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NCT01238237 · ClinicalTrials.gov registry record · Phase 1
Super-Selective Intraarterial Cerebral Infusion of Cetuximab (Erbitux) for Treatment of Relapsed/Refractory GBM and AA
A Phase 1 study of Anaplastic Astrocytoma and GBM, sponsored by Northwell Health.
- Completed
- Registry status
- Phase 1
- Development phase
- 15
- Enrollment target
- 1
- Study location
NCT01238237: Completed Phase 1 study of Anaplastic Astrocytoma and GBM, sponsored by Northwell Health.
NCT01238237 is a Phase 1 study of Anaplastic Astrocytoma and GBM that has completed, run by Northwell Health. The registered enrollment target is 15 participants, below the 57-participant average among 30 other Anaplastic Astrocytoma trials with a reported enrollment target (74% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01238237, a Phase 1 study of Anaplastic Astrocytoma and GBM, has completed, sponsored by Northwell Health.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 15 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. 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, Cetuximab (Erbitux) 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 Cetuximab can be safely used by direct intracranial superselective intraarterial infusion up to a dose of 500mg/m2 to ultimately enhance survival of patients with relapsed/refractory GBM/AA. By achieving the aims of this study the investigators will determine the the toxicity profile and maximum tolerated dose (MTD) of SIACI Cetuximab. The investigators expect that this study will provide important information regarding the utility of SIACI Cetuximab therapy for malignant glioma, and may alter the way these drugs are delivered to the investigators patients in the near future.
Conditions Studied
Interventions
- DRUG Superselective Intraarterial Cerebral Infusion of Cetuximab
Study Locations (1)
New York
- Lenox Hill Brain Tumor Center - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2009-12 |
| Est. Completion | 2016-01 |
| Phase | Phase 1 |
What the finished NCT01238237 record still lists
NCT01238237 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 57-participant average among 30 other Anaplastic Astrocytoma trials with a reported enrollment target (74% lower).
The record links to 4 conditions, with Anaplastic Astrocytoma appearing as the primary indexed condition, and to 1 intervention - of which Superselective Intraarterial Cerebral Infusion of Cetuximab is the first listed.
NCT01238237 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT01238237 about?
NCT01238237 is a clinical study titled "Super-Selective Intraarterial Cerebral Infusion of Cetuximab (Erbitux) for Treatment of Relapsed/Refractory 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. Initial therapy consists of either surgical resection, external beam radiation or both. All patients experience a recurrence after first-...
What is the current status of trial NCT01238237?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 15 participants. The study started on 2009-12. Estimated completion is 2016-01.
What conditions does trial NCT01238237 study?
This clinical trial studies the following conditions: Anaplastic Astrocytoma, GBM, Glioblastoma Multiforme (GBM), Anaplastic Astrocytoma (AOA).
What interventions are being tested in trial NCT01238237?
The interventions under investigation include: Superselective Intraarterial Cerebral Infusion of Cetuximab (DRUG).
Who is sponsoring clinical trial NCT01238237?
This trial is sponsored by Northwell Health, which has 370 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01238237 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01238237's enrollment target sits among peer trials
15 26th of 30 higher than 4 of 30 other Anaplastic Astrocytoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Anaplastic Astrocytoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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