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Tolerability of Cannabis in Patients Receiving Concurrent Chemoradiation for Glioblastoma

NCT03246113 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2019-08-13

No results posted yet for this study

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

Interventions

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.

DRUG

Temozolomide

Oral alkylating agent with demonstrated antitumor activity.

RADIATION

Radiation Therapy

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

Sponsors & Collaborators

  • New York State Psychiatric Institute

    lead OTHER

Principal Investigators

  • Margaret Haney, PhD · Professor of Neurobiology (in Psychiatry) at Columbia University

  • Tony J Wang, MD · Associate Professor of Radiation Oncology at Columbia University Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-19
Primary Completion
2019-05-09
Completion
2019-05-09
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03246113 on ClinicalTrials.gov