This study assesses the safety and efficacy of repeat monthly dosing of super-selective intra-arterial cerebral infusion (SIACI) of cetuximab and bevacizumab in patients \< 22 years of age.
Documented histologic diagnosis of relapsed or refractory glioblastoma multiforme (GBM), anaplastic astrocytoma (AA), fibrillary astrocytomas (FA), pilomyxoid astrocytoma (PXA), oligodendroglioma, or anaplastic mixed oligoastrocytoma (AOA), or radiologically diagnosed diffuse intrinsic brainstem glioma (DIPG)
Must have at least one confirmed and evaluable tumor site
Must have a Karnofsky or Lansky performance status ≥60%.
No chemotherapy for three weeks prior to treatment
Females who are pregnant or lactating
Females of childbearing potential and fertile men will be informed as to the potential risk of procreation while participating in this research trial and will be advised that they must use effective contraception during and for a period of three months after the treatment period. If they do not agree, they will be ineligible for the study
Patients with significant concurrent medical or psychiatric conditions that would place them at increased risk or affect their ability to receive or comply with treatment or post-treatment clinical monitoring
Single group
SIACI of cetuximab and bevacizumab
DrugSubjects will receive monthly dosing of bevacizumab (15 mg/kg) and cetuximab (200mg/m2)
Number of Treatment Related Adverse Events
The number of treatment-related adverse events will be assessed and graded according to the NCI Common Toxicity Criteria, version 5.0.
Composite Overall Response Rate (CORR)
The overall response proportion along with a 95% confidence interval will be estimated via binomial proportions. We will define "evaluable" patients as patients who met eligibility requirements and have initiated therapy.
Progression-free survival (PFS)
PFS will be measured from the date of the first dose of SIACI Cetuximab/Avastin to the date of progression.
Overall Survival (OS)
OS will be measured from the date of diagnosis to the date of death
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