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Nanoparticle Formulation

CED with MTX110 for Brain Cancer

Phase 1
Waitlist Available
Led By Stergios Zacharoulis, MD
Research Sponsored by Stergios Zacharoulis
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Radiological diagnosis of DIPG with tumor confined to the region of the pons or thalami without cystic changes or hematoma obstructing the planned catheter trajectories
Subjects must be able to undergo MR-imaging with gadolinium-based contrast administration (e.g. no ferrous-containing implants, no pacemakers, etc.)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

Study Summary

This trial is testing a new way to give drugs to children with brain tumors. The drugs are put directly into the tumor, which may reduce side effects for the patient.

Who is the study for?
Children aged 3 to under 18 with a specific brain tumor called diffuse midline glioma, who haven't had previous treatments except for radiotherapy and procedures for fluid in the brain. They must be generally healthy, not pregnant or breastfeeding, able to have an MRI with contrast dye, and without severe infections or allergies to the study drugs.Check my eligibility
What is being tested?
The trial is testing how much of a drug called MTX110 can be safely given directly into the tumor using Convection-Enhanced Delivery (CED) in children with newly diagnosed diffuse midline gliomas. The goal is to bypass the blood-brain barrier and reduce side effects by delivering MTX110 and gadolinium straight to the tumor over several days.See study design
What are the potential side effects?
Possible side effects include reactions at the infusion site, changes in blood tests reflecting organ function, potential bleeding issues due to direct delivery of medication into the brain tissue, allergic reactions to MTX110 or gadolinium, and general risks associated with anesthesia.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You have a specific type of brain tumor located in the pons or thalami, without certain changes or blockages.
Select...
You should be able to have an MRI scan with a special dye called gadolinium, which may not be possible if you have certain metal implants or a pacemaker.
Select...
You have a specific type of brain tumor in the thalamus that does not have cysts or bleeding blocking the planned treatment.
Select...
You have a good level of physical ability and daily functioning.
Select...
You do not have allergies to drugs or substances similar to MTX110 or gadolinium compounds.
Select...
If you have a history of seizures or epilepsy, you need to be taking medication for it, and the medication should be at the right level in your blood.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of Adverse Events
Maximum Tolerated Dose (MTD) of MTX110
Secondary outcome measures
Overall survival (OS) or time to death
Score on PedsQL 4.0 Brain Tumor Module
Steady state volume of drug distribution
+1 more

Side effects data

From 2021 Phase 1 & 2 trial • 7 Patients • NCT03566199
71%
Headache
57%
Fatigue
57%
Muscle weakness right-sided
57%
Ataxia
57%
Dizziness
43%
Cough
43%
Electrocardiogram QT corrected interval prolonged
43%
White blood cell decreased
43%
Gait disturbance
43%
Abducens nerve disorder
43%
Lymphocyte count decreased
43%
Hypokalemia
43%
Nasal congestion
43%
Pain
29%
Paresthesia
29%
Neck pain
29%
Facial nerve disorder
29%
Skin and subcutaneous tissue disorders - Other
29%
Dysarthria
29%
Trigeminal nerve disorder
29%
Vagus nerve disorder
29%
Nervous system disorders - Other
29%
Dysphagia
29%
Muscle weakness left-sided
29%
Hypomagnesemia
29%
Constipation
14%
Vomiting
14%
Hematoma
14%
Stridor
14%
Urticaria
14%
Hemoglobin increased
14%
Diarrhea
14%
Accessory nerve disorder
14%
Dysgeusia
14%
Aspartate aminotransferase increased
14%
Neutrophil count decreased
14%
Weight loss
14%
Hypoglycemia
14%
Hiccups
14%
Skin ulceration
14%
Hypertension
14%
Anemia
14%
Glossopharyngeal nerve disorder
14%
Aphonia
14%
Dysphasia
14%
Psychiatric disorders - Other
14%
Sinus tachycardia
14%
Eye disorders - Other
14%
Urinary incontinence
14%
Allergic reaction
14%
Blood bilirubin increased
14%
Wound dehiscence
14%
Irritability
14%
Tremor
14%
External ear pain
14%
Hyperkalemia
14%
Alanine aminotransferase increased
14%
Hearing impaired
14%
Corneal ulcer
14%
Fall
14%
Epistaxis
14%
Hyperglycemia
14%
Agitation
14%
Hypotension
14%
Sinus bradycardia
14%
Blurred vision
14%
Insomnia
14%
Otitis externa
14%
Urinary tract pain
14%
External ear inflammation
14%
Urinary urgency
100%
80%
60%
40%
20%
0%
Study treatment Arm
Phase 1: Treatment (MTX110)

