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

Solid Tumor Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02255292
• Other study ID #: CBD- HMO-CTIL
• Status: Not yet recruiting
• Phase: Phase 2
• First received: September 23, 2014
• Last updated: October 1, 2014
• Start date: November 2014
• Est. completion date: July 2015

Study information

• Verified date: September 2014
• Source: Hadassah Medical Organization
• Contact: Yakir Rottenberg, MD MPH
• Phone: 00 97226777111
• Email: ryakir[@]hadassah.org.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Solid Tumor

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hadassah Medical Organization

References & Publications (1)

Mechoulam R, Peters M, Murillo-Rodriguez E, Hanus LO. Cannabidiol--recent advances. Chem Biodivers. 2007 Aug;4(8):1678-92. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Response Rate according to 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.	At baseline and at 8 weeks from time of first dose, by CT scans for RECIST 1.1	No