Status:
TERMINATED
Tolerability of Cannabis in Patients Receiving Concurrent Chemoradiation for Glioblastoma
Lead Sponsor:
New York State Psychiatric Institute
Conditions:
Glioblastoma
Eligibility:
All Genders
21-70 years
Phase:
PHASE1
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 canna...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 19 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 9 2019
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT03246113
Start Date
March 19 2018
End Date
May 9 2019
Last Update
August 13 2019
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Columbia University Medical Center- Department of Radiation Oncology
New York, New York, United States, 10032
2
New York State Psychiatric Institute
New York, New York, United States, 10032