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

Detailed criteria

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

Drug
SIACI of cetuximab and bevacizumab
Subjects will receive monthly dosing of bevacizumab (15 mg/kg) and cetuximab (200mg/m2)

Location

Jackson Memorial Hospital
Miami, Florida
hmccrea@med.miami.edu 305-585-3627

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

Summary

Eligibility

Interventions

Location

Compensation

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Details

Conditions