Tolerability of Cannabis in Patients Receiving Concurrent Chemoradiation for Glioblastoma

Sponsor

New York State Psychiatric Institute (Other)

Overall Status

Terminated

CT.gov ID

NCT03246113

Collaborator

(none)

Enrollment

Locations

Arm

13.7

Actual Duration (Months)

0.5

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Glioblastoma	Drug: Cannabis Drug: Temozolomide Radiation: Radiation Therapy	Phase 1

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

1 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Investigation of Cannabis For Tolerability and Feasibility in Patients Receiving Concurrent Chemoradiation for Glioblastoma.

Actual Study Start Date :

Mar 19, 2018

Actual Primary Completion Date :

May 9, 2019

Actual Study Completion Date :

May 9, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cannabis + Chemoradiation 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 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. Other Names: Marijuana Drug: Temozolomide Oral alkylating agent with demonstrated antitumor activity. Radiation: Radiation Therapy standard fractionation radiotherapy of 60 Gy in 30 treatments with temozolomide.

Arm

Intervention/Treatment

Experimental: Cannabis + Chemoradiation

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

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.

Other Names:

Marijuana

Drug: Temozolomide

Oral alkylating agent with demonstrated antitumor activity.

Radiation: Radiation Therapy

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

Outcome Measures

Primary Outcome Measures

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] [6 weeks]
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.

Secondary Outcome Measures

Number of Radiation Induced Toxicities [6 weeks]
All patients receiving radiation treatments are routinely seen by the radiation oncologist once a week for a status check. The RTOG cooperative group common toxicity criteria will be used to assess for neurological toxicities including paresthesia, weakness, somnolence or agitation, incoordination, headache, hearing deficit, tremor, speech deficit, and ataxia.
Number of Opioid Medications Administered [6 weeks]
Patients will be asked to provide to us the number of opioid medications they took over the 6-week treatment course. The amount of opioids used will be converted to oral morphine equivalents and tallied for each day.

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
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

Sponsors and Collaborators

New York State Psychiatric Institute

Investigators

Principal Investigator: 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Margaret Haney, Professor of Neurobiology (in Psychiatry), New York State Psychiatric Institute

ClinicalTrials.gov Identifier:

NCT03246113

Other Study ID Numbers:

IRB#7290

First Posted:

Aug 11, 2017

Last Update Posted:

Aug 13, 2019

Last Verified:

Aug 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Margaret Haney, Professor of Neurobiology (in Psychiatry), New York State Psychiatric Institute

GBM WHO Grade IV

Additional relevant MeSH terms:

Glioblastoma

Temozolomide

Study Results

No Results Posted as of Aug 13, 2019