Actively Recruiting
FUS Etoposide for DMG
Led by Columbia University · Updated on 2026-01-28
10
Participants Needed
1
Research Sites
234 weeks
Total Duration
On this page
Sponsors
C
Columbia University
Lead Sponsor
F
Focused Ultrasound Foundation
Collaborating Sponsor
AI-Summary
What this Trial Is About
The blood brain barrier (BBB) prevents some drugs from successfully reaching the target tumor. Focused Ultrasound (FUS) using microbubbles and neuro-navigator controlled sonication is a non-invasive method of temporarily opening up the blood brain barrier to allow a greater concentration of the drug to reach into the brain tumor. This may improve response and may also reduce system side effects in the patient. The primary purpose of this study is to evaluate the feasibility of safely opening the blood brain barrier in children with progressive diffuse midline gliomas (DMG) treated with oral etoposide using focused ultrasound with microbubbles and neuro-navigator-controlled sonication. For the purpose of the study, the investigators will be opening up the blood brain barrier temporarily in one or two locations around the tumor using the non-invasive focused ultrasound technology, and administrating oral etoposide in children with progressive diffuse midline glioma.
CONDITIONS
Official Title
FUS Etoposide for DMG
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ages 4 to 21 years
- Radiological diagnosis of Diffuse Midline Glioma involving the pons, thalami, or histological confirmation of H3K27M mutation
- Evidence of clinical and/or radiographic progression of disease
- Lansky performance status score of at least 60 for subjects 16 years or younger
- Karnofsky performance status of at least 60 for subjects older than 16 years
- Adequate hematologic function: neutrophil count ≥ 1,500/µL, platelet count ≥ 100,000/µL, normal PTT and APTT
- Adequate renal function: potassium and magnesium levels within normal limits, serum creatinine below institutional upper limit or creatinine clearance ≥ 60 mL/min/1.73m2
- Adequate hepatic function: total bilirubin below institutional upper limit, AST/ALT ≤ 2.5 times institutional upper limit
- Fully recovered from prior anticancer therapy with specific minimum waiting periods
- Stable or decreasing dose of steroids and stable anti-seizure medication for at least 1 week
- Ability to give consent
You will not qualify if you...
- Prior etoposide therapy
- Unable to tolerate study procedures or anesthesia
- Uncontrolled seizure disorder
- Pregnancy or breastfeeding
- Currently receiving another investigational drug or anticancer agent
- QTc > 450 msec on screening EKG
- Active systemic infection
- Allergy to etoposide or gadolinium compounds
- Implanted metallic or electrical devices
- Uncontrollable hypertension
- Documented bleeding disorder
- History of structural cardiac anomalies or arrhythmias
- History or signs of stroke in the FUS target area
- Recent SARS-CoV-2 infection requiring hospitalization and anticoagulation
- Coagulopathy or anticoagulant therapy
- Signs of impending herniation or intratumoral hemorrhage
- Spinal cord diffuse midline glioma
- Receiving drugs with suspected central nervous system toxicity
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Columbia University Irving Medical Center
New York, New York, United States, 10032
Actively Recruiting
Research Team
S
Stergios Zacharoulis, MD
CONTACT
J
James H Garvin, MD, PhD
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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