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

Study Overview
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Brief Summary
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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.

Conditions
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Solid Tumor

Intervention / Treatment
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* Drug: cannabidiol (CBD)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: cannabidiol (CBD)<br>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)<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |