Study on Repeated Targeted Brain Infusions of Bevacizumab (Avastin) for Treating Recurrent Aggressive Brain Tumors
Sponsor: Northwell Health
ClinicalTrials ID:NCT01269853
This clinical trial is testing a new way to deliver the drug Bevacizumab directly to the brain to treat aggressive brain tumors that have returned after initial treatment. The study aims to find out if this method is safe and more effective than the standard intravenous treatment.
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Program Overview
This study focuses on treating aggressive brain tumors, specifically glioblastoma multiforme (GBM) and anaplastic astrocytoma (AA), which are known for their rapid growth and poor survival rates. Traditional treatments include surgery and radiation, but these tumors often return. The study is testing a new method of delivering the drug Bevacizumab directly into the brain's blood vessels to see if it can better control the tumors compared to the usual intravenous method. Researchers hope this approach will improve patients' quality of life and survival rates.
Description
Currently, patients with recurring glioblastoma multiforme (GBM) receive Bevacizumab (Avastin) through an IV every two weeks until their tumor grows significantly. However, it's unclear if the drug effectively reaches the brain due to the blood-brain barrier. A previous study showed that delivering Bevacizumab directly into the brain's blood vessels (intraarterial) is safe and effective. This new study will test if repeated intraarterial doses are safe and if combining this method with the standard IV treatment improves outcomes.
The study involves two groups: one receiving only intraarterial Bevacizumab and the other receiving both intraarterial and biweekly IV Bevacizumab. Treatment continues until MRI scans show tumor progression after three intraarterial treatments, at which point patients will leave the study.
Before treatment, patients will receive Mannitol to help the drug cross the blood-brain barrier. This method has been safely used in previous studies. The study aims to provide insights into whether this new delivery method can change how brain tumor treatments are administered.
Eligibility Criteria
Inclusion Criteria
- Must be 18 years or older.
- Have a confirmed diagnosis of relapsed or treatment-resistant glioblastoma multiforme (GBM), anaplastic astrocytoma (AA), or anaplastic mixed oligoastrocytoma (AOA).
- Must have at least one confirmed tumor site that can be evaluated, proven by biopsy.
- Must have a Karnofsky performance status of 70% or equivalent ECOG level of 0-2.
- Must agree to use effective contraception during and for three months after treatment.
Exclusion Criteria
- Have received more than two cycles of Bevacizumab at 10mg/kg (two IV infusions).
- Women who are pregnant or breastfeeding.
- Have significant medical or psychiatric conditions that increase risk or affect ability to comply with treatment and monitoring.
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