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
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.
Arms & interventions
- DrugSIACI of cetuximab and bevacizumab
Subjects will receive monthly dosing of bevacizumab (15 mg/kg) and cetuximab (200mg/m2)
Outcome measures
Primary
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.
Time frame: 1 month post injection
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.
Time frame: 6 months
Progression-free survival (PFS)
PFS will be measured from the date of the first dose of SIACI Cetuximab/Avastin to the date of progression.
Time frame: 1 year
Overall Survival (OS)
OS will be measured from the date of diagnosis to the date of death
Time frame: 1 year
Eligibility criteria
Study locations (1)
Jackson Memorial Hospital
Miami, Florida, 33136
References
- McCrea HJ, Ivanidze J, O'Connor A, Hersh EH, Boockvar JA, Gobin YP, Knopman J, Greenfield JP. Intraarterial delivery of bevacizumab and cetuximab utilizing blood-brain barrier disruption in children with high-grade glioma and diffuse intrinsic pontine glioma: results of a phase I trial. J Neurosurg Pediatr. 2021 Aug 6;28(4):371-379. doi: 10.3171/2021.3.PEDS20738. Print 2021 Oct 1.(PubMed)