RecruitingPhase 2NCT05629702

ARISTOCRAT: Blinded Trial of Temozolomide +/- Cannabinoids

A Randomised Controlled Phase II Trial of Temozolomide With or Without Cannabinoids in Patients With Recurrent Glioblastoma

Sponsor

University of Birmingham

Enrollment

120 participants

Start Date

Feb 3, 2023

Study Type

INTERVENTIONAL

Conditions

Brain Tumor Glioblastoma Brain Tumor, Recurrent Cannabis

Summary

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).

Eligibility

Min Age: 16 Years

Plain Language Summary

Simplified for easier understanding

This study (called ARISTOCRAT) is testing whether adding cannabinoids (cannabis-based compounds) to temozolomide chemotherapy improves outcomes for people with a type of brain cancer called glioblastoma (GBM) that has come back after initial treatment. Temozolomide is already used to treat GBM, and lab studies suggest cannabinoids may enhance its effects. **You may be eligible if...** - You are 16 or older - You have glioblastoma (IDH wild type, MGMT promoter methylated) that has come back for the first time and is being considered for systemic treatment - You previously completed standard radiation and temozolomide chemotherapy (at least 3 cycles) - Your tumor is confirmed to have recurred by a neuroradiologist - Your general health and organ function are adequate - You are willing and able to comply with study requirements **You may NOT be eligible if...** - Your tumor has molecular features inconsistent with GBM (e.g. BRAF mutation or PXA features) - You have had another invasive cancer within the past 5 years (minor exceptions apply) - You have certain medication interactions or inability to take oral medications - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGNabiximols

Oromucosal spray

DRUGTemozolomide

Oral capsule

DRUGNabiximols-matched placebo

Nabiximols-matched placebo oromucosal spray

Locations(22)

Glan Clwyd Hospital

Bodelwyddan, Denbighshire, United Kingdom

Mount Vernon Hospital, The Hillingdon Hospitals NHS Foundation Trust

Northwood, Middlesex, United Kingdom

Aberdeen Royal Infirmary, NHS Grampian

Aberdeen, United Kingdom

Belfast City Hospital, Belfast Health and Social Care Trust

Belfast, United Kingdom

Queen Elizabeth Hospital Birmingham, University Hospitals Birmingham NHS Foundation Trust

Birmingham, United Kingdom

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

Bristol, United Kingdom

Addenbrooke's Hospital, Cambridge University Hospitals NHS Foundation Trust

Cambridge, United Kingdom

Velindre Cancer Centre, Velindre University NHS Trust

Cardiff, United Kingdom

Western General Hospital, NHS Lothian

Edinburgh, United Kingdom

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

Glasgow, United Kingdom

Castle Hill Hospital, Hull University Teaching Hospitals NHS Trust

Hull, United Kingdom

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

Leeds, United Kingdom

St Bartholomew's Hospital, Barts Health NHS Trust

London, United Kingdom

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

London, United Kingdom

Charing Cross Hospital, Imperial College Healthcare NHS Trust

London, United Kingdom

Maidstone Hospital, Maidstone and Tunbridge Wells NHS Trust

Maidstone, United Kingdom

The Christie Hospital, The Christie NHS Foundation Trust

Manchester, United Kingdom

Clatterbridge Cancer Centre, The Clatterbridge Cancer Centre NHS Foundation Trust

Metropolitan Borough of Wirral, United Kingdom

City Hospital, Nottingham University Hospitals NHS Trust

Nottingham, United Kingdom

Churchill Hospital, Oxford University Hospitals NHS Foundation Trust

Oxford, United Kingdom

Derriford Hospital, University Hospitals Plymouth NHS Trust

Plymouth, United Kingdom

Southampton General Hospital, University Hospital Southampton NHS Foundation Trust

Southampton, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT05629702

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