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

NCT ID: NCT05956821

Last Updated: 2025-12-08

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-19
• Study Completion Date: 2029-12-01

Brief 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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

SIACI of cetuximab and bevacizumab

Participants in this group will receive Cetuximab and Bevacizumab infusion into an artery each month for up to approximately one year.

Group Type: EXPERIMENTAL

SIACI of cetuximab and bevacizumab

Intervention Type: DRUG

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

Interventions

SIACI of cetuximab and bevacizumab

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

Intervention Type: DRUG

Other Intervention Names

erbitux; avastin

Eligibility Criteria

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
• 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 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

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Miami

OTHER

Sponsor Role: lead

Responsible Party

Heather McCrea, MD

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Heather McCrea, MD

Role: PRINCIPAL_INVESTIGATOR

University of Miami

Locations

Jackson Memorial Hospital

Miami, Florida, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Heather McCrea, MD

Role: CONTACT

hmccrea@med.miami.edu

305-585-3627

Facility Contacts

Heather McCrea, MD

Role: primary

hmccrea@med.miami.edu

305-585-3627

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.

Reference Type: BACKGROUND

PMID: 34359048 (View on PubMed)

Other Identifiers

20230032

Identifier Type: -

Identifier Source: org_study_id