Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02861898
The ClinicalTrials.gov registry entry for NCT02861898 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 33 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 109-participant average among 199 other Glioblastoma trials with a reported enrollment target (70% lower). The listed sponsor is Northwell Health, which has 370 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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
Similar trials for Glioblastoma
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.
-
A Phase I/II Study of IVONESCIMAB in Recurrent Glioblastoma
RECRUITING · Phase 1
-
CARv3-TEAM-E T Cells in Glioblastoma
RECRUITING · Phase 1
-
CUE-102 in Recurrent Glioblastoma
RECRUITING · Phase 1
-
Adenovirus Mediated Suicide Gene Therapy With Radiotherapy in Progressive Astrocytoma.
RECRUITING · Phase 1
-
Laser Interstitial Thermal Therapy (LITT) and Lomustine (CCNU) for Recurrent Glioblastoma
RECRUITING · Phase 1
-
HSV-tk and XRT and Chemotherapy for Newly Diagnosed GBM
RECRUITING · Phase 1
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.