ARISTOCRAT: Blinded Trial of Temozolomide +/- Cannabinoids
United Kingdom120 participantsStarted 2023-02-03
Plain-language 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).
Who can participate
Age range16 Years
SexALL
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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
* Tot…
What they're measuring
1
Overall survival time (OS)
Timeframe: Time in whole days from date of randomisation to the date of death from any cause, assessed at a minimum of 12 months..