OncoMatch/Clinical Trials/NCT05278208
Lutathera for Treatment of Recurrent or Progressive High-Grade CNS Tumors
Is NCT05278208 recruiting? Yes, currently enrolling (May 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
Cancer type
Glioblastoma
Diffuse Intrinsic Pontine Glioma
Prior therapy
Must have received: standard therapy
Patients must have recurred/progressed following prior standard therapy for their tumor.
Must have received: surgical resection or radiation — meningioma, atypical meningioma, or anaplastic meningioma
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-TOC, 90Y-DOTATATE, 90Y-TOC)
Prior or current treatment with 177Lu-DOTATATE/TOC or 90Y-DOTATATE/TOC.
Lab requirements
Blood counts
Absolute neutrophil count ≥ 1.0 x 10^9 cells/L; Platelets ≥100 x 10^9 cells/L (unsupported, defined as no platelet transfusion within 7 days); 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 (see Schwartz et al. J. Peds, 106:522, 1985)
Liver function
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
Cardiac function
Ejection fraction of ≥ 55% by echocardiogram; Serum electrolytes (Sodium, Potassium, Chloride) within institutional limits of normal (patients can be on enteral supplementation)
Patients must have adequate organ and marrow function, both for eligibility for enrollment, and to begin each subsequent cycle of Lutathera, as defined below: Adequate Bone Marrow Function... Adequate Renal Function... Adequate Liver Function... Adequate Cardiac Function...
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
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