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Allogeneic Natural Killer Cells in Patients With Advanced Metastatic Breast Cancer

Phase 2
18 Years
Not Enrolling
Breast Cancer

Thank you

Trial Information

Allogeneic Natural Killer Cells in Patients With Advanced Metastatic Breast Cancer

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.

Inclusion Criteria

Inclusion criteria:

- Diagnosis of metastatic breast cancer that has progressed on or failed at least one
salvage chemotherapy regimen for metastatic disease and that meets the following
disease specific related criteria:

- Measureable metastatic disease per Response Evaluation Criteria In Solid Tumor
(RECIST) - bone only not eligible.

- Disease progression while receiving prior therapy with a hormonal agent (if
estrogen/progesterone receptor-positive) and/or trastuzumab (Herceptin®) (if
HER2-neu positive)

- Brain metastases allowed provided they are stable for ≥ 3 months after prior

- Related HLA-haploidentical natural killer cell donor available (by ≥ class I
serologic typing)

- Male or female

- Performance status 50-100%

- Platelet count ≥ 80,000/mm³ (unsupported by transfusions)

- Hemoglobin ≥ 9 g/dL (unsupported by transfusions)

- Absolute neutrophil count ≥ 1,000/mm³ (unsupported by sargramostim [GM-CSF] or
filgrastim [G-CSF])

- Creatinine ≤ 2.0 mg/dL

- Liver function tests < 5 times normal

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- LVEF > 40%*

- Pulmonary function > 50%* (DLCO corrected AND FEV_1)

- No active infection (i.e., afebrile, off antibiotics, and no uninvestigated
radiologic lesions)

Exclusion Criteria:

- At least 3 days since prior prednisone or other immunosuppressive medications

- No other concurrent therapy for cancer

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of Patients Who Had Expansion of Natural Killer Cells

Outcome Description:

Successful Natural Killer (NK) cell expansion is defined as detection of an absolute circulating donor-derived NK cell count of >100 cells/ul of whole blood 14 days after infusion with <5% donor T and B cells in mononuclear population (in metastatic breast cancer patients).

Outcome Time Frame:

Day 14

Safety Issue:


Principal Investigator

Jeffrey Miller, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Masonic Cancer Center, University of Minnesota


United States: Food and Drug Administration

Study ID:




Start Date:

April 2006

Completion Date:

January 2010

Related Keywords:

  • Breast Cancer
  • stage IV breast cancer
  • male breast cancer
  • recurrent breast cancer
  • Breast Neoplasms



Masonic Cancer Center at University of Minnesota Minneapolis, Minnesota  55455