CED With Irinotecan Liposome Injection Using Real Time Imaging in Children With Diffuse Intrinsic Pontine Glioma (DIPG) (PNOC 009)
NCT03086616 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 6
Last updated 2023-04-06
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
Conditions
- Diffuse Intrinsic Pontine Glioma
Interventions
- DRUG
-
Convection Enhanced Delivery (CED) of Nanoliposomal irinotecan (nal-IRI)
Nal-IRI will be given directly into the tumor using CED.
Sponsors & Collaborators
-
The V Foundation for Cancer Research
collaborator OTHER -
Pacific Pediatric Neuro-Oncology Consortium
collaborator OTHER -
Sabine Mueller, MD, PhD
lead OTHER
Principal Investigators
-
Sabine Mueller, MD, PhD, MAS · University of California, San Francisco
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 2 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2017-10-31
- Primary Completion
- 2021-10-04
- Completion
- 2021-10-04
- FDA Drug
- Yes
Countries
- United States
Study Locations
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