None listed
Conditions
Brief summary
The purpose of this study is to investigate the efficacy of two strengths of oral medicinal cannabis oil in patients who have been diagnosed with recurrent glioblastoma multiforme (GBM). Who is it for? You may be eligible to join this study if you are aged 18 years or above and have been diagnosed with a recurrent brain malignancy (GBM): MRI revealing recurrent tumour growth. Study details Participants will be randomised to receive one of two different CBD:THC strains for 12 weeks. Each participant will have a MRI at baseline and at 12 weeks. Blood work will be conducted at baseline, 4 weeks, 8 weeks and 12 weeks. How this study will contribute to research and/or Treatment This research will assist medical doctors and patients understanding if medicinal cannabis can assist their treatment in slowing glioma tumour re-growth or growth in conjunction with standard treatment and dosage of medicinal cannabis.
Interventions
Medicinal cannabis imported from overseas.
NB: CBD is cannabidiol, THC is Delta-9– tetrahydrocannabinol.
The administration of this drug will be for 12 weeks per participant and it is an oil which will be ingested orally. The drug will be self administered or by a carer/family member/appointed person.
Arm 1: Standard treatment[1] plus CBD:THC (1:1) (6mg/mL:6mg/mL)
Arm 2: Standard treatment plus CBD:THC (1:4) (3.8mg/mL:15mg/mL)
[1] Standard treatment is defined as chemotherapy, radiation, immu
Medicinal cannabis imported from overseas. NB: CBD is cannabidiol, THC is Delta-9– tetrahydrocannabinol. The administration of this drug will be for 12 weeks per participant and it is an oil which will be ingested orally. The drug will be self administered or by a carer/family member/appointed person. Arm 1: Standard treatment[1] plus CBD:THC (1:1) (6mg/mL:6mg/mL) Arm 2: Standard treatment plus CBD:THC (1:4) (3.8mg/mL:15mg/mL) [1] Standard treatment is defined as chemotherapy, radiation, immunotherapy, or any other cancer related treatment requested by the participants medical specialists and including best supportive and palliative care. Dosing for this trial will start at 0.25 ml (of either arm 1 or 2 of the combined THC:CBD whole plant extract oil) of the oral medicinal cannabis oil per day and titrated up according to participant’s weight and symptoms. As oral ingestion has to be processed by the liver, effects will be slower than smoking or vaporizing of cannabis. It can take anywhere from 1-1.5 hours for effects to be noticed and can take 2-4 hours to reach its peak effect. Dose will start at 0.25mL at night. If the person is able to function normally the next day, the dose will be increased 0.3mL, if they were not able to function as normal, the dose will be decreased to 0.2mL next night. Each night, the dose will either go up or down by 0.05mL depending on how the participant feels. The research nurse/assistant will be phoning the participant each morning to assess how the person is feeling to determine if they should titrate up or down or stay at that dose. Previous trials on oral administration of medicinal cannabis have shown that dose escalation or titration is best choice for the participants. Previous trials, although not on patients with cancer have documented the first dose as 2.7mg THC:2.5mg CBD. These trials increased a dose every 2-3 hours over 24 to 48 hour period till the person felt they were affected by the dose. The dose is then stabilized at that amount for that person and the dose documented. The maximum dose documented in this trial was 48 administrations over 24 hour period. Adherence or fidelity will be assessed by blood pathology tests for THC and CBD levels in the blood at 4 weeks, 8 weeks and 12 weeks. The blood pathology results will be assessed by the primary investigator and the research team. If there is poor adherence or fidelity, the research team will contact the participant to inquire about taking the dose.
Sponsors
Endeavour College of Natural Health
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Diagnosis: Recurrent Glioblastoma multiforme (GMB) * Recurrent Cancer Definition: Cancer that has recurred (come back), usually after a period of time during which the cancer could not be detected. The cancer may come back to the same place as the original (primary) tumor or to another place in the body. Also called recurrence. (National Cancer Institute Dictionary for Cancer) 1. Have been diagnosed with a recurrent brain malignancy (GBM): MRI revealing recurrent tumour growth 2. Greater than or equal to 18 years of age 3. Patient status: a) Liver function: Total bilirubin less than or equal to 2 ULN, ALT or AST is less than or equal to 2.5 ULN (or less than 5 in case of liver impairment). b) Serum creatinine is less than or equal to 1.5 ULN 4. Willing to consider participating in a clinical trial using oral medicinal cannabis 5. Diagnosis of recurrent tumour progression 6. Individuals who have no history of substance abuse within the last 2 years 7. Pregnancy: a) Negative test in women of childbearing potential b) Use of effective contraceptive method during the whole treatment and up to 3 months post completion of the treatment in both males and females
Exclusion criteria
1. Pregnant or breast feeding women. 2. Severe cognitively impaired patients who are unable to understand or comprehend the participation in the trial 3. Individuals who have severe mental illness e.g. bipolar disorder, schizophrenia 4. Non-English speaking individuals 5. Severe bacterial, viral or fungal infection (Grade great than 2 NCI-CTCAE v 4.0) 6. Participation in another interventional clinical trial 7. Individuals who have a past history of cannabis addition or major substance abuse (dependence on cannabis) 8. Past history of adverse events from cannabis 9. Individuals who have had an adverse event from past cannabis use 10. Individuals who have had a past history of myocardial infarctions (MI) or angina pectoris. 11. Severe liver and kidney disease. 12. Continued use of another medicinal cannabis product during the trial
Outcome results
None listed