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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

Tracking Information
First Submitted Date  ICMJE September 23, 2014
First Posted Date  ICMJE October 2, 2014
Last Update Posted Date October 2, 2014
Study Start Date  ICMJE November 2014
Estimated Primary Completion Date July 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 1, 2014)		 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study: Pure CBD as Single-agent for Solid Tumor.
Official Title  ICMJE Not Provided
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Solid Tumor
Intervention  ICMJE 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
Study Arms  ICMJE 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.
Intervention: Drug: cannabidiol (CBD)
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: October 1, 2014)		 60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2015
Estimated Primary Completion Date July 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02255292
Other Study ID Numbers  ICMJE CBD- HMO-CTIL
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Rotenberg Yakir, Hadassah Medical Organization
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Hadassah Medical Organization
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Hadas Lemberg, PhD Hadassah Medical Organization
PRS Account Hadassah Medical Organization
Verification Date September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP