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

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ClinicalTrials.gov Identifier: NCT01260506
Recruitment Status : Unknown
Verified October 2015 by Vascular Biogenics Ltd. operating as VBL Therapeutics.
Recruitment status was:  Active, not recruiting
First Posted : December 15, 2010
Last Update Posted : October 15, 2015
Sponsor:
Information provided by (Responsible Party):
Vascular Biogenics Ltd. operating as VBL Therapeutics

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

Condition or disease Intervention/treatment Phase
Glioblastoma Multiforme Drug: VB-111 Drug: Bevacizumab Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : December 2010
Estimated Primary Completion Date : December 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Bevacizumab
U.S. FDA Resources

Arm Intervention/treatment
Experimental: VB-111
Antiangiogenic and vascular disruptive agent
Drug: VB-111 Drug: Bevacizumab
Upon progression, subjects will receive a combination therapy of VB-111 and standard of care bevacizumab



Primary Outcome Measures :
  1. Overall Survival [ Time Frame: From date of study entry until the date of death from any cause (up to 10 years) ]

Secondary Outcome Measures :
  1. Progression Free Survival [ Time Frame: 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01260506


Locations
United States, Massachusetts
Dana Farber Cancer Institute
Boston, Massachusetts, United States
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States
United States, Texas
Uthsc- Ctrc
San Antonio, Texas, United States
Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, Israel, 64239
Sponsors and Collaborators
Vascular Biogenics Ltd. operating as VBL Therapeutics

Responsible Party: Vascular Biogenics Ltd. operating as VBL Therapeutics
ClinicalTrials.gov Identifier: NCT01260506     History of Changes
Other Study ID Numbers: VB-111-122
First Posted: December 15, 2010    Key Record Dates
Last Update Posted: October 15, 2015
Last Verified: October 2015

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

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