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Lutathera for Recurrent or Progressive High-Grade Brain and Spinal Cord Tumors

This study is testing Lutathera (Lutetium Lu 177 dotatate) for people aged 4 to 39 with certain types of brain and spinal cord tumors (High Grade Glioma, Meningioma, Embryonal Tumor, Medulloblastoma, Anaplastic Ependymoma) that have come back or gotten worse. Lutathera is a targeted therapy that works by binding to specific receptors (SST2A) on tumor cells, which can help control cell growth. You would receive Lutathera intravenously (through a vein) once every 8 weeks for up to 4 doses over 8 months. The main goals are to find the safest dose and see how well it works, especially in children aged 4 to under 12 years. To join, your tumor must show uptake on a special scan called a DOTATATE PET. The current status of this study is unclear.

Study design
This is an interventional study planning to enroll 65 participants. It is designed to evaluate the safety and effectiveness of Lutathera.
What's involved
You would receive Lutathera intravenously once every 8 weeks for a total of up to 4 cycles (8 months). Imaging studies must be done within three weeks prior to enrollment, and other clinical evaluations within 7 days.
Compensation
Not stated in the trial record.
Follow-up
The study will measure the incidence of treatment-related side effects for up to 2 months, and the maximum tolerated dose and recommended dose for up to 8 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05278208

Lutathera for Treatment of Recurrent or Progressive High-Grade CNS Tumors

Recruiting
PHASE1Ages 4–39InterventionalTreatment
Nationwide Children's Hospital
~65 participants
Updated 2026-07-20 on ClinicalTrials.gov
What's tested:LUTATHERA® (Lutetium Lu 177 dotatate)

At a glance

Recruiting sites
2 of 4 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Estimate MTD of Lutathera in pediatric CNS patients 4 to <12 years
Measured over up to 8 months
+3 more outcomes measured

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

Explore related trials

Anaplastic EpendymomaDiffuse Intrinsic Pontine GliomaEmbryonal NeoplasmMalignant GliomaMedulloblastomaMeningiomaPrimary Central Nervous System NeoplasmSomatostatin Receptor

NCT05278208

Where you'd take part

This study runs at 4 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvaniastudy coordinator listed

    Not yet recruiting

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohiostudy coordinator listed

    Recruiting

  • Nationwide Children's Hospital

    Columbus, Ohiostudy coordinator listed

    Recruiting

  • Children's Hospital Colorado

    Aurora, Coloradono site contact published

    Withdrawn

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Margot Lazow, MD · PRINCIPAL_INVESTIGATOR · Nationwide Children's Hospital

Who to contact

Kelsey H Troyer, PhD
[email protected]
614-722-8566
Email the study team

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Eligibility criteria

Inclusion

Phase I Age Patient must be ≥ 4 and \<12 years of age at the time of enrollment. Disease Status: Patients who participate in the efficacy expansion cohort must have bi-dimensionally measurable disease, defined as at least one lesion that can be accurately measured in at least two dimensions Patients with measurable extraneural disease only are also eligible.
Phase II Age Patient must be 12 to \</=39 years at the time of enrollment.
Craniospinal irradiation or total body irradiation or radiation to \> 50% of pelvis \> 3 months prior to enrollment.
Focal irradiation \> 4 weeks prior to enrollment
≥ 6 months since allogeneic stem cell transplant prior to enrollment with no evidence of active graft vs. host disease
≥ 3 months since autologous stem cell transplant prior to enrollment
Phase I: Patients must be off thrombopoietin receptor agonists for at least 1 week prior to enrollment (e.g. romiplostim, eltrombopag)
Phase II: Patients can receive concurrent thrombopoietin receptor agonists
Patients with neurological deficits should have deficits that are stable for a minimum of 1 week prior to enrollment, documented by a detailed neurological exam.
Patients with seizure disorders may be enrolled if seizures are well controlled.
Adequate Bone Marrow Function as defined as:
Absolute neutrophil count ≥ 1.0 x 109 cells/ L
Platelets ≥100 x 109 cells/ L (unsupported, defined as no platelet transfusion within 7 days)
Hemoglobin ≥8 g/dl (may receive transfusions)
Adequate Renal Function as defined as:
Creatinine clearance or radioisotope GFR \>70mL/min/1.73m2 OR
A serum creatinine based on (Schwartz et al. J. Peds, 106:522, 1985) age/gender as follows:
Adequate Liver Function as defined as:
Total bilirubin ≤ 3 times institutional upper limit of normal (ULN) for age
AST(SGOT)/ALT(SGPT) ≤ 3 times institutional ULN
Serum albumin ≥ 2g/dL
Coagulation parameters: INR \<1.5 times ULN and aPTT \<1.5 times ULN unless patients are receiving therapeutic anticoagulation which affects these parameters
Adequate Cardiac Function as defined as:
Ejection fraction of ≥ 55% by echocardiogram
Serum electrolytes (Sodium, Potassium, Chloride) within institutional limits of normal (patients can be on enteral supplementation)

Exclusion

Tumor with evidence of clinically significant uncal herniation or midline shift.
Tumor with diameter of \>5cm in one dimension on T2/FLAIR.
Tumor that in the opinion of the site investigator shows significant mass effect in either the brain or spine.
Patients with a history of any other malignancy, except patients with a secondary brain tumor if the patient's prior malignancy has been in remission for at least 5 years from the end of treatment.
Patients with any clinically significant unrelated systemic illness (serious infections or significant cardiac, pulmonary, hepatic or other organ dysfunction), that in the opinion of the investigator would compromise the patient's ability to tolerate protocol therapy, put them at additional risk for toxicity or would interfere with the study procedures or results.
Patients with type I diabetes.
Patients who are receiving any other anti-cancer or investigational drug therapy are ineligible.
Prior or current treatment with 177Lu-DOTATATE/TOC or 90Y-DOTATATE/TOC.

What this trial measures

  • Estimate MTD of Lutathera in pediatric CNS patients 4 to <12 yearsup 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.

  • Estimate RP2D of Lutathera in pediatric CNS patients 4 to <12 yearsup 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.

  • Calculate the incidence of treatment related adverse events as assessed by CTCAE v5.0 in pediatric (4 to <12 yo) CNS patients treated with Lutatheraup 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

  • Assess PFS of Lutathera in CNS patients 12 to </=39 yearsup 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