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Looking for participantsPhase2

ARISTOCRAT: Blinded Trial of Temozolomide +/- Cannabinoids

Sponsor: University of Birmingham

NCT ID: NCT05629702

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Nabiximols (drug), Temozolomide (drug), Nabiximols-matched placebo (drug)
How long the study runs
Study runs about 50 months (dates as stated)
About the drug or intervention
Nabiximols — drug: Oromucosal spray · Temozolomide — drug: Oral capsule · Nabiximols-matched placebo — drug: Nabiximols-matched placebo oromucosal spray
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
16 Years and over
Who
All
Number of participants
120
Started
2023-02-03
Last checked
2026-04

Plain English Summary

What is this study?

  • • Testing a new treatment for glioblastoma
  • • Phase2 - 120 participants
  • • 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)

Who can take part?

  • • Ages 16 Years and over
  • • Diagnosed with glioblastoma

Where?

  • • Bodelwyddan - Glan Clwyd Hospital
  • • Northwood - Mount Vernon Hospital, The Hillingdon Hospitals NHS Foundation Trust
  • • Aberdeen - Aberdeen Royal Infirmary, NHS Grampian
  • • Belfast - Belfast City Hospital, Belfast Health and Social Care Trust
  • • +18 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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).

More detail

This is a phase II, multi-centre, double-blind, placebo-controlled, randomised trial to compare the cannabinoid Nabiximols (Sativex®) with placebo in patients with recurrent MGMT methylated glioblastoma treated with temozolomide (TMZ). The trial will randomise a target number of 120 patients on a 2:1 basis to receive either Nabiximols or Nabiximols-matched placebo, in combination with standard TMZ. Patients will be followed up at 4-weekly assessments for a minimum of 52 weeks from the start of trial treatment or until death, whichever is sooner. MRI scanning will be performed at screening, week 10, week 22, week 30, then 3-monthly after commencing trial treatment as per standard practice. The trial includes an initial feasibility study of 40 patients to confirm safety, compliance and achievability of planned target recruitment. There are no formal criteria for evaluation of feasibility but once 40 patients have been recruited, the independent Data Monitoring Committee will review the adverse event data, details on protocol treatment received, monthly recruitment rates and projected recruitment in order to make recommendations on trial continuation. The original phase II trial design allowed potential expansion of recruitment into a phase III trial, should the emerging phase II results warrant this development; however, the trial was revised to a standard phase II design to lower the recruitment targets in 2025 The trial will be linked to the Tessa Jowell BRAIN MATRIX (TJBM) programme; utilising TJBM infrastructure, opening the same participating sites, and aligning the data collection and Quality of Life assessments already embedded in TJBM. This collaboration will allow data sharing within the platform thereby streamlining patient entry and provide additional oversight through TJBM. Patients recruited to TJBM who are potentially eligible for ARISTOCRAT may be identified and suggested to sites for consideration to the trial.

GlioblastomaBrain TumorCannabisBrain Tumor, Recurrent

How this trial compares with your answers

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What we know so far

Condition· Matched your search
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Still need:

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 16 Years and over
  • Who can join: All genders

Biomarkers mentioned

IDH wild typePRBRAFhave a negative

Treatment history

Treatments you must have had:

  • ✓ been received
  • ✓ side-effects ≤ Grade 2

What the study is looking for

  • ✓Histological diagnosis of MGMT promoter methylated, IDH wild type (WT) GBM with consistent local molecular pathology...
  • ✓A minimum of 3 cycles of after surgery TMZ must have been received.
  • ✓A minimum of Stable Disease (SD) (or Partial Response (PR)/Complete Response (CR)) at the end of first-line...
  • ✓≥3 months since day 28 of the last cycle of TMZ.
  • ✓Good overall fitness (Karnofsky 60).

