Trial Outcomes & Findings for A Study of Subcutaneous Bevacizumab in Relapsed / Progressive Glioblastoma (NCT NCT02157103)
NCT ID: NCT02157103
Last Updated: 2018-05-17
Results Overview
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.
COMPLETED
PHASE2
3 participants
1 cycle (3 weeks)
2018-05-17
Participant Flow
Patients were recruited at Winship Cancer Institute and Emory University Hospital Midtown from January 2014 to April 2017.
Participant milestones
| Measure |
Bevacizumab
Cycle 1 (each cycle is 3 weeks): Bevacizumab 25 mg in 1 ml subcutaneously daily.
Bevacizumab 25 mg in 1 ml subcutaneously daily: Bevacizumab delivered by subcutaneous injection instead of intravenous infusion.
|
|---|---|
|
Overall Study
STARTED
|
3
|
|
Overall Study
COMPLETED
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of Subcutaneous Bevacizumab in Relapsed / Progressive Glioblastoma
Baseline characteristics by cohort
| Measure |
Bevacizumab
n=3 Participants
Cycle 1 (each cycle is 3 weeks): Bevacizumab 25 mg in 1 ml subcutaneously daily.
Bevacizumab 25 mg in 1 ml subcutaneously daily: Bevacizumab delivered by subcutaneous injection instead of intravenous infusion.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=39 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=39 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=39 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=39 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=39 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=39 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=39 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=39 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=39 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Bevacizumab
n=3 Participants
Cycle 1 (each cycle is 3 weeks): Bevacizumab 25 mg in 1 ml subcutaneously daily.
Bevacizumab 25 mg in 1 ml subcutaneously daily: Bevacizumab delivered by subcutaneous injection instead of intravenous infusion.
|
|---|---|
|
Number of Participants With Change in Peritumoral Enhancement/Edema
No change in edema
|
1 Participants
|
|
Number of Participants With Change in Peritumoral Enhancement/Edema
Decrease in radiation-related edema
|
2 Participants
|
SECONDARY outcome
Timeframe: During first 3 weeks of studySubcutaneous 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.
Outcome measures
| Measure |
Bevacizumab
n=3 Participants
Cycle 1 (each cycle is 3 weeks): Bevacizumab 25 mg in 1 ml subcutaneously daily.
Bevacizumab 25 mg in 1 ml subcutaneously daily: Bevacizumab delivered by subcutaneous injection instead of intravenous infusion.
|
|---|---|
|
Number of Toxicities Reported in Study Participants
|
0 Toxicities
|
SECONDARY outcome
Timeframe: Within 2 months of starting intravenous bevacizumabPopulation: One patient did not switch to standard of care 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.
Outcome measures
| Measure |
Bevacizumab
n=2 Participants
Cycle 1 (each cycle is 3 weeks): Bevacizumab 25 mg in 1 ml subcutaneously daily.
Bevacizumab 25 mg in 1 ml subcutaneously daily: Bevacizumab delivered by subcutaneous injection instead of intravenous infusion.
|
|---|---|
|
Number of Participants With Change in Edema After Conversion From Study Treatment to Intravenous Bevacizumab
No change in edema after switch
|
1 Participants
|
|
Number of Participants With Change in Edema After Conversion From Study Treatment to Intravenous Bevacizumab
Decrease of edema after switch
|
1 Participants
|
Adverse Events
Bevacizumab
Serious adverse events
| Measure |
Bevacizumab
n=3 participants at risk
Cycle 1 (each cycle is 3 weeks): Bevacizumab 25 mg in 1 ml subcutaneously daily.
Bevacizumab 25 mg in 1 ml subcutaneously daily: Bevacizumab delivered by subcutaneous injection instead of intravenous infusion.
|
|---|---|
|
Blood and lymphatic system disorders
Low platelets
|
33.3%
1/3
|
Other adverse events
| Measure |
Bevacizumab
n=3 participants at risk
Cycle 1 (each cycle is 3 weeks): Bevacizumab 25 mg in 1 ml subcutaneously daily.
Bevacizumab 25 mg in 1 ml subcutaneously daily: Bevacizumab delivered by subcutaneous injection instead of intravenous infusion.
|
|---|---|
|
Skin and subcutaneous tissue disorders
Bruising
|
66.7%
2/3
|
|
Nervous system disorders
Headache
|
33.3%
1/3
|
|
Gastrointestinal disorders
Nausea
|
33.3%
1/3
|
Additional Information
William L. Read, MD, Principal Investigator
Emory University
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place