NCT03566199

MTX110 by Convection-Enhanced Delivery in Treating Participants With Newly-Diagnosed Diffuse Intrinsic Pontine Glioma

An Open Label Single Arm Phase I/II Study of MTX110 Delivered by Convection-enhanced Delivery (CED) in Patients With Diffuse Intrinsic Pontine Glioma (DIPG) Previously Treated With External Beam Radiation Therapy

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Sabine Mueller, MD, PhD · Academic / Other
• Sex: All
• Age: 2 Years – 21 Years
• Healthy volunteers: Not accepted

Summary

This phase I/II trial studies the side effects of panobinostat nanoparticle formulation MTX110 (MTX110) in treating participants with newly-diagnosed diffuse intrinsic pontine glioma. Panobinostat nanoparticle formulation MTX110 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Detailed description

PRIMARY OBJECTIVES: I. To determine the safety and tolerability of repeated administration of MTX110 co-infused with gadoteridol given by intratumoral convection enhanced delivery in children with newly diagnosed diffuse intrinsic pontine glioma (DIPG). SECONDARY OBJECTIVES: I. To determine the clinical efficacy of repeated administration of MTX110 given by intratumoral convection-enhanced delivery (CED) in children with newly diagnosed DIPG in the confines of a phase I and early efficacy study. OUTLINE: This is a phase I, dose-escalation study followed by a phase II study. Participants receive panobinostat nanoparticle formulation MTX110 intratumorally (IT) by CED infusion on day 1 or days 1 and 2 as determined by dose level. Courses repeat every 4-8 weeks for up to 24 months in the absence of disease progression or unacceptable toxicity. After completion of study treatment participants are followed up at 30 days and then every 2 months.

Conditions

• Diffuse Intrinsic Pontine Glioma

Interventions

Type	Name	Description
DRUG	Panobinostat Nanoparticle Formulation MTX110	Given IT
DRUG	Convection-Enhanced Delivery (CED)	Undergo CED

Timeline

• Start date: 2018-05-22
• Primary completion: 2021-03-31
• Completion: 2021-03-31
• First posted: 2018-06-25
• Last updated: 2022-02-25
• Results posted: 2022-02-25

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study