We'd like your feedback
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
Prof
Susan
Short
+44(0)113 343 8434
S.C.Short@leeds.ac.uk
Mr
Rhys
Mant
+44 (0)121 414 6788
aristocrat@trials.bham.ac.uk
Prof
Susan
Short
+44(0)113 343 8434
S.C.Short@leeds.ac.uk
More information about this study, what is involved and how to take part can be found on the study website.
Glioblastoma multiforme
This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.
Glioblastoma multiforme (GBM) is a type of brain tumour. When it is first diagnosed, patients are usually treated with surgery and then a combination of radiotherapy and chemotherapy with temozolomide. Unfortunately, although this often slows or stops the disease from growing for a period of time, in most cases, usually a few months after the end of the original treatment, the tumour starts to grow again. This can be detected by a magnetic resonance imaging (MRI) scan (a type of imaging that visualises the internal structures). When this happens patients may experience new symptoms or a repeat of previous symptoms.
There are few treatments available that work well at this stage to slow the growth of the tumour. Therefore, we need to develop new and better treatments to make patients live longer and feel better. The ARISTOCRAT trial is investigating whether adding a second drug (Sativex, a cannabinoid or cannabis-based medicine) to the drug already used, temozolomide, works better than temozolomide alone. Temozolomide is the chemotherapy drug that patients will have had before, both with radiotherapy and then afterwards by itself.
In a small trial already completed investigating the combination of temozolomide and Sativex, there were some interesting results suggesting that taking both drugs together was safe to give and may have an effect on the growth of brain tumours. To see if this treatment does work we need to do a much larger trial and compare the new treatment (temozolomide plus Sativex) to temozolomide (temozolomide plus placebo).
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
2024 Protocol article in https://doi.org/10.1186/s12885-023-11792-4 (added 16/01/2024)
You can take part if:
Current inclusion criteria as of 31/08/2023:
1. Histological diagnosis of MGMT promoter methylated, IDH wild type (WT) glioblastoma multiforme (GBM) with consistent local molecular pathology (repeat biopsy at recurrence is NOT required)
2. First recurrence of GBM planned for systemic treatment as determined by local Multidisciplinary Team (MDT), including agreement of a Consultant Neuro-Radiologist that imaging changes are most in keeping with recurrence and not pseudo-progression and patient is planned for systemic treatment. Patients with a prior recurrence treated by surgical resection alone are eligible at time of first recurrence planned for systemic treatment.
3. Patients must have received initial first-line treatment with standard dose conventionally fractionated radiotherapy (i.e., 40 Gy in 15 fractions or 54-60 Gy in 28-33 fractions; other regimes may be considered in consultation with the ARISTOCRAT Trial Office) with concomitant and adjuvant temozolomide (TMZ)
3.1 Minimum of 3 cycles of adjuvant TMZ must have been received
3.2. Minimum of SD (or PR/CR) at the end of first-line treatment
4. ≥3 months since day 28 of the last cycle of TMZ
5. Karnofsky Performance Status ≥60
6. Adequate hematologic, renal, and hepatic function within 14 days prior to randomisation:
6.1. Absolute neutrophil count (ANC) ≥1.5 x 109/L
6.2. Platelet count ≥100 x 109/L
6.3. Serum creatinine clearance (measured or calculated (using local standard practice)) >30 ml/min
6.4. Total serum bilirubin ≤1.5 x upper limit of normal (ULN)
6.5. Liver transaminases <2.5 x ULN
7. If surgery has been performed for first recurrence then the wound must be adequately healed and there must be residual enhancing disease on MRI within 21 days of surgery or new enhancement at later follow-up deemed suitable for systemic treatment
8. Recovered from previous treatment side-effects ≤ Grade 2
9. If on systemic steroids, must be on stable (≥7 days) or decreasing dose of steroids
10. Willing and able to provide trial-specific informed consent
11. Willing and able to comply with trial requirements
12. Aged 16 years old and over
1
You may not be able to take part if:
Current exclusion criteria as of 08/11/2022:
