Health Trials

ARISTOCRAT: Blinded Trial of Temozolomide +/- Cannabinoids

ConditionsGlioblastomaBrain TumorCannabisBrain Tumor, Recurrent
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age16+
SponsorUniversity of Birmingham

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).

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Nabiximols
  • Temozolomide
  • Nabiximols-matched placebo

Treatment groups

120 Participants
are divided into 2 treatment groups

Sponsors and collaborators

University of Birmingham

Lead sponsor

University of Leeds

Collaborator

The Brain Tumour Charity

Collaborator

Jazz Pharmaceuticals

Collaborator

Source ClinicalTrials.gov