BevacizuMAV : Evaluation of the efficacy and safety of anti-angiogenic treatment with intravenous bevacizumab in patients with symptomatic cerebral arteriovenous malformations

Phase 1

• Conditions: cerebral arteriovenous malformations; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: CTIS2023-508464-30-00
• Lead Sponsor: Hopital Fondation Adolphe De Rothschild

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-10-23
• Last Update Posted: 21 August 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 54

Inclusion Criteria

Patient over 18 years, With a symptomatic cerebral AVM (chronic headache, focal neurological deficit, cognitive impairment, epilepsy) of Spetzler and Martin grade III, IV or V, With functional signs and symptoms not sequellar to a previous bleeding episode AND disabling (mRS>1), Ineligible for therapeutic intervention (endovascular or neurosurgery or radiosurgery), With normal bone marrow, liver and kidney function, For women of childbearing potential: negative pregnancy test within 14 days prior to inclusion and effective contraception for up to 6 months after the end of treatment, Having received informed consent to participate in the study, Affiliated or beneficiary of a social security plan

Exclusion Criteria

Known allergy to bevacizumab or an excipient, Patient under legal protection, Pregnant or breast-feeding women, Hypersensitivity to Chinese hamster ovary (CHO) cell products or other recombinant human or humanized antibodies, Contraindication to cerebral MRI (claustrophobia, pacemaker or other implantable device contraindicating MRI), Absolute or relative contraindication to gadolinium injection (history of true allergic reaction or intolerance to gadobutrol, renal failure with creatinine clearance <15mL/min, pregnant or breast-feeding woman), Proteinuria = 2+ on urine dipstick (patients with proteinuria =2+ on urine dipstick will need to have proteinuria = 1g protein on 24-hour urine to be eligible), Uncontrolled hypertension (PAS >150 and/or PAD > 100 mmHg), History of hypertensive crisis or hypertensive encephalopathy, Congestive heart failure (New York Heart Association Grade II or higher), Previous myocardial infarction or unstable angina in the preceding 12 months, Symptomatic peripheral vascular disease, Patient with balanced blood pressure on quadritherapy, Patients with severe coronary artery disease or recent ACS, Vascular disease (aortic aneurysm, aortic dissection), Major surgery, open biopsy or significant traumatic lesion within 4 weeks prior to inclusion, or anticipation of need for major surgery during study period, Biopsy or other minor surgical procedure, excluding placement of a vascular access device, within 7 days prior to inclusion, History of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within 6 months of inclusion, Significant unhealed wound, ulcer or bone fracture, Thrombotic episode within 6 months prior to inclusion, Atrial fibrillation

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified