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Tolerability of Cannabis in Patients Receiving Concurrent Chemoradiation for Glioblastoma

Primary Purpose

Glioblastoma

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Cannabis
Temozolomide
Radiation Therapy
Sponsored by
New York State Psychiatric Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glioblastoma focused on measuring GBM WHO Grade IV

Eligibility Criteria

21 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Columbia University Medical Center- Department of Radiation Oncology
  • New York State Psychiatric Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cannabis + Chemoradiation

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Number of Radiation Induced Toxicities
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
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.

Full Information

First Posted
July 25, 2017
Last Updated
August 9, 2019
Sponsor
New York State Psychiatric Institute
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1. Study Identification

Unique Protocol Identification Number
NCT03246113
Brief Title
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

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Terminated
Why Stopped
Lack of subject interest due to study design
Study Start Date
March 19, 2018 (Actual)
Primary Completion Date
May 9, 2019 (Actual)
Study Completion Date
May 9, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
New York State Psychiatric Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glioblastoma
Keywords
GBM WHO Grade IV

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cannabis + Chemoradiation
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Cannabis
Other Intervention Name(s)
Marijuana
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Temozolomide
Intervention Description
Oral alkylating agent with demonstrated antitumor activity.
Intervention Type
Radiation
Intervention Name(s)
Radiation Therapy
Intervention Description
standard fractionation radiotherapy of 60 Gy in 30 treatments with temozolomide.
Primary Outcome Measure Information:
Title
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Description
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.
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Number of Radiation Induced Toxicities
Description
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.
Time Frame
6 weeks
Title
Number of Opioid Medications Administered
Description
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.
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Margaret Haney, PhD
Organizational Affiliation
Professor of Neurobiology (in Psychiatry) at Columbia University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Tony J Wang, MD
Organizational Affiliation
Associate Professor of Radiation Oncology at Columbia University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Columbia University Medical Center- Department of Radiation Oncology
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
New York State Psychiatric Institute
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Tolerability of Cannabis in Patients Receiving Concurrent Chemoradiation for Glioblastoma

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