NCT01105650

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)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: Masonic Cancer Center, University of Minnesota · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Ovarian Cancer
• Fallopian Tube Cancer
• Primary Peritoneal Cancer
• Breast Cancer

Interventions

Type	Name	Description
DRUG	Fludarabine	Administered intravenously, 25 mg/m\^2, days -6 through -2 (5 days).
DRUG	Cyclophosphamide	Administered intravenously, 60 mg/kg, days -5 and -4.
DRUG	Cyclosporine	Administered intravenously, CsA 1.5 mg/kg for target dose range of 150-250 ng/mL day -3 through day +14
BIOLOGICAL	Natural killer cells	Administered by infusion over less than 1 hour, no more than 8.0 x 10\^7 cells/kg will be given.
DRUG	IL-2	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).
DRUG	Methylprednisolone	Administered intravenously (IV) 10 mg/kg Days -2 to +4 and 1 mg/kg Days +5 to +9
DRUG	Methylprednisolone	Administered intravenously (IV) 1 mg/kg Days -2 to +9
DRUG	Interleukin-2	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).

Timeline

• Start date: 2010-07-01
• Primary completion: 2014-04-01
• Completion: 2014-04-01
• First posted: 2010-04-16
• Last updated: 2017-12-28
• Results posted: 2017-02-24

Locations

1 site across 1 country: United States