A Phase 3, Pivotal Trial of VB-111 Plus Bevacizumab vs. Bevacizumab in Patients With Recurrent Glioblastoma (GLOBE)
Trial ID or NCT#
NCT02511405
Status
NOT RECRUITING
Purpose
The purpose of this pivotal, phase 3, randomized, multicenter study is to compare VB-111 plus bevacizumab to bevacizumab in adult patients with recurrent Glioblastoma.
Official Title
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
Eligibility Criteria
Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No
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.
Investigator(s)
Seema Nagpal, MD
Neuro-oncologist
Clinical Professor, Neurology & Neurological Sciences
Clinical Professor (By courtesy), Neurosurgery
Reena Thomas, MD PhD
Neuro-oncologist
Clinical Associate Professor, Neurology & Neurological Sciences
Clinical Associate Professor (By courtesy), Neurosurgery
Contact us to find out if this trial is right for you.
Contact
CCTO
650-498-7061
View on ClinicalTrials.gov
