Treatment of Relapsed/Refractory Intracranial Glioma in Patients Under 22 Years of Age

Part of paid clinical trials in Miami, Florida.

Sponsor
University of Miami
Study ID
NCT05956821
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Anaplastic Astrocytoma
  • DIPG Brain Tumor
  • Diffuse Intrinsic Brainstem Glioma
  • Diffuse Intrinsic Pontine Glioma
  • Fibrillary Astrocytomas
  • Glioblastoma Multiforme
  • H3 K27M
  • Oligodendroglioma

Eligibility Criteria

Sex
ALL
Age
1 Year - 21 Years
Healthy Volunteers
Accepted

Interventions

Study Details

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.

Key Dates

Start date
Jun 19, 2025
Status verified
Dec 2025
Primary completion
Oct 1, 2029
Completion
Dec 1, 2029

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

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.

Primary Outcome Measure

Number of Treatment Related Adverse Events [ Time Frame: 1 month post injection ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Jackson Memorial HospitalMiamiFlorida33136
Heather McCrea, MD
[email protected]
305-585-3627
Heather McCrea, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Jackson Memorial Hospital· Miami, FL

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