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Single-Arm Open-Label Multicenter Study of VB-111 in Patients With Recurrent Glioblastoma Multiforme | Clinical Trials | Clareo Health

COMPLETEDPHASE1/PHASE2

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

NCT01260506•Vascular Biogenics Ltd. operating as VBL Therapeutics

View on ClinicalTrials.gov

Summary

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

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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 (cediranib, 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. Subjects who suffered from an acute cardiac event within the last 12 months;
•6. Subjects with active vascular disease, either myocardial or peripheral;
•7. Subjects with proliferative and/or vascular retinopathy;
•8. Subjects with known active second malignancy;

Locations (4)

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Duke University Medical Center

Durham, North Carolina, United States

Uthsc- Ctrc

San Antonio, Texas, United States

Tel Aviv Sourasky Medical Center

Tel Aviv, Israel

Key Dates

Start Date

December 1, 2010

Primary Completion Date

July 23, 2015

Completion Date

December 20, 2018

Last Updated

April 24, 2020

Enrollment

ESTIMATED participants

Conditions

Glioblastoma Multiforme

Interventions

VB-111

DRUG

Bevacizumab

DRUG

Collection of Blood and Urine Samples in Patients Receiving Radiation Therapy for Glioblastoma Multiforme

NCT00083512

Glioblastoma Multiforme

View study

RECRUITING

Targeted Pediatric High-Grade Glioma Therapy

NCT05839379

High Grade GliomaDiffuse Intrinsic Pontine Glioma+7 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 24, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Collection of Blood and Urine Samples in Patients Receiving Radiation Therapy for Glioblastoma Multiforme

Targeted Pediatric High-Grade Glioma Therapy

Study of TLX101-Tx Plus Standard of Care (SoC) Versus SoC Alone for the Treatment of Patients With Recurrent Glioblastoma

Improving Understanding of Glioblastoma Through Preservation of Biologically Active Brain Tissue

Study of Pembrolizumab and M032 (NSC 733972)

Carmustine Wafer in Combination With Retifanlimab and Radiation With/Without Temozolomide in Subjects With Glioblastoma