drugset / Trial / NCT00652899

Allogeneic Natural Killer Cells in Patients With Recurrent Ovarian Cancer, Fallopian Tube, and Primary Peritoneal Cancer

NCT00652899

Phase 2 Terminated 14 enrolled Masonic Cancer Center, University of Minnesota
Non-randomizedSingle-groupOpen-labelTreatment

Summary

RATIONALE: Giving chemotherapy, such as cyclophosphamide and fludarabine, and total-body irradiation before a donor natural killer cell infusion helps stop the growth of tumor cells. It also helps stop the patient's immune system from rejecting the donor's natural killer cells. Aldesleukin may stimulate the natural killer cells to kill ovarian, fallopian tube, or primary peritoneal cancer cells. Treating the donor natural killer cells with aldesleukin may help the natural killer cells kill more tumor cells. PURPOSE: This phase II trial is studying how well giving laboratory-treated donor natural killer cells together with aldesleukin works when given after cyclophosphamide, fludarabine, and total-body irradiation in treating patients with recurrent and/or metastatic ovarian, fallopian tube, or primary peritoneal cancer.

Timeline

Start
2008-03
Primary completion
2009-08
Completion
2009-08

Drugs

EvaluationDrugModalityDoseRoute
Subject TROCULEUCEL Cell therapy 1.5e+07 cells/kg
Subject TROCULEUCEL Cell therapy 8e+07 cells/kg
Background Allopurinol Small molecule 300 mg Oral
Background Cyclophosphamide Other / unclassified 60 mg/m2 Intravenous
Background Fludarabine Small molecule 25 mg/m2 Intravenous
Background aldesleukin Protein / enzyme biologic 1e+07 iu Subcutaneous