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Patients receiving Cyclosporine (CsA) and Natural Killer (NK) cells infusion (created from donor lymphapheresis) after preparative regimen of Fludarabine and Cyclophosphamide. Interleukin-2 (IL-2) 6 million units 3 times a week x 6 doses given post NK cell infusion.

Patients receiving Cyclosporine (CsA), methylprednisolone and natural killer cells (NK) infusion (created from donor lymphapheresis) after preparative regimen of Fludarabine and Cyclophosphamide. Interleukin-2 (IL-2) 6 million units 3 times a week x 6 doses given post NK cell infusion.

Patients receiving Cyclosporine (CsA), methylprednisolone and natural killer (NK) cells infusion (created from donor lymphapheresis) after preparative regimen of Fludarabine and Cyclophosphamide. Interleukin-2 (IL-2) 6 million units 3 times a week x 6 doses given post NK cell infusion.

Patients receiving Cyclosporine (CsA), no methylprednisolone, eliminating IL-2 doses 4-6 and receiving Natural Killer (NK) cells infusion (created from donor lymphapheresis) after preparative regimen of Fludarabine and Cyclophosphamide. Interleukin-2 (IL-2) 6 million units 3 times a week x 3 doses given post NK cell infusion.

Administered intravenously, 25 mg/m\^2, days -6 through -2 (5 days).

Administered intravenously, 60 mg/kg, days -5 and -4.

Administered intravenously, CsA 1.5 mg/kg for target dose range of 150-250 ng/mL day -3 through day +14

Administered by infusion over less than 1 hour, no more than 8.0 x 10\^7 cells/kg will be given.

Natural killer cells

Will be given subcutaneously at 9 million units 3 times a week for a total of 6 doses, beginning 4 hours after NK cell infusion. (For patients weighing less than 45 kilograms, will be given at 5 million units/m\^2 3 times per week for 6 doses).

IL-2

Administered intravenously (IV) 10 mg/kg Days -2 to +4 and 1 mg/kg Days +5 to +9

Administered intravenously (IV) 1 mg/kg Days -2 to +9

Will be given subcutaneously at million units 3 times a week for a total of 3 doses, beginning 4 hours after NK cell infusion. (For patients weighing less than 45 kilograms, will be given at 3 million units/m\^2 3 times per week for 6 doses).

Melissa Geller, MD

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.

Allogeneic Natural Killer (NK) Cells for Ovarian, Fallopian Tube, Peritoneal and Metastatic Breast Cancer

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)

Response includes Complete Response (CR), Partial Response (PR), and Stable Disease (SD) as defined by Response Evaluation Criteria In Solid Tumors Criteria (RECIST v.1.1) for target lesions and assessed by CT or MRI. Complete Response (CR), disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for Progressive Disease.

Time from study entry until progressive disease or data collection cutoff.

Masonic Cancer Center, University of Minnesota

Fludarabine: Administered intravenously, 25 mg/m\^2, days -6 through -2 (5 days).

Cyclophosphamide: Administered intravenously, 60 mg/kg, days -5 and -4.

Cyclosporine (CsA): Administered intravenously, 1.5 mg/kg for target dose range of 150-250 ng/mL day -3 through day +14

Natural Killer cells: Administered by infusion over less than 1 hour; no more than 8.0 x 10\^7 cells/kg will be given.

Interleukin- 2 (IL-2): Given subcutaneously at 9 million units 3 times a week for a total of 6 doses, beginning 4 hours after NK cell infusion. (For patients weighing less than 45 kilograms, IL-2 will be given at 5 million units/m\^2 3 times per week for 6 doses).

Arm 1: CsA

Fludarabine: Administered intravenously, 25 mg/m\^2, days -6 through -2 (5 days).

Cyclophosphamide: Administered intravenously, 60 mg/kg, days -5 and -4.

Cyclosporine (CsA): Administered intravenously, 1.5 mg/kg for target dose range of 150-250 ng/mL day -3 through day +14

Natural Killer cells: Administered by infusion over less than 1 hour; no more than 8.0 x 10\^7 cells/kg will be given.

Interleukin- 2 (IL-2): Given subcutaneously at 9 million units 3 times a week for a total of 6 doses, beginning 4 hours after NK cell infusion. (For patients weighing less than 45 kilograms, IL-2 will be given at 5 million units/m\^2 3 times per week for 6 doses).

Methylprednisolone: Administered intravenously,10 mg/kg Days -2 to +4 and 1 mg/kg Days +5 to +9.

Arm 2: CsA/Methylprednisolone (10mg)/6 Doses of Interleukin-2

Fludarabine: Administered intravenously, 25 mg/m\^2, days -6 through -2 (5 days).

Cyclophosphamide: Administered intravenously, 60 mg/kg, days -5 and -4.

Cyclosporine (CsA ): Administered intravenously, 1.5 mg/kg for target dose range of 150-250 ng/mL day -3 through day +14

Natural Killer cells: Administered by infusion over less than 1 hour; no more than 8.0 x 10\^7 cells/kg will be given.

Interleukin- 2 (IL-2): Given subcutaneously at 9 million units 3 times a week for a total of 6 doses, beginning 4 hours after NK cell infusion. (For patients weighing less than 45 kilograms, IL-2 will be given at 5 million units/m\^2 3 times per week for 6 doses).

Methylprednisolone: Administered intravenously, 1 mg/kg Days -2 to +9

Arm 3: CsA/Methylprednisolone (1mg)/6 Doses of Interleukin-2

Total

Age, Categorical

Sex: Female, Male

Dr. Melissa Geller

Response Rate

Number of participants with progressive disease at one year:

Arm 1: 2 out of 3; Arm 2: 1 out of 3; Arm 3: 5 out of 7

Time to Disease Progression

Number of Participants With Progressive Disease at One Year

Overall Survival

Fludarabine: Administered intravenously, 25 mg/m\^2, days -6 through -2 (5 days).

Cyclophosphamide: Administered intravenously, 60 mg/kg, days -5 and -4.

Cyclosporine (CsA ): Administered intravenously, 1.5 mg/kg for target dose range of 150-250 ng/mL day -3 through day +14

Natural Killer cells: Administered by infusion over less than 1 hour; no more than 8.0 x 10\^7 cells/kg will be given.

Interleukin-2 (IL-2): Given subcutaneously at 9 million units 3 times a week for a total of 3 doses, beginning 4 hours after NK cell infusion. (For patients weighing less than 45 kilograms, IL-2 will be given at 3 million units/m\^2 3 times per week for 3 doses).

Arm 4: CsA/no Methylprednisolone/3 Doses of Interleukin-2

Overall Study

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Allogeneic Natural Killer (NK) Cells for Ovarian, Fallopian Tube, Peritoneal and Metastatic Breast Cancer	NCT01105650	Ovarian Cancer Fallopian Tube ... Primary Periton... Breast Cancer	Fludarabine Cyclophosphamid... Cyclosporine Natural killer ... IL-2 Methylprednisol... Methylprednisol... Interleukin-2	18 Years -	Masonic Cancer Center, University of Minnesota
Allogeneic Natural Killer (NK) Cells for Ovarian, Fallopian Tube, Peritoneal and Metastatic Breast Cancer	NCT01105650	Ovarian Cancer Fallopian Tube ... Primary Periton... Breast Cancer	Fludarabine Cyclophosphamid... Cyclosporine Natural killer ... IL-2 Methylprednisol... Methylprednisol... Interleukin-2	18 Years -	Masonic Cancer Center, University of Minnesota

Spots Global Cancer Trial Database for refractory fallopian tube cancer