This pilot trial studies how well marijuana works in reducing the side effects of radiation therapy in participants with glioblastoma undergoing chemoradiotherapy. Marijuana includes multiple active compounds, called cannabinoids, which have different actions relevant to cancer treatment such as reducing inflammation, pain and nausea, as well as anti-seizure and neuroprotective properties.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03246113.
PRIMARY OBJECTIVES:
I. To determine the feasibility and effects of cannabis with high concentration of cannabidiol (CBD) on patients receiving radiation for glioblastoma (GBM).
OUTLINE:
Participants smoke or vaporize marijuana cigarettes 3-5 days a week over 6 weeks for 21-30 sessions. Each session occurs immediately before daily radiation therapy in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, participants are followed up at 1 month.
Trial PhasePhase I
Trial Typesupportive care
Lead OrganizationNYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
Principal InvestigatorMargaret Haney