Solid Tumor Clinical Trial
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.
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 |
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Hadassah Medical Organization |
Mechoulam R, Peters M, Murillo-Rodriguez E, Hanus LO. Cannabidiol--recent advances. Chem Biodivers. 2007 Aug;4(8):1678-92. Review. — View Citation
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 |
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