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Cannabis spray could boost chemo for deadly brain tumors

NCT ID NCT05629702

Disease control Sponsor: University of Birmingham Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase II trial tests whether adding a cannabis-based mouth spray (nabiximols) to standard chemotherapy helps people with recurrent glioblastoma live longer. About 120 adults whose brain tumor has returned after initial treatment will receive either the cannabis spray or a placebo, alongside chemo. The study is double-blind, meaning neither patients nor doctors know who gets the real spray, to ensure fair results.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Nabiximols (cannabinoid spray, also known as Sativex) plus temozolomide chemotherapy
What this could lead to
If it works, this could point toward a new way to extend survival for people with recurrent glioblastoma, a type of brain cancer with very few options.
What could go wrong
This is a mid-stage trial with only 120 patients, so results may not be conclusive. Cannabinoids can cause side effects like dizziness or nausea, and the added benefit over standard chemo alone is unproven.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 120 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2023

Expected to finish

Apr 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

16 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

brain cancer brain neoplasm cannabis dependence glioblastoma Recurrence

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Brain tumor Brain tumor, recurrent Cannabis Glioblastoma

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    16 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Aberdeen Royal Infirmary, NHS Grampian

    RECRUITING

    Aberdeen, AB25 2ZN, United Kingdom

  • Addenbrooke's Hospital, Cambridge University Hospitals NHS Foundation Trust

    RECRUITING

    Cambridge, CB2 0QQ, United Kingdom

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

    WITHDRAWN

    Glasgow, G12 0YN, United Kingdom

  • Belfast City Hospital, Belfast Health and Social Care Trust

    WITHDRAWN

    Belfast, BT9 7AB, United Kingdom

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

    ACTIVE_NOT_RECRUITING

    Bristol, BS2 8ED, United Kingdom

  • Castle Hill Hospital, Hull University Teaching Hospitals NHS Trust

    RECRUITING

    Hull, HU16 5JQ, United Kingdom

  • Charing Cross Hospital, Imperial College Healthcare NHS Trust

    RECRUITING

    London, W6 8RF, United Kingdom

  • Churchill Hospital, Oxford University Hospitals NHS Foundation Trust

    RECRUITING

    Oxford, OX3 9DU, United Kingdom

  • City Hospital, Nottingham University Hospitals NHS Trust

    RECRUITING

    Nottingham, NG5 1PB, United Kingdom

  • Clatterbridge Cancer Centre, The Clatterbridge Cancer Centre NHS Foundation Trust

    RECRUITING

    Metropolitan Borough of Wirral, CH63 4JY, United Kingdom

  • Derriford Hospital, University Hospitals Plymouth NHS Trust

    RECRUITING

    Plymouth, PL6 8DH, United Kingdom

  • Glan Clwyd Hospital

    WITHDRAWN

    Bodelwyddan, Denbighshire, LL18 5UJ, United Kingdom

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

    RECRUITING

    London, SE1 9RT, United Kingdom

  • Maidstone Hospital, Maidstone and Tunbridge Wells NHS Trust

    RECRUITING

    Maidstone, ME16 9QQ, United Kingdom

  • Mount Vernon Hospital, The Hillingdon Hospitals NHS Foundation Trust

    RECRUITING

    Northwood, Middlesex, HA6 2RN, United Kingdom

  • Queen Elizabeth Hospital Birmingham, University Hospitals Birmingham NHS Foundation Trust

    RECRUITING

    Birmingham, B15 2TH, United Kingdom

  • Southampton General Hospital, University Hospital Southampton NHS Foundation Trust

    WITHDRAWN

    Southampton, SO16 6YD, United Kingdom

  • St Bartholomew's Hospital, Barts Health NHS Trust

    RECRUITING

    London, EC1A 7BE, United Kingdom

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

    RECRUITING

    Leeds, LS9 7TF, United Kingdom

  • The Christie Hospital, The Christie NHS Foundation Trust

    RECRUITING

    Manchester, M20 4BX, United Kingdom

  • Velindre Cancer Centre, Velindre University NHS Trust

    RECRUITING

    Cardiff, CF15 7QZ, United Kingdom

  • Western General Hospital, NHS Lothian

    WITHDRAWN

    Edinburgh, EH4 2XU, United Kingdom

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