Targeted delivery of Bevacizumab for treating aggressive brain tumors
Super-Selective Intraarterial Intracranial Infusion of Bevacizumab (Avastin) for Glioblastoma Multiforme
This study is testing a new way to deliver a cancer drug directly to the blood vessels of aggressive brain tumors in patients with recurrent glioblastoma to see if it helps them live longer and feel better.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Global Neurosciences Institute Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Philadelphia, Pennsylvania) |
| Trial ID | NCT02285959 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the use of super-selective intraarterial cerebral infusion (SIACI) to deliver Bevacizumab directly to the blood vessels feeding glioblastoma multiforme (GBM) tumors. By threading a catheter from the femoral artery to the brain, the study aims to increase the concentration of the drug at the tumor site while minimizing systemic side effects. The trial focuses on patients with recurrent grade IV GBM who have undergone prior surgical resection. The goal is to improve treatment outcomes and prolong survival for patients suffering from this aggressive form of brain cancer.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 with a confirmed diagnosis of recurrent grade IV glioblastoma multiforme who meet specific health criteria.
Not a fit: Patients with non-recurrent GBM or those who have not undergone prior surgical resection may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly enhance the effectiveness of treatment for glioblastoma multiforme and improve patient survival rates.
How similar studies have performed: While the approach of targeted intraarterial infusion is innovative, similar studies have shown promise in enhancing drug delivery to brain tumors.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Philadelphia, Pennsylvania
- Philadelphia, Pennsylvania, United States (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.