Who cannot take part

  • ✗Pathology inconsistent with IDH WT GBM (e.g. patients with molecular features of PXA or BRAF mutation will be excluded).
  • ✗Prior invasive cancer (except non-melanoma skin cancer), unless disease free for a minimum of one year.
  • ✗Prior treatment with stereotactic radiotherapy, brachytherapy or Convection Enhanced Delivery (CED) of any agent.
  • ✗Prior treatment, apart from debulking surgery, for first recurrence of GBM.
  • ✗Any active co-morbidity making patient unsuitable for trial treatment in the view of the Investigator.
See the full criteria
Inclusion Criteria: * Histological diagnosis of MGMT promoter methylated, IDH wild type (WT) GBM with consistent local molecular pathology (repeat biopsy at recurrence is NOT required). * 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. Patients with a prior recurrence treated by surgical resection alone are eligible at time of first recurrence planned for systemic treatment. * 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 TMZ. * A minimum of 3 cycles of adjuvant TMZ must have been received. * A minimum of Stable Disease (SD) (or Partial Response (PR)/Complete Response (CR)) at the end of first-line treatment (measured by Response Assessment for Neuro-Oncology (RANO) criteria). * ≥3 months since day 28 of the last cycle of TMZ. * Karnofsky Performance Status ≥60. * Adequate hematologic, renal, and hepatic function within 14 days prior to randomisation: * Absolute neutrophil count (ANC) ≥1.5 x 109/L * Platelet count ≥100 x 109/L * Serum creatinine clearance (measured or calculated (using local standard practice)) \>30ml/min * Total serum bilirubin ≤1.5 x upper limit of normal (ULN) * Liver transaminases \<2.5 x ULN * 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. * Recovered from previous treatment side-effects ≤ Grade 2. * If on systemic steroids, must be on stable (≥7 days) or decreasing dose of steroids. * Willing and able to provide trial-specific informed consent. * Willing and able to comply with trial requirements. * Age ≥16. * Able to start treatment within 28 days of randomisation. Exclusion Criteria: * Pathology inconsistent with IDH WT GBM (e.g. patients with molecular features of PXA or BRAF mutation will be excluded). * Prior invasive malignancy (except non-melanoma skin cancer), unless disease free for a minimum of one year. * Prior treatment with stereotactic radiotherapy, brachytherapy or Convection Enhanced Delivery (CED) of any agent. * Prior treatment, apart from debulking surgery, for first recurrence of GBM. * Any active co-morbidity making patient unsuitable for trial treatment in the view of the Investigator. * Personal history of schizophrenia, other psychotic illness, severe personality disorder or other significant psychiatric diagnosis other than depression associated with their underlying glioma condition. * Prior allergic reaction or significant toxicity (≥Grade 3 CTCAE) related to TMZ treatment. * Current or recent cannabis or cannabinoid-based medications within 28 days of randomisation and/or unwilling to abstain for the duration of the trial. * 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 treatment. o Women of childbearing age must have a negative pregnancy test within 7 days prior to randomisation. * 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 treatment. * Contra-indication to MRI or gadolinium. * Hereditary galactose intolerance, total lactase deficiency or glucose-galactose malabsorption. * Known hypersensitivity to cannabinoids or excipients of the IMP. * Known history of current or prior alcohol or drug dependence. * Known Hepatitis B (HBV), Cytomegalovirus (CMV) or opportunistic infection. * Has received a live vaccine within 28 days prior to randomisation. * Unable to administer oromucosal medication due to mucosal lesions or other issues. * Participation in another therapeutic clinical trial whilst taking part in this trial. * Any psychological, familial, sociological or geographical condition hampering protocol compliance.

Where Is This Study? (22 UK sites)

Glan Clwyd Hospital

Bodelwyddan LL18 5UJ, United Kingdom

WITHDRAWN

Mount Vernon Hospital, The Hillingdon Hospitals NHS Foundation Trust

Northwood HA6 2RN, United Kingdom

Recruiting
Site contact (verified)
Thomas CarterPrincipal Investigator

Aberdeen Royal Infirmary, NHS Grampian

Aberdeen AB25 2ZN, United Kingdom

Recruiting
Site contact (verified)
Rafael MoleronPrincipal Investigator

Belfast City Hospital, Belfast Health and Social Care Trust

Belfast BT9 7AB, United Kingdom

WITHDRAWN
Hospital R&D contact (matched)

Alison Murphy

alison.murphy@belfasttrust.hscni.net028 9063 6366

Queen Elizabeth Hospital Birmingham, University Hospitals Birmingham NHS Foundation Trust

