Skip to main content
Eligibility
for people ages 18 years and up
Location
at San Francisco, California and other locations
Dates
study started
Principal Investigator

Description

Summary

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

Keywords

Glioblastoma rGBM Recurrent Glioblastoma Recurrent GBM Bevacizumab

Eligibility

You can join if…

Open to people ages 18 years and up

  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.

You CAN'T join if...

  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.

Locations

  • Kaiser Permanente - Redwood City Medical Center
    Redwood City, California, United States
  • Stanford University
    Stanford, California, United States
  • The Center for Cancer Prevention and Treatment
    Orangevale, California, United States
  • University of California Los Angeles
    Los Angeles, California, United States
  • University of California Irvine Medical Center
    Irvine, California, United States

Details

Status
in progress, not accepting new patients
Start Date
Sponsor
Vascular Biogenics Ltd. operating as VBL Therapeutics
Links
VBL Therapeutics Company Website
The Official Globe Trial Website
ID
NCT02511405
Phase
Phase 3
Lead Scientist
Nicholas Butowski
Study Type
Interventional
Last Updated
January 1, 2017