Neuroblastoma Recurrent Clinical Trial
Official title:
Quadruple Immunotherapy for Paediatric Patients With Relapsed or Refractory Neuroblastoma
This is a single-arm clinical trial to evaluate the efficacy and safety of quadruple immunotherapy with natural killer (NK) cells, anti-GD2 antibody, cytokines (interleukin-2 (IL-2) and granulocyte-macrophage colony stimulating factor (GM-CSF)) and retinoid X receptor gamma (RXRg) agonist spironolactone for paediatric patients with relapsed or refractory neuroblastoma.
Included patients will receive intravenous infusion of donor NK cells on day 0, and anti-GD2 antibody (dinutuximab) on day -6 to day -2. IL-2 will be given subcutaneously on day -1, day +1, day +3, day +5, day +7, and day +9. Subcutaneous injection of GM-CSF will be started on day 0, given daily till neutrophil count >1000/mm3. Spironolactone will be started orally on day -1, given three times daily till cessation of GM-CSF. Alternative anti-GD2 antibody (Naxitamab) can be used instead of dinutuximab, to be given on day -5, day -3, day +1 and day +3. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT03242603 -
Immunotherapy of Neuroblastoma Patients Using a Combination of Anti-GD2 and NK Cells
|
Phase 1/Phase 2 | |
| Terminated |
NCT04560166 -
Naxitamab and GM-CSF in Combination With IT in Patients With High-Risk Neuroblastoma
|
Phase 2 | |
| Active, not recruiting |
NCT02139397 -
Study of DFMO in Combination With Bortezomib for Relapsed or Refractory Neuroblastoma
|
Phase 1/Phase 2 | |
| Recruiting |
NCT04903899 -
177Lutetium-DOTATATE in Children With Primary Refractory or Relapsed High-risk Neuroblastoma
|
Phase 2 | |
| Active, not recruiting |
NCT04239092 -
9-ING-41 in Pediatric Patients With Refractory Malignancies.
|
Phase 1 | |
| Recruiting |
NCT03373097 -
Anti-GD2 CAR T Cells in Pediatric Patients Affected by High Risk and/or Relapsed/Refractory Neuroblastoma or Other GD2-positive Solid Tumors
|
Phase 1/Phase 2 | |
| Completed |
NCT01467986 -
Multimodal Molecular Targeted Therapy to Treat Relapsed or Refractory High-risk Neuroblastoma
|
Phase 2 | |
| Completed |
NCT02258815 -
CH14.18 1021 Antibody and IL2 After Haplo SCT in Children With Relapsed Neuroblastoma
|
Phase 2 |