<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/NCT03246113</url>
  </required_header>
  <id_info>
    <org_study_id>IRB#7290</org_study_id>
    <nct_id>NCT03246113</nct_id>
  </id_info>
  <brief_title>Tolerability of Cannabis in Patients Receiving Concurrent Chemoradiation for Glioblastoma</brief_title>
  <official_title>Investigation of Cannabis For Tolerability and Feasibility in Patients Receiving Concurrent Chemoradiation for Glioblastoma.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>New York State Psychiatric Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>New York State Psychiatric Institute</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The goal of this single arm Phase I feasibility study is to investigate the tolerability of&#xD;
      cannabis with concurrent chemoradiation in the treatment of glioblastoma multiforme (GBM). A&#xD;
      strain of cannabis provided by The National Institute of Drug Abuse (NIDA) that has a high&#xD;
      concentration of cannabidiol (CBD) and a low concentration of THC (relative to average street&#xD;
      cannabis) will be tested in order to maximize clinical efficacy while minimizing intoxicating&#xD;
      side effects in this medically-ill population.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this study is to determine the feasibility and the effects of cannabis with&#xD;
      high concentrations of CBD in patients receiving chemoradiation for GBM. This is not a&#xD;
      therapeutic study for the treatment of glioblastoma. Patients will first complete a cannabis&#xD;
      sampling session to assess for initial marijuana tolerability. Proceeding this, patients will&#xD;
      complete 3-5 outpatient smoking sessions per week over a 6 week period. During each session,&#xD;
      patients will be given 90 minutes to smoke 0.5 to 2 cannabis cigarettes. Outcome measures&#xD;
      will include measures of pain, mood, nausea, quality of life, and the both the potentially&#xD;
      positive and negative subjective effects of cannabis. Food intake, opioid use, and compliance&#xD;
      to cannabis treatment will be investigated. It is hypothesized that concurrent use of&#xD;
      cannabis with chemoradiation in the treatment of patients with GBM will be feasible, well&#xD;
      tolerated and may decrease radiation-induced toxicities.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Lack of subject interest due to study design&#xD;
  </why_stopped>
  <start_date type="Actual">March 19, 2018</start_date>
  <completion_date type="Actual">May 9, 2019</completion_date>
  <primary_completion_date type="Actual">May 9, 2019</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 Treatment-Emergent Adverse Events [Safety and Tolerability]</measure>
    <time_frame>6 weeks</time_frame>
    <description>Number of cannabis-related adverse events&#xD;
A 44-item computerized subjective-effects questionnaire visual analog scale (VAS), comprising a series of 100-mm lines labeled 'not at all' (0 mm) at one end and 'extremely' at the other end, will be completed at baseline, after the 90 minutes of cannabis availability and at the end of the session. The VAS included mood, physical symptom, and drug effect descriptors; participants will be instructed to rate the extent to which each descriptor applied to them at that moment.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Radiation Induced Toxicities</measure>
    <time_frame>6 weeks</time_frame>
    <description>All patients receiving radiation treatments are routinely seen by the radiation oncologist once a week for a status check. The RTOG cooperative group common toxicity criteria will be used to assess for neurological toxicities including paresthesia, weakness, somnolence or agitation, incoordination, headache, hearing deficit, tremor, speech deficit, and ataxia.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Opioid Medications Administered</measure>
    <time_frame>6 weeks</time_frame>
    <description>Patients will be asked to provide to us the number of opioid medications they took over the 6-week treatment course. The amount of opioids used will be converted to oral morphine equivalents and tallied for each day.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">1</enrollment>
  <condition>Glioblastoma</condition>
  <arm_group>
    <arm_group_label>Cannabis + Chemoradiation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will receive a cannabis strain with high cannabidiol (4.8%) and low Delta-9-THC (3.23%). Patients will smoke the cannabis over a 2 hour session (from 0.5 - 2.0 cannabis cigarettes) before receiving chemoradiation therapy with radiation and concurrent temozolomide.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cannabis</intervention_name>
    <description>Cannabis cigarettes provided by NIDA that contain high levels of CBD (4.8%) and low levels of THC (3.23%). Patients will smoke one-half (1/2) to two (2) cannabis cigarettes prior to receiving chemoradiation.</description>
    <arm_group_label>Cannabis + Chemoradiation</arm_group_label>
    <other_name>Marijuana</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Temozolomide</intervention_name>
    <description>Oral alkylating agent with demonstrated antitumor activity.</description>
    <arm_group_label>Cannabis + Chemoradiation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Radiation Therapy</intervention_name>
    <description>standard fractionation radiotherapy of 60 Gy in 30 treatments with temozolomide.</description>
    <arm_group_label>Cannabis + Chemoradiation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of Glioblastoma requiring standard care chemoradiation of concurrent&#xD;
             Temozolomide and 60 Gy of radiation given over 30 treatments&#xD;
&#xD;
          -  Age 21-70&#xD;
&#xD;
          -  Able to give informed consent, and comply with study procedures&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Meet DSM-V criteria for current major psychiatric illness, such as bipolar disorder,&#xD;
             major depression, active suicidal intent, or psychosis that could be exacerbated by&#xD;
             the administration of cannabis&#xD;
&#xD;
          -  Meet DSM-V criteria for major neurological disorder, such as mild cognitive impairment&#xD;
             or neurodegenerative disorders (such as movement disorders, dementia), that could be&#xD;
             exacerbated by the administration of cannabis.&#xD;
&#xD;
          -  Women who are not practicing an effective form of birth control (condoms, diaphragm,&#xD;
             birth control pill, IUD) or currently pregnant.&#xD;
&#xD;
          -  Current (weekly) use of cannabis.&#xD;
&#xD;
