Breast Cancer Clinical Trial
Official title:
Lymphodepleting Chemotherapy and T-Cell Suppression Followed By Allogeneic Natural Killer Cells and IL-2 in Patients With Recurrent Ovarian, Fallopian Tube, Primary Peritoneal Cancer and Advanced Metastatic Breast Cancer (MT2009-30)
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.
The donor NK cells are infused on day 0, after a non-myeloablative preparative regimen of
cyclophosphamide and fludarabine plus a cyclosporine A (CsA) based immunosuppressive therapy.
Subcutaneous interleukin-2 (IL-2) is started the evening of the NK infusion and continued
three times a week for 6 doses total.
Up to 4 sequential immunosuppressive platforms will be tested (Arms 1 and 2 are currently
closed) to identify a platform where patients have the potential for successful NK cell
expansion (defined as an absolute circulating donor derived NK cell count of > 100 cells/μl
14 days after NK cell infusion). Once a clinical platform is determined, the platform will be
expanded to a total of 18 patients. The primary goal of this extended phase is to obtain
preliminary efficacy information.
Follow-up for disease response is for 1 year from the NK cell infusion, with the possibility
of re-treatment for patients who experience at least a clinical benefit who progress after 6
months.
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