Tolerability of Cannabis in Patients Receiving Concurrent Chemoradiation for Glioblastoma

• Status: Terminated
• Trial end date: 2019-05-09
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: New York State Psychiatric Institute
• Treatments: Temozolomide

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.