Trial Design

1Treatment groups
Experimental Treatment
Group I: MTX110 and CEDExperimental Treatment2 Interventions
All patients enrolled in the study will receive infusion of MTX110 and Gadolinium delivered by the CED delivery system directly into the tumor over 9-11 days.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Infusate with MTX110 and gadolinium
2020
Completed Phase 1
~10
Convection-Enhanced Delivery (CED)
2020
Completed Phase 2
~20

Find a Location

Who is running the clinical trial?

Stergios ZacharoulisLead Sponsor
Luca SzalontayLead Sponsor
Midatech Pharma US Inc.Industry Sponsor
2 Previous Clinical Trials
35 Total Patients Enrolled

Media Library

MTX110 (Nanoparticle Formulation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04264143 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who meets the criteria for enrollment in this research project?

"To partake in this clinical trial, enrollees should have diffuse intrinsic pontine glioma and inhabit the age range of 3 to 18. The total number of participants is expected to reach 9 individuals."

Answered by AI

What are the chief aims of this research?

"This clinical trial will be conducted over a fortnight and it's primary objective is to evaluate Adverse Events Incidence. Secondary goals include ascertaining the Overall Survival (OS) rate, Time to Tumor Progression/Recurrence (PFS), and Steady State Volume of Drug Distribution – all determined by follow-up with participants per 3-6 months or magnetic resonance imaging scans."

Answered by AI

Are there any openings left for enrollment in this clinical trial?

"According to data available on clinicaltrials.gov, this study is currently seeking applicants; it was initially posted in March of 2020 and recently revised in early March 2022."

Answered by AI

What is the upper limit of participants for this clinical trial?

"Indeed, the records on clinicaltrials.gov demonstrate that this medical trial is recruiting right now. It was first posted on March 10th 2020 and revised most recently on March 8th 2022. For its success, 9 participants need to be enlisted from one site."

Answered by AI

Does the research study allow participants of under 65 years to take part?

"This scientific research requires participants to fall between the ages of 3 and 18. Data collected thus far shows that 143 studies include individuals younger than 18, while 247 include seniors above 65 years old."

Answered by AI

What potential risks are associated with Convection-Enhanced Delivery (CED) for humans?

"Our evaluation concluded that Convection-Enhanced Delivery (CED) is cautiously safe, scoring a 1 on our scale. This low score indicates limited data regarding the efficacy and safety of CED."

Answered by AI

Has Convection-Enhanced Delivery (CED) been studied in past clinical trials?

"Currently, 10 CED trials are active with none of them at the Phase 3 stage. Birmingham, Alabama is one hub for such research; however, 26 other locations across America offer clinical studies related to Convection-Enhanced Delivery (CED)."

Answered by AI

Who else is applying?

What state do they live in?
Massachusetts
How old are they?
< 18
What site did they apply to?
Columbia University Irving Medical Center
What portion of applicants met pre-screening criteria?
Met criteria

How responsive is this trial?

Typically responds via
Email
Average response time
  • < 2 Days
Most responsive sites:
  1. Columbia University Irving Medical Center: < 48 hours
~2 spots leftby Mar 2025