OncoMatch/Clinical Trials/NCT05629702
ARISTOCRAT: Blinded Trial of Temozolomide +/- Cannabinoids
Is NCT05629702 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Nabiximols and Temozolomide for glioblastoma.
Treatment: Nabiximols · Temozolomide — 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).
Check if I qualifyExtracted eligibility criteria
Cancer type
Glioblastoma
Biomarker criteria
Required: MGMT promoter methylation
MGMT promoter methylated
Required: IDH1 wild-type
IDH wild type (WT)
Required: IDH2 wild-type
IDH wild type (WT)
Excluded: BRAF mutation
patients with molecular features of PXA or BRAF mutation will be excluded
Prior therapy
Must have received: radiation therapy — first-line
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
Must have received: alkylating agent (temozolomide) — first-line
concomitant and adjuvant TMZ
Cannot have received: stereotactic radiotherapy
Prior treatment with stereotactic radiotherapy
Cannot have received: brachytherapy
Prior treatment with...brachytherapy
Cannot have received: Convection Enhanced Delivery
Prior treatment with...Convection Enhanced Delivery (CED) of any agent
Cannot have received: systemic therapy
Exception: apart from debulking surgery
Prior treatment, apart from debulking surgery, for first recurrence of GBM
Cannot have received: temozolomide (temozolomide)
Prior allergic reaction or significant toxicity (≥Grade 3 CTCAE) related to TMZ treatment
Lab requirements
Blood counts
Absolute neutrophil count (ANC) ≥1.5 x 10^9/L; Platelet count ≥100 x 10^9/L
Kidney function
Serum creatinine clearance >30ml/min
Liver function
Total serum bilirubin ≤1.5 x upper limit of normal (ULN); Liver transaminases <2.5 x ULN
Adequate hematologic, renal, and hepatic function within 14 days prior to randomisation: * Absolute neutrophil count (ANC) ≥1.5 x 10^9/L * Platelet count ≥100 x 10^9/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
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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