1. Pathology inconsistent with IDH WT glioblastoma multiforme (GBM) (e.g. patients with molecular features of PXA or BRAF mutation (on original pathology) will be excluded)2. Prior invasive malignancy (except non-melanoma skin cancer), unless disease free for a minimum of one year3. Prior treatment with stereotactic radiotherapy, brachytherapy or Convection Enhanced Delivery (CED) of any agent4. Prior treatment, apart from debulking surgery, for first recurrence of GBM5. Any active co-morbidity making patient unsuitable for trial treatment in the view of the Investigator6. Personal history of schizophrenia, other psychotic illness, severe personality disorder or other significant psychiatric diagnosis other than depression associated with their underlying glioma condition7. Prior allergic reaction or significant toxicity (≥Grade 3 CTCAE) related to temozolomide treatment8. Current or recent cannabis or cannabinoid-based medications within 30 days of randomisation and/or unwilling to abstain for the duration of the trial9. Women who are pregnant, breastfeeding or a woman of childbearing potential who is unwilling to use effective contraceptive methods during trial treatment and for 6 months after completion of trial treatment9.1. Women of childbearing age must have a negative pregnancy test within 7 days prior to randomisation10. Men who are sexually active and unwilling/unable to use medically acceptable forms of contraception during trial treatment or for 6 months after completion of trial treatment11. Contra-indication to MRI or gadolinium12. Hereditary galactose intolerance, total lactase deficiency or glucose-galactose malabsorption13. Known hypersensitivity to cannabinoids or excipients of the IMP14. Known history of current or prior alcohol or drug dependence15. Known Hepatitis B (HBV), Cytomegalovirus (CMV) or opportunistic infection16. Has received a live vaccine within 28 days prior to randomisation17. Unable to administer oromucosal medication due to mucosal lesions or other issues18. Participation in another therapeutic clinical trial whilst taking part in this trial19. Any psychological, familial, sociological or geographical condition hampering protocol compliance
_____
Previous exclusion criteria:
1. Pathology inconsistent with IDH WT glioblastoma multiforme (GBM) (e.g. patients with molecular features of PXA or BRAF mutation (on original pathology) will be excluded)2. Prior invasive malignancy (except non-melanoma skin cancer), unless disease free for a minimum of one year3. Prior treatment with stereotactic radiotherapy, brachytherapy or Convection Enhanced Delivery (CED) of any agent4. Prior treatment, apart from debulking surgery, for first recurrence of GBM5. Any active co-morbidity making patient unsuitable for trial treatment in the view of the Investigator6. Personal history of schizophrenia, other psychotic illness, severe personality disorder or other significant psychiatric diagnosis other than depression associated with their underlying glioma condition7. Prior allergic reaction or significant toxicity (≥Grade 3 CTCAE) related to temozolomide treatment8. Current or recent cannabis or cannabinoid-based medications within 30 days of randomisation and/or unwilling to abstain for the duration of the trial9. Women who are pregnant, breastfeeding or a woman of childbearing potential who is unwilling to use effective contraceptive methods during trial treatment and for 6 months after completion of trial treatment9.1. Women of childbearing age must have a negative pregnancy test within 7 days prior to randomisation10. Men who are sexually active and unwilling/unable to use medically acceptable forms of contraception during trial treatment or for 6 months after completion of trial treatment11. Contra-indication to MRI or gadolinium12. Hereditary galactose intolerance, total lactase deficiency or glucose-galactose malabsorption13. Known hypersensitivity to cannabinoids or excipients of the IMP14. Known history of current or prior alcohol or drug dependence15. Unable to administer oromucosal medication due to mucosal lesions or other issues16. Participation in another therapeutic clinical trial whilst taking part in this trial17. Any psychological, familial, sociological or geographical condition hampering protocol compliance
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
Prof
Susan
Short
+44(0)113 343 8434
S.C.Short@leeds.ac.uk
Prof
Susan
Short
+44(0)113 343 8434
S.C.Short@leeds.ac.uk
Mr
Rhys
Mant
+44 (0)121 414 6788
aristocrat@trials.bham.ac.uk
More information about this study, what is involved and how to take part can be found on the study website.
The study is sponsored by University of Birmingham and funded by Brain Tumour Charity.
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
Or CPMS 52902
You can print or share the study information with your GP/healthcare provider or contact the research team directly.
