Solid Tumor
Conditions
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.
Interventions
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
Sponsors
Hadassah Medical Organization
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Contacts
Primary ContactYakir Rottenberg, MD MPH
Outcome results
None listed