Bevacizumab Therapy for Brain Arteriovenous Malformation
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|ClinicalTrials.gov Identifier: NCT02314377|
Recruitment Status : Completed
First Posted : December 11, 2014
Last Update Posted : March 3, 2020
|Condition or disease||Intervention/treatment||Phase|
|Brain Arteriovenous Malformation||Drug: Bevacizumab||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Bevacizumab Therapy for Brain Arteriovenous Malformation|
|Study Start Date :||June 2016|
|Actual Primary Completion Date :||December 1, 2018|
|Actual Study Completion Date :||December 1, 2019|
Experimental: AVM treatment with Bevacizumab
Bevacizumab infusion dose of 5mg/kg q 2 weeks for 12 weeks (2.5 mg/week).
Bevacizumab dosing of 5mg/kg q 2 weeks for 12 weeks (2.5 mg/week).
Other Name: avastin
- Our primary outcome will be change in AVM volume from pre-treatment MRI. [ Time Frame: 12, 26 and 52 weeks ]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.
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02314377
|United States, California|
|University of California San Francisco|
|San Francisco, California, United States, 94143|
|Principal Investigator:||Daniel Cooke, MD||UCSF Medical Center|