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

• Status: Terminated
• Trial end date: 2010-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Masonic Cancer Center, University of Minnesota
• Treatments: Cyclophosphamide; Fludarabine; Fludarabine phosphate; Interleukin-2

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 treatment

• 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