CED With Irinotecan Liposome Injection Using Real Time Imaging in Children With Diffuse Intrinsic Pontine Glioma (DIPG) (PNOC 009)
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|ClinicalTrials.gov Identifier: NCT03086616|
Recruitment Status : Completed
First Posted : March 22, 2017
Last Update Posted : January 5, 2022
|Condition or disease||Intervention/treatment||Phase|
|Diffuse Intrinsic Pontine Glioma||Drug: Convection Enhanced Delivery (CED) of Nanoliposomal irinotecan (nal-IRI)||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||6 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Actual Study Start Date :||October 31, 2017|
|Actual Primary Completion Date :||October 4, 2021|
|Actual Study Completion Date :||October 4, 2021|
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.
Drug: Convection Enhanced Delivery (CED) of Nanoliposomal irinotecan (nal-IRI)
Nal-IRI will be given directly into the tumor using CED.
Other Name: Irinotecan Liposome Injection
- Number of Participants Experiencing Treatment-Related Adverse Events (AE) [ Time Frame: 12 months ]Safety of repeated CED of nal-IRI following standard of care focal radiotherapy will be assessed by monitoring for adverse events, scheduled laboratory assessments, vital sign measurements, and physical examinations for subjects who receive the vaccination. The severity of toxicities will be graded according to the NCI CTCAE v4.0. Adverse events and clinically significant laboratory abnormalities (meeting Grade 3, 4, or 5 criteria according to CTCAE) will be summarized by maximum intensity and relationship to study drug(s). Grade 1 and 2 adverse events will be summarized if related to study therapy. Descriptive statistics will be utilized to display the data on toxicity
- Overall Survival (OS) at 12 months (OS12) [ Time Frame: 12 months ]Any eligible subject treated on the dose level that will be investigated within the expansion cohort will be considered evaluable for clinical efficacy. Analyses will be performed after all enrolled patients have completed 12 months, or whenever the status of all patients has been established, whichever comes first. The primary analysis will be based on the Kaplan-Meier method. Kaplan-Meier estimates and the associated 95% confidence intervals (CI) will be calculated
- Distribution of Gadolinium [ Time Frame: 12 months ]Assessment of observed distribution of gadolinium compared to pre-treatment modeling of the drug distribution utilizing predictive imaging software.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03086616
|United States, California|
|University of California, San Francisco|
|San Francisco, California, United States, 94158|
|Study Chair:||Sabine Mueller, MD, PhD, MAS||University of California, San Francisco|