A Study of Subcutaneous Bevacizumab in Relapsed / Progressive Glioblastoma
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|ClinicalTrials.gov Identifier: NCT02157103|
Recruitment Status : Completed
First Posted : June 5, 2014
Results First Posted : April 13, 2018
Last Update Posted : May 17, 2018
This research will involve patients with glioblastoma. The drug bevacizumab (Avastin) is FDA approved for the treatment of glioblastoma that gets worse after standard therapy. For glioblastoma, bevacizumab is given by vein every 14 days. The purpose of this study is to see if bevacizumab works as well when it is given as a daily subcutaneous shot as it does when given intravenously. A subcutaneous shot is like an insulin shot or a heparin shot. The dose of bevacizumab given on this study is in total slightly lower than the FDA approved dose for glioblastoma.
About 10 people will take part in the study. Participants or caregivers will be educated on injection and given prefilled syringes to take home. Participants or caregivers will administer bevacizumab subcutaneously each day. The bevacizumab will be stored in the refrigerator.
Follow up visits will be weekly for the first 3 weeks, then every 3 weeks. After 18 weeks, the follow up interval can be increased to every 6 weeks at the treating physician's discretion.
Participants can keep taking the bevacizumab until:
- Tests show that they are not benefiting from it,
- The participant has a bad side effect related to study treatment,
- The participant can no longer comply with study requirements, or
- The participant or doctor feels it is no longer in the participant's best interest.
|Condition or disease||Intervention/treatment||Phase|
|Glioblastoma||Drug: Bevacizumab 25 mg in 1 ml subcutaneously daily||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||3 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Subcutaneous Bevacizumab in Relapsed / Progressive Glioblastoma|
|Actual Study Start Date :||January 2014|
|Actual Primary Completion Date :||November 2016|
|Actual Study Completion Date :||January 2018|
Cycle 1 (each cycle is 3 weeks): Bevacizumab 25 mg in 1 ml subcutaneously daily.
Drug: Bevacizumab 25 mg in 1 ml subcutaneously daily
Bevacizumab delivered by subcutaneous injection instead of intravenous infusion.
Other Name: Avastin
- Number of Participants With Change in Peritumoral Enhancement/Edema [ Time Frame: 1 cycle (3 weeks) ]To describe MRI response regarding edema and enhancement of glioblastoma and radiation-related brain enhancement when treated with subcutaneous bevacizumab daily. The therapeutic benefit of bevacizumab as regards glioblastoma multiforme (GBM) is largely due to the normalization of brain vasculature. This normalization appears on contrast-enhanced MRI as a reduction in enhancement and reduction in edema. For purposes of this study, any reduction in enhancement/edema by 25% or more will be considered a response.
- Number of Toxicities Reported in Study Participants [ Time Frame: During first 3 weeks of study ]Subcutaneous bevacizumab may have toxicities unique to the subcutaneous administration and not seen with intravenous bevacizumab. During the first 3 weeks we will watch for such toxicities. Toxicities will be described and graded using the Common Toxicity Criteria for Adverse Effects (CTCAE) v3.
- Number of Participants With Change in Edema After Conversion From Study Treatment to Intravenous Bevacizumab [ Time Frame: Within 2 months of starting intravenous bevacizumab ]Participants may switch from subcutaneous bevacizumab on study to standard of care intravenous bevacizumab. In these participants, we will measure decrease of edema after this switch. A further decrease in edema after making this switch would suggest intravenous to be superior to subcutaneous as regards decreasing edema. The therapeutic benefit of bevacizumab as regards GBM is largely due to the normalization of brain vasculature. This normalization appears on contrast-enhanced MRI as a reduction in edema. For purposes of this study, any reduction in edema by 25% or more will be considered a response.
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): NCT02157103
|United States, Georgia|
|Emory University Hospital Midtown|
|Atlanta, Georgia, United States, 30308|
|Emory University Winship Cancer Institutute|
|Atlanta, Georgia, United States, 30322|
|Principal Investigator:||William L. Read, MD||Emory University|