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A Study: Pure CBD as Single-agent for Solid Tumor.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02255292
Recruitment Status : Unknown
Verified September 2014 by Rotenberg Yakir, Hadassah Medical Organization.
Recruitment status was:  Not yet recruiting
First Posted : October 2, 2014
Last Update Posted : October 2, 2014
Sponsor:
Information provided by (Responsible Party):
Rotenberg Yakir, Hadassah Medical Organization

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Solid Tumor Drug: cannabidiol (CBD) Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : November 2014
Estimated Primary Completion Date : July 2015
Estimated Study Completion Date : July 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Cannabidiol

Arms and Interventions
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Arm Intervention/treatment
Experimental: cannabidiol (CBD)
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.
 Drug: cannabidiol (CBD)
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


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]
    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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Confirmed solid cancer
  • Approved license for using cannabis (from the ministry of health: Israel)
  • Progression of all the available standard therapy / unfit to standard therapy according to oncologist's view
  • Measurable disease as determined by RECIST
  • Life expectancy of at least 6 months
  • Eastern Cooperative Oncology Group (ECOG) performance status < or = 2
  • Aged 18 years old and more

Exclusion Criteria:

  • Received cannabis therapy for any indication
  • Previous systemic therapy of less than 3 weeks prior to and, if present, any acute toxicity > grade 1.
  • Clinically significant cardiac disease or any history of psychosis
  • Pregnancy or breast feeding
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02255292


Contacts
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Contact: Yakir Rottenberg, MD MPH 00 97226777111 ryakir@hadassah.org.il

Sponsors and Collaborators
Hadassah Medical Organization
Investigators
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Study Chair: Hadas Lemberg, PhD Hadassah Medical Organization
More Information
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Publications:

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Responsible Party: Rotenberg Yakir, Hadas Lemberg, PhD, Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT02255292    
Other Study ID Numbers: CBD- HMO-CTIL
First Posted: October 2, 2014    Key Record Dates
Last Update Posted: October 2, 2014
Last Verified: September 2014
Additional relevant MeSH terms:
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Cannabidiol
Anticonvulsants