Using targeted delivery of Bevacizumab for treating recurrent brain tumors
Official title: Phase I/II Trial Of Repeated Super-selective Intraarterial Cerebral Infusion Of Bevacizumab (Avastin) for Treatment of Relapsed/Refractory Glioblastoma Multiforme and Anaplastic Astrocytoma.
Run by Northwell Health · NCT01269853 · Data updated 2026-11-12
This study is testing a new way to deliver the cancer drug Bevacizumab directly to the brain to see if it helps people with recurrent brain tumors live longer and feel better compared to the usual method of giving it through an IV.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 54 (estimated) |
| Sponsor | Northwell Health Academic / other |
| Drugs / interventions | Bevacizumab, radiation, chemotherapy |
| Locations | 1 site (New York, New York) |
| Status | Recruiting |
| Started | October 2010 |
| Main results expected | October 2028 |
| Study ends | October 2029 |
| Registry record updated | June 1, 2026 |
| Trial ID | NCT01269853 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include adults aged 18 and older with a confirmed diagnosis of relapsed or refractory GBM or AA and a Karnofsky performance status of 70% or higher.
✕Probably not a fit
Patients who have previously received more than two cycles of Bevacizumab or those with significant medical or psychiatric conditions may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial investigates the safety and efficacy of repeated super-selective intraarterial cerebral infusion of Bevacizumab (Avastin) for patients with relapsed glioblastoma multiforme (GBM) and anaplastic astrocytoma (AA). The study aims to determine if this method can improve progression-free survival and overall survival compared to the standard intravenous administration. Participants will receive Bevacizumab through a targeted intraarterial approach, which may enhance drug delivery across the blood-brain barrier. The trial is designed as a two-arm open-label, non-randomized study, building on previous findings that indicated the safety of this delivery technique.
Why it matters
Potential benefit: If successful, this approach could significantly improve treatment outcomes and quality of life for patients with aggressive brain tumors.
How similar studies have gone: Previous studies have shown promising results with similar intraarterial delivery techniques, suggesting potential for success in this approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 18 years of age or older. * Patients with a documented histologic diagnosis of relapsed or refractory glioblastoma multiforme (GBM), anaplastic astrocytoma (AA) or anaplastic mixed oligoastrocytoma (AOA). * Patients must have at least one confirmed and evaluable tumor site. A confirmed tumor site is one in which is biopsy-proven. * Patients must have a Karnofsky performance status 70% (or the equivalent ECOG level of 0-2). * Patients must agree to use a medically effective method of contraception during and for a period of three months after the treatment period. Exclusion Criteria: * Previous treatment with greater than 2 cycles of Bevacizumab at 10mg/kg (2 IV Infusions). * Women who are pregnant or lactating. * Patients with significant inter-current 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 it's running
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Lenox Hill Brain Tumor Center
New York, New York, United States Recruiting
Study contacts
- Principal investigator: John Boockvar, MD — Feinstein Institute for Medical Research
- Study coordinator: John Boockvar, MD
- Email: jboockvar@nshs.edu
- Phone: 212-434-3905
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.