Using targeted delivery of Bevacizumab for treating recurrent brain tumors
Phase I/II Trial Of Repeated Super-selective Intraarterial Cerebral Infusion Of Bevacizumab (Avastin) for Treatment of Relapsed/Refractory Glioblastoma Multiforme and Anaplastic Astrocytoma.
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 |
| Enrollment | 54 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Northwell Health Academic / other |
| Drugs / interventions | Bevacizumab, radiation, chemotherapy |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT01269853 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: Previous studies have shown promising results with similar intraarterial delivery techniques, suggesting potential for success in this approach.
Eligibility criteria
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 this trial is running
New York, New York
- 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
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.