Tolerability of Cannabis in Patients Receiving Concurrent Chemoradiation for Glioblastoma
| Status: | Recruiting |
|---|---|
| Conditions: | Brain Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 21 - 70 |
| Updated: | 3/15/2019 |
| Start Date: | March 19, 2018 |
| End Date: | December 31, 2019 |
| Contact: | Margaret Haney, PhD |
| Email: | mh235@cumc.columbia.edu |
| Phone: | 646-774-6153 |
Investigation of Cannabis For Tolerability and Feasibility in Patients Receiving Concurrent Chemoradiation for Glioblastoma.
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.
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.
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.
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.
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.
We found this trial at
2
sites
1051 Riverside Dr
New York, New York 10032
New York, New York 10032
646-774-5000
Phone: 646-774-6153
New York State Psychiatric Institute The New York State Psychiatric Institute (NYSPI), established in 1895,...
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New York, New York 10032
Phone: 212-305-7077
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