CED With Irinotecan Liposome Injection Using Real Time Imaging in Children With Diffuse Intrinsic Pontine Glioma (DIPG)
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|ClinicalTrials.gov Identifier: NCT03086616|
Recruitment Status : Recruiting
First Posted : March 22, 2017
Last Update Posted : August 9, 2019
|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)|
|Estimated Enrollment :||19 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 :||May 23, 2017|
|Estimated Primary Completion Date :||September 2020|
|Estimated Study Completion Date :||September 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 4-6 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 with Adverse Events related to treatment [ 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.
- 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.
- 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
|Contact: Sabine Mueller, MD, PhD, MAS||(415) firstname.lastname@example.org|
|Contact: Aubrie Drechsler||(415) email@example.com|
|United States, California|
|UCSF Helen Diller Family Comprehensive Cancer Center||Recruiting|
|San Francisco, California, United States, 94158|
|Contact: Sabine Mueller, MD 415-476-3831 firstname.lastname@example.org|
|Study Chair:||Sabine Mueller, MD, PhD, MAS||University of California, San Francisco|