Clinical Trial Details
Braintumor Website

[Information provided by: ClinicalTrials.gov, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]

NCT02511405 : A Phase 3, Pivotal Trial of VB-111 Plus Bevacizumab vs. Bevacizumab in Patients With Recurrent Glioblastoma (GLOBE)
PhasePhase 3
AgesMin: 18 Years Max: N/A
Eligibility
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.
LinksPermanent Link to THIS page: http://virtualtrials.com/nct/display1trial.cfm?nct=NCT02511405      |      Link to official Clinicaltrials.gov listing
Locations
London, Ontario
Canada

Facility: London Health Sciences Centre
Investigator: David Macdonald, MD
Contact: David Macdonald, MD Phone: 519-685-8640
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Ottawa, Ontario
Canada

Facility: Ottawa Hospital
Investigator: Garth Nicholas, MD
Contact: Nicholas Garth, MD Phone: 613-737-7700
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Haifa,
Israel

Facility: Rambam Medical Center
Investigator: Tzahala Tzuk-Shina, MD
Contact: Guy Frumin Phone: 972-4-777-3014
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Jerusalem,
Israel

Facility: Hadassah Medical Center
Investigator: Alexander Lossos, MD
Contact: Anat Mordchi Phone: 972-50-7874601
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Petach Tikvah,
Israel

Facility: Rabin Medical Center
Investigator: Shlomit Yust, MD
Contact: Simona Segal Phone: 972-3-9378077
Email not avaialable

Ramat Gan,
Israel

Facility: Chaim Sheba Medical Center
Investigator: Leor Zach, MD
Contact: Moran Ben Ghiat Phone: 972-3-5304436
Email not avaialable

Tel Aviv,
Israel

Facility: Tel Aviv Sourasky Medical Center
Investigator: Felix Bokstein, MD
Contact: Tsipi Tobak Phone: 972-52-4266265
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Birmingham, Alabama
Facility: University of Alabama
Investigator: X. Stan Han, MD
Contact: X. Stan Han, MD Phone: 205-934-1432
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Rogers, Arizona
Facility: Highlands Oncology Group
Investigator: Joseph Beck, MD
Contact: Lindsay Shelby Phone: 479-878-7024
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Irvine, California
Facility: University of California Irvine Medical Center
Investigator: Jose Carrillo, MD
Contact: Jinah Chung Phone: 714-456-8442
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Los Angeles, California
Facility: University of California Los Angeles
Investigator: Timothy Cloughesy, MD
Contact: Emese Filka Phone: 310-794-3521
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Orangevale, California
Facility: The Center for Cancer Prevention and Treatment
Investigator: Lars Anker, MD
Contact: Melinda Lima Phone: 714-734-6200
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Redwood City, California
Facility: Kaiser Permanente - Redwood City Medical Center
Investigator: Scott Peak, MD
Contact: Nisha Hazari Phone: 650-299-2290
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San Diego, California
Facility: University of California
Investigator: David Piccioni, MD
Contact: Ryan M O'Connell Phone: 858-822-5377
Email not avaialable

San Francisco, California
Facility: University of California San Francisco
Investigator: Nicholas Butowski, MD
Contact: Jessica Carlson Phone: 415-514-5521
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Stanford, California
Facility: Stanford University
Investigator: Seema Nagpal, MD
Contact: Cathy K Recht, RN, MS Phone: 650-723-6095
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Denver, Colorado
Facility: Colorado Neurological Institute
Investigator: Michael Pearlman, MD
Contact: Alicia Novak Phone: 303-806-7423
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Washington, District of Columbia
Facility: The George Washington University Medical Faculty Associates
Investigator: Jonathan Sherman, MD
Contact: Stacy Tam-Siu Phone: 202-741-2602
Email not avaialable

Gainsville, Florida
Facility: University of Florida Preston A. Wells, Jr. Center for Brain Tumor Therapy
Investigator: David Tran, MD
Contact: Adrienne Royster
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Orlando, Florida
Facility: Orlando Health
Investigator: Nicholas G Avgeropoulos, MD
Contact: Teal Stocker Phone: 321-843-2546
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Atlanta, Georgia
Facility: Piedmont Physicians Neuro-Oncology
Investigator: Erin Dunbar, MD
Contact: Jacene Myrie Phone: 404-425-7927
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Chicago, Illinois
Facility: Northwestern University
Investigator: Priya Kumthekar, MD
Contact: Sara Duffey
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Chicago, Illinois
Facility: The University of Chicago
Investigator: Rimas Lukas, MD
Contact: Jennifer Nam Phone: 773-702-7716
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Kansas City, Kansas
Facility: University of Kansas Medical Center
Investigator: Michael Salacz, MD
Contact: Clinical Trials Nurse Navigator Phone: 913-945-7552
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Louisville, Kentucky
Facility: University of Louisville
Investigator: Eric Burton, MD
Contact: James Graham Brown Cancer Center Clinical Trials Office Phone: 502-562-3429
Email not avaialable

