Study on Bevacizumab for Patients with Symptomatic Cerebral Arteriovenous Malformations

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What is this study about?

This clinical trial is focused on studying the effects of a treatment for patients with cerebral arteriovenous malformations (AVMs). AVMs are abnormal connections between arteries and veins in the brain, which can lead to symptoms like chronic headaches, neurological issues, cognitive problems, and seizures. The treatment being tested is called bevacizumab, which is given as an intravenous infusion. Bevacizumab is a medication that helps reduce the growth of blood vessels, which may help alleviate the symptoms caused by AVMs.

The purpose of this study is to evaluate how effective and safe bevacizumab is for patients with symptomatic cerebral AVMs who cannot undergo other types of treatment like surgery or radiation. Participants in the study will receive bevacizumab infusions every two weeks for a total of three months. The study will monitor changes in symptoms and overall health over a period of six months to see if there are improvements in conditions such as headaches, neurological function, and quality of life.

Throughout the study, participants will undergo regular assessments, including brain imaging tests like MRI to check for changes in the AVMs and any potential side effects. The study aims to provide valuable information on whether bevacizumab can be a beneficial treatment option for those with cerebral AVMs who have limited treatment choices. A comparison will be made between those receiving the treatment and those who do not, to determine the effectiveness of bevacizumab in improving symptoms and overall well-being.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying age, medical condition, and other criteria such as normal bone marrow, liver, and kidney function.

For women of childbearing potential, a negative pregnancy test is required within 14 days prior to inclusion, along with effective contraception for up to 6 months after the end of treatment.

2 treatment phase

The treatment involves receiving intravenous injections of bevacizumab at a dose of 5 mg per kilogram of body weight.

These injections are administered every 14 days over a period of 3 months, totaling 6 injections.

The medication is delivered as a solution for infusion, specifically Aybintio 25 mg/ml concentrate mixed with 100 mL of NaCl 0.9%.

3 monitoring and evaluation

Throughout the trial, regular monitoring is conducted to assess the impact of the treatment on symptoms such as chronic headache, neurological deficits, cognitive impairment, and epilepsy.

Primary evaluation occurs at 6 months, focusing on improvements in cognitive and neurological scores, headache severity, and epilepsy balance.

Secondary evaluations include changes in brain MRI findings, quality of life scores, and any adverse events.

4 follow-up

Follow-up assessments are conducted at 12 months to evaluate long-term effects of the treatment.

These assessments include cognitive and neurological scores, quality of life measures, and monitoring for any cerebral hemorrhage or adverse events.

Who Can Join the Study?

Patient must be over 18 years old.
Must have a symptomatic cerebral AVM. This means a condition in the brain with symptoms like chronic headaches, problems with movement or sensation, trouble with thinking, or epilepsy. The AVM should be of Spetzler and Martin grade III, IV, or V, which are specific classifications of the condition.
Must have symptoms that are not due to a previous bleeding episode and are disabling. This means the symptoms significantly affect daily life, with a score greater than 1 on the mRS. The mRS, or modified Rankin Scale, is a measure of disability.
Must be ineligible for therapeutic intervention. This means the patient cannot have treatments like endovascular therapy, neurosurgery, or radiosurgery.
Must have normal function of the bone marrow, liver, and kidneys. These are important parts of the body that help produce blood cells, process substances, and filter waste.
For women who can have children: Must have a negative pregnancy test within 14 days before joining the study and use effective birth control for up to 6 months after the treatment ends.
Must have given informed consent to participate in the study. This means the patient understands the study and agrees to take part.
Must be affiliated with or a beneficiary of a social security plan. This means having access to a system that provides health and financial support.

Who Cannot Join the Study?

Patients who can undergo interventional therapy for their condition cannot participate.
Patients who are not experiencing disabling symptoms from their condition cannot participate.
Patients who are not within the specified age range cannot participate. The age range is typically defined in the study details.
Patients who are part of a vulnerable population, which means they might need special protection or care, cannot participate.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Fondation A De Rothschild	Paris	France

Trial status

Country	Status	Recruitment Start
France	Recruiting	15.01.2024

Trial locations

Investigated drugs:

Bevacizumab

Bevacizumab is a medication used in this trial to treat patients with symptomatic cerebral arteriovenous malformations. It is administered through intravenous injections. The main goal of using bevacizumab in this study is to evaluate its effectiveness and safety in reducing disabling symptoms over a period of six months. Patients receive the medication every 14 days for three months, totaling six injections.

Investigated diseases:

Cerebral arteriovenous malformation haemorrhagic

Cerebral Arteriovenous Malformations – These are abnormal connections between arteries and veins in the brain, bypassing the capillary system. They can lead to a variety of symptoms, including headaches, seizures, and neurological deficits, depending on their size and location. Over time, these malformations may cause increased pressure on surrounding brain tissue, potentially leading to bleeding or other complications. The progression of symptoms can vary widely among individuals, with some experiencing significant issues while others may remain asymptomatic. The condition is considered rare and can be challenging to manage due to its complex nature.

Trial ID:

2023-508464-30-00

Protocol code:

BevacizuMAV

Trial Phase:

Therapeutic exploratory (Phase II)

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