This clinical trial investigates a new treatment approach for patients with glioblastoma (GBM), a type of aggressive brain cancer, after their first recurrence. The study is divided into two groups, each testing a combination of three drugs: bevacizumab, trimipramine, and atezolizumab.
The main objective is to explore whether combining these three drugs can improve outcomes for people facing a recurrence of glioblastoma.
In the first group, 45 patients receive all three drugs—bevacizumab, trimipramine, and atezolizumab—after being diagnosed with a first recurrence of GBM. The goal is to evaluate how effective this combination is in treating the disease.
In the second group, 5 patients who require surgery for their recurrent tumor will begin treatment with trimipramine and atezolizumab before the operation. After recovering from surgery, they continue with all three drugs, including bevacizumab. This part of the study aims to measure how much trimipramine reaches the brain tumor and the fluid around the brain and spine.
The three drugs being tested work in different ways:
- Bevacizumab is a drug that blocks the growth of new blood vessels, which helps slow down tumor growth.
- Trimipramine is an antidepressant that may also help reprogram immune cells in the brain to fight cancer.
- Atezolizumab is a medicine that boosts the immune system’s ability to attack cancer cells.
To join the trial, patients must fulfil the following criteria:
- Confirmed glioblastoma and be in their first recurrence.
- Not have had surgery or other invasive procedures in the past four weeks.
- Not having prostate problems or glaucoma
- Not be taking other experimental drugs.
Common side effects of trimipramine include drowsiness, dry mouth, constipation, blurred vision, and weight gain. Serious risks may include heart rhythm problems and low blood pressure. Atezolizumab may cause fatigue, nausea, fever, and more serious immune-related complications. Bevacizumab can lead to high blood pressure, bleeding, or blood clots.