NCT00376805

Allogeneic Natural Killer (NK) Cells in Patients With Advanced Metastatic Breast Cancer

Allogeneic Natural Killer Cells in Patients With Advanced Metastatic Breast Cancer

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Masonic Cancer Center, University of Minnesota · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Giving chemotherapy before a donor natural killer (NK) cell infusion helps stop the growth of tumor cells. It also helps stop the patient's immune system from rejecting the donor's cells. Giving NK cells from a related donor may kill the tumor cells. PURPOSE: This study furthers the research of previous studies (MT2003-01 and MT2004-25) which were to determine a specific preparatory regimen (cyclophosphamide and fludarabine) could create an environment in which infused NK cells can grow and effectively treat patients with relapsed AML. This study will test the previous regimen in patients with breast cancer.

Detailed description

We believe that administration of related allogeneic (donor) natural killer cells along with IL-2, rather than autologous natural killer cells will provide the most effective anticancer therapy in this setting, and wish to test this approach. To do this, we will select a related donor who is partially HLA-matched with the study subject, to increase the likelihood that donor natural killer cells will kill the subject's cancer cells. We will also give chemotherapy drugs to increase the subject's tolerance for the donor natural killer cells. We will test the use of donor natural killer (NK) cell infusions. The immune system has a special way that it sees and identifies cancer cells or foreign agents (like viruses). The subject's own NK cells may not attack their cancer because NK cells see the tumor cells as "self" (a coating on the cell surface identifies a cell as "self" or "non-self"). We have reason to believe that NK cells may not kill cancer cells because NK cells have special receptors that "turn them off" when they encounter cancer cells (by seeing them as "self"). We may be able to get around this problem by using donor NK cells. Finally, subjects will receive a dose of subcutaneous IL-2 3 times a week (for 2 weeks) which has been proven safe in our previous studies to stimulate the natural killer cells.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	Fludarabine	administered intravenously 25 mg/m\^2 times 5 doses
DRUG	Cyclophosphamide	administered intravenously 60 mg/kg days times 2 doses.
RADIATION	Total body irradiation	200 cGy (gray) on day -1
OTHER	Natural killer cell infusion	Infused cell dose is within the range of 1.5-8.0 x 10\^7/kg. Cell counts are based on total cells infused after the activation culture and washing determined on the morning of infusion.
BIOLOGICAL	Interleukin-2	administered subcutaneously (10 MU) 3 times per week for 6 doses

Timeline

• Start date: 2006-04-01
• Primary completion: 2009-09-01
• Completion: 2010-01-01
• First posted: 2006-09-15
• Last updated: 2017-12-28
• Results posted: 2010-08-12

Locations

1 site across 1 country: United States