Phase I/II Trial of Repeat Dosing of Super-Selective Intraarterial Infusion of Erbitux (Cetuximab) and Avastin (Bevacizumab) for Treatment of Relapsed/Refractory Intracranial Glioma in Patients Under 22 Years of Age
University of Miami
Summary
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.
Eligibility
- Age range
- 1–21 years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: * 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 * Patients must have adequate hematologic reserve with absolute neutrophils≥1000/mm3 and plate…
Interventions
- DrugSIACI of cetuximab and bevacizumab
Subjects will receive monthly dosing of bevacizumab (15 mg/kg) and cetuximab (200mg/m2)
Location
- Jackson Memorial HospitalMiami, Florida