FUS Etoposide for DMG

PHASE1RecruitingINTERVENTIONAL
Enrollment

10

Participants

Timeline

Start Date

June 5, 2023

Primary Completion Date

December 31, 2025

Study Completion Date

December 31, 2027

Conditions
Diffuse Intrinsic Pontine GliomaDiffuse Midline Glioma, H3 K27M-Mutant
Interventions
DRUG

Etoposide; Oral, 50 Mg

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.

DEVICE

Focused ultrasound with neuro-navigator-controlled sonication

Focused ultrasound sonication will be performed a maximum of three times a week for two weeks with two weeks of rest.

Trial Locations (1)

10032

RECRUITING

Columbia University Irving Medical Center, New York

All Listed Sponsors
collaborator

Focused Ultrasound Foundation

OTHER

lead

Columbia University

OTHER