          -  Patients on supplemental oxygen or history of chronic obstructive pulmonary disease&#xD;
             (COPD).&#xD;
&#xD;
          -  Cardiovascular Disease&#xD;
&#xD;
          -  Compromised Immunity&#xD;
&#xD;
          -  Patients with a history of substance use disorder other than nicotine, such an opiate&#xD;
             use disorder.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Margaret Haney, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Professor of Neurobiology (in Psychiatry) at Columbia University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Tony J Wang, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Associate Professor of Radiation Oncology at Columbia University Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Columbia University Medical Center- Department of Radiation Oncology</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10032</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>New York State Psychiatric Institute</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10032</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2019</verification_date>
  <study_first_submitted>July 25, 2017</study_first_submitted>
  <study_first_submitted_qc>August 7, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 11, 2017</study_first_posted>
  <last_update_submitted>August 9, 2019</last_update_submitted>
  <last_update_submitted_qc>August 9, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">August 13, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>New York State Psychiatric Institute</investigator_affiliation>
    <investigator_full_name>Margaret Haney</investigator_full_name>
    <investigator_title>Professor of Neurobiology (in Psychiatry)</investigator_title>
  </responsible_party>
  <keyword>GBM WHO Grade IV</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Glioblastoma</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>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/NCT03246113
org study id: IRB#7290
nct id: NCT03246113
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
The goal of this single arm Phase I feasibility study is to investigate the tolerability of
      cannabis with concurrent chemoradiation in the treatment of glioblastoma multiforme (GBM). A
      strain of cannabis provided by The National Institute of Drug Abuse (NIDA) that has a high
      concentration of cannabidiol (CBD) and a low concentration of THC (relative to average street
      cannabis) will be tested in order to maximize clinical efficacy while minimizing intoxicating
      side effects in this medically-ill population.
The purpose of this study is to determine the feasibility and the effects of cannabis with
      high concentrations of CBD in patients receiving chemoradiation for GBM. This is not a
      therapeutic study for the treatment of glioblastoma. Patients will first complete a cannabis
      sampling session to assess for initial marijuana tolerability. Proceeding this, patients will
      complete 3-5 outpatient smoking sessions per week over a 6 week period. During each session,
      patients will be given 90 minutes to smoke 0.5 to 2 cannabis cigarettes. Outcome measures
      will include measures of pain, mood, nausea, quality of life, and the both the potentially
      positive and negative subjective effects of cannabis. Food intake, opioid use, and compliance
      to cannabis treatment will be investigated. It is hypothesized that concurrent use of
      cannabis with chemoradiation in the treatment of patients with GBM will be feasible, well
      tolerated and may decrease radiation-induced toxicities.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
time frame: 6 weeks
description: Number of cannabis-related adverse events
A 44-item computerized subjective-effects questionnaire visual analog scale (VAS), comprising a series of 100-mm lines labeled 'not at all' (0 mm) at one end and 'extremely' at the other end, will be completed at baseline, after the 90 minutes of cannabis availability and at the end of the session. The VAS included mood, physical symptom, and drug effect descriptors; participants will be instructed to rate the extent to which each descriptor applied to them at that moment.
measure: Number of Radiation Induced Toxicities
time frame: 6 weeks
description: All patients receiving radiation treatments are routinely seen by the radiation oncologist once a week for a status check. The RTOG cooperative group common toxicity criteria will be used to assess for neurological toxicities including paresthesia, weakness, somnolence or agitation, incoordination, headache, hearing deficit, tremor, speech deficit, and ataxia.
measure: Number of Opioid Medications Administered
time frame: 6 weeks
description: Patients will be asked to provide to us the number of opioid medications they took over the 6-week treatment course. The amount of opioids used will be converted to oral morphine equivalents and tallied for each day.
arm group label: Cannabis + Chemoradiation
arm group type: Experimental
description: Patients will receive a cannabis strain with high cannabidiol (4.8%) and low Delta-9-THC (3.23%). Patients will smoke the cannabis over a 2 hour session (from 0.5 - 2.0 cannabis cigarettes) before receiving chemoradiation therapy with radiation and concurrent temozolomide.
intervention type: Drug
intervention name: Cannabis
description: Cannabis cigarettes provided by NIDA that contain high levels of CBD (4.8%) and low levels of THC (3.23%). Patients will smoke one-half (1/2) to two (2) cannabis cigarettes prior to receiving chemoradiation.
arm group label: Cannabis + Chemoradiation
other name: Marijuana
intervention type: Drug
intervention name: Temozolomide
description: Oral alkylating agent with demonstrated antitumor activity.
arm group label: Cannabis + Chemoradiation
intervention type: Radiation
intervention name: Radiation Therapy
description: standard fractionation radiotherapy of 60 Gy in 30 treatments with temozolomide.
arm group label: Cannabis + Chemoradiation
criteria: 
gender: All
minimum age: 21 Years
maximum age: 70 Years
healthy volunteers: No
last name: Margaret Haney, PhD
role: Principal Investigator
affiliation: Professor of Neurobiology (in Psychiatry) at Columbia University
last name: Tony J Wang, MD
role: Principal Investigator
affiliation: Associate Professor of Radiation Oncology at Columbia University Medical Center
facility: 
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: New York State Psychiatric Institute
investigator full name: Margaret Haney
investigator title: Professor of Neurobiology (in Psychiatry)
mesh term: Glioblastoma
mesh term: Temozolomide
sharing ipd: No