NCT07909811

Novel endOvascular Therapy With beVAcizumab and Cannabinoids for Glioblastoma

StatusNot Yet Recruiting

PhasePhase 1

SponsorUnity Health Toronto

Primary completionDec 1, 2027 (estimated)

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Record History

All 1 version: 1 with changes below.

Oct 26, 2026 Study First Submitted

Endpoints

Primary

Regimen-Limiting Toxicity

Timeframe: From the first nabiximols dose until 6 months after the last nabiximols dose

Arms and interventions

InterventionExperimental

Combination products: Bevacizumab

About this trial

The goal of this clinical trial is to learn if a combined treatment of bevacizumab delivered directly to the brain tumour and a cannabis-based oral spray (nabiximols) can be given safely and practically alongside standard radiation and chemotherapy in adults with newly diagnosed glioblastoma. The main questions it aims to answer are: How many participants have serious side effects (regimen-limiting toxicities) from the combined treatment? Can participants receive and complete the planned treatment, and how often does the catheter procedure succeed? Participants will: Receive standard care: radiation with the chemotherapy drug temozolomide Take a nabiximols (Sativex) mouth spray daily for 12 months, starting at 2 sprays a day and slowly increasing to the highest dose they tolerate (up to 12 sprays a day) Have three treatment sessions in which a thin catheter is guided through an artery to the tumour's blood vessels to deliver mannitol, which briefly opens the brain's protective barrier, followed by bevacizumab.

Trial details

Enrollment: 6 participants (estimated)
Started: Dec 1, 2026
Study completion: Dec 1, 2028 (estimated)
Eligibility: 18 and older, all sexes, no healthy volunteers
Design: Interventional, open label, treatment
Conditions: GBM
First posted: Nov 2, 2026
Registry updated: Nov 2, 2026
Last verified: Oct 2026

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