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Study of Cetuximab and Bevacizumab for Relapsed/Refractory Glioma in Patients Under 22

This study is looking at a treatment for children and young adults (ages 1 to 21) with certain types of brain tumors (glioma) that have come back or haven't responded to previous treatments. It's testing the safety and effectiveness of giving two drugs, cetuximab and bevacizumab, directly into the brain's arteries each month. Researchers will be watching for any side effects and how well the tumors respond to the treatment. They also want to see how long patients live without their disease getting worse. The study aims to enroll 20 participants, but its current recruitment status is unclear.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 20 participants.
What's involved
Participants will receive monthly doses of bevacizumab and cetuximab. The study will measure side effects at 1 month, tumor response at 6 months, and progression-free survival at 1 year.
Compensation
Not stated in the trial record.
Follow-up
The study measures outcomes up to 1 year after treatment.

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NCT05956821

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

Recruiting
PHASE1Ages 1–21InterventionalTreatment
University of Miami
~20 participants
Updated 2025-12-08 on ClinicalTrials.gov
What's tested:SIACI of cetuximab and bevacizumab

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of Treatment Related Adverse Events
Measured over 1 month post injection
+3 more outcomes measured

Conditions

Glioblastoma Multiforme
Anaplastic Astrocytoma
Fibrillary Astrocytomas
Oligodendroglioma
Diffuse Intrinsic Brainstem Glioma
Diffuse Intrinsic Pontine Glioma
DIPG Brain Tumor
H3 K27M

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Anaplastic AstrocytomaDiffuse Intrinsic Pontine GliomaFibrillary AstrocytomaGlioblastomaMouse Anaplastic OligoastrocytomaOligodendrogliomaPilomyxoid AstrocytomaH3 K27M Variant

Where it's being run

1 sites across 1 states
Florida1

Study leadership

  • Heather McCrea, MD · PRINCIPAL_INVESTIGATOR · University of Miami

Who to contact

Heather McCrea, MD
[email protected]
305-585-3627
Email the study team

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Eligibility criteria

Inclusion

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 platelets ≥100,000/ mm3
Pre-enrollment chemistry parameters must show: bilirubin\<1.5x the institutional upper limit of normal (IUNL); Aspartate Aminotransferase( AST) or Alanine transaminase (ALT)\<2.5x IUNL and creatinine\<1.5x IUNL
Pre-enrollment coagulation parameters (PT and PTT) must be ≤1.5x the IUNL
Growth factor(s): Must not have received within 1 week of entry onto this study
Steroids: Systemic corticosteroid therapy is permissible in patients with Central Nervous System (CNS) tumors for treatment of increased intracranial pressure or symptomatic tumor edema. Patients with CNS tumors who are receiving dexamethasone must be on a stable or decreasing dose for at least 1 week prior to study entry.
Patients of reproductive age must agree to use a medically effective method of contraception during and for a period of three months after the treatment period. A pregnancy test will be performed on each premenopausal female of childbearing potential immediately prior to entry into the research study
Patients or their parents/guardians must be able to understand and give written informed consent. Informed consent must be obtained at the time of patient screening
Because of known concerns with Avastin and wound healing, craniotomy patients are eligible for the treatment if they have had a craniotomy greater than two weeks prior to Intra-Arterial (IA) therapy. Craniotomy or major procedure after SIACI Avastin therapy should wait 4 weeks. Minor surgeries may be performed after two weeks

Exclusion

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

What this trial measures

  • Number of Treatment Related Adverse Events1 month post injection

    The number of treatment-related adverse events will be assessed and graded according to the NCI Common Toxicity Criteria, version 5.0.

  • Composite Overall Response Rate (CORR)6 months

    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.

  • Progression-free survival (PFS)1 year

    PFS will be measured from the date of the first dose of SIACI Cetuximab/Avastin to the date of progression.

  • Overall Survival (OS)1 year

    OS will be measured from the date of diagnosis to the date of death