Recruiting
Phase 1
Phase 2

Intracranial Glioma

Sponsor:

University of Miami

Code:

NCT05956821

Conditions

Glioblastoma Multiforme

Anaplastic Astrocytoma

Fibrillary Astrocytomas

Oligodendroglioma

Diffuse Intrinsic Brainstem Glioma

Eligibility Criteria

Sex: All

Age: 1 - 21

Healthy Volunteers: Accepted

Interventions

SIACI of cetuximab and bevacizumab

Study Details

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

Study ID

NCT05956821

Start date

Jun 19, 2025

Status verified date

Dec, 2025

Completion date

Dec 1, 2029

Anticipated

Primary completion date

Oct 1, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 1 - 21

Healthy Volunteers: Accepted

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

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 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.

Interventions

SIACI of cetuximab and bevacizumab

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

Primary outcome measure

  • Number of Treatment Related Adverse Events [ Time Frame: 1 month post injection ]
  • Composite Overall Response Rate (CORR) [ Time Frame: 6 months ]
  • Progression-free survival (PFS) [ Time Frame: 1 year ]
  • Overall Survival (OS) [ Time Frame: 1 year ]

Central Contacts and Locations

Central contacts

Heather McCrea, MD

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

Locations

Jackson Memorial Hospital

Recruiting

Miami, Florida, United States, 33136

Contacts

Heather McCrea, MD

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

Principal Investigator:

Heather McCrea, MD

More Information

Sponsor

University of Miami

Last update posted

Dec 8, 2025

Last verified

Dec, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Miami on 2025-12-08.