Trial · NCT04264143
CED of MTX110 Newly Diagnosed Diffuse Midline Gliomas
NCT04264143, Phase 1, Completed, Luca Szalontay
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. CED of MTX110 Newly Diagnosed Diffuse Midline Gliomas. Trials, record NCT04264143. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04264143
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- CED of MTX110 Newly Diagnosed Diffuse Midline Gliomas
- NCT number
- NCT04264143
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 9 participants, actual
- Lead sponsor
- Luca Szalontay
- Conditions
- Diffuse Intrinsic Pontine Glioma, Diffuse Pontine and Thalamic Gliomas, Diffuse Midline Glioma
- Interventions
- Infusate with MTX110 and gadolinium, Convection-Enhanced Delivery (CED)
- First posted
- 2020-02-11
- Last updated
- 2023-12-18
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence of Adverse Events | Up to six weeks after second infusion | Safety of repeated convection-enhanced delivery (CED) of MTX110 will be reported by summarizing the incidence rate of adverse events observed or reported. Adverse events will be graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. |
| Primary | Maximum Tolerated Dose (MTD) of MTX110 | 14 days | The MTD will be determined based on the number of dose limiting toxicities (DLT) observed in each of the titrated doses. |
| Secondary | Steady state volume of drug distribution | 14 days | Measured by volumetric contrast enhancement intensity on MRI and magnetic resonance (MR) spectroscopy |
| Secondary | Time to tumor progression/recurrence (PFS) | 2 years | PFS is defined as the duration of time from start of MTX110 treatment to time of progression or death from any cause, whichever occurs first. |
| Secondary | Overall survival (OS) or time to death | 2 years | Overall survival is defined as the duration of time from the start of MTX110 treatment to death from any cause. OS will be measured by follow-up with a study participant every 3-6 months until death for any reason. |
| Secondary | Score on PedsQL 4.0 Brain Tumor Module | 2 years | The 24-item PedsQL 4.0 Brain Tumor Module encompasses six scales: (1) cognitive problems (seven items), (2) pain and hurt (three items), (3) movement and balance (three items), (4) procedural anxiety (three items), (5) nausea (five items), and (6) worry (three items). Each item is measured with a 5-point Likert scale from 0 (never a problem) to 4 (almost always a problem), which is then transformed on a scale from 0-100. Higher scores indicate lower problems and therefore a better outcome. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04264143
GET https://conductscience.org/api/trials/v1/NCT04264143/registered