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

Status: Recruiting
Phase: Phase 1/Phase 2
Diagnosis: Brain/Neuro Cancer: Recurrent Glioblastoma
NCT ID: NCT01260506 (View complete trial on
DFCI Protocol ID: 10-433


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


Conducting Institutions:
Dana-Farber Cancer Institute

Overall PI:
Patrick Wen, MD, Dana-Farber Cancer Institute

Site-responsible Investigators:

Dana-Farber Cancer Institute: Lisa Doherty,

Eligibility Criteria

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 (cedirinib, 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. Requires therapeutic anti-coagulation; 6. Subjects who suffered from an acute cardiac event within the last 12 months; 7. Subjects with active vascular disease, either myocardial or peripheral; 8. Subjects with proliferative and/or vascular retinopathy; 9. Subjects with known active second malignancy;
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