CClinicalTrials.gg
Status unknownNCT02255292Updated Oct 2, 2014

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

A Phase 2 interventional study of cannabidiol (CBD) in Solid Tumor, sponsored by Hadassah Medical Organization. Status unknown. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-10-02.

Sponsored by Hadassah Medical Organization · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Sep 2014), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
60
Allocation
Not applicable
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Solid Tumor
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In context

Lead sponsor

Hadassah Medical Organization is the lead sponsor of 659 studies on the registry; 54 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts 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

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
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Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    cannabidiol (CBD)

    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

  • Drugcannabidiol (CBD)

    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

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What researchers measure

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.

    Time frame: At baseline and at 8 weeks from time of first dose, by CT scans for RECIST 1.1

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Study locations

No study locations are listed for this record.

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References and documents

Publications

  • 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. PubMed 17712814 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 2, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02255292
Lead sponsor
Hadassah Medical Organization
Responsible party
Rotenberg Yakir (Hadas Lemberg, PhD, Hadassah Medical Organization) — Principal investigator
First posted
Oct 2, 2014
Start date
Nov 2014
Primary completion
Jul 2015 (estimated)
Completion
Jul 2015 (estimated)
Last update
Oct 2, 2014

Study contacts

Yakir Rottenberg, MD MPH
Contact
ryakir@hadassah.org.il
00 97226777111
Hadas Lemberg, PhD
study chair · Hadassah Medical Organization

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2014. You cannot join it, but the record below documents what was studied.

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