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

Hadassah Medical Center

Status and phase: Unknown; Phase 2

Conditions: Solid Tumor

Treatments: Drug: cannabidiol (CBD)

Study type: Interventional

Funder types: Other

Identifiers

NCT02255292

CBD- HMO-CTIL

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

cannabidiol (CBD)

Experimental group

Description:

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.

Treatment:

Drug: cannabidiol (CBD)