Shreveport, Louisiana
Facility: Louisiana State University Health Science Center
Investigator: Gary Burton, MD
Contact: Janice Yager Phone: 318-813-1403
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Boston, Massachusetts
Facility: Beth Israel Deaconess Medical Center
Investigator: Patrick Wen, MD
Contact: Janlyn Murphy Phone: 617-667-1832
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Boston, Massachusetts
Facility: Dana Farber Cancer Institute
Investigator: Patrick Wen, MD
Contact: Jennifer Barrs
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Ann Arbor, Michigan
Facility: University of Michigan Comprehensive Cancer Center
Investigator: Aaron Mammoser, MD
Contact: Cancer AnswerLine Phone: 800-865-1125
Email not avaialable

Detroit, Michigan
Facility: Henry Ford Health System
Investigator: Tobias Walbert, MD
Contact: John Gaggin Phone: 313-916-3731
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Minneapolis, Minnesota
Facility: Metro-MN Community Oncology Research Consortium
Investigator: Richard Peterson, MD
Contact: Betsy Wagner Phone: 952-993-1555
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St. Louis, Missouri
Facility: Washington University School of Medicine
Investigator: Jian Campian, MD
Contact: Madelyn Kissel Phone: 314-747-5384
Email not avaialable

Lebanon, New Hampshire
Facility: Dartmouth Hitchcock Medical Center
Investigator: Lara Ronan, MD
Contact: Neal Wilson Phone: 603-653-0590
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Amherst, New York
Facility: Dent Neurosciences Research Center
Investigator: Laszlo Mechtler, MD
Contact: Rebecca Hogan Phone: 716-558-5670
Email not avaialable

Lake Success, New York
Facility: North Shore University Hospital
Investigator: Michael Schulder, MD
Contact: Michael Schulder, MD Phone: 516-470-6901
Email not avaialable

New York, New York
Facility: Columbia University Medical Center
Investigator: Teri Kreisl, MD
Contact: Teri Kreisl, MD Phone: 212-342-0571
Email not avaialable

New York, New York
Facility: Derald H. Ruttenberg Treatment Center
Investigator: Adilia Hormigo, MD
Contact: Angela Stangarone Phone: 212-241-9843
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Rochester, New York
Facility: University of Rochester Medical Center
Investigator: Nimish Mohile, MD
Contact: Jennifer Serventi Phone: 585-276-3971
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Stony Brook, New York
Facility: Stony Brook University, Neurology Associates of Stony Brook
Investigator: Agnieszka Kowalska, mD
Contact: Agnieszka Kowalska, MD Phone: 631-444-2599
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Syracuse, New York
Facility: SUNY Upstate Medical University
Investigator: Mijung Lee, MD
Contact: Clinical Trials Office Phone: 315-464-5476
Email not avaialable

Chapel Hill, North Carolina
Facility: University of North Carolina at Chapel Hill
Investigator: Frances Collichio, MD
Contact: Kristen Gazda Phone: 919-966-4432
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Winston Salem, North Carolina
Facility: Wake Forest Baptist Medical Center
Investigator: Glenn Lesser, MD
Contact: Glenn Lesser, MD Phone: 336-716-9527
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Hershey, Pennsylvania
Facility: Penn State Milton S Hershey Medical Center
Investigator: Michael Glantz, MD
Contact: Tammy Rider Phone: 717-531-0003
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Pittsburgh, Pennsylvania
Facility: University of Pittsburgh Medical Center
Investigator: Jan Drappatz, MD
Contact: Sarah J Anderson, BA, BSN, RN Phone: 412-647-8569
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Austin, Texas
Facility: Texas Oncology-Austin Midtown
Investigator: Morris D Groves, MD
Contact: Kristen Brueggemann
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Dallas, Texas
Facility: Baylor Health Neuro-Oncology Associates
Investigator: Karen Fink, MD
Contact: Grace Townsend Phone: 214-818-8382
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Dallas, Texas
Facility: University of Texas Southwestern Medical Center
Investigator: Edward Pan, MD
Contact: Pamela Kurian Phone: 214-648-5874
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Houston, Texas
Facility: MD Anderson
Investigator: John de Groot, MD
Contact: Kathy Hunter, RN, OCN, CCRP Phone: 713-745-5769
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San Antonio, Texas
Facility: UTHSCSA
Investigator: Andrew Brenner, MD
Contact: Epp Goodwin Phone: 210-450-5798
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Salt Lake City, Utah
Facility: Huntsman Cancer Institute at The University of Utah
Investigator: Randy Jensen, MD
Contact: Adam Cohen, MD Phone: 801-587-4024
Email not avaialable

Charlottesville, Virginia
Facility: University of Virginia
Investigator: David Schiff, MD
Contact: Johanna Loomba Phone: 434-924-5859
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Seattle, Washington
Facility: Swedish Medical Center
Investigator: Tara Benkers, MD
Contact: Mary Lessig Phone: 206-386-3878
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Madison, Wisconsin
Facility: University of Wisconsin
Investigator: H Ian Robins, MD
Contact: Cancer Connect Phone: 1-800-622-8922
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