OncoMatch/Clinical Trials/NCT03966651
A Clinical Study Evaluating the Safety of Peptide Receptor Radionuclide Therapy (PRRT) With 177Lu-DOTA0-Tyr3-Octreotate in Children With Refractory or Recurrent Neuroblastoma Expressing Somatostatin Receptors.
Is NCT03966651 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies PRRT with 177Lu-DOTATATE for neuroblastoma.
Treatment: PRRT with 177Lu-DOTATATE — This study is a multicenter, open label phase I dose escalation trial designed to define the Maximum Tolerated Dose (MTD) of 177Lu-DOTATATE in children with refractory or recurrent neuroblastoma. 177Lu-DOTATATE will be delivered intravenously for 2 cycles, 6 weeks apart. The duration of study participation of each patient will be 5 months.
Check if I qualifyExtracted eligibility criteria
Cancer type
Neuroblastoma
Disease stage
Required: Stage REFRACTORY
Prior therapy
Cannot have received: chemotherapy
Exception: within 4 weeks prior to the start of study treatment
Chemotherapy within 4 weeks prior to the start of study treatment
Cannot have received: high dose chemotherapy with stem cell transplantation
Exception: within 3 months prior to start study treatment
high dose chemotherapy with stem cell transplantation within 3 months prior to start study treatment
Cannot have received: long acting somatostatin analogues
Exception: within 30 days prior to start of study treatment
long acting somatostatin analogues within 30 days prior to start of study treatment
Cannot have received: biological therapy or investigational agents
Exception: within 4 weeks prior to the start of study treatment or prior to passing 5 half-lives, i.e. systemic clearance, whatever comes first
biological therapy or investigational agents within 4 weeks prior to the start of study treatment or prior to passing 5 half-lives, i.e. systemic clearance, whatever comes first
Cannot have received: molecular radiotherapy (PRRT, 131ImiBG)
Any previous molecular radiotherapy (PRRT, 131ImiBG or other)
Cannot have received: external beam radiation therapy
Exception: within 30 days before starting study treatment
External Beam Radiation (EBR) therapy within 30 days before starting study treatment
Cannot have received: extensive external beam radiation therapy
Exception: to more than 25% of the bone marrow; for two kidneys: D50% (Right+ left kidneys) ≥15Gy and D30% (Right+ left kidneys) ≥ 20Gy; in case of a single remaining kidney (D50% ≥ 15Gy)
Prior extensive EBR therapy: to more than 25% of the bone marrow; for two kidneys : D50% (Right+ left kidneys) ≥15Gy and D30% (Right+ left kidneys) ≥ 20Gy; In case of a single remaining kidney (D50% ≥ 15Gy)
Lab requirements
Blood counts
if no bone marrow disease: platelets ≥ 100 x 109/l (unsupported for 72 hours) absolute neutrophil count (anc) ≥ 0.75 x 109/l hemoglobin > 7.5 g/dl (transfusions are allowed). in case of bone marrow disease: platelets ≥ 75 x109/l (unsupported for 72 hours) anc ≥0.5 x 109/l hemoglobin > 7.5 g/dl (transfusions are allowed)
Kidney function
serum creatinine ≤1.5 uln for age; if higher, a calculated glomerular filtration rate (gfr) (2009 schwartz formula) must be ≥ 60 ml/min/1.73 m2
Liver function
ast and alt ≤2.5 uln and total bilirubin ≤1.5 uln. in case of liver metastases, ast and alt ≤5 uln and total bilirubin ≤2.5 uln
Cardiac function
shortening fraction ≥ 28% or ejection fraction ≥ 55% by echocardiogram, with no clinical congestive heart failure associated. normal pulmonary artery pressure.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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