Treatment of Relapsed/Refractory Intracranial Glioma in Patients Under 22 Years of Age

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age1-21
SponsorUniversity of Miami

About this trial

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 criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • SIACI of cetuximab and bevacizumab

Treatment groups

20 Participants
are divided into 1 treatment group

Sponsors and collaborators