drugset / Trial / NCT01576692
Combination Chemotherapy, Monoclonal Antibody, and Natural Killer Cells in Treating Young Patients With Recurrent or Refractory Neuroblastoma
Phase 1
Completed
34 enrolled
St. Jude Children's Research Hospital
CURE Childhood Cancer, Inc. · collab
NaSingle-groupOpen-labelTreatment
Summary
This is a safety / feasibility trial evaluating the combination of a humanized anti-GD2 antibody (HU14.18K322A) manufactured at the Children's GMP, LLC at St. Jude with allogeneic natural killer (NK) cells and standard chemotherapy in children with relapsed or refractory neuroblastoma.
Timeline
- Start
- 2012-04
- Primary completion
- 2014-10
- Completion
- 2018-10-17
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Dinutuximab | Monoclonal antibody | 40 mg/m2 | — |
| Subject | TROCULEUCEL | Cell therapy | 100000 cells/kg | — |
| Subject | TROCULEUCEL | Cell therapy | 4e+08 cells/kg | — |
| Background | Carboplatin | Small molecule | 8 unknown | Intravenous |
| Background | Cyclophosphamide | Other / unclassified | 400 mg/m2 | Intravenous |
| Background | Etoposide | Small molecule | 100 mg/m2 | — |
| Background | Ifosfamide | Small molecule | 2 g | Intravenous |
| Background | Irinotecan | Small molecule | 50 mg/m2 | Intravenous |
| Background | Temozolomide | Small molecule | 150 mg/m2 | Oral |
| Background | Topotecan | Small molecule | 1.2 mg/m2 | Intravenous |