase 1 participants with recurrent GBM/GS.
measure: Median Freedom from Local Progression (FFLP) in phase 1 participants with recurrent GBM/GS
time frame: Until study stops or death; up to approximately 3 years.
description: FFLP defined as time from date of registration to the date of documented local progressive disease. Determined by mRANO criteria.
This measure includes only phase 1 participants with recurrent GBM/GS.
measure: Median Overall Survival (OS) in phase 1 participants with recurrent GBM/GS
time frame: Until study stops or death; up to approximately 3 years.
description: OS defined as time from date of registration to date of death or last follow up. Determined by Kaplan Meier method.
This measure includes only phase 1 participants with recurrent GBM/GS.
arm group label: Phase 0 - Recurrent glioblastoma (GBM) / gliosarcoma (GS)
arm group type: Experimental
description: Mycophenolate mofetil
arm group label: Phase 1 - Recurrent GBM / GS
arm group type: Experimental
description: Mycophenolate mofetil; radiation therapy
arm group label: Phase 1 - Newly Diagnosed GBM / GS
arm group type: Experimental
description: Mycophenolate mofetil; radiation therapy; temozolomide
intervention type: Drug
intervention name: Mycophenolate Mofetil
description: 500-2000mg orally twice daily, one week prior to re-resection (2 participants at each of 4 dose levels: 500mg, 1000mg, 1500mg and 2000mg)
arm group label: Phase 0 - Recurrent glioblastoma (GBM) / gliosarcoma (GS)
other name: MMF
intervention type: Radiation
intervention name: Radiation Therapy
description: 40.5 Gy in 15 fractions
arm group label: Phase 1 - Recurrent GBM / GS
other name: RT
intervention type: Procedure
intervention name: Re-resection (as part of standard of care)
description: Re-resection or biopsy of tumor as part of standard of care
arm group label: Phase 0 - Recurrent glioblastoma (GBM) / gliosarcoma (GS)
intervention type: Drug
intervention name: Temozolomide
description: Temozolomide capsules are an approved oral chemotherapeutic drug for the treatment of adult patients with newly diagnosed GBM/GS concomitantly with radiotherapy and then as adjuvant treatment. The dosing and timing of temozolomide therapy will be determined as per standard-of-care for the individual patient by the treating oncologist.
arm group label: Phase 1 - Newly Diagnosed GBM / GS
other name: TMZ
intervention type: Drug
intervention name: Mycophenolate Mofetil
description: 250-2000mg orally twice daily, one week prior to and concurrent with RT.
arm group label: Phase 1 - Recurrent GBM / GS
other name: MMF
intervention type: Drug
intervention name: Mycophenolate Mofetil
description: 250-2000mg orally twice daily, one week prior to and concurrent with RT and cyclic chemotherapy with temozolomide.
arm group label: Phase 1 - Newly Diagnosed GBM / GS
other name: MMF
intervention type: Radiation
intervention name: Radiation Therapy
description: 60 Gy in 30 fractions
arm group label: Phase 1 - Newly Diagnosed GBM / GS
other name: RT
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Nathan Clarke, MD
role: Principal Investigator
affiliation: University of Michigan Rogel Cancer Center
facility: 
status: Recruiting
contact: 
investigator: 
country: United States
responsible party type: Sponsor
mesh term: Glioblastoma
mesh term: Astrocytoma
mesh term: Gliosarcoma
mesh term: Recurrence
mesh term: Mycophenolic Acid
mesh term: Temozolomide
sharing ipd: No