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A Randomised Controlled Phase II Trial Of Temozolomide With Or Without Cannabinoids In Patients With Recurrent Glioblastoma
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Actively Recruiting
Phase 2
Age: 16 Years +
All Genders
ID05629702
A Randomised Controlled Phase II Trial of Temozolomide With or Without Cannabinoids in Patients With Recurrent Glioblastoma
Led by University of Birmingham
Updated on 2026-05-05
120
Participants Needed
22
Research Sites
30 weeks
Total Duration
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AI-Summary
Brief Title
Who Can Participate
AI-Screening
Your Study Journey
Trial Site Locations
Research Team
How is the study designed?
Similar Trials
Frequently Asked Questions
Research Publications
Sponsors
University of Birmingham
Lead Sponsor
University of Leeds
Collaborating Sponsor
The Brain Tumour Charity
Collaborating Sponsor
AI-Summary
What This Trial Is About
Researchers are evaluating the cannabinoid Nabiximols Sativex added to the standard chemotherapy temozolomide TMZ in patients with recurrent MGMT methylated glioblastoma GBM. This phase II, multi-center, double-blind, placebo-controlled, randomized trial aims to compare Nabiximols with a matched placebo alongside TMZ treatment. The study is linked with the Tessa Jowell BRAIN MATRIX program to streamline patient entry and data sharing while providing additional oversight. Participants will be randomly assigned in a 2:1 ratio to receive either Nabiximols or placebo, both combined with temozolomide. Temozolomide is given orally once daily on days 1-5 of each 28-day cycle, starting at 150mg/m2 in cycle 1 and increasing to 200mg/m2 in subsequent cycles, for up to six cycles. Nabiximols or placebo sprays are self-titrated up to 12 sprays per day over the first 14 days of cycle 1, continuing for up to six cycles. Patients will attend 4-weekly follow-up visits for at least 52 weeks or until death. MRI scans are scheduled at screening, weeks 10, 22, 30, and then every three months after starting treatment. Researchers will monitor overall survival, progression-free survival, health-related quality of life, and adverse events. The initial 40 patients will be evaluated for safety, compliance, and recruitment feasibility before continuing the trial. Total participation may last up to a year or more depending on individual outcomes.
CONDITIONS
Brief Title
ARISTOCRAT: Blinded Trial of Temozolomide +/- Cannabinoids
Who Can Participate
Age: 16 Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Histological diagnosis of MGMT promoter methylated, IDH wild type glioblastoma.
- First recurrence of glioblastoma planned for systemic treatment confirmed by imaging and multidisciplinary team.
- Received initial first-line radiotherapy with concomitant and adjuvant temozolomide.
- At least 3 cycles of adjuvant temozolomide completed.
- Stable disease or better at end of first-line treatment.
- At least 3 months since last temozolomide cycle.
- Karnofsky Performance Status of 60 or higher.
- Adequate blood counts and organ function within 14 days prior to randomisation.
- If surgery for recurrence done, wound healed and residual disease visible on MRI within 21 days.
- Recovery from previous treatment side effects at Grade 2 or less.
- On stable or decreasing steroid dose if applicable.
- Able and willing to provide informed consent and comply with trial requirements.
- Age 16 years or older.
- Able to start treatment within 28 days of randomisation.
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You will not qualify if you...
- Glioblastoma pathology inconsistent with IDH wild type.
- Prior invasive cancer except certain skin cancers unless disease-free for 1 year.
- Previous stereotactic radiotherapy, brachytherapy, or convection enhanced delivery treatments.
- Prior treatment for first recurrence other than debulking surgery.
- Active medical conditions making trial treatment unsuitable.
- History of schizophrenia, psychotic illness, severe personality disorder, or significant psychiatric diagnosis except depression related to glioma.
- Prior allergic reaction or severe toxicity to temozolomide.
- Current or recent cannabis or cannabinoid use within 28 days or unwillingness to abstain.
- Pregnant or breastfeeding women or women of childbearing potential not using effective contraception.
