Single-Arm Open-Label Multicenter Study of VB-111 in Patients With Recurrent Glioblastoma Multiforme



Status:Unknown status
Conditions:Brain Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:10/25/2018
Start Date:December 2010

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The purpose of this study is to evaluate the safety, tolerability and efficacy of VB-111 in
patients with Relapsed Glioblastoma Multiforme.


Inclusion Criteria:

1. Subjects must have a histologically confirmed diagnosis of glioblastoma multiforme or
gliosarcoma;

2. Measurable disease by RANO criteria;

3. Disease progression or recurrence following standard of care treatment with
temozolomide and radiation;

4. An interval of at least 4 weeks between prior surgical resection and study enrollment;

5. An interval of at least 12 weeks between prior radiotherapy or at least 4 weeks from
prior chemotherapy, and enrollment in this protocol;

6. Recovered to Grade 1 or less from the toxic effects of any earlier intervention;

7. Karnofsky performance status > 60%

Exclusion Criteria:

1. Prior anti-angiogenic therapy including VEGF sequestering agents (ie bevacizumab,
aflibercept, etc) or VEGFR inhibitors (cediranib, pazopanib, sunitinib, sorafenib,
etc);

2. Prior stereotactic radiotherapy;

3. Active infection;

4. Evidence of CNS haemorrhage CTCAE grade 2 or above on baseline MRI;

5. Subjects who suffered from an acute cardiac event within the last 12 months;

6. Subjects with active vascular disease, either myocardial or peripheral;

7. Subjects with proliferative and/or vascular retinopathy;

8. Subjects with known active second malignancy;
We found this trial at
4
sites
2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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Boston, MA
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San Antonio, Texas
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San Antonio, TX
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Tel Aviv,
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