cancer of the nervous system Neuroblastoma
Conditions
Interventions
177Lu-DOTATATE will be administered intravenously in two doses. The minimum
time between
treatments is 2 weeks. A maximum of 2 cycles may be given. Refer to section 7.3
for further details.
Sponsors
Karolinska University Hospital
Eligibility
Age
No minimum to 64 Years
Inclusion criteria
Inclusion criteria: 1.1. Histologically confirmed diagnosis of neuroblastoma 1.2. Immunohistochemical staining for somatostatin receptors (SSTR) performed from primary tumor tissue when available 2. Relapsed or primary refractory high-risk neuroblastoma: INSS stage 4 disease or INRGSS stage M disease 3. Age >18 months of age at the time of enrolment into this study 4. Life expectancy of greater than 3 months 5. Performance Status 5.1. Karnofsky > 50% (for patients > 12 years of age) 5.2. Lansky > 50% (for patients 1.0 x 109/L 8.1.3. Absolute Platelets > 100 x 109/L 8.2. Biochemistry: 8.2.1. Bilirubin within 1.5 x ULN 8.2.2. ALT within 2.5 x ULN 8.2.3. AST within 2.5 x ULN 8.2.4. GGT within 5 x ULN 8.2.5. ALP within 5 x ULN 8.2.6. Glomerular filtration rate >50mL/min/1.73m2 assessed by a recognised method, such as inulin, 51Cr-EDTA, 99mTc-DTPA or iohexol clearance and performed within 2 months prior to registration 8.2.7. Urinary catecholamine metabolites measured within 2 months prior to registration 9. Peripheral blood stem cells (PBSC) 9.1. A minimum of 2 x106 CD34+ cells/kg (optimally 6 x106 CD34+ cells/kg) must be available for each study subject prior to registering 10. Written informed consent from patient and/or parent(s) or legal guardian(s)
Exclusion criteria
Exclusion criteria: 1. Not fit enough to undergo proposed study treatment, as assessed by national PI, considering precautions defined in the latest version of the Lutathera SmPC 2. Pregnant or lactating patient 3. Concurrent treatment with any anti-tumor agents 4. Prior treatment with other radiolabeled somatostatin analogues 5. Hypersensitivity to any component of the investigational drug Lutathera® 6. Treatment with long-acting somatostatin analogues within 30 days prior the administration of Lutathera®
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response by the Revised International Neuroblastoma Response Criteria (INRC) at 1 month after the completion of therapy | — |
Secondary
| Measure | Time frame |
|---|---|
| • Response by the Revised INRC criteria at 4 months after the completion of therapy • Progression free survival (PFS) • Overall survival (OS) • Hematological and renal toxicity according to CTCAE 5.0 • Response assesed as a lesional analysis of the relationship between absorbed dose received in each measurable lesion and response in the lesion | — |
Countries
Netherlands
Outcome results
None listed