Glioblastoma MultiformePhase 1/2NCT05956821
Treatment of Relapsed/Refractory Intracranial Glioma in Patients Under 22 Years of Age
A Phase 1/2 study testing SIACI of cetuximab and bevacizumab in people with Glioblastoma Multiforme and Anaplastic Astrocytoma, run by University of Miami at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year to 21 yearsHealthy volunteers can take part
- Conditions the study is for
- Glioblastoma Multiforme, Anaplastic Astrocytoma, Fibrillary Astrocytomas
- What is being tested?
- SIACI of cetuximab and bevacizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Jun 2025to 1 Dec 2029
- Phase
- Phase 1/2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 21 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Show all 12Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Jackson Memorial Hospital
Miami, Florida, 33136
Heather McCrea, MD, 305-585-3627, hmccrea@med.miami.edu
Heather McCrea, MD
About this study
Official title: 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
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
- Being tested
- SIACI of cetuximab and bevacizumab
- Medical subject headings
- Glioblastoma, Astrocytoma, Oligodendroglioma, Diffuse Intrinsic Pontine Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SIACI of cetuximab and bevacizumabDrug
Also called erbitux, avastin
Subjects will receive monthly dosing of bevacizumab (15 mg/kg) and cetuximab (200mg/m2)
| Study group | Role | What they receive |
|---|---|---|
| SIACI of cetuximab and bevacizumab | Experimental | Participants in this group will receive Cetuximab and Bevacizumab infusion into an artery each month for up to approximately one year. Receives: Drug: SIACI of cetuximab and bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Treatment Related Adverse Events
The number of treatment-related adverse events will be assessed and graded according to the NCI Common Toxicity Criteria, version 5.0.
Measured: 1 month post injection
Composite Overall Response Rate (CORR)
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.
Measured: 6 months
Progression-free survival (PFS)
PFS will be measured from the date of the first dose of SIACI Cetuximab/Avastin to the date of progression.
Measured: 1 year
Overall Survival (OS)
OS will be measured from the date of diagnosis to the date of death
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2023
- Study start19 Jun 2025
- Primary completion1 Oct 2029 (estimated)
- Study completion1 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Glioblastoma MultiformeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Heather McCrea, MD, University of Miami
- Investigators
- Heather McCrea, MD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05956821
- Sponsor's protocol ID
- 20230032
- Status last verified
- Dec 2025
- First submitted
- 14 Jul 2023
- Last updated
- 8 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34359048