RecruitingPhase 1Phase 2NCT05956821

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

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


Sponsor

University of Miami

Enrollment

20 participants

Start Date

Jun 19, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 1 YearMax Age: 21 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a treatment that delivers the drug Avastin (bevacizumab) directly into the brain's blood supply via a specialized arterial injection, for children and adults with relapsed or treatment-resistant brain tumors including glioblastoma and diffuse brainstem glioma. **You may be eligible if...** - You have a confirmed or radiologically diagnosed relapsed or treatment-resistant brain tumor (such as glioblastoma, anaplastic astrocytoma, oligodendroglioma, or brainstem glioma) - You have at least one measurable tumor site - You have a Karnofsky/Lansky performance score of 60% or higher (able to care for self with some help) - You have adequate blood counts and organ function **You may NOT be eligible if...** - You are pregnant or breastfeeding - You have significant uncontrolled medical or psychiatric conditions - You had a craniotomy (brain surgery) less than 2 weeks ago Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSIACI of cetuximab and bevacizumab

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


Locations(1)

Jackson Memorial Hospital

Miami, Florida, United States

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NCT05956821


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