Clinical Trials Logo

Clinical Trial Summary

The blood brain barrier (BBB) prevents some drugs from successfully reaching the target source. Convection-Enhanced Delivery (CED) is a method of direct infusion of drugs under controlled pressure to the tumor that may reduce systemic side effects of drugs in the patient. The purpose of this Phase I study is to find the maximum tolerated dose of MTX110 (a water-soluble Panobinostat nanoparticle formulation) and Gadolinium that can be given safely in children with newly diagnosed diffuse midline gliomas. All patients enrolled in the study will receive infusion of MTX110 and Gadolinium delivered with a pump directly into the tumor over 9-11 days.


Clinical Trial Description

Diffuse midline gliomas (DMGs), constitute 10% of all pediatric central nervous system (CNS) tumors. Subjects with Diffuse Intrinsic Pontine Gliomas (DIPG) have a poor prognosis with a median survival that is usually reported to be 9 months, and nearly 90% of children die within 18 months from diagnosis. The mainstay of treatment is radiation to the primary tumor site. Surgical resection does not influence outcome and is often not feasible in this part of the central nervous system. Many promising drugs for central nervous system (CNS) disorders have failed to attain clinical success due to an intact blood brain barrier (BBB), limiting their access form the systemic circulation into the brain. Systemic administration of high doses may increase delivery to the brain, but this approach risks significant side effects and systemic toxicities. Direct delivery of the drugs to the brain by injection into the parenchyma bypasses the BBB, however, drug distribution form the site of injection tends to be limited. The convection-enhanced delivery (CED) of drugs describes the infusion of drugs under controlled pressure to the brain parenchyma via targeted microcatheter. This technique facilitates and deliver higher drug concentrations in brain tissue or tumor. The BBB can now operate to retain drug and to significantly reduce systemic side effects. In addition, the fact that panobinostat seems to be most efficacious clinically available drug against DIPG cells. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04264143
Study type Interventional
Source Columbia University
Contact
Status Completed
Phase Phase 1
Start date March 10, 2020
Completion date November 22, 2023

See also
  Status Clinical Trial Phase
Completed NCT01922076 - Adavosertib and Local Radiation Therapy in Treating Children With Newly Diagnosed Diffuse Intrinsic Pontine Gliomas Phase 1
Recruiting NCT05476939 - Biological Medicine for Diffuse Intrinsic Pontine Glioma (DIPG) Eradication 2.0 Phase 3
Terminated NCT03330197 - A Study of Ad-RTS-hIL-12 + Veledimex in Pediatric Subjects With Brain Tumors Including DIPG Phase 1/Phase 2
Terminated NCT03690869 - REGN2810 in Pediatric Patients With Relapsed, Refractory Solid, or Central Nervous System (CNS) Tumors and Safety and Efficacy of REGN2810 in Combination With Radiotherapy in Pediatric Patients With Newly Diagnosed or Recurrent Glioma Phase 1/Phase 2
Active, not recruiting NCT02992015 - Gemcitabine in Newly-Diagnosed Diffuse Intrinsic Pontine Glioma Early Phase 1
Terminated NCT01182350 - Molecularly Determined Treatment of Diffuse Intrinsic Pontine Gliomas (DIPG) Phase 2
Recruiting NCT04837547 - PEACH TRIAL- Precision Medicine and Adoptive Cellular Therapy Phase 1
Active, not recruiting NCT04911621 - Adjuvant Dendritic Cell Immunotherapy for Pediatric Patients With High-grade Glioma or Diffuse Intrinsic Pontine Glioma Phase 1/Phase 2
Not yet recruiting NCT06333899 - Lorlatinib for Newly-Diagnosed High-Grade Glioma With ROS or ALK Fusion Early Phase 1
Completed NCT00879437 - Valproic Acid, Radiation, and Bevacizumab in Children With High Grade Gliomas or Diffuse Intrinsic Pontine Glioma Phase 2
Active, not recruiting NCT02420613 - Vorinostat and Temsirolimus With or Without Radiation Therapy in Treating Younger Patients With Newly Diagnosed or Progressive Diffuse Intrinsic Pontine Glioma Phase 1
Completed NCT03086616 - CED With Irinotecan Liposome Injection Using Real Time Imaging in Children With Diffuse Intrinsic Pontine Glioma (DIPG) (PNOC 009) Phase 1
Recruiting NCT01837862 - A Phase I Study of Mebendazole for the Treatment of Pediatric Gliomas Phase 1/Phase 2
Not yet recruiting NCT06093165 - RE-irradiation of Diffuse MIdline Glioma paTients N/A
Withdrawn NCT03632317 - A Study of Panobinostat in Combination With Everolimus for Children and Young Adults With Gliomas Phase 2
Completed NCT02502708 - Study of the IDO Pathway Inhibitor, Indoximod, and Temozolomide for Pediatric Patients With Progressive Primary Malignant Brain Tumors Phase 1
Recruiting NCT02233049 - Biological Medicine for Diffuse Intrinsic Pontine Glioma (DIPG) Eradication Phase 2
Completed NCT00996723 - Clinical Trial Evaluating the Combination of Vandetanib and Dasatinib During and After Radiation Therapy (RT) in Children With Newly Diagnosed Diffuse Intrinsic Pontine Glioma (DIPG) Phase 1
Recruiting NCT05009992 - Combination Therapy for the Treatment of Diffuse Midline Gliomas Phase 2
Recruiting NCT04049669 - Pediatric Trial of Indoximod With Chemotherapy and Radiation for Relapsed Brain Tumors or Newly Diagnosed DIPG Phase 2