MT2007-19R: WCC #53 Allogeneic Natural Killer Cells in Patients With Recurrent Ovarian Cancer, Fallopian Tube, and Primary Peritoneal Cancer
- To evaluate the in vivo expansion of an infused allogeneic natural killer (NK) cell
product following a preparative regimen comprising cyclophosphamide, fludarabine
phosphate, and total-body irradiation in treating patients with recurrent and/or
metastatic ovarian, fallopian tube, or primary peritoneal cancer.
- To characterize the quantitative and qualitative toxicities of this treatment regimen.
- To estimate disease response (complete or partial response) or clinical benefit (stable
disease for > 6 months) as measured by Response Evaluation Criteria in Solid Tumours
- To estimate time to progression and overall survival.
- To estimate the association between clinical response and donor/recipient KIR ligand
- To evaluate immune activation of the in vivo expanded haploidentical allogeneic NK
cells and its effect on the immune system.
- Preparative regimen: Patients receive fludarabine phosphate IV on days 6 to 2 preceding
natural killer (NK) cell infusion and cyclophosphamide IV on days 5 and 4 preceding NK
cell infusion. Patients also undergo total-body irradiation on day 1 preceding NK cell
- Allogeneic natural killer (NK) cell administration and aldesleukin: Patients receive
aldesleukin-activated haploidentical allogeneic NK cells intravenously (IV) on day 0.
Beginning 4-6 hours after allogeneic NK cell infusion, patients receive aldesleukin
subcutaneously (SC) 3 times a week for 6 doses.
Patients achieving any initial response (complete or partial response) or a clinical benefit
(stable disease for > 6 months) who progress after 6 months may receive 1 re-treatment
course as above.
Blood samples are collected at baseline, on days 0, 7, 14, and 28, and then at 2 and 3
months post NK cell infusion for cytokine measurements, immunophenotyping, functional
analyses, and testing for persistence of donor cells.
After completion of study treatment, patients are followed periodically for at least 1 year.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Number of Patients With In Vivo Expansion of Infused Allogeneic Natural Killer (NK) Cell Product
Detection of an absolute donor derived cell count of > or = 100 cells/mL after NK cell infusion.
Melissa A. Geller, MD
Masonic Cancer Center, University of Minnesota
United States: Food and Drug Administration
|Masonic Cancer Center at University of Minnesota||Minneapolis, Minnesota 55455|