Actively Recruiting
ARISTOCRAT: Blinded Trial of Temozolomide +/- Cannabinoids
Led by University of Birmingham · Updated on 2026-05-05
120
Participants Needed
22
Research Sites
216 weeks
Total Duration
On this page
Sponsors
U
University of Birmingham
Lead Sponsor
U
University of Leeds
Collaborating Sponsor
AI-Summary
What this Trial Is About
ARISTOCRAT is a phase II, multi-centre, double-blind, placebo-controlled, randomised trial to compare the cannabinoid Nabiximols with placebo in patients with recurrent MGMT methylated glioblastoma (GBM) treated with temozolomide (TMZ).
CONDITIONS
Official Title
ARISTOCRAT: Blinded Trial of Temozolomide +/- Cannabinoids
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histological diagnosis of MGMT promoter methylated, IDH wild type glioblastoma confirmed by local pathology
- First recurrence of glioblastoma planned for systemic treatment as determined by local multidisciplinary team
- Agreement by neuro-radiologist that imaging changes show recurrence, not pseudo-progression
- Patients who had prior recurrence treated only by surgery are eligible at first recurrence planned for systemic treatment
- Received initial first-line treatment with standard dose radiotherapy and concomitant and adjuvant temozolomide
- Received a minimum of 3 cycles of adjuvant temozolomide
- Achieved at least stable disease, partial response, or complete response at end of first-line treatment
- At least 3 months since day 28 of last temozolomide cycle
- Karnofsky Performance Status 60 or higher
- Adequate blood, kidney, and liver function within 14 days before randomisation
- If surgery was performed at first recurrence, wound must be healed and MRI shows residual or new enhancing disease suitable for systemic treatment
- Recovered from prior treatment side effects to grade 2 or less
- If on systemic steroids, dose must be stable for 7 days or decreasing
- Willing and able to provide informed consent and comply with trial requirements
- Age 16 years or older
- Able to start treatment within 28 days of randomisation
You will not qualify if you...
- Pathology inconsistent with IDH wild type glioblastoma (e.g., molecular features of PXA or BRAF mutation)
- Prior invasive cancer except non-melanoma skin cancer unless disease-free for at least one year
- Prior stereotactic radiotherapy, brachytherapy, or Convection Enhanced Delivery treatment
- Prior treatment for first recurrence other than debulking surgery
- Any active co-morbidity making trial treatment unsuitable
- History of schizophrenia, psychotic illness, severe personality disorder, or significant psychiatric diagnosis other than glioma-associated depression
- Prior allergic reaction or severe toxicity to temozolomide
- Current or recent cannabis or cannabinoid use within 28 days or unwillingness to abstain during trial
- Women who are pregnant, breastfeeding, or of childbearing potential unwilling to use contraception during and for 6 months after trial
- Men unwilling or unable to use contraception during and for 6 months after trial
- Contraindication to MRI or gadolinium contrast
- Hereditary galactose intolerance, lactase deficiency, or glucose-galactose malabsorption
- Known hypersensitivity to cannabinoids or trial medication components
- History of alcohol or drug dependence
- Known infection with Hepatitis B, Cytomegalovirus, or opportunistic infections
- Received live vaccine within 28 days before randomisation
- Unable to use oromucosal medication due to mucosal lesions or other issues
- Participation in another therapeutic clinical trial during this study
- Psychological, familial, sociological, or geographical conditions that impair protocol compliance
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 22 locations
1
Glan Clwyd Hospital
Bodelwyddan, Denbighshire, United Kingdom, LL18 5UJ
Withdrawn
2
Mount Vernon Hospital, The Hillingdon Hospitals NHS Foundation Trust
Northwood, Middlesex, United Kingdom, HA6 2RN
Actively Recruiting
3
Aberdeen Royal Infirmary, NHS Grampian
Aberdeen, United Kingdom, AB25 2ZN
Actively Recruiting
4
Belfast City Hospital, Belfast Health and Social Care Trust
Belfast, United Kingdom, BT9 7AB
Withdrawn
5
Queen Elizabeth Hospital Birmingham, University Hospitals Birmingham NHS Foundation Trust
Birmingham, United Kingdom, B15 2TH
Actively Recruiting
6
Bristol Haematology & Oncology Centre, University Hospitals Bristol & Weston NHS Foundation Trust
Bristol, United Kingdom, BS2 8ED
Active, Not Recruiting
7
Addenbrooke's Hospital, Cambridge University Hospitals NHS Foundation Trust
Cambridge, United Kingdom, CB2 0QQ
Actively Recruiting
8
Velindre Cancer Centre, Velindre University NHS Trust
Cardiff, United Kingdom, CF15 7QZ
Actively Recruiting
9
Western General Hospital, NHS Lothian
Edinburgh, United Kingdom, EH4 2XU
Withdrawn
10
Beatson West of Scotland Cancer Centre, NHS Greater Glasgow & Clyde
Glasgow, United Kingdom, G12 0YN
Withdrawn
11
Castle Hill Hospital, Hull University Teaching Hospitals NHS Trust
Hull, United Kingdom, HU16 5JQ
Actively Recruiting
12
St James's University Hospital, Leeds Teaching Hospitals NHS Trust
Leeds, United Kingdom, LS9 7TF
Actively Recruiting
13
St Bartholomew's Hospital, Barts Health NHS Trust
London, United Kingdom, EC1A 7BE
Actively Recruiting
14
Guy's Hospital, Guy's and St Thomas' NHS Foundation Trust
London, United Kingdom, SE1 9RT
Actively Recruiting
15
Charing Cross Hospital, Imperial College Healthcare NHS Trust
London, United Kingdom, W6 8RF
Actively Recruiting
16
Maidstone Hospital, Maidstone and Tunbridge Wells NHS Trust
Maidstone, United Kingdom, ME16 9QQ
Actively Recruiting
17
The Christie Hospital, The Christie NHS Foundation Trust
Manchester, United Kingdom, M20 4BX
Actively Recruiting
18
Clatterbridge Cancer Centre, The Clatterbridge Cancer Centre NHS Foundation Trust
Metropolitan Borough of Wirral, United Kingdom, CH63 4JY
Actively Recruiting
19
City Hospital, Nottingham University Hospitals NHS Trust
Nottingham, United Kingdom, NG5 1PB
Actively Recruiting
20
Churchill Hospital, Oxford University Hospitals NHS Foundation Trust
Oxford, United Kingdom, OX3 9DU
Actively Recruiting
21
Derriford Hospital, University Hospitals Plymouth NHS Trust
Plymouth, United Kingdom, PL6 8DH
Actively Recruiting
22
Southampton General Hospital, University Hospital Southampton NHS Foundation Trust
Southampton, United Kingdom, SO16 6YD
Withdrawn
Research Team
R
Rhys Mant
CONTACT
J
Joshua Savage
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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