Single-Arm Open-Label Multicenter Study of VB-111 in Patients With Recurrent Glioblastoma Multiforme
Primary Purpose
Glioblastoma Multiforme
Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
VB-111
Bevacizumab
Sponsored by
About this trial
This is an interventional treatment trial for Glioblastoma Multiforme focused on measuring Relapsed Glioblastoma Multiforme, GBM
Eligibility Criteria
Inclusion Criteria:
- Subjects must have a histologically confirmed diagnosis of glioblastoma multiforme or gliosarcoma;
- Measurable disease by RANO criteria;
- Disease progression or recurrence following standard of care treatment with temozolomide and radiation;
- An interval of at least 4 weeks between prior surgical resection and study enrollment;
- An interval of at least 12 weeks between prior radiotherapy or at least 4 weeks from prior chemotherapy, and enrollment in this protocol;
- Recovered to Grade 1 or less from the toxic effects of any earlier intervention;
- Karnofsky performance status > 60%
Exclusion Criteria:
- Prior anti-angiogenic therapy including VEGF sequestering agents (ie bevacizumab, aflibercept, etc) or VEGFR inhibitors (cediranib, pazopanib, sunitinib, sorafenib, etc);
- Prior stereotactic radiotherapy;
- Active infection;
- Evidence of CNS haemorrhage CTCAE grade 2 or above on baseline MRI;
- Subjects who suffered from an acute cardiac event within the last 12 months;
- Subjects with active vascular disease, either myocardial or peripheral;
- Subjects with proliferative and/or vascular retinopathy;
- Subjects with known active second malignancy;
Sites / Locations
- Dana Farber Cancer Institute
- Duke University Medical Center
- Uthsc- Ctrc
- Tel Aviv Sourasky Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
VB-111
Arm Description
Antiangiogenic and vascular disruptive agent
Outcomes
Primary Outcome Measures
Overall Survival
Secondary Outcome Measures
Progression Free Survival
Full Information
NCT ID
NCT01260506
First Posted
December 13, 2010
Last Updated
April 23, 2020
Sponsor
Vascular Biogenics Ltd. operating as VBL Therapeutics
1. Study Identification
Unique Protocol Identification Number
NCT01260506
Brief Title
Single-Arm Open-Label Multicenter Study of VB-111 in Patients With Recurrent Glioblastoma Multiforme
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
December 2010 (undefined)
Primary Completion Date
July 23, 2015 (Actual)
Study Completion Date
December 20, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vascular Biogenics Ltd. operating as VBL Therapeutics
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to evaluate the safety, tolerability and efficacy of VB-111 in patients with Relapsed Glioblastoma Multiforme.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glioblastoma Multiforme
Keywords
Relapsed Glioblastoma Multiforme, GBM
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
75 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
VB-111
Arm Type
Experimental
Arm Description
Antiangiogenic and vascular disruptive agent
Intervention Type
Drug
Intervention Name(s)
VB-111
Intervention Type
Drug
Intervention Name(s)
Bevacizumab
Intervention Description
Upon progression, subjects will receive a combination therapy of VB-111 and standard of care bevacizumab
Primary Outcome Measure Information:
Title
Overall Survival
Time Frame
From date of study entry until the date of death from any cause (up to 10 years)
Secondary Outcome Measure Information:
Title
Progression Free Survival
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subjects must have a histologically confirmed diagnosis of glioblastoma multiforme or gliosarcoma;
Measurable disease by RANO criteria;
Disease progression or recurrence following standard of care treatment with temozolomide and radiation;
An interval of at least 4 weeks between prior surgical resection and study enrollment;
An interval of at least 12 weeks between prior radiotherapy or at least 4 weeks from prior chemotherapy, and enrollment in this protocol;
Recovered to Grade 1 or less from the toxic effects of any earlier intervention;
Karnofsky performance status > 60%
Exclusion Criteria:
Prior anti-angiogenic therapy including VEGF sequestering agents (ie bevacizumab, aflibercept, etc) or VEGFR inhibitors (cediranib, pazopanib, sunitinib, sorafenib, etc);
Prior stereotactic radiotherapy;
Active infection;
Evidence of CNS haemorrhage CTCAE grade 2 or above on baseline MRI;
Subjects who suffered from an acute cardiac event within the last 12 months;
Subjects with active vascular disease, either myocardial or peripheral;
Subjects with proliferative and/or vascular retinopathy;
Subjects with known active second malignancy;
Facility Information:
Facility Name
Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
Country
United States
Facility Name
Uthsc- Ctrc
City
San Antonio
State/Province
Texas
Country
United States
Facility Name
Tel Aviv Sourasky Medical Center
City
Tel Aviv
ZIP/Postal Code
64239
Country
Israel
12. IPD Sharing Statement
Learn more about this trial
Single-Arm Open-Label Multicenter Study of VB-111 in Patients With Recurrent Glioblastoma Multiforme
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