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Super-Selective Intraarterial Intracranial Infusion of Bevacizumab (Avastin) for Glioblastoma Multiforme

This study is currently recruiting participants.
Verified June 2017 by Erol Veznedaroglu, Global Neurosciences Institute
Sponsor:
ClinicalTrials.gov Identifier:
NCT02285959
First Posted: November 7, 2014
Last Update Posted: June 21, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Erol Veznedaroglu, Global Neurosciences Institute
  Purpose
The high-grade malignant brain tumor 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 durations of only 9-12 months for GBM. Initial therapy consists of surgical resection, external beam radiation or both. Currently, all patients experience a recurrence after this first-line therapy, so improvements in both first-line and salvage therapy are critical to enhancing quality-of-life and prolonging survival. Superselective Intraarterial Cerebral Infusion (SIACI) is a technique that can effectively increase the concentration of drug delivered to the brain while sparing the body of systemic side effects. This technique threads a tiny catheter through the patient's femoral artery in the leg, up through the body and neck and into the brain. Once the catheter reaches the brain, chemotherapy is released to the blood vessels that feed the tumor.

Condition Intervention Phase
Glioblastoma Multiforme Drug: Bevacizumab Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Super-Selective Intraarterial Intracranial Infusion of Bevacizumab (Avastin) for Glioblastoma Multiforme

Resource links provided by NLM:


Further study details as provided by Erol Veznedaroglu, Global Neurosciences Institute:

Primary Outcome Measures:
  • Number of Participants with Adverse Events as a Measure of Safety [ Time Frame: 3 years ]
    The frequency of adverse events will be quantified until disease progression or death.


Secondary Outcome Measures:
  • Tumor Response [ Time Frame: 3 years ]

Estimated Enrollment: 30
Study Start Date: June 2014
Estimated Study Completion Date: June 2020
Estimated Primary Completion Date: June 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intra Arterial Bevacizumab
Repeated Intra Arterial bevacizumab injections at 15 mg/kg every 3 weeks
Drug: Bevacizumab
Other Name: Avastin

  Eligibility

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:

  • Histologically confirmed diagnosis of GBM
  • Grade IV GBM tumors that have recurred after total resection
  • Age > 18 years
  • At least four weeks following any recent surgery
  • Patients must have a Karnofsky performance status ≥60% and an expected survival of ≥ three months.
  • No IV chemotherapy for three weeks prior to treatment under this research protocol and no external beam radiation for four weeks prior to treatment under this research protocol.
  • Patients must have adequate hematologic reserve
  • Pre-enrollment coagulation parameters (PT and PTT) must be adequate.
  • 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.
  • Patients must be able to understand and give written informed consent. Informed consent must be obtained at the time of patient screening.

Exclusion Criteria:

  • Women who are pregnant or lactating.
  • Women of childbearing potential and fertile men will be informed as to the potential risk of procreation while participating in this research trial and will be advised that they must 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.
  Contacts and Locations
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): NCT02285959


Locations
United States, Pennsylvania
Recruiting
Philadelphia, Pennsylvania, United States
Contact: Christina Maxwell       cmaxwell@gnineuro.org   
Sponsors and Collaborators
Global Neurosciences Institute
  More Information

Responsible Party: Erol Veznedaroglu, MD FAANS FACS FAHA, Global Neurosciences Institute
ClinicalTrials.gov Identifier: NCT02285959     History of Changes
Other Study ID Numbers: GlobalNI
First Submitted: November 4, 2014
First Posted: November 7, 2014
Last Update Posted: June 21, 2017
Last Verified: June 2017

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