Finding studies
Finding studies
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Lead
Sabine Mueller, MD, PhD
With
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.
Age
2–21
Sex
ALL
Healthy volunteers
Not accepted