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

Phase 2

• Conditions: Solid Tumor
• Interventions: Drug: cannabidiol (CBD)

• Registration Number: NCT02255292
• Lead Sponsor: Hadassah Medical Organization

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 available

Study Timeline

• Status Verified: 2014-09
• Study First Submitted: 2014-09-23
• Study First Submitted QC: 2014-10-01
• Last Update Submitted: 2014-10-01
• Study First Posted: 2014-10-02
• Last Update Posted: 2014-10-02
• Study Start: 2014-11
• Primary Completion: 2015-07
• Study Completion: 2015-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
cannabidiol (CBD)	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.

Primary Outcome Measures

Name	Time	Method
Overall Response Rate according to RECIST 1.1	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.