ClinicalTrials.gov
ClinicalTrials.gov Menu

Tolerability of Cannabis in Patients Receiving Concurrent Chemoradiation for Glioblastoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03246113
Recruitment Status : Recruiting
First Posted : August 11, 2017
Last Update Posted : August 20, 2018
Sponsor:
Information provided by (Responsible Party):
Margaret Haney, New York State Psychiatric Institute

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 Type : Interventional
Estimated Enrollment : 15 participants
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 : March 19, 2018
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Marijuana

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 Name: Marijuana

Drug: Temozolomide
Oral alkylating agent with demonstrated antitumor activity.

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




Primary Outcome Measures :
  1. Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] [ Time Frame: 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 :
  1. Number of Radiation Induced Toxicities [ Time Frame: 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.

  2. Number of Opioid Medications Administered [ Time Frame: 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   21 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03246113


Contacts
Contact: Margaret Haney, PhD 646-774-6153 mh235@cumc.columbia.edu
Contact: Mariamne Reyna 646-317-4244 mo2213@cumc.columbia.edu

Locations
United States, New York
Columbia University Medical Center- Department of Radiation Oncology Recruiting
New York, New York, United States, 10032
Contact: Tony J Wang, MD    212-305-7077    tjw2117@cumc.columbia.edu   
Contact: Mariamne Reyna    646-317-4244    mo2213@cumc.columbia.edu   
New York State Psychiatric Institute Recruiting
New York, New York, United States, 10032
Contact: Margaret Haney, PhD    646-774-6153    Meg.Haney@nyspi.columbia.edu   
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

Responsible Party: Margaret Haney, Professor of Neurobiology (in Psychiatry), New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT03246113     History of Changes
Other Study ID Numbers: IRB#7290
First Posted: August 11, 2017    Key Record Dates
Last Update Posted: August 20, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Margaret Haney, New York State Psychiatric Institute:
GBM WHO Grade IV

Additional relevant MeSH terms:
Glioma
Glioblastoma
Astrocytoma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Temozolomide
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents