Loading clinical trials...

Treatment of Relapsed/Refractory Intracranial Glioma in Patients Under 22 Years of Age | Clinical Trials | Clareo Health

RECRUITINGPHASE1/PHASE2

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

NCT05956821•University of Miami

View on ClinicalTrials.gov

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

1 - 21 years

Sex

ALL

Healthy Volunteers

Yes

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 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
+2 more criteria

Exclusion Criteria

•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

Locations (1)

Jackson Memorial Hospital

Miami, Florida, United States

Key Dates

Start Date

June 19, 2025

Primary Completion Date

October 1, 2029

Completion Date

December 1, 2029

Last Updated

December 8, 2025

Enrollment

ESTIMATED participants

Conditions

Glioblastoma MultiformeAnaplastic AstrocytomaFibrillary AstrocytomasOligodendrogliomaDiffuse Intrinsic Brainstem GliomaDiffuse Intrinsic Pontine GliomaDIPG Brain TumorH3 K27M

Interventions

SIACI of cetuximab and bevacizumab

DRUG

Contacts

Heather McCrea, MD

CONTACT

305-585-3627 hmccrea@med.miami.edu

Targeted Pediatric High-Grade Glioma Therapy

NCT05839379

High Grade GliomaDiffuse Intrinsic Pontine Glioma+7 more

View study

RECRUITING

Collection of Blood and Urine Samples in Patients Receiving Radiation Therapy for Glioblastoma Multiforme

NCT00083512

Glioblastoma Multiforme

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 8, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Targeted Pediatric High-Grade Glioma Therapy

Collection of Blood and Urine Samples in Patients Receiving Radiation Therapy for Glioblastoma Multiforme

Study of TLX101-Tx Plus Standard of Care (SoC) Versus SoC Alone for the Treatment of Patients With Recurrent Glioblastoma

Improving Understanding of Glioblastoma Through Preservation of Biologically Active Brain Tissue

Study of Pembrolizumab and M032 (NSC 733972)

Carmustine Wafer in Combination With Retifanlimab and Radiation With/Without Temozolomide in Subjects With Glioblastoma