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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Vascular Biogenics Ltd. operating as VBL Therapeutics
Sponsor:
Information provided by (Responsible Party):
Vascular Biogenics Ltd. operating as VBL Therapeutics
ClinicalTrials.gov Identifier:
NCT01260506
First received: December 13, 2010
Last updated: January 6, 2014
Last verified: January 2014
  Purpose

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


Condition Intervention Phase
Glioblastoma Multiforme
Drug: VB-111
Drug: Bevacizumab
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Vascular Biogenics Ltd. operating as VBL Therapeutics:

Primary Outcome Measures:
  • Progression Free Survival [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall Survival [ Time Frame: Lifetime ] [ Designated as safety issue: No ]

Estimated Enrollment: 90
Study Start Date: December 2010
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: VB-111
Antiangiogenic and vascular disruptive agent
Drug: VB-111 Drug: Bevacizumab
Upon progression, subjects will receive a combination therapy of VB-111 every 2 months and standard of care bevacizumab

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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;
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01260506

Contacts
Contact: Yael Cohen, MD +972-3-634-6450 yaelc@vblrx.com

Locations
United States, Massachusetts
Dana Farber Cancer Institute Recruiting
Boston, Massachusetts, United States
Contact: Patrick Wen, MD       Patrick_Wen@dfci.harvard.edu   
Contact: Kelly Hempfling    617-632-6668    kellye_hempfling@dfci.harvard.edu   
United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States
Contact: Katherine Peters, MD       katherine.peters@duke.edu   
Contact: Sharon Evans    919-684-0762    sharon.evans@duke.edu   
Principal Investigator: Katherine Peters, MD         
United States, Texas
Uthsc- Ctrc Recruiting
San Antonio, Texas, United States
Contact: Andrew Brenner, MD       BrennerA@uthscsa.edu   
Contact: Cherie Noles    (210) 450-5964    NolesC@uthscsa.edu   
Principal Investigator: Andrew Brenner, MD         
Israel
Tel Aviv Sourasky Medical Center Recruiting
Tel Aviv, Israel, 64239
Contact: Deborah Blumenthal, MD    +972-52-426-6304    deborahblumenthal@gmail.com   
Sponsors and Collaborators
Vascular Biogenics Ltd. operating as VBL Therapeutics
  More Information

No publications provided

Responsible Party: Vascular Biogenics Ltd. operating as VBL Therapeutics
ClinicalTrials.gov Identifier: NCT01260506     History of Changes
Other Study ID Numbers: VB-111-122
Study First Received: December 13, 2010
Last Updated: January 6, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Vascular Biogenics Ltd. operating as VBL Therapeutics:
Relapsed Glioblastoma Multiforme, GBM

Additional relevant MeSH terms:
Glioblastoma
Astrocytoma
Glioma
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Germ Cell and Embryonal
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Bevacizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Antineoplastic Agents
Growth Inhibitors
Growth Substances
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014