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Not Recruiting
Trial ID: NCT02511405
A Phase 3, Randomized, Controlled, Double-Arm, Open-Label, Multi-center Study of VB-111 Combined With Bevacizumab vs. Bevacizumab Monotherapy in Patients With Recurrent Glioblastoma
Clinical Associate Professor, Neurology & Neurological Sciences Clinical Associate Professor (By courtesy), Neurosurgery
Clinical Associate Professor, Neurology & Neurological Sciences Clinical Associate Professor (By courtesy), Neurosurgery
Inclusion Criteria:
1. First or second progression of Glioblastoma;
2. Measurable disease by RANO criteria at progression;
3. Patients ≥18 years of age;
4. Patient may have been operated for recurrence. If operated: residual and measurable
disease after surgery is required;
5. Surgery completed at least 28 days before randomization;
6. An interval of at least 12 weeks between prior radiotherapy or at least 23 days from
prior chemotherapy, 42 days from nitrosoureas and enrollment in this study;
7. Adequate performance, i.e."Karnofsky Performance Score" of at least 70%;
8. Adequate renal, liver, and bone marrow function according to the following criteria:
- Absolute neutrophil count ≥1500 cells/ml,
- Platelets ≥ 100,000 cells/ml,
- Total bilirubin within upper limit of normal (ULN),
- Aspartate aminotransferase (AST) ≤ 2.0 X ULN,
- Serum creatinine level ≤ ULN or creatinine clearance ≥ 50 ml/min for patients
with creatinine levels above normal limits (creatinine clearance calculated by
the Cockcroft-Gault formula, see Appendix II),
- PT, PTT (in seconds) not to be prolonged beyond >20% of the upper limits of
normal.
Exclusion Criteria:
1. Prior anti-angiogenic therapy including VEGF sequestering agents (i.e. bevacizumab,
aflibercept, etc.) or VEGFR inhibitors (cedirinib, pazopanib, sunitinib, sorafenib,
etc.);
2. Prior stereotactic radiotherapy;
3. Pregnant or breastfeeding patients;
4. Concomitant medication that may interfere with study results; e.g. immunosuppressive
agents other than corticosteroids;
5. Active infection;
6. Evidence of significant CNS haemorrhage i.e. CTCAE grade 2 or above;
7. Expected to have surgery during study period;
8. Patients with active vascular disease, either myocardial or peripheral (i.e. acute
coronary syndrome, cerebral stroke, transient ischemic attack or arterial thrombosis
or symptomatic peripheral vascular disease within the past 3 months);
9. Patients with known proliferative and/or vascular retinopathy;
10. Patients with known liver disease (alcoholic, drug/toxin induced, genetic, or
autoimmune);
11. Patients with known active second malignancy other than non-melanoma skin cancers,
non-metastatic prostate cancer, in situ cervical cancer, and ductal or lobular
carcinoma in situ of the breast. Patients are not considered to have a currently
active malignancy if they have completed anticancer therapy and have been disease free
for greater than 2 years prior to screening;
12. Patients testing positive to one of the following viruses: HIV, HBV and HCV within the
last 6 months;
13. Patients that have undergone major surgery within the last 4 weeks before enrollment;
14. Patients who have received treatment with any other investigational agent within 4
weeks before enrollment.
drug: VB-111 + bevacizumab
drug: Bevacizumab
Not Recruiting
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