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

NCT02255292 | Unknown Phase 2

• 1 other identifier: CBD- HMO-CTIL
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Solid Tumor

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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.

Drug: cannabidiol (CBD)

Interventions

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

cannabidiol (CBD)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hadassah Medical Organization: lead

Related Publications (1)

• 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.

  PMID: 17712814 BACKGROUND

MeSH Terms

Interventions

Cannabidiol

Intervention Hierarchy (Ancestors)

Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals

Study Officials

• Hadas Lemberg, PhD

  Hadassah Medical Organization

  STUDY CHAIR

Central Study Contacts

Yakir Rottenberg, MD MPH

CONTACT

00 97226777111; ryakir@hadassah.org.il

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Hadas Lemberg, PhD

Study Record Dates

• First Submitted: September 23, 2014
• First Posted: October 2, 2014
• Study Start: November 1, 2014
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: October 2, 2014

Record last verified: 2014-09