Intraarterial Infusion Of Erbitux and Bevacizumab For Relapsed/Refractory Intracranial Glioma In Patients Under 22
Status:
Recruiting
Trial end date:
2025-01-01
Target enrollment:
Participant gender:
Summary
Central nervous system (CNS) malignancies are the second most common malignancy and the most
common solid tumor of childhood, including adolescence. Annually in the United States,
approximately 2,200 children are diagnosed with CNS malignancy and rates appear to be
increasing. CNS tumors are the leading cause of death from solid tumors in children. Survival
duration after diagnosis in children is highly variable depending in part on age at
diagnosis, location of tumor, and extent of resection; however, most children with high grade
glioma die within 3 years of diagnosis. All patients with high grade glioma experience a
recurrence after first-line therapy, so improvements in both first-line and salvage therapy
are critical to enhancing quality-of-life and prolonging survival. It is unknown if currently
used intravenous (IV) therapies even cross the blood brain barrier (BBB). We have shown in
previous phase I trials that a single Superselective Intra-arterial Cerebral Infusion (SIACI)
of Cetuximab and/or Bevacizumab is safe for the treatment of recurrent glioblastoma
multiforme (GBM) in adults, and we are currently evaluating the efficacy of this treatment.
Therefore, this phase I/II clinical research trial is an extension of that trial in that we
seek to test the hypothesis that intra-arterial Cetuximab and Bevacizumab is safe and
effective in the treatment of relapsed/refractory glioma in patients <22 years of age. We
expect that this project will provide important information regarding the utility of SIACI
Cetuximab and Bevacizumab therapy for malignant glioma in patients <22 years of age and may
alter the way these drugs are delivered to our patients in the near future.