Tolerability of Cannabis in Patients Receiving Concurrent Chemoradiation for Glioblastoma

NCT03246113 | Terminated Phase 1 FDA Drug

• 1 other identifier: IRB#7290
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 2

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.

Conditions

Glioblastoma

Keywords

GBM WHO Grade IV

Outcome Measures

Primary Outcomes (1)

• Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

  Number of cannabis-related adverse events A 44-item computerized subjective-effects questionnaire visual analog scale (VAS), comprising a series of 100-mm lines labeled 'not at all' (0 mm) at one end and 'extremely' at the other end, will be completed at baseline, after the 90 minutes of cannabis availability and at the end of the session. The VAS included mood, physical symptom, and drug effect descriptors; participants will be instructed to rate the extent to which each descriptor applied to them at that moment.

  6 weeks

Secondary Outcomes (2)

• Number of Radiation Induced Toxicities

  6 weeks

• Number of Opioid Medications Administered

  6 weeks

Study Arms (1)

Cannabis + Chemoradiation

EXPERIMENTAL

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.

Drug: Cannabis; Drug: Temozolomide; Radiation: Radiation Therapy

Interventions

Cannabis DRUG

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.

Also known as: Marijuana

Cannabis + Chemoradiation

Temozolomide DRUG

Oral alkylating agent with demonstrated antitumor activity.

Cannabis + Chemoradiation

Radiation Therapy RADIATION

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

Cannabis + Chemoradiation

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• New York State Psychiatric Institute: lead

Study Sites (2)

Columbia University Medical Center- Department of Radiation Oncology

New York, New York, 10032, United States

Location

New York State Psychiatric Institute

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Glioblastoma

Interventions

nabiximols; Temozolomide; Radiotherapy

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Dacarbazine; Triazenes; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Therapeutics

Study Officials

• Margaret Haney, PhD

  Professor of Neurobiology (in Psychiatry) at Columbia University

  PRINCIPAL INVESTIGATOR

• Tony J Wang, MD

  Associate Professor of Radiation Oncology at Columbia University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Neurobiology (in Psychiatry)

Study Record Dates

• First Submitted: July 25, 2017
• First Posted: August 11, 2017
• Study Start: March 19, 2018
• Primary Completion: May 9, 2019
• Study Completion: May 9, 2019
• Last Updated: August 13, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)