In Situ Injection of Anti-angiogenics in Patients With Brain Arteriovenous Malformations Not Eligible for Exclusion Treatment
Condition(s) studied
Investigational drug(s) / intervention(s)
Single in situ intra-arterial injection of bevacizumab: 3 Escalating doses of an in situ intra-arterial injection of Bevacizumab (5 mg/kg, 7.5 mg/kg, 10 mg/kg)
Study summary
Brain arteriovenous malformations (bAVMs) are rare aggressive vascular malformations affecting mostly young and healthy adults. The most frequent revealing condition (in almost 50% of cases) is an intra-cerebral hemorrhage, which is a considerable source of disability and mortality. The only way to prevent a bleeding or a rebleeding is to perform an exclusion treatment (endovascular embolization, microsurgery, stereotactic radiosurgery, or a combination of these techniques). The major drawback of these treatments is the risk of severe complications, which can reach 20%, especially in patients presenting a bAVM with complex angio-architecture (i.e., grade IV to V in the Spetzler Martin grading scale). There is a growing evidence about the strong implication of angiogenesis (mainly mediated by the type A vascular endothelial growth factor \[VEGF-A\]) on the size and growth of the bAVM and even in the occurrence of bleeding events. Our hypothesis is that an in situ injection of bevacizumab, a monoclonal antibody inhibiting VEGF-A, in patients with bAVM deemed not suitable for exclusion treatment may be safe and help to reduce the nidus volume.
Eligibility
Primary outcome measure(s)
- Dose limiting toxicity — Days 0 (day of the injection) to day 30
Dose limiting toxicity defined as the occurrence within 30 days of the in situ injection of bevacizumab of one of the following events: * Symptomatic venous/arterial thromboembolic events : pulmonary embolism, deep venous thrombosis, ischemic stroke, related to an arterial occlusion * Severe cytopenia defined as:Anemia defined as hemoglobin level less than 8.0 g/dL grade ≥ III,Thrombocytopenia \< 50 G/L grade ≥ III * Neutropenia \< 1000/μ L grade ≥ IV * Hypertension grade ≥ III * Symptomatic intracranial hemorrhage, resulting in transient/permanent neurological deficit * Any bleeding requiring transfusion * Leukoencephalopathy grade ≥ III * Onset of intractable seizures ≥ Grade III * Thrombo-embolic complication during the procedure leading to permanent deficit/death * Intracranial arterial perforation with the microcatheter/ microguide wire resulting in symptomatic hemorrhage causing any disability/death. * Any other serious adverse reaction resulting in any disability or death
Trial sites (5)
| Facility | City | Region | Status |
|---|---|---|---|
| CHU de Limoges, Hôpital Dupuytren | Limoges | France | |
| CHU de Nancy, Hôpital Central | Nancy | France | |
| APHP, Hôpital Pitié-Salpêtrière | Paris | France | |
| Centre Hospitalier Sainte-Anne | Paris | France | |
| CHU de Rouen, Hôpital Charles-Nicolle | Rouen | France |
More Assistance Publique - Hôpitaux de Paris trials in France
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07075757 on ClinicalTrials.gov ↗ ← All trials in France