Trials / Recruiting
RecruitingNCT02800486
Super Selective Intra-arterial Repeated Infusion of Cetuximab (Erbitux) With Reirradiation for Treatment of Relapsed/Refractory GBM, AA, and AOA
Phase II Trial of Super Selective Intra-arterial Repeated Infusion of Cetuximab (Erbitux) With Reirradiation for Treatment of Relapsed/Refractory Glioblastoma Multiforme, Anaplastic Astrocytoma, and Anaplastic Oligoastrocytoma
- Status
- Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 37 (estimated)
- Sponsor
- Northwell Health · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Primary 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 of EFGR (Epidermal Growth Factor Receptor), which is associated with poor prognosis. Several methods of inhibiting this receptor have been tested, including monoclonal antibodies, vaccines, and tyrosine kinase inhibitors. The investigators hypothesize that in patients with recurring GBM, intracranial superselective intra-arterial infusion of Cetuximab (CTX), at a dose of 250mg/m2 in conjunction with hypofractionated radiation, will be safe and efficacious and prevent tumor progression in patients with recurrent, residual GBM.
Conditions
- Glioblastoma
- Anaplastic Astrocytoma
- Anaplastic Oligoastrocytoma
- Glioma
- Brain Neoplasm
- Brain Cancer
- Brain Tumor
- Brain Tumor, Recurrent
- Brain Neoplasm, Malignant
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Intra-arterial Cetuximab | |
| DRUG | Intra-arterial Mannitol | |
| RADIATION | Hypofractionated re-irradiation |
Timeline
- Start date
- 2016-05-01
- Primary completion
- 2035-05-01
- Completion
- 2036-05-01
- First posted
- 2016-06-15
- Last updated
- 2026-04-13
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT02800486. Inclusion in this directory is not an endorsement.