Recruiting
Phase 1

Bevacizumab

Sponsor:

Global Neurosciences Institute

Code:

NCT02285959

Conditions

Glioblastoma Multiforme

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Bevacizumab

Study Details

Brief 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.

Conditions

Glioblastoma Multiforme

Study ID

NCT02285959

Start date

Jun, 2014

Status verified date

Aug, 2022

Completion date

Jun, 2025

Anticipated

Primary completion date

Jun, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Intra Arterial Bevacizumab

Repeated Intra Arterial bevacizumab injections at 15 mg/kg every 3 weeks

Interventions

Bevacizumab

Primary outcome measure

  • Number of Participants with Adverse Events as a Measure of Safety [ Time Frame: 3 years ]

Central Contacts and Locations

Locations

Recruiting

Philadelphia, Pennsylvania, United States

Contacts

Mandy Binning

MBinning@gnineuro.org

More Information

Sponsor

Global Neurosciences Institute

Last update posted

Aug 10, 2022

Last verified

Aug, 2022

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Global Neurosciences Institute on 2022-08-10.