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NCT07909811

PHASE1

Novel endOvascular Therapy With beVAcizumab and Cannabinoids for Glioblastoma

Sponsor: Unity Health Toronto

View on ClinicalTrials.gov

Summary

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2026-12-01

Completion Date

2028-12-01

Last Updated

2026-11-02

Healthy Volunteers

Conditions

GBM

Interventions

COMBINATION_PRODUCT

Bevacizumab

Participants receive standard radiation and temozolomide chemotherapy together with a daily cannabis-based mouth spray (nabiximols, titrated up to 12 sprays a day for 12 months) and three catheter-guided infusions of bevacizumab (15 mg/kg) directly into the tumour's arteries, each given after mannitol briefly opens the blood-brain barrier, at least 45 days apart.

Inclusion Criteria: Competent and able to give informed consent Aged 18 years or older Histopathological confirmation of glioblastoma (WHO 2021) via biopsy or maximal safe resection KPS ≥70 Estimated life expectancy of at least 3 months Agreement to use effective contraception Adequate baseline laboratory values Exclusion Criteria: Previous treatment with bevacizumab; pregnancy or lactation Serious cardiovascular disease, clinically significant heart failure, or uncontrolled hypertension (≥150/100 mmHg despite therapy) Intracranial hemorrhage (history, Grade ≥2 on baseline MRI, or active bleeding); bleeding diathesis; anticoagulation or dual antiplatelet therapy that cannot be safely interrupted Arterial thromboembolic event within 6 months; venous thromboembolism within 3 months Major surgery or significant trauma within 28 days (the qualifying biopsy or resection is exempt), or an unhealed wound Gastrointestinal perforation, fistula or abscess within 6 months; nephrotic syndrome; significant renal impairment Arterial pathology precluding safe super-selective catheterization Hypersensitivity to bevacizumab, nabiximols, mannitol or (unmanageable) iodinated contrast Personal or first-degree family history of schizophrenia or other psychotic disorder Potent CYP3A4 or CYP2C9 inhibitors or inducers; nephrotoxic or neurotoxic agents that cannot be withheld Well-established anuria due to severe renal disease, or requirement for renal replacement therapy. Severe dehydration or hypovolemia that has not been corrected prior to the procedure. Pre-existing plasma hyperosmolarity, defined as serum osmolality \> 320 mOsm/kg. Clinically significant, uncorrected electrolyte or acid-base disturbance, including serum sodium outside 130-150 mmol/L or serum potassium outside 3.0-5.5 mmol/L. Any other significant intercurrent medical or psychiatric condition that, in the judgement of the investigator, would place the patient at increased risk or affect their ability to receive or comply with treatment or post-treatment clinical monitoring.