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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
Sponsor:
Information provided by (Responsible Party):
William Read, Emory University

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Glioblastoma
Intervention Drug: Bevacizumab 25 mg in 1 ml subcutaneously daily
Enrollment 3
Recruitment Details Patients were recruited at Winship Cancer Institute and Emory University Hospital Midtown from January 2014 to April 2017.
Pre-assignment Details  
Arm/Group Title Bevacizumab
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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.

Period Title: Overall Study
Started 3
Completed 3
Not Completed 0
Arm/Group Title Bevacizumab
Hide Arm/Group Description

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 Number of Baseline Participants 3
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants
<=18 years
0
   0.0%
Between 18 and 65 years
2
  66.7%
>=65 years
1
  33.3%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants
Female
2
  66.7%
Male
1
  33.3%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants
Hispanic or Latino
0
   0.0%
Not Hispanic or Latino
3
 100.0%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
3
 100.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 3 participants
3
1.Primary Outcome
Title Number of Participants With Change in Peritumoral Enhancement/Edema
Hide Description 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.
Time Frame 1 cycle (3 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Bevacizumab
Hide Arm/Group Description:

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 Number of Participants Analyzed 3
Measure Type: Count of Participants
Unit of Measure: Participants
No change in edema
1
  33.3%
Decrease in radiation-related edema
2
  66.7%
2.Secondary Outcome
Title Number of Toxicities Reported in Study Participants
Hide Description 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.
Time Frame During first 3 weeks of study
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Bevacizumab
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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 Number of Participants Analyzed 3
Measure Type: Number
Unit of Measure: Toxicities
0
3.Secondary Outcome
Title Number of Participants With Change in Edema After Conversion From Study Treatment to Intravenous Bevacizumab
Hide Description 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.
Time Frame Within 2 months of starting intravenous bevacizumab
Hide Outcome Measure Data
Hide Analysis Population Description
One patient did not switch to standard of care intravenous bevacizumab.
Arm/Group Title Bevacizumab
Hide Arm/Group Description:

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 Number of Participants Analyzed 2
Measure Type: Count of Participants
Unit of Measure: Participants
No change in edema after switch
1
  50.0%
Decrease of edema after switch
1
  50.0%
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Bevacizumab
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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.

All-Cause Mortality
Bevacizumab
Affected / at Risk (%)
Total   0/3 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Bevacizumab
Affected / at Risk (%)
Total   1/3 (33.33%) 
Blood and lymphatic system disorders   
Low platelets *  1/3 (33.33%) 
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Bevacizumab
Affected / at Risk (%)
Total   2/3 (66.67%) 
Gastrointestinal disorders   
Nausea *  1/3 (33.33%) 
Nervous system disorders   
Headache *  1/3 (33.33%) 
Skin and subcutaneous tissue disorders   
Bruising *  2/3 (66.67%) 
*
Indicates events were collected by non-systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: William L. Read, MD, Principal Investigator
Organization: Emory University
Phone: 404-778-1900
Responsible Party: William Read, Emory University
ClinicalTrials.gov Identifier: NCT02157103     History of Changes
Other Study ID Numbers: IRB00062998
Winship2299-12 ( Other Identifier: Winship Cancer Institute )
First Submitted: February 14, 2014
First Posted: June 5, 2014
Results First Submitted: March 14, 2018
Results First Posted: April 13, 2018
Last Update Posted: May 17, 2018