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NCT00968240 · ClinicalTrials.gov registry record · Phase 1
Super-Selective Intraarterial Intracranial Infusion of Avastin (Bevacizumab)
A Phase 1 study, sponsored by Northwell Health.
- Completed
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
NCT00968240 is a Phase 1 study that has completed, run by Northwell Health. The registered enrollment target is 30 participants.
The verdict
NCT00968240, a Phase 1 study, has completed, sponsored by Northwell Health.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
Study Summary
The high-grade malignant brain tumors, glioblastoma multiforme (GBM) and anaplastic astrocytoma (AA), 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, and 3-4 years for AA. Initial therapy consists of either surgical resection, external beam radiation or both. All patients experience a recurrence after first-line therapy, so improvements in both first-line and salvage therapy are critical to enhancing quality-of-life and prolonging survival. It is unknown if currently used intravenous (IV) therapies even cross the blood brain barrier (BBB). 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. One currently used drug called, Bevacizumab (Avastin) has been shown to be active in human brain tumors but its actual CNS penetration is unknown. This phase I clinical research trial will test the hypothesis that Bevacizumab can be safely used by direct intracranial superselective intraarterial infusion up to a dose of 10mg/kg to ultimately enhance survival of patients with relapsed/refractory GBM/AA. By achieving the aims of this study we will determine the toxicity profile and maximum tolerated dose (MTD of SIACI Bevacizumab. We expect that this project will provide important information regarding the utility of SIACI Bevacizumab therapy for malignant glioma, and may alter the way these drugs are delivered to our patients in the near future.
Interventions
- DRUG Super-Selective Intraarterial Intracranial Infusion of BEVACIZUMAB
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2009-07 |
| Est. Completion | 2014-01 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00968240
The ClinicalTrials.gov registry entry for NCT00968240 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Northwell Health, which has 370 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Super-Selective Intraarterial Intracranial Infusion of BEVACIZUMAB is the first listed.
NCT00968240 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00968240 about?
NCT00968240 is a clinical study titled "Super-Selective Intraarterial Intracranial Infusion of Avastin (Bevacizumab)". The high-grade malignant brain tumors, glioblastoma multiforme (GBM) and anaplastic astrocytoma (AA), 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 G...
What is the current status of trial NCT00968240?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2009-07. Estimated completion is 2014-01.
What interventions are being tested in trial NCT00968240?
The interventions under investigation include: Super-Selective Intraarterial Intracranial Infusion of BEVACIZUMAB (DRUG).
Who is sponsoring clinical trial NCT00968240?
This trial is sponsored by Northwell Health, which has 370 total clinical trials registered on ClinicalTrials.gov.
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