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
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.
Arms & interventions
- DrugIntra-arterial Cetuximab
- DrugIntra-arterial Mannitol
- RadiationHypofractionated re-irradiation
Outcome measures
Primary
Progression Free Survival (PFS)
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.
Time frame: 6 months
Overall Survival (OS)
OS will be calculated as the time from treatment initiation to the date of death.
Time frame: 2 years
Secondary
Composite overall response rate (CORR) through the Response Evaluation Criteria In Solid Tumors (RECIST)
Time frame: 6 months
Toxicities graded according to the NCI Common Toxicity Criteria (CTCAE) version 4.03
Time frame: 6 months
Eligibility criteria
Study locations (1)
Lenox Hill Brain Tumor Center
New York, New York, 10075