Super-selective Intra-arterial Repeated Infusion of Cetuximab for the Treatment of Newly Diagnosed Glioblastoma
Status:
Recruiting
Trial end date:
2023-06-01
Target enrollment:
Participant gender:
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.