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

Part of paid clinical trials in San Francisco, California.

Sponsor
Sabine Mueller, MD, PhD
Study ID
NCT03086616
Phase
PHASE1
Status
Completed

Conditions

  • Diffuse Intrinsic Pontine Glioma

Eligibility Criteria

Sex
ALL
Age
2 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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

Key Dates

Start date
Oct 31, 2017
Status verified
Apr 2023
Primary completion
Oct 4, 2021
Completion
Oct 4, 2021

Study Design

Enrollment
6 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Newly Diagnosed DIPG
    Convection Enhanced Delivery (CED) of Nanoliposomal irinotecan (nal-IRI): Nal-IRI given directly into the tumor using a method called CED to newly diagnosed DIPG subjects after completion of radiotherapy. CED will be performed every 4-8 weeks. Drug concentration will start at 20mg/ml and escalate up to 40 mg/ml concentration.

Primary Outcome Measure

Number of Participants Experiencing Treatment-Related Adverse Events (AE) [ Time Frame: 12 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of California, San FranciscoSan FranciscoCalifornia94158-

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University of California, San Francisco· San Francisco, CA

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