Actively Recruiting
Treatment of Relapsed/Refractory Intracranial Glioma in Patients Under 22 Years of Age
Led by University of Miami · Updated on 2025-12-08
20
Participants Needed
1
Research Sites
232 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Treatment of Relapsed/Refractory Intracranial Glioma in Patients Under 22 Years of Age
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Documented diagnosis of relapsed or refractory glioblastoma multiforme, anaplastic astrocytoma, fibrillary astrocytomas, pilomyxoid astrocytoma, oligodendroglioma, or anaplastic mixed oligoastrocytoma, or radiologically diagnosed diffuse intrinsic brainstem glioma
- At least one confirmed and evaluable tumor site
- Karnofsky or Lansky performance status of 60% or higher
- No chemotherapy within three weeks prior to treatment
- Adequate blood counts with absolute neutrophils of at least 1000/mm3 and platelets of at least 100,000/mm3
- Liver function tests with bilirubin less than 1.5 times the upper limit of normal, AST or ALT less than 2.5 times the upper limit of normal
- Kidney function with creatinine less than 1.5 times the upper limit of normal
- Coagulation tests (PT and PTT) less than or equal to 1.5 times the upper limit of normal
- No growth factors received within one week before entering the study
- Stable or decreasing dose of systemic corticosteroids for at least one week prior to study entry if receiving dexamethasone
- Agree to use effective contraception during and for three months after treatment if of reproductive age
- Ability to understand and provide written informed consent
- Craniotomy patients eligible if surgery was more than two weeks before intra-arterial therapy; major surgery must wait four weeks after SIACI Avastin therapy
- Minor surgeries allowed after two weeks
You will not qualify if you...
- Pregnant or lactating females
- Fertile men and females of childbearing potential who do not agree to use effective contraception during and for three months after treatment
- Significant concurrent medical or psychiatric conditions that increase risk or affect ability to comply with treatment or monitoring
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Jackson Memorial Hospital
Miami, Florida, United States, 33136
Actively Recruiting
Research Team
H
Heather McCrea, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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