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 : Recruiting
First Posted : June 25, 2018
Last Update Posted : June 25, 2018
|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)|
|Estimated Enrollment :||24 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|
|Estimated Primary Completion Date :||September 1, 2019|
|Estimated Study Completion Date :||September 1, 2020|
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
- Safety of repeated convection-enhanced delivery (CED) of MTX110 following standard of care focal radiotherapy [ Time Frame: up to 5 years ]Safety of repeated convection-enhanced delivery (CED) of MTX110 following standard of care focal radiotherapy will be reported by summarizing the incidence of adverse events by maximum intensity and relationship to study drug. Adverse events will be graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
- Overall survival at 12 months [ Time Frame: Up to 12 Months ]Analyses will be performed after all enrolled subjects have completed 12 months, or whenever the status of all subjects has been established, whichever comes first.
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
|Contact: Jenna Weight||415-502-1600||PNOC_Regulatory@ucsf.edu|
|United States, California|
|University of California, San Francisco||Recruiting|
|San Francisco, California, United States, 94158|
|Contact: Jenna Weight 415-502-1600 PNOC_Regulatory@ucsf.edu|
|Principal Investigator: Sabine Mueller, M.D.|
|United States, New York|
|Memorial Sloan Kettering Cancer Center||Not yet recruiting|
|New York, New York, United States, 10065|
|Contact: Mark Souweidane, M.D. 212-639-2336 firstname.lastname@example.org|
|Principal Investigator: Mark Souweidane, M.D.|
|Principal Investigator:||Sabine Mueller, M.D.||University of California, San Francisco|