<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/NCT02255292</url>
  </required_header>
  <id_info>
    <org_study_id>CBD- HMO-CTIL</org_study_id>
    <nct_id>NCT02255292</nct_id>
  </id_info>
  <brief_title>A Study: Pure CBD as Single-agent for Solid Tumor.</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hadassah Medical Organization</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hadassah Medical Organization</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Increasing lines of evidence support an antitumourigenic effect of cannabinoids, including&#xD;
      the cannabidiol (CBD) which does not posses the psychotropic effects of&#xD;
      D9-tetrahydrocannabinol (THC). These include anti-proliferative and pro-apoptotic effects and&#xD;
      they are known to interfere with several mechanisms in the tumorgenesis. Yet, evidence from&#xD;
      clinical trials among cancer patients is needed. The aim of the current study is to evaluate&#xD;
      the impact of CBD as single treatment among cancer patients.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>November 2014</start_date>
  <completion_date type="Anticipated">July 2015</completion_date>
  <primary_completion_date type="Anticipated">July 2015</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Overall Response Rate according to RECIST 1.1</measure>
    <time_frame>At baseline and at 8 weeks from time of first dose, by CT scans for RECIST 1.1</time_frame>
    <description>ORR per RECIST 1.1 calculated as the proportion of patients with a best overall response defined as complete response or partial response (CR+PR) as assessed by investigatorand RECIST criteria.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Solid Tumor</condition>
  <arm_group>
    <arm_group_label>cannabidiol (CBD)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients with confirmed solid cancer, after progression of all the available standard therapy or unfit to standard therapy according to oncologist's view, measurable disease as determined by RECIST using CT, life expectancy of at least 6 months, Eastern Cooperative Oncology Group (ECOG) performance status &lt; or = 2 and aged 18 years old and more will be included in the current study.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>cannabidiol (CBD)</intervention_name>
    <description>Patients with confirmed solid cancer, after progression of all the available standard therapy or unfit to standard therapy according to oncologist's view, measurable disease as determined by RECIST using CT, life expectancy of at least 6 months, Eastern Cooperative Oncology Group (ECOG) performance status &lt; or = 2 and aged 18 years old and more will be included in the current study</description>
    <arm_group_label>cannabidiol (CBD)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Confirmed solid cancer&#xD;
&#xD;
          -  Approved license for using cannabis (from the ministry of health: Israel)&#xD;
&#xD;
          -  Progression of all the available standard therapy / unfit to standard therapy&#xD;
             according to oncologist's view&#xD;
&#xD;
          -  Measurable disease as determined by RECIST&#xD;
&#xD;
          -  Life expectancy of at least 6 months&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group (ECOG) performance status &lt; or = 2&#xD;
&#xD;
          -  Aged 18 years old and more&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Received cannabis therapy for any indication&#xD;
&#xD;
          -  Previous systemic therapy of less than 3 weeks prior to and, if present, any acute&#xD;
             toxicity &gt; grade 1.&#xD;
&#xD;
          -  Clinically significant cardiac disease or any history of psychosis&#xD;
&#xD;
          -  Pregnancy or breast feeding&#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>Hadas Lemberg, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Hadassah Medical Organization</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Yakir Rottenberg, MD MPH</last_name>
    <phone>00 97226777111</phone>
    <email>ryakir@hadassah.org.il</email>
  </overall_contact>
  <reference>
    <citation>Mechoulam R, Peters M, Murillo-Rodriguez E, Hanus LO. Cannabidiol--recent advances. Chem Biodivers. 2007 Aug;4(8):1678-92. doi: 10.1002/cbdv.200790147.</citation>
    <PMID>17712814</PMID>
  </reference>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>September 23, 2014</study_first_submitted>
  <study_first_submitted_qc>October 1, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 2, 2014</study_first_posted>
  <last_update_submitted>October 1, 2014</last_update_submitted>
  <last_update_submitted_qc>October 1, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 2, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hadassah Medical Organization</investigator_affiliation>
    <investigator_full_name>Rotenberg Yakir</investigator_full_name>
    <investigator_title>Hadas Lemberg, PhD</investigator_title>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cannabidiol</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/NCT02255292
org study id: CBD- HMO-CTIL
nct id: NCT02255292
lead sponsor: 
has dmc: No
Increasing lines of evidence support an antitumourigenic effect of cannabinoids, including
      the cannabidiol (CBD) which does not posses the psychotropic effects of
      D9-tetrahydrocannabinol (THC). These include anti-proliferative and pro-apoptotic effects and
      they are known to interfere with several mechanisms in the tumorgenesis. Yet, evidence from
      clinical trials among cancer patients is needed. The aim of the current study is to evaluate
      the impact of CBD as single treatment among cancer patients.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Overall Response Rate according to RECIST 1.1
time frame: At baseline and at 8 weeks from time of first dose, by CT scans for RECIST 1.1
description: ORR per RECIST 1.1 calculated as the proportion of patients with a best overall response defined as complete response or partial response (CR+PR) as assessed by investigatorand RECIST criteria.
arm group label: cannabidiol (CBD)
arm group type: Experimental
description: Patients with confirmed solid cancer, after progression of all the available standard therapy or unfit to standard therapy according to oncologist's view, measurable disease as determined by RECIST using CT, life expectancy of at least 6 months, Eastern Cooperative Oncology Group (ECOG) performance status < or = 2 and aged 18 years old and more will be included in the current study.
intervention type: Drug
intervention name: cannabidiol (CBD)
description: Patients with confirmed solid cancer, after progression of all the available standard therapy or unfit to standard therapy according to oncologist's view, measurable disease as determined by RECIST using CT, life expectancy of at least 6 months, Eastern Cooperative Oncology Group (ECOG) performance status < or = 2 and aged 18 years old and more will be included in the current study
arm group label: cannabidiol (CBD)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Hadas Lemberg, PhD
role: Study Chair
affiliation: Hadassah Medical Organization
last name: Yakir Rottenberg, MD MPH
phone: 00 97226777111
email: ryakir@hadassah.org.il
citation: Mechoulam R, Peters M, Murillo-Rodriguez E, Hanus LO. Cannabidiol--recent advances. Chem Biodivers. 2007 Aug;4(8):1678-92. doi: 10.1002/cbdv.200790147.
PMID: 17712814
responsible party type: Principal Investigator
investigator affiliation: Hadassah Medical Organization
investigator full name: Rotenberg Yakir
investigator title: Hadas Lemberg, PhD
mesh term: Cannabidiol