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Marijuana in Reducing Side Effects of Radiation Therapy in Participants with Glioblastoma Undergoing Chemoradiotherapy

Trial Status: Active

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.

Inclusion Criteria

  • Diagnosis of glioblastoma requiring standard care chemoradiation of concurrent Temozolomide and 60 gray (Gy) of radiation given over 30 treatments
  • Able to give informed consent, and comply with study procedures
  • History of previous experience with smoking or marijuana

Exclusion Criteria

  • Meet Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-V) criteria for current major psychiatric illness, such as bipolar disorder, major depression, active suicidal intent, or psychosis that could be exacerbated by the administration of cannabis
  • Meet criteria for major neurological disorder, such as mild cognitive impairment or neurodegenerative disorders (such as movement disorders, dementia), that could be exacerbated by the administration of cannabis
  • Women who are not practicing an effective form of birth control (condoms, diaphragm, birth control pill, intrauterine device [IUD]) or currently pregnant
  • Current (weekly) use of cannabis
  • Subjects on supplemental oxygen or history of chronic obstructive pulmonary disease (COPD)
  • Cardiovascular disease
  • Compromised immunity
  • Subjects with a history of substance use disorder other than nicotine, such an opiate use disorder

New York

New York
NYP / Columbia University Medical Center / Herbert Irving Comprehensive Cancer Center
Status: ACTIVE
Contact: Margaret Haney
Phone: 646-774-6153

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 Phase Phase I

Trial Type Supportive care

Lead Organization
NYP / Columbia University Medical Center / Herbert Irving Comprehensive Cancer Center

Principal Investigator
Margaret Haney

  • Primary ID NYSPI 7290
  • Secondary IDs NCI-2018-00336
  • Clinicaltrials.gov ID NCT03246113