Clinical trial NCT03246113: Tolerability of Cannabis in Patients Receiving Concurrent Chemoradiation for Glioblastoma
Official title: Investigation of Cannabis For Tolerability and Feasibility in Patients Receiving Concurrent Chemoradiation for Glioblastoma.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Glioblastoma
Keywords: GBM WHO Grade IV
Lead sponsor: New York State Psychiatric Institute
Sponsor class: OTHER
First posted: 2017-08-11
Enrollment: 1
Sex: ALL
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility 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.

Primary outcomes:
measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
timeFrame: 6 weeks
Secondary outcomes:
measure: Number of Radiation Induced Toxicities
timeFrame: 6 weeks
measure: Number of Opioid Medications Administered
timeFrame: 6 weeks
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Medical Center- Department of Radiation Oncology
state: New York
city: New York
country: United States
facility: New York State Psychiatric Institute
state: New York
Study officials:
affiliation: Professor of Neurobiology (in Psychiatry) at Columbia University
name: Margaret Haney, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Associate Professor of Radiation Oncology at Columbia University Medical Center
name: Tony J Wang, MD
role: PRINCIPAL_INVESTIGATOR
References: