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Repeated Super-Selective Intraarterial Cerebral Infusion of Bevacizumab (Avastin) for Treatment of Newly Diagnosed GBM

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ClinicalTrials.gov Identifier: NCT01811498
Recruitment Status : Recruiting
First Posted : March 14, 2013
Last Update Posted : May 17, 2019
Sponsor:
Collaborator:
Feinstein Institute for Medical Research
Information provided by (Responsible Party):
John Boockvar, MD Zucker SOM @Hofstra/Northwell, Feinstein Institute for Medical Research

Brief Summary:
The high-grade malignant brain tumors, glioblastoma multiforme (GBM), comprise the majority of all primary brain tumors in adults. This group of tumors also exhibits the most aggressive behavior, resulting in median overall survival of only 9-12 months. Initial therapy consists of either surgical resection, external beam radiation, or both. All patients experience a recurrence after first-line therapy, so improvements in both first-line and salvage therapy are critical to enhancing quality-of-life and prolonging survival. It is unknown if currently used intravenous (IV) therapies even cross the blood brain barrier (BBB). We have shown in a previous phase I trial that a single Superselective Intraarterial Cerebral Infusion (SIACI) of Bevacizumab (up to 15mg/kg) is safe and effective in the treatment of recurrent GBM. Therefore, this phase I/II clinical research trial is an extension of that trial in that we seek to test the hypothesis that repeated dosing of intra-arterial Bevacizumab is safe and effective in the treatment of newly diagnosed malignant glioma. By achieving the aims of this study we will also determine if repeated intra-arterial Bevacizumab improves progression free and overall survival in newly diagnosed patients. We expect that this project will provide important information regarding the utility of repeated SIACI Bevacizumab therapy for malignant glioma, and may alter the way these drugs are delivered to our patients in the near future.

Condition or disease Intervention/treatment Phase
Glioblastoma Multiforme Brain Tumor Drug: Bevacizumab Phase 1 Phase 2

Detailed Description:

The experimental aspects of this experimental plan will include:

  1. Subjects will first be treated with Mannitol prior to chemotherapy infusion (Mannitol 20%; delivered IA, 12.5 mL over 2 minutes) in order to disrupt the blood brain barrier. This technique has been used in several thousand subjects in previous studies for the IA delivery of chemotherapy for malignant glioma.
  2. Subjects will then be treated with repeated intraarterial delivery (SIACI) of Bevacizumab. Each subject will receive one dose of IA Bevacizumab on day 30, followed by chemoradiation. SIACI of Bevacizumab will be repeated every three months for a total of 3 infusions.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I/II Trial of Repeated Super-Selective Intraarterial Cerebral Infusion of Bevacizumab (Avastin) for Treatment of Newly Diagnosed Glioblastoma Multiforme
Study Start Date : February 2013
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Bevacizumab

Arm Intervention/treatment
Experimental: SIACI of Bevacizumab
Superselective Intraarterial Cerebral Infusion (SIACI) of Bevacizumab
Drug: Bevacizumab
Other Name: Avastin




Primary Outcome Measures :
  1. Composite overall response rate (CORR) [ Time Frame: 6 month ]
    Composite overall response rate (CORR) through the Response Assessment in Neuro-Oncology (RANO)

  2. Progression-free survival (PFS) and Overall survival (OS) [ Time Frame: 6-month ]
    OS will be measured from the date of the first dose of SIACI Bevacizumab to the date of death. A two-year follow-up time is expected to determine the safety of repeated superselective intracranial intraarterial infusions of Bevacizumab at a dose of 15 mg/kg IA.


Secondary Outcome Measures :
  1. Toxicities [ Time Frame: 1 month ongoing ]
    The descriptive frequency of subjects experiencing toxicities will be tabulated.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Criteria for Inclusion:

  • Male or female patients of ≥18 years of age.
  • Patients with documented histologic diagnosis of glioblastoma multiforme (newly diagnosed)
  • Patients must have at least one confirmed and evaluable tumor site.∗

    *A confirmed tumor site is one which is biopsy-proven. NOTE: Radiographic procedures (e.g., Gd-enhanced MRI or CT scans) documenting existing lesions must have been performed within three weeks of treatment on this research study.

  • Patients must have a Karnofsky performance status ≥70% (or the equivalent ECOG level of 0-2) and an expected survival of ≥ three months.
  • Patients must agree to use a medically effective method of contraception during and for a period of three months after the treatment period. A pregnancy test will be performed on each premenopausal female of childbearing potential immediately prior to entry into the research study.

Criteria for Exclusion:

  • Previous treatment with Bevacizumab.
  • Women who are pregnant or lactating.
  • Women of childbearing potential and fertile men who decline to use effective contraception during and for a period of three months after the treatment period.
  • Patients with significant intercurrent medical or psychiatric conditions that would place them at increased risk or affect their ability to receive or comply with treatment or post-treatment clinical monitoring.

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): NCT01811498


Contacts
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Contact: John Boockvar, MD 212-434-3905 jboockvar@nshs.edu
Contact: Tamika Wong, MPH 212-434-3900 twong4@nshs.edu

Locations
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United States, New York
Lenox Hill Brain Tumor Center Recruiting
New York, New York, United States, 10065
Contact: John Boockvar, MD       jboockvar@nshs.edu   
Principal Investigator: John Boockvar, MD         
Sub-Investigator: David Langer, MD         
Sub-Investigator: Rafael Ortiz, MD         
Sub-Investigator: Alexis Demopolous, MD         
Sub-Investigator: Ashley Ray, NP         
Sub-Investigator: Tamika Wong, MPH         
Sub-Investigator: Sherese Fralin, NP         
Sponsors and Collaborators
Northwell Health
Feinstein Institute for Medical Research
Investigators
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Principal Investigator: John Boockvar, MD Feinstein Institute for Medical Research

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Responsible Party: John Boockvar, MD Zucker SOM @Hofstra/Northwell, Professor, Feinstein Institute for Medical Research
ClinicalTrials.gov Identifier: NCT01811498    
Other Study ID Numbers: 14-352
First Posted: March 14, 2013    Key Record Dates
Last Update Posted: May 17, 2019
Last Verified: May 2019
Additional relevant MeSH terms:
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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
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors