drugset / Trial / NCT01105650
Allogeneic Natural Killer (NK) Cells for Ovarian, Fallopian Tube, Peritoneal and Metastatic Breast Cancer
Non-randomizedSingle-groupOpen-labelTreatment
Summary
This is a single center phase II trial designed to optimize a clinical platform of lymphodepleting chemotherapy and T-cell suppression to promote the persistence, function, and expansion of allogeneic natural killer (NK) cells in patients with recurrent ovarian, fallopian tube, primary peritoneal cancer and advanced metastatic breast cancer.
Timeline
- Start
- 2010-07
- Primary completion
- 2014-04
- Completion
- 2014-04
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Methylprednisolone | Other / unclassified | 1 mg/kg | Intravenous |
| Subject | Methylprednisolone | Other / unclassified | 10 mg/kg | Intravenous |
| Subject | TROCULEUCEL | Cell therapy | 8e+07 cells/kg | — |
| Subject | aldesleukin | Protein / enzyme biologic | 3e+06 iu/kg | Subcutaneous |
| Subject | aldesleukin | Protein / enzyme biologic | 5e+06 iu/kg | Subcutaneous |
| Subject | aldesleukin | Protein / enzyme biologic | 9e+06 iu | Subcutaneous |
| Background | Cyclophosphamide | Other / unclassified | 60 mg/kg | Intravenous |
| Background | Cyclosporine | Peptide | 1.5 mg/kg | Intravenous |
| Background | Fludarabine | Small molecule | 25 mg/m2 | Intravenous |