- Men unwilling or unable to use contraception during and 6 months after treatment.
- Contraindications to MRI or gadolinium contrast.
- Certain hereditary metabolic disorders.
- Known allergy to cannabinoids or study drug ingredients.
- History of alcohol or drug dependence.
- Known hepatitis B, cytomegalovirus, or opportunistic infection.
- Live vaccine within 28 days prior to randomisation.
- Unable to use oromucosal medication.
- Participation in another therapeutic clinical trial concurrently.
- Psychological, familial, social, or geographic conditions interfering with protocol compliance.
AI-Screening
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for MRI scanning and assessments
Treatment
Duration - Up to 6 cycles of 28 days each
Participants receive temozolomide and either Nabiximols or a matched placebo as an oromucosal spray. Temozolomide is taken orally once daily for days 1-5 of each 28-day cycle, up to 6 cycles. Nabiximols or placebo is self-titrated over days 1-14 in cycle 1, up to 12 sprays per day for up to 6 cycles.
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Weekly visits for up to 24 weeks for treatment assessments and adverse event monitoring
Follow-up
Duration - At least 52 weeks from treatment start
Participants are followed up with 4-weekly assessments for a minimum of 52 weeks from the start of trial treatment or until death, whichever is sooner. MRI scans are performed at week 10, week 22, week 30, then every 3 months thereafter.
4-weekly visits for at least 52 weeks including MRI scans at specified time points
Trial Site Locations
Total: 22 locations
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Mount Vernon Hospital, The Hillingdon Hospitals NHS Foundation Trust
- Northwood, Middlesex, United Kingdom, HA6 2RN
- Actively Recruiting
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Aberdeen Royal Infirmary, NHS Grampian
- Aberdeen, United Kingdom, AB25 2ZN
- Actively Recruiting
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Queen Elizabeth Hospital Birmingham, University Hospitals Birmingham NHS Foundation Trust
- Birmingham, United Kingdom, B15 2TH
- Actively Recruiting
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Addenbrooke's Hospital, Cambridge University Hospitals NHS Foundation Trust
- Cambridge, United Kingdom, CB2 0QQ
- Actively Recruiting
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Velindre Cancer Centre, Velindre University NHS Trust
- Cardiff, United Kingdom, CF15 7QZ
- Actively Recruiting
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Castle Hill Hospital, Hull University Teaching Hospitals NHS Trust
- Hull, United Kingdom, HU16 5JQ
- Actively Recruiting
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St James's University Hospital, Leeds Teaching Hospitals NHS Trust
- Leeds, United Kingdom, LS9 7TF
- Actively Recruiting
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St Bartholomew's Hospital, Barts Health NHS Trust
- London, United Kingdom, EC1A 7BE
- Actively Recruiting
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Guy's Hospital, Guy's and St Thomas' NHS Foundation Trust
- London, United Kingdom, SE1 9RT
- Actively Recruiting
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Charing Cross Hospital, Imperial College Healthcare NHS Trust
- London, United Kingdom, W6 8RF
- Actively Recruiting
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Maidstone Hospital, Maidstone and Tunbridge Wells NHS Trust
- Maidstone, United Kingdom, ME16 9QQ
- Actively Recruiting
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The Christie Hospital, The Christie NHS Foundation Trust
- Manchester, United Kingdom, M20 4BX
- Actively Recruiting
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Clatterbridge Cancer Centre, The Clatterbridge Cancer Centre NHS Foundation Trust
- Metropolitan Borough of Wirral, United Kingdom, CH63 4JY
- Actively Recruiting
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City Hospital, Nottingham University Hospitals NHS Trust
- Nottingham, United Kingdom, NG5 1PB
- Actively Recruiting
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Churchill Hospital, Oxford University Hospitals NHS Foundation Trust
- Oxford, United Kingdom, OX3 9DU
- Actively Recruiting
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Derriford Hospital, University Hospitals Plymouth NHS Trust
- Plymouth, United Kingdom, PL6 8DH
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