Birmingham B15 2TH, United Kingdom

Recruiting
Site contact (verified)
Sara MeadePrincipal Investigator

Bristol Haematology & Oncology Centre, University Hospitals Bristol & Weston NHS Foundation Trust

Bristol BS2 8ED, United Kingdom

ACTIVE_NOT_RECRUITING
Hospital R&D contact (matched)

Diana Benton

research@uhbw.nhs.uk0117 342 0233

Addenbrooke's Hospital, Cambridge University Hospitals NHS Foundation Trust

Cambridge CB2 0QQ, United Kingdom

Recruiting
Site contact (verified)
Fiona HarrisPrincipal Investigator

Velindre Cancer Centre, Velindre University NHS Trust

Cardiff CF15 7QZ, United Kingdom

Recruiting
Site contact (verified)
Jillian MacLeanPrincipal Investigator

Western General Hospital, NHS Lothian

Edinburgh EH4 2XU, United Kingdom

WITHDRAWN

Beatson West of Scotland Cancer Centre, NHS Greater Glasgow & Clyde

Glasgow G12 0YN, United Kingdom

WITHDRAWN
Hospital R&D contact (matched)

Radek Penar

radoslaw.penar@nhs.scotn/a

Castle Hill Hospital, Hull University Teaching Hospitals NHS Trust

Hull HU16 5JQ, United Kingdom

Recruiting
Hospital R&D contact (matched)

James Illingworth

hyp-tr.development.research@nhs.net01482 461883 or 461903

St James's University Hospital, Leeds Teaching Hospitals NHS Trust

Leeds LS9 7TF, United Kingdom

Recruiting
Site contact (verified)
Fiona CollinsonPrincipal Investigator

St Bartholomew's Hospital, Barts Health NHS Trust

London EC1A 7BE, United Kingdom

Recruiting
Site contact (verified)
Rachel LewisPrincipal Investigator

Guy's Hospital, Guy's and St Thomas' NHS Foundation Trust

London SE1 9RT, United Kingdom

Recruiting
Site contact (verified)
Lucy BrazilPrincipal Investigator

Charing Cross Hospital, Imperial College Healthcare NHS Trust

London W6 8RF, United Kingdom

Recruiting
Site contact (verified)
Matthew WilliamsPrincipal Investigator

Maidstone Hospital, Maidstone and Tunbridge Wells NHS Trust

Maidstone ME16 9QQ, United Kingdom

Recruiting
Site contact (verified)
Samantha FornerPrincipal Investigator

The Christie Hospital, The Christie NHS Foundation Trust

Manchester M20 4BX, United Kingdom

Recruiting
Site contact (verified)
Catherine McBainPrincipal Investigator

Clatterbridge Cancer Centre, The Clatterbridge Cancer Centre NHS Foundation Trust

Metropolitan Borough of Wirral CH63 4JY, United Kingdom

Recruiting
Site contact (verified)
Shaveta MehtaPrincipal Investigator

City Hospital, Nottingham University Hospitals NHS Trust

Nottingham NG5 1PB, United Kingdom

Recruiting
Site contact (verified)
Karen FowerakerPrincipal Investigator

Churchill Hospital, Oxford University Hospitals NHS Foundation Trust

Oxford OX3 9DU, United Kingdom

Recruiting
Hospital R&D contact (matched)

Shahista Hussain

ouhtma@ouh.nhs.uk---

Derriford Hospital, University Hospitals Plymouth NHS Trust

Plymouth PL6 8DH, United Kingdom

Recruiting
Hospital R&D contact (matched)

R&D Manager

plh-tr.RD-office@nhs.net01752 431776

Southampton General Hospital, University Hospital Southampton NHS Foundation Trust

Southampton SO16 6YD, United Kingdom

WITHDRAWN
Hospital R&D contact (matched)

Dr Mikayala King

researchmanagement@uhs.nhs.uk023 81208215

How to Get in Touch

Rhys Mant

Sponsor contact

CONTACT

+441214146788 aristocrat@trials.bham.ac.uk

Joshua Savage

Sponsor contact

CONTACT

j.savage.1@bham.ac.uk
Data sourced from ClinicalTrials.gov · Last verified: 2026-04