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

Last updated: August 8, 2022
Sponsor: Global Neurosciences Institute
Overall Status: Active - Recruiting

Phase

1

Condition

Glioblastoma Multiforme

Gliomas

Astrocytoma

Treatment

N/A

Clinical Study ID

NCT02285959
GlobalNI
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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 andno external beam radiation for four weeks prior to treatment under this researchprotocol.
  • 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 andfor a period of three months after the treatment period. A pregnancy test will beperformed on each premenopausal female of childbearing potential immediately prior toentry into the research study.
  • Patients must be able to understand and give written informed consent. Informedconsent must be obtained at the time of patient screening.

Exclusion

Exclusion Criteria:

  • Women who are pregnant or lactating.
  • Women of childbearing potential and fertile men will be informed as to the potentialrisk of procreation while participating in this research trial and will be advisedthat they must use effective contraception during and for a period of three monthsafter the treatment period.
  • Patients with significant intercurrent medical or psychiatric conditions that wouldplace them at increased risk or affect their ability to receive or comply withtreatment or post-treatment clinical monitoring.

Study Design

Total Participants: 30
Study Start date:
June 01, 2014
Estimated Completion Date:
June 30, 2025

Connect with a study center

  • Capital Institute for Neurosciences

    Trenton, New Jersey 08638
    United States

    Site Not Available

  • Philadelphia, Pennsylvania
    United States

    Active - Recruiting

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