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NCT02861898 · ClinicalTrials.gov registry record · Phase 1
Super-selective Intra-arterial Repeated Infusion of Cetuximab for the Treatment of Newly Diagnosed Glioblastoma
A Phase 1 study of Glioblastoma and Brain Tumor, sponsored by Northwell Health.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 33
- Enrollment target
- 1
- Study location
NCT02861898: Recruiting Phase 1 study of Glioblastoma and Brain Tumor, sponsored by Northwell Health.
NCT02861898 is a Phase 1 study of Glioblastoma and Brain Tumor that is actively recruiting participants, run by Northwell Health. The registered enrollment target is 33 participants, below the 109-participant average among 199 other Glioblastoma trials with a reported enrollment target (70% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02861898, a Phase 1 study of Glioblastoma and Brain Tumor, is actively recruiting participants, sponsored by Northwell Health.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 33 participants
- Enrollment target
- 1
- Study location
Study Summary
Primary brain cancer kills up to 10,000 Americans a year. These brain tumors are typically treated by surgery, radiation therapy and chemotherapy, either individually or in combination. Present therapies are inadequate, as evidenced by the low 5-year survival rate for brain cancer patients, with median survival at approximately 12 months. Glioma is the most common form of primary brain cancer, afflicting approximately 7,000 patients in the United States each year. These highly malignant cancers remain a significant unmet clinical need in oncology. GBM often has a high expression EFGR (Epidermal Growth Factor Receptor) which is blocked by Cetuximab (CTX). The investigators have recently completed a separate Phase I clinical trial using superselective intra-arterial cerebral infusion (SIACI) of CTX after blood brain barrier disruption (BBBD) for recurrent GBM (Chakraborty et al, in revision, Journal of Neurooncology). The investigators found that intra-arterial infusion of CTX is well tolerated with few adverse effects. The investigators hypothesize that in patients with newly diagnosed GBM, repeated SIACI of this drug after BBBD will be safe and efficacious for our patients when combined with standard chemoradiation (STUPP protocol). This trial will be a non-randomized open label Phase I/II clinical trial. In addition to standard chemotherapy and radiation therapy (STUPP protocol) the patient will be given CTX intra-arterially after BBBD for a total of three doses at approximately post surgery days 30, 120 and 210.
Primary Outcome
The 6-month PFS will be estimated by calculating the proportion of patients who are alive at 6 months from treatment commencement and are progression-free.
Conditions Studied
Interventions
- DRUG Intra-arterial Cetuximab
- DRUG Intra-arterial Mannitol
Study Locations (1)
New York
- Lenox Hill Brain Tumor Center - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 33 participants |
| Start Date | 2016-06 |
| Est. Completion | 2027-12 |
| Phase | Phase 1 |
What NCT02861898 shows while recruiting
NCT02861898 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 33 participants, a relatively small participant target, below the 109-participant average among 199 other Glioblastoma trials with a reported enrollment target (70% lower).
The record links to 7 conditions, with Glioblastoma appearing as the primary indexed condition, and to 2 interventions - of which Intra-arterial Cetuximab is the first listed.
NCT02861898 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT02861898 about?
NCT02861898 is a clinical study titled "Super-selective Intra-arterial Repeated Infusion of Cetuximab for the Treatment of Newly Diagnosed Glioblastoma". Primary brain cancer kills up to 10,000 Americans a year. These brain tumors are typically treated by surgery, radiation therapy and chemotherapy, either individually or in combination. Present therapies are inadequate, as evidenced by the low 5-year survival rate for brain cancer patients, with med...
What is the current status of trial NCT02861898?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 33 participants. The study started on 2016-06. Estimated completion is 2027-12.
What conditions does trial NCT02861898 study?
This clinical trial studies the following conditions: Glioblastoma, Brain Tumor, Brain Cancer, GBM, Brain Neoplasm.
What interventions are being tested in trial NCT02861898?
The interventions under investigation include: Intra-arterial Cetuximab (DRUG), Intra-arterial Mannitol (DRUG).
Who is sponsoring clinical trial NCT02861898?
This trial is sponsored by Northwell Health, which has 370 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02861898 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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Where NCT02861898's enrollment target sits among peer trials
33 120th of 199 higher than 80 of 199 other Glioblastoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Glioblastoma 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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