FUS Etoposide for DMG

Part of paid clinical trials in New York, New York.

Sponsor
Columbia University
Study ID
NCT05762419
Phase
PHASE1
Status
Recruiting
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Conditions

  • Diffuse Intrinsic Pontine Glioma
  • Diffuse Midline Glioma, H3 K27M-Mutant

Eligibility Criteria

Sex
ALL
Age
4 Years - 21 Years
Healthy Volunteers
Not accepted

Interventions

  • Etoposide; Oral, 50 Mg — DRUG
    Subjects will receive focused ultrasound sonication followed by once daily oral etoposide (50mg/m\^2/dose). Oral etoposide will be taken every day for 21 days, followed by one week of rest. For the first cycle, etoposide will be administered immediately following confirming of the blood brain barrier opening through contrast magnetic resonance imaging (MRI) which will occur within 4 hours of the focused ultrasound procedure. For subsequent cycles, etoposide will be administered immediately following the focused ultrasound procedure. Subjects may continue for a maximum of 4 cycles.
  • Focused ultrasound with neuro-navigator-controlled sonication — DEVICE
    Focused ultrasound sonication will be performed a maximum of three times a week for two weeks with two weeks of rest.

Study Details

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.

Key Dates

Start date
Jun 5, 2023
Status verified
Jan 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2027

Study Design

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

Arms

  • Experimental: Focused ultrasound using oral etoposide
    All patients enrolled in the study will be treated with oral etoposide after receiving focused ultrasound (FUS) treatment with microbubbles and neuro-navigator-controlled sonication.

Primary Outcome Measure

Number of total adverse events [ Time Frame: Up to 90 days after the end of the last focused ultrasound treatment ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Columbia University Irving Medical CenterNew YorkNew York10032
Stergios Zacharoulis, MD
[email protected]
Stergios Zacharoulis, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Columbia University Irving Medical Center· New York, NY

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