A Phase 2 Randomised, Double Blind Clinical Trial assessing the Tolerability of Two different Ratios of Medicinal Cannabis in patients with Glioblastoma multiforme (GBM).

Phase 2

Completed

• Conditions: Glioblastoma multiform; Cancer - Brain

• Registration Number: ACTRN12617001287325
• Lead Sponsor: Endeavour College of Natural Health

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-09-06
• Last Update Posted: 24 January 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 82

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes in quality of life (QoL) as quantified by the FACT-Br between the two medicinal cannabis groups from baseline (week 0) to 12 weeks.[A comparison of scores for the FACT-Br will be conducted for baseline (week 0) and week 12. ]