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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| cannabidiol (CBD) | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cannabidiol (CBD) | Drug | 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yakir Rottenberg, MD MPH | Contact | 00 97226777111 | ryakir@hadassah.org.il |
| Name | Affiliation | Role |
|---|---|---|
| Hadas Lemberg, PhD | Hadassah Medical Organization | Study Chair |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17712814 | Background | 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. |
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| ID | Term |
|---|---|
| D002185 | Cannabidiol |
| ID | Term |
|---|---|
| D002186 | Cannabinoids |
| D013729 | Terpenes |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
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