<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/NCT03796507</url>
  </required_header>
  <id_info>
    <org_study_id>RSRB00003258</org_study_id>
    <nct_id>NCT03796507</nct_id>
  </id_info>
  <brief_title>Early Temozolomide in Patients With High-Grade Gliomas in Rehabilitation</brief_title>
  <official_title>Early Post-surgical Temozolomide Therapy in Patients With High-Grade Gliomas Admitted to Acute Rehabilitation: A Feasibility Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Rochester</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institutes of Health (NIH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Rochester</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>
      The purpose of this study is to investigate the feasibility of a possible treatment regimen&#xD;
      that could be used to delay tumor progression in patients with glioblastoma. The study is&#xD;
      being conducted in patients who qualify for inpatient rehabilitation, as this population is&#xD;
      particularly vulnerable to delays in initiation of chemoradiation and further tumor growth in&#xD;
      the period between surgical resection and the start of treatment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a pilot study to evaluate the feasibility and safety of early postsurgical&#xD;
      temozolomide therapy prior to initiation of standard chemoradiation regimen in patients with&#xD;
      glioblastoma who undergo inpatient rehabilitation. The study will be conducted with adult&#xD;
      patients who qualify for inpatient rehabilitation following surgical resection of&#xD;
      pathologically confirmed Grade IV glioma. Patients will begin a 21-day cycle of temozolomide&#xD;
      starting 14 days after surgery at 75mg per square meter of body surface area daily to serve&#xD;
      as bridge therapy. Patients will then progress to receive standard therapy following their&#xD;
      rehabilitation stay. Patients will be assessed for their ability to complete the chemotherapy&#xD;
      protocol without dose-limiting toxicity as well as complete inpatient rehabilitation&#xD;
      successfully. Additionally, we will be assessing for tumor progression between the time of&#xD;
      surgery and the time of treatment initiation.&#xD;
&#xD;
      If this study shows the expected results, the research team plans to proceed to a larger&#xD;
      trial assessing the efficacy of early TMZ in patients with glioblastoma (GBM) who are&#xD;
      admitted to acute inpatient rehabilitation compared to the current standard of care.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Hiring freeze of research personnel due to COVID pandemic&#xD;
  </why_stopped>
  <start_date type="Anticipated">September 1, 2021</start_date>
  <completion_date type="Anticipated">December 15, 2021</completion_date>
  <primary_completion_date type="Anticipated">December 15, 2021</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>The number of patient who fail to complete temozolomide (TMZ)</measure>
    <time_frame>1 month</time_frame>
    <description>The number of subjects who fail to complete early TMZ plus inpatient rehabilitation for any reason, including adverse events or progression or patient withdrawal</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mean functional independence measure (FIM) score</measure>
    <time_frame>1 month</time_frame>
    <description>FIM is comprised of 18 items, grouped into 2 subscales -motor and cognition. Each item is scored on a 7 point ordinal scale, ranging from a score of 1 to a score of 7. The higher the score, the more independent the patient is in performing the task associated with that item therefore the better the health outcome. The total score for the FIM instrument (the sum of the motor and cognition subscale scores) will be a value between 18 and 126.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Response rate to TMZ</measure>
    <time_frame>1 month</time_frame>
    <description>The response rate to early TMZ will be evaluated by comparing the MRI of the head before and after one course using the Response Assessment in Neuro-Oncology (RANO) criteria. The response rate will be reported with a (two-sided) 90% confidence interval. The RANO criteria consists of 5 elements: T1 Gadolinium enhancing disease, T2/FLAIR assessment, new lesions, use of corticosteroids and clinical status. Patients will be categorized as complete response, partial response, stable disease or progressive disease.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Glioma of Brain</condition>
  <arm_group>
    <arm_group_label>Temozolomide Arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This study will only include one treatment group who will receive oral temozolomide at 75 mg per square meter of body surface area daily for 21 days before progressing to standard chemoradiation treatment.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Temozolomide</intervention_name>
    <description>oral temozolomide at 75 mg per square meter of body surface area daily for 21 days</description>
    <arm_group_label>Temozolomide Arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult patients, aged 18+&#xD;
&#xD;
          -  Newly diagnosed World Health Organization (WHO) Grade IV glioma, confirmed on&#xD;
             pathology&#xD;
&#xD;
          -  Karnofsky Performance Score ≥ 60&#xD;
&#xD;
          -  Subject has undergone biopsy, subtotal resection, or gross total resection of tumor&#xD;
&#xD;
          -  Subject has been evaluated by physical therapy and thought to be a candidate for acute&#xD;
             rehabilitation&#xD;
&#xD;
          -  Subject must be accepted for admission on 5-1200 unit at Strong Memorial Hospital&#xD;
&#xD;
          -  Subject must be able to provide informed consent&#xD;
&#xD;
          -  Subject must meet the following laboratory parameters:&#xD;
