Arteriovenous malformation Trials in Disease

Study on Bevacizumab for Patients with Symptomatic Cerebral Arteriovenous Malformations

This clinical trial is investigating bevacizumab as a treatment option for patients with symptomatic cerebral arteriovenous malformations (AVMs). AVMs are abnormal connections between arteries and veins in the brain that bypass the normal capillary system, which can lead to various symptoms including chronic headaches, seizures, neurological problems, and cognitive difficulties.

Main inclusion criteria:

• Patients must be over 18 years old
• Must have a symptomatic cerebral AVM classified as Spetzler and Martin grade III, IV, or V
• Must experience disabling symptoms (not caused by previous bleeding) that significantly affect daily life, with a modified Rankin Scale score greater than 1
• Must be ineligible for standard therapeutic interventions such as endovascular therapy, neurosurgery, or radiosurgery
• Must have normal bone marrow, liver, and kidney function
• Women of childbearing potential must have a negative pregnancy test within 14 days before joining the study and use effective birth control for up to 6 months after treatment ends
• Must be affiliated with or a beneficiary of a social security plan

Main exclusion criteria:

• Patients who can undergo standard interventional therapy
• Patients who are not experiencing disabling symptoms
• Patients who are part of a vulnerable population requiring special protection or care

Focus and goal of the trial:

The primary goal of this study is to evaluate the effectiveness and safety of bevacizumab in reducing disabling symptoms in patients with cerebral AVMs who have limited treatment options. The trial follows a structured timeline over six months, with follow-up extending to 12 months. Participants receive intravenous injections of bevacizumab at a dose of 5 mg per kilogram of body weight every 14 days for 3 months, totaling 6 injections.

Throughout the study, regular monitoring assesses improvements in cognitive and neurological scores, headache severity, and seizure control. Brain MRI scans are performed to track changes in the AVMs and monitor for potential side effects. Secondary evaluations include quality of life measurements and documentation of any adverse events. The study compares outcomes between those receiving treatment and those who do not, to determine whether bevacizumab can effectively improve symptoms and overall well-being.

Investigational drug:

Bevacizumab is the medication being tested in this trial. It is a monoclonal antibody that works by blocking vascular endothelial growth factor (VEGF), a protein essential for the formation of new blood vessels. By inhibiting VEGF, bevacizumab helps reduce abnormal blood vessel growth, which may alleviate symptoms caused by cerebral AVMs. The medication is administered as an intravenous infusion, specifically using Aybintio 25 mg/ml concentrate mixed with 100 mL of saline solution.

Summary

Currently, there is one clinical trial available for patients with symptomatic cerebral arteriovenous malformations who cannot receive standard surgical or interventional treatments. This trial is being conducted in France and focuses on evaluating bevacizumab, an anti-angiogenic medication, as a potential therapeutic option. The study specifically targets patients with high-grade AVMs (Spetzler and Martin grades III, IV, or V) who experience disabling symptoms affecting their daily lives. The trial's structured approach includes a three-month treatment period followed by ongoing monitoring to assess both short-term and long-term outcomes, including symptom improvement, quality of life, and safety. This research may provide valuable insights into alternative treatment options for patients with limited therapeutic choices.