Trial · NCT05278208
Lutathera for Treatment of Recurrent or Progressive High-Grade CNS Tumors
NCT05278208, Phase 1, Phase 2, Recruiting, Nationwide Children's Hospital
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Lutathera for Treatment of Recurrent or Progressive High-Grade CNS Tumors. Trials, record NCT05278208. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05278208
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Lutathera for Treatment of Recurrent or Progressive High-Grade CNS Tumors
- NCT number
- NCT05278208
- Status
- Recruiting
- Phases
- Phase 1, Phase 2
- Enrollment
- 65 participants, estimated
- Lead sponsor
- Nationwide Children's Hospital
- Conditions
High Grade Glioma, Meningioma, Embryonal Tumor, Medulloblastoma, Anaplastic Ependymoma, Recurrent Diffuse Intrinsic Pontine Glioma, Recurrent Malignant Glioma, Recurrent Medulloblastoma, Recurrent Primary Central Nervous System Neoplasm, Refractory Diffuse Intrinsic Pontine Glioma, Refractory Malignant Glioma, Refractory Medulloblastoma, Refractory Primary Central Nervous System Neoplasm
- Interventions
- LUTATHERA® (Lutetium Lu 177 dotatate)
- First posted
- 2022-03-14
- Last updated
- 2026-07-20
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Estimate MTD of Lutathera in pediatric CNS patients 4 to <12 years | up to 8 months | To estimate the maximum tolerated dose (MTD) of Lutathera in pediatric patients between 4 and 12 to \</=39 yearsof age with recurrent and/or progressive high-grade CNS tumors or meningiomas that demonstrate uptake on DOTATATE PET. |
| Primary | Estimate RP2D of Lutathera in pediatric CNS patients 4 to <12 years | up to 8 months | To estimate the recommended Phase II dose (RP2D) of Lutathera in pediatric patients between 4 and 12 to \</=39 years of age with recurrent and/or progressive high-grade CNS tumors or meningiomas that demonstrate uptake on DOTATATE PET. |
| Primary | Calculate the incidence of treatment related adverse events as assessed by CTCAE v5.0 in pediatric (4 to <12 yo) CNS patients treated with Lutathera | up to 2 months | To define and describe the toxicities of Lutathera in pediatric patients with recurrent and/or progressive high-grade CNS tumors or meningiomas that demonstrate uptake on DOTATATE PET. This will include calculating the number of participants with Lutathera-related adverse events as assessed by CTCAE v 5.0 |
| Primary | Assess PFS of Lutathera in CNS patients 12 to </=39 years | up to 6 months | To assess efficacy, evaluated by 6 month progression-free survival, of treatment with Lutathera in adolescent and young adult patients age 12 to \</=39 years with recurrent and/or progressive high-grade CNS tumors or meningiomas that demonstrate uptake on DOTATATE PET |
| Secondary | Objective Response Rate of Lutathera in CNS patients 12 to </=39 years | up to 8 months | To evaluate the objective response rate of Lutathera in adolescent and young adult patients age 12 to \</=39 years with recurrent and/or progressive high-grade CNS tumors or meningiomas that demonstrate uptake on DOTATATE PET. |
| Secondary | Calculate the incidence of treatment related adverse events as assessed by CTCAE v5.0 in CNS patients 12 </=39 years treated with Lutathera | up to 8 months | To establish the safety and toxicity of Lutathera 200 mCi every 8-week dosing in adolescent and young adult patients age 12 to \</=39 years with recurrent and/or progressive high-grade CNS tumors or meningiomas that demonstrate uptake on DOTATATE PET. This will include calculating the number of participants with, as well as severity and frequency of, Lutathera-related adverse events as assessed by CTCAE v 5.0 |
| Other | Anti-tumor activity of Lutathera | up to 8 months | Document anti-tumor activity of Lutathera through assessment of ORR, PFS in patients with recurrent or progressive High-Grade CNS tumors or meningiomas |
| Other | Prevalence of SST2A expression in patients with different high-grade CNS tumors | up to 8 months | Describe prevalence and heterogeneity of SST2A expression (IHC) in patients with recurrent or progressive High-Grade CNS tumors or meningiomas |
| Other | Correlation of SST2A expression with clinical and molecular features in high-grade CNS tumor patients treated with Lutathera | up to 8 months | Assess correlation of SST2A expression with uptake on DOTATATE PET, response to Lutathera therapy, and relevant clinical and molecular features within the confines of a Phase I/II study in patients with recurrent or progressive High-Grade CNS tumors or meningiomas treated with Lutathera |
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.
Papers47
The papers the trial lists on ClinicalTrials.gov.
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/NCT05278208
GET https://conductscience.org/api/trials/v1/NCT05278208/papers?page=2