&#xD;
               -  Absolute neutrophil count &gt; 1.5 x103/uL&#xD;
&#xD;
               -  Platelet count &gt; 140 x103/uL&#xD;
&#xD;
               -  Alanine transaminase &lt; 135 U/L&#xD;
&#xD;
               -  Aspartate transaminase &lt; 120 U/L&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subject has received previous treatment for high-grade glioma&#xD;
&#xD;
          -  Subject has other active malignancy&#xD;
&#xD;
          -  Subject is currently pregnant or breastfeeding&#xD;
&#xD;
          -  Subject is a women of childbearing potential who is not using a reliable method of&#xD;
             contraception&#xD;
&#xD;
          -  Subject has history of hypersensitivity to temozolomide&#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>Kevin A Walter, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Rochester Medical Center, Dept. of Neurosurgery</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Rochester Medical Center</name>
      <address>
        <city>Rochester</city>
        <state>New York</state>
        <zip>14642</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>January 4, 2019</study_first_submitted>
  <study_first_submitted_qc>January 4, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 8, 2019</study_first_posted>
  <last_update_submitted>April 6, 2021</last_update_submitted>
  <last_update_submitted_qc>April 6, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 9, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Rochester</investigator_affiliation>
    <investigator_full_name>Kevin Walter</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>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>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03796507
org study id: RSRB00003258
nct id: NCT03796507
lead sponsor: 
collaborator: 
is fda regulated drug: Yes
is fda regulated device: No
The purpose of this study is to investigate the feasibility of a possible treatment regimen
      that could be used to delay tumor progression in patients with glioblastoma. The study is
      being conducted in patients who qualify for inpatient rehabilitation, as this population is
      particularly vulnerable to delays in initiation of chemoradiation and further tumor growth in
      the period between surgical resection and the start of treatment.
This is a pilot study to evaluate the feasibility and safety of early postsurgical
      temozolomide therapy prior to initiation of standard chemoradiation regimen in patients with
      glioblastoma who undergo inpatient rehabilitation. The study will be conducted with adult
      patients who qualify for inpatient rehabilitation following surgical resection of
      pathologically confirmed Grade IV glioma. Patients will begin a 21-day cycle of temozolomide
      starting 14 days after surgery at 75mg per square meter of body surface area daily to serve
      as bridge therapy. Patients will then progress to receive standard therapy following their
      rehabilitation stay. Patients will be assessed for their ability to complete the chemotherapy
      protocol without dose-limiting toxicity as well as complete inpatient rehabilitation
      successfully. Additionally, we will be assessing for tumor progression between the time of
      surgery and the time of treatment initiation.

      If this study shows the expected results, the research team plans to proceed to a larger
      trial assessing the efficacy of early TMZ in patients with glioblastoma (GBM) who are
      admitted to acute inpatient rehabilitation compared to the current standard of care.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: The number of patient who fail to complete temozolomide (TMZ)
time frame: 1 month
description: The number of subjects who fail to complete early TMZ plus inpatient rehabilitation for any reason, including adverse events or progression or patient withdrawal
measure: Mean functional independence measure (FIM) score
time frame: 1 month
description: FIM is comprised of 18 items, grouped into 2 subscales -motor and cognition. Each item is scored on a 7 point ordinal scale, ranging from a score of 1 to a score of 7. The higher the score, the more independent the patient is in performing the task associated with that item therefore the better the health outcome. The total score for the FIM instrument (the sum of the motor and cognition subscale scores) will be a value between 18 and 126.
measure: Response rate to TMZ
time frame: 1 month
description: The response rate to early TMZ will be evaluated by comparing the MRI of the head before and after one course using the Response Assessment in Neuro-Oncology (RANO) criteria. The response rate will be reported with a (two-sided) 90% confidence interval. The RANO criteria consists of 5 elements: T1 Gadolinium enhancing disease, T2/FLAIR assessment, new lesions, use of corticosteroids and clinical status. Patients will be categorized as complete response, partial response, stable disease or progressive disease.
arm group label: Temozolomide Arm
arm group type: Experimental
description: This study will only include one treatment group who will receive oral temozolomide at 75 mg per square meter of body surface area daily for 21 days before progressing to standard chemoradiation treatment.
intervention type: Drug
intervention name: Temozolomide
description: oral temozolomide at 75 mg per square meter of body surface area daily for 21 days
arm group label: Temozolomide Arm
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Kevin A Walter, MD
role: Principal Investigator
affiliation: University of Rochester Medical Center, Dept. of Neurosurgery
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Rochester
investigator full name: Kevin Walter
investigator title: Professor
mesh term: Glioma
mesh term: Temozolomide
sharing ipd: Undecided