Bevacizumab Therapy for brain arteriovenous malformation that is not amenable to surgical intervention.
Brain AVMs are relatively rare, though their potential for ICH along with the existence of effective treatments makes their diagnosis and management essential to the community. The 2-4% annual incidence of such secondary ICH creates controversy regarding treatment for asymptomatic patients. Brain AVMs thus require multidisciplinary evaluation for optimal management especially for surgical grades III - V lesions that often require some combination of embolization, microsurgery, and/or radiosurgical treatment. Currently there is no designated medical therapy for bAVM, though there is growing animal and human evidence supporting a role for bevacizumab to reduce the size of AVMs in the brain and liver, respectively. This proposal is a pilot study to assess the efficacy and safety of bevacizumab in humans with bAVMs.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
2
Bevacizumab dosing of 5mg/kg q 2 weeks for 12 weeks (2.5 mg/week).
University of California San Francisco
San Francisco, California, United States
Our primary outcome will be change in AVM volume from pre-treatment MRI.
AVM volume will be assessed by review of standardized 1.5 mm slices in the axial plane. The contour of the vascular mass using time-of-flight MR angiography sequences will generate a cross-sectional area at each slice level. The volume will be estimated by summing the imputed volume of each slice. This is the standard method in radiation oncology used to assess bAVM volume for radiosurgery treatment planning using commercial software (Leksell GammaPlan). The source images and measurement images will be archived on a research workstation. After a baseline MR examination, follow-up MRs will be performed at 12, 26 and 52 weeks.
Time frame: 12, 26 and 52 weeks
Serum VEGF levels
Time frame: at baseline and at 12, 26 and 52 weeks
Urine analysis
Time frame: at baseline and at 12, 26 and 52 weeks
Physical exam
Time frame: at baseline and at 12, 26 and 52 weeks
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