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CED of MTX110 Newly Diagnosed Diffuse Midline Gliomas

NCT04264143 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2023-12-18

No results posted yet for this study

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.

Conditions

  • Diffuse Intrinsic Pontine Glioma
  • Diffuse Pontine and Thalamic Gliomas
  • Diffuse Midline Glioma

Interventions

DRUG

Infusate with MTX110 and gadolinium

Pulses 1 and 2 will be prepared with 30, 60 or 90 uM concentration of MTX110. The infusate consists of gadolinium and MTX110 (30, 60, or 90 uM) at approximately 1:100 ratio.

DEVICE

Convection-Enhanced Delivery (CED)

CED is the method by which the drug are delivered to the brain under controlled pressure to the brain by targeted micro-catheters.

Sponsors & Collaborators

  • Midatech Pharma US Inc.

    collaborator INDUSTRY

  • Luca Szalontay

    lead OTHER

Principal Investigators

  • Luca Szalontay, MD · Columbia University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
3 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-03-10
Primary Completion
2022-04-25
Completion
2023-11-22
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04264143 on ClinicalTrials.gov