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Tolerability of Cannabis in Patients Receiving Concurrent Chemoradiation for Glioblastoma

Study Purpose

The goal of this single arm Phase I feasibility study is to investigate the tolerability of cannabis with concurrent chemoradiation in the treatment of glioblastoma multiforme (GBM). A strain of cannabis provided by The National Institute of Drug Abuse (NIDA) that has a high concentration of cannabidiol (CBD) and a low concentration of THC (relative to average street cannabis) will be tested in order to maximize clinical efficacy while minimizing intoxicating side effects in this medically-ill population.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	21 Years - 70 Years
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- Diagnosis of Glioblastoma requiring standard care chemoradiation of concurrent Temozolomide and 60 Gy of radiation given over 30 treatments.

- Age 21-70.

- Able to give informed consent, and comply with study procedures.

Exclusion Criteria:

- Meet 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 DSM-V 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, IUD) or currently pregnant.

- Current (weekly) use of cannabis.

- Patients on supplemental oxygen or history of chronic obstructive pulmonary disease (COPD).

- Cardiovascular Disease.

- Compromised Immunity.

- Patients with a history of substance use disorder other than nicotine, such an opiate use disorder.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT03246113
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 1
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	New York State Psychiatric Institute
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Margaret Haney, PhDTony J Wang, MD
Principal Investigator Affiliation	Professor of Neurobiology (in Psychiatry) at Columbia UniversityAssociate Professor of Radiation Oncology at Columbia University Medical Center
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Terminated
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Glioblastoma

Additional Details

The purpose of this study is to determine the feasibility and the effects of cannabis with high concentrations of CBD in patients receiving chemoradiation for GBM. This is not a therapeutic study for the treatment of glioblastoma. Patients will first complete a cannabis sampling session to assess for initial marijuana tolerability. Proceeding this, patients will complete 3-5 outpatient smoking sessions per week over a 6 week period. During each session, patients will be given 90 minutes to smoke 0.5 to 2 cannabis cigarettes. Outcome measures will include measures of pain, mood, nausea, quality of life, and the both the potentially positive and negative subjective effects of cannabis. Food intake, opioid use, and compliance to cannabis treatment will be investigated. It is hypothesized that concurrent use of cannabis with chemoradiation in the treatment of patients with GBM will be feasible, well tolerated and may decrease radiation-induced toxicities.

Arms & Interventions

Arms

Experimental: Cannabis + Chemoradiation

Patients will receive a cannabis strain with high cannabidiol (4.8%) and low Delta-9-THC (3.23%). Patients will smoke the cannabis over a 2 hour session (from 0.5 - 2.0 cannabis cigarettes) before receiving chemoradiation therapy with radiation and concurrent temozolomide.

Interventions

Drug: - Cannabis

Cannabis cigarettes provided by NIDA that contain high levels of CBD (4.8%) and low levels of THC (3.23%). Patients will smoke one-half (1/2) to two (2) cannabis cigarettes prior to receiving chemoradiation.

Drug: - Temozolomide

Oral alkylating agent with demonstrated antitumor activity.

Radiation: - Radiation Therapy

standard fractionation radiotherapy of 60 Gy in 30 treatments with temozolomide.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

New York, New York

Status

Address

Columbia University Medical Center- Department of Radiation Oncology

New York, New York, 10032

New York State Psychiatric Institute, New York, New York