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
- Are there results?
- Not yet: the study is under way
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
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- 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.
- More trials run by University of MiamiThe sponsor's other registered studies.
- 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
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05956821
- Acronym / sponsor ID
- 20230032
- Conditions
- Glioblastoma Multiforme, Anaplastic Astrocytoma, Fibrillary Astrocytomas, Oligodendroglioma, Diffuse Intrinsic Brainstem Glioma, Diffuse Intrinsic Pontine Glioma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- 19 Jun 2025 (actual)
- Primary completion
- 1 Oct 2029 (estimated)
- Study completion
- 1 Dec 2029 (estimated)
- First posted
- 21 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SIACI of cetuximab and bevacizumab | Experimental | Drug: SIACI of cetuximab and bevacizumabParticipants in this group will receive Cetuximab and Bevacizumab infusion into an artery each month for up to approximately one year. |
Who may qualify
- Ages
- 1 year to 21 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SIACI of cetuximab and bevacizumabAlso: erbitux, avastinSubjects will receive monthly dosing of bevacizumab (15 mg/kg) and cetuximab (200mg/m2) | Drug | SIACI of cetuximab and bevacizumab |
Primary outcome
Number of Treatment Related Adverse Events
Time frame: 1 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)
Time frame: 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)
Time frame: 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)
Time frame: 1 year
OS will be measured from the date of diagnosis to the date of death
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2025.
- Background: PubMed 34359048McCrea 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Heather McCrea, MD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Heather McCrea, MD (305-585-3627, hmccrea@med.miami.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Treatment Related Adverse Events (time frame: 1 month post injection). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05956821, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2025.