NCT05956821 Treatment of Relapsed/Refractory Intracranial Glioma in Patients Under 22 Years of Age
| NCT ID | NCT05956821 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | University of Miami |
| Condition | Glioblastoma Multiforme |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2025-06-19 |
| Primary Completion | 2029-10-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 20 participants in total. It began in 2025-06-19 with a primary completion date of 2029-10-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Heather McCrea, MD
PRINCIPAL INVESTIGATOR
University of Miami
Frequently Asked Questions
Who can join the NCT05956821 clinical trial?
This trial is open to participants of all sexes, aged 1 Year or older, up to 21 Years, studying Glioblastoma Multiforme. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05956821 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05956821 currently recruiting?
Yes, NCT05956821 is actively recruiting participants. Contact the research team at hmccrea@med.miami.edu for enrollment information.
Where is the NCT05956821 trial being conducted?
This trial is being conducted at Miami, United States.
Who is sponsoring the NCT05956821 clinical trial?
NCT05956821 is sponsored by University of Miami. The principal investigator is Heather McCrea, MD at University of Miami. The trial plans to enroll 20 participants.
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