Clinical Trial: Bevacizumab Therapy for Brain Arteriovenous Malformation
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: Bevacizumab Therapy for Brain Arteriovenous Malformation
Brief Summary: Bevacizumab Therapy for brain arteriovenous malformation that is not amenable to surgical intervention.
Detailed Summary: 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.
Sponsor: University of California, San Francisco
Current Primary Outcome: Our primary outcome will be change in AVM volume from pre-treatment MRI. [ Time Frame: 12, 26 and 52 weeks ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- 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 ]
Original Secondary Outcome: Same as current
Information By: University of California, San Francisco
Dates:
Date Received: November 25, 2014
Date Started: June 2016
Date Completion: July 2018
Last Updated: June 2, 2016
Last Verified: June 2016