Trials / Recruiting
RecruitingNCT02861898
Super-selective Intra-arterial Repeated Infusion of Cetuximab for the Treatment of Newly Diagnosed Glioblastoma
Phase I/II Trial of Super-selective Intra-arterial Repeated Infusion of Cetuximab for the Treatment of Newly Diagnosed Glioblastoma
- Status
- Recruiting
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 33 (estimated)
- Sponsor
- Northwell Health · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
- Glioblastoma
- Brain Cancer
- Brain Neoplasm
- Brain Tumor
- Brain Neoplasm, Malignant
- EGFR Gene Overexpression
- GBM
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Intra-arterial Cetuximab | |
| DRUG | Intra-arterial Mannitol |
Timeline
- Start date
- 2016-06-01
- Primary completion
- 2026-12-01
- Completion
- 2027-12-01
- First posted
- 2016-08-10
- Last updated
- 2025-04-09
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT02861898. Inclusion in this directory is not an endorsement.