Tolerability of Cannabis in Patients Receiving Concurrent Chemoradiation for Glioblastoma
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|ClinicalTrials.gov Identifier: NCT03246113|
Recruitment Status : Recruiting
First Posted : August 11, 2017
Last Update Posted : August 20, 2018
|Condition or disease||Intervention/treatment||Phase|
|Glioblastoma||Drug: Cannabis Drug: Temozolomide Radiation: Radiation Therapy||Phase 1|
|Study Type :||Interventional|
|Estimated Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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.
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
Oral alkylating agent with demonstrated antitumor activity.
Radiation: Radiation Therapy
standard fractionation radiotherapy of 60 Gy in 30 treatments with temozolomide.
- 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.
- 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.
- 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.
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
|Contact: Margaret Haney, PhDemail@example.com|
|Contact: Mariamne Reynafirstname.lastname@example.org|
|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 email@example.com|
|Contact: Mariamne Reyna 646-317-4244 firstname.lastname@example.org|
|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|
|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|