MTX110 by Convection-Enhanced Delivery in Treating Participants With Newly-Diagnosed Diffuse Intrinsic Pontine Glioma (PNOC015)
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|ClinicalTrials.gov Identifier: NCT03566199|
Recruitment Status : Completed
First Posted : June 25, 2018
Results First Posted : February 25, 2022
Last Update Posted : February 25, 2022
|Condition or disease||Intervention/treatment||Phase|
|Diffuse Intrinsic Pontine Glioma||Drug: Panobinostat Nanoparticle Formulation MTX110 Drug: Convection-Enhanced Delivery (CED)||Phase 1 Phase 2|
I. To determine the safety and tolerability of repeated administration of MTX110 co-infused with gadoteridol given by intratumoral convection enhanced delivery in children with newly diagnosed diffuse intrinsic pontine glioma (DIPG).
I. To determine the clinical efficacy of repeated administration of MTX110 given by intratumoral convection-enhanced delivery (CED) in children with newly diagnosed DIPG in the confines of a phase I and early efficacy study.
OUTLINE: This is a phase I, dose-escalation study followed by a phase II study.
Participants receive panobinostat nanoparticle formulation MTX110 intratumorally (IT) by CED infusion on day 1 or days 1 and 2 as determined by dose level. Courses repeat every 4-8 weeks for up to 24 months in the absence of disease progression or unacceptable toxicity.
After completion of study treatment participants are followed up at 30 days and then every 2 months.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||7 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open Label Single Arm Phase I/II Study of MTX110 Delivered by Convection-enhanced Delivery (CED) in Patients With Diffuse Intrinsic Pontine Glioma (DIPG) Previously Treated With External Beam Radiation Therapy|
|Actual Study Start Date :||May 22, 2018|
|Actual Primary Completion Date :||March 31, 2021|
|Actual Study Completion Date :||March 31, 2021|
Experimental: Treatment (MTX110)
Participants receive panobinostat nanoparticle formulation MTX110 IT by CED infusion on day 1 or days 1 and 2 as determined by dose level. Courses repeat every 4-8 weeks for up to 24 months in the absence of disease progression or unacceptable toxicity.
Drug: Panobinostat Nanoparticle Formulation MTX110
Drug: Convection-Enhanced Delivery (CED)
Other Name: CED
- Proportion of Participants With Grade 3 or Higher, Treatment-related, Adverse Events [ Time Frame: Up to 12 Months ]Adverse events and clinically significant laboratory abnormalities which meet Grade 3, 4, or 5 criteria according to Common Terminology Criteria for Adverse Events (CTCAE) classified by investigators and treating physicians as related to study treatment (probable, possible, and definite) will be summarized by maximum intensity/grade. Adverse events will be graded according to CTCAE version 4.0.
- Overall Survival Rate (OS) at 12 Months [ Time Frame: Up to 12 Months ]Overall survival is defined as the percentage of participants alive from time of diagnosis up to 12 months.
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): NCT03566199
|United States, California|
|University of California, San Francisco|
|San Francisco, California, United States, 94158|
|Principal Investigator:||Sabine Mueller, M.D.||University of California, San Francisco|