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NCT01811498 · ClinicalTrials.gov registry record · Phase 1
Repeated Super-Selective Intraarterial Cerebral Infusion of Bevacizumab (Avastin) for Treatment of Newly Diagnosed GBM
A Phase 1 study, sponsored by Northwell Health.
- Completed
- Registry status
- Phase 1
- Development phase
- 31
- Enrollment target
NCT01811498 is a Phase 1 study that has completed, run by Northwell Health. The registered enrollment target is 31 participants.
The verdict
NCT01811498, a Phase 1 study, has completed, sponsored by Northwell Health.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 31 participants
- Enrollment target
Study Summary
The high-grade malignant brain tumors, glioblastoma multiforme (GBM), 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 of only 9-12 months. 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). We have shown in a previous phase I trial that a single Superselective Intraarterial Cerebral Infusion (SIACI) of Bevacizumab (up to 15mg/kg) is safe and effective in the treatment of recurrent GBM. Therefore, this phase I/II clinical research trial is an extension of that trial in that we seek to test the hypothesis that repeated dosing of intra-arterial Bevacizumab is safe and effective in the treatment of newly diagnosed malignant glioma. By achieving the aims of this study we will also determine if repeated intra-arterial Bevacizumab improves progression free and overall survival in newly diagnosed patients. We expect that this project will provide important information regarding the utility of repeated SIACI Bevacizumab therapy for malignant glioma, and may alter the way these drugs are delivered to our patients in the near future.
Interventions
- DRUG Bevacizumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Start Date | 2013-02 |
| Est. Completion | 2021-10 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01811498
The ClinicalTrials.gov registry entry for NCT01811498 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 31 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 Bevacizumab is the first listed.
NCT01811498 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01811498 about?
NCT01811498 is a clinical study titled "Repeated Super-Selective Intraarterial Cerebral Infusion of Bevacizumab (Avastin) for Treatment of Newly Diagnosed GBM". The high-grade malignant brain tumors, glioblastoma multiforme (GBM), 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 of only 9-12 months. Initial therapy consists of either surgical re...
What is the current status of trial NCT01811498?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 31 participants. The study started on 2013-02. Estimated completion is 2021-10.
What interventions are being tested in trial NCT01811498?
The interventions under investigation include: Bevacizumab (DRUG).
Who is sponsoring clinical trial NCT01811498?
This trial is sponsored by Northwell Health, which has 370 total clinical trials registered on ClinicalTrials.gov.
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