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NCT01269853 · ClinicalTrials.gov registry record · Phase 1
Repeated Super-selective Intraarterial Cerebral Infusion of Bevacizumab (Avastin) for Treatment of Relapsed GBM and AA
A Phase 1 study of Glioblastoma Multiforme and Anaplastic Astrocytoma, sponsored by Northwell Health.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 54
- Enrollment target
- 1
- Study location
NCT01269853 is a Phase 1 study of Glioblastoma Multiforme and Anaplastic Astrocytoma that is actively recruiting participants, run by Northwell Health. The registered enrollment target is 54 participants, below the 96-participant average among 88 other Glioblastoma Multiforme trials with a reported enrollment target (44% lower). The trial reports 1 study location across 1 state.
The verdict
NCT01269853, a Phase 1 study of Glioblastoma Multiforme and Anaplastic Astrocytoma, is actively recruiting participants, sponsored by Northwell Health.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 54 participants
- Enrollment target
- 1
- Study location
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). The investigators have shown in a previous phase I trial that a single Super-selective 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 the investigators seek to test the hypothesis that repeated dosing of intraarterial Bevacizumab is safe and effective in the treatment of recurrent malignant glioma. By achieving the aims of this study the investigators will also determine if IV therapy with Bevacizumab should be combined with repeated selected intraarterial Bevacizumab to improve progression free and overall survival. The investigators 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 the patients in the near future.
Conditions Studied
Interventions
- DRUG Bevacizumab
Study Locations (1)
New York
- Lenox Hill Brain Tumor Center - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 54 participants |
| Start Date | 2010-10 |
| Est. Completion | 2027-10 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01269853
The ClinicalTrials.gov registry entry for NCT01269853 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 54 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 96-participant average among 88 other Glioblastoma Multiforme trials with a reported enrollment target (44% lower). The listed sponsor is Northwell Health, which has 370 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Glioblastoma Multiforme appearing as the primary indexed condition, and to 1 intervention - of which Bevacizumab is the first listed.
NCT01269853 reports 1 study location spanning 1 distinct geographic area - top geographies include New York.
Frequently Asked Questions
What is clinical trial NCT01269853 about?
NCT01269853 is a clinical study titled "Repeated Super-selective Intraarterial Cerebral Infusion of Bevacizumab (Avastin) for Treatment of Relapsed GBM and AA". 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 NCT01269853?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 54 participants. The study started on 2010-10. Estimated completion is 2027-10.
What conditions does trial NCT01269853 study?
This clinical trial studies the following conditions: Glioblastoma Multiforme, Anaplastic Astrocytoma.
What interventions are being tested in trial NCT01269853?
The interventions under investigation include: Bevacizumab (DRUG).
Who is sponsoring clinical trial NCT01269853?
This trial is sponsored by Northwell Health, which has 370 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01269853 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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