NCT03086616

CED With Irinotecan Liposome Injection Using Real Time Imaging in Children With Diffuse Intrinsic Pontine Glioma (DIPG) (PNOC 009)

A Phase I and Early Efficacy Study of Convection Enhanced Delivery of Irinotecan Liposome Injection Using Real Time Imaging With Gadolinium in Children With Diffuse Intrinsic Pontine Glioma

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Sabine Mueller, MD, PhD · Academic / Other
• Sex: All
• Age: 2 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase I and Early Efficacy Study of Convection Enhanced Delivery (CED) of irinotecan liposome injection (nal-IRI) Using Real Time Imaging with Gadolinium in Children with Diffuse Intrinsic Pontine Glioma who have completed focal radiotherapy

Detailed description

This study will assess the safety and tolerability of repeated administration of nal-IRI co-infused with gadoteridol given by intratumoral CED in children with newly diagnosed DIPG.

Conditions

• Diffuse Intrinsic Pontine Glioma

Interventions

Type	Name	Description
DRUG	Convection Enhanced Delivery (CED) of Nanoliposomal irinotecan (nal-IRI)	Nal-IRI will be given directly into the tumor using CED.

Timeline

• Start date: 2017-10-31
• Primary completion: 2021-10-04
• Completion: 2021-10-04
• First posted: 2017-03-22
• Last updated: 2023-04-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study