OncoMatch/Clinical Trials/NCT05278208
Lutathera for Treatment of Recurrent or Progressive High-Grade CNS Tumors
Is NCT05278208 recruiting? Yes, currently enrolling (Sep 2026). This Phase 1/2 trial studies LUTATHERA® (Lutetium Lu 177 dotatate) for high grade glioma.
Treatment: LUTATHERA® (Lutetium Lu 177 dotatate) — This study will evaluate the safety and efficacy of Lutathera (177Lu-DOTATATE) in patients with progressive or recurrent High-Grade Central Nervous System (CNS) tumors and meningiomas that demonstrate uptake on DOTATATE PET. The drug will be given intravenously once every 8 weeks for a total of up to 4 doses over 8 months in patients aged 4 to \<12 years (Phase I) or 12 to \</=39 years (Phase II) to test its safety and efficacy, respectively. Funding Source - FDA OOPD (grant number FD-R-0532-01)
Check if I qualifyExtracted eligibility criteria
Treatments studied
Radioligand therapy
Cancer type
Glioblastoma
Meningioma
Diffuse Intrinsic Pontine Glioma
Demographics
Prior therapy
Must have received: standard therapy for CNS tumor
Patients must have recurred/progressed following prior standard therapy for their tumor. Note: Patients with meningioma, atypical meningioma, or anaplastic meningioma must have received at least surgical resection or radiation.
Cannot have received: 177Lu-DOTATATE/TOC or 90Y-DOTATATE/TOC (177Lu-DOTATATE, 177Lu-DOTATOC, 90Y-DOTATATE, 90Y-DOTATOC)
Prior or current treatment with 177Lu-DOTATATE/TOC or 90Y-DOTATATE/TOC.
Lab requirements
Blood counts
ANC ≥ 1.0 x 10^9/L; platelets ≥100 x 10^9/L (unsupported); hemoglobin ≥8 g/dl (may receive transfusions)
Kidney function
Creatinine clearance or radioisotope GFR >70mL/min/1.73m2 OR age/gender-based serum creatinine maximums
Liver function
Total bilirubin ≤ 3x ULN for age; AST(SGOT)/ALT(SGPT) ≤ 3x ULN; serum albumin ≥ 2g/dL; INR <1.5x ULN and aPTT <1.5x ULN unless on therapeutic anticoagulation
Cardiac function
Ejection fraction ≥ 55% by echocardiogram; serum electrolytes (Na, K, Cl) within institutional limits of normal (supplementation allowed)
Patients must have adequate organ and marrow function, for eligibility and enrollment, as defined below: ... (see full details above)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Children's Hospital Colorado · Aurora, Colorado
- Cincinnati Children's Hospital Medical Center · Cincinnati, Ohio
- Nationwide Children's Hospital · Columbus, Ohio
- Children's Hospital of Philadelphia · Philadelphia, Pennsylvania
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT05278208 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior 177Lu-DOTATATE/TOC or 90Y-DOTATATE/TOC disqualifies patients from enrollment.
Is there an age limit?
Yes. Patients must be 39 years or younger and at least 4 years old.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
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