Clinical Trials /

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

NCT02285959

Description:

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.

Related Conditions:
  • Glioblastoma
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: Super-Selective Intraarterial Intracranial Infusion of Bevacizumab (Avastin) for Glioblastoma Multiforme
  • Official Title: Super-Selective Intraarterial Intracranial Infusion of Bevacizumab (Avastin) for Glioblastoma Multiforme

Clinical Trial IDs

  • ORG STUDY ID: GlobalNI
  • NCT ID: NCT02285959

Conditions

  • Glioblastoma Multiforme

Interventions

DrugSynonymsArms
BevacizumabAvastinIntra Arterial Bevacizumab

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.

Trial Arms

NameTypeDescriptionInterventions
Intra Arterial BevacizumabExperimentalRepeated Intra Arterial bevacizumab injections at 15 mg/kg every 3 weeks
  • Bevacizumab

Eligibility 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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Number of Participants with Adverse Events as a Measure of Safety
Time Frame:3 years
Safety Issue:
Description:The frequency of adverse events will be quantified until disease progression or death.

Secondary Outcome Measures

Measure:Tumor Response
Time Frame:3 years
Safety Issue:
Description:

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Global Neurosciences Institute

Last Updated

March 15, 2016