Mini-Allogeneic Peripheral Blood Progenitor Cell Transplantation For Recurrent or Metastatic Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      Primary Objectives:

        1. To assess the feasibility of mini-allogeneic Peripheral Blood Progenitor Cell (PBPC)
           transplantation in patients with recurrent or metastatic breast cancer.

        2. To determine the success rate (complete remission without severe toxicity or death) at
           100 days after the transplant and long-term progression free survival (PFS) rate.

        3. To examine the graft vs. breast cancer effect of allogeneic PBPC transplantation.
    

Detailed description: 
      If tumors shrink by standard-dose chemotherapy, patients will receive moderate dose
      chemotherapy to prepare for the blood stem cell transplant. The drug fludarabine will be
      given by vein on days 1-5. The drug melphalan will be given by vein on days 4 and 5. Day 6
      will be a rest day; no drugs will be given. The blood stem cell transplant will be given on
      day 7. Bone marrow from the matched donor may be used instead of blood stem cells,
      particularly for unrelated donors. A catheter (tube) will be placed in a large vein in the
      chest to reduce the number of times patients are stuck with a needle.

      Researchers will collect blood stem cells from your brother or sister or from an unrelated
      donor using granulocyte colony-stimulating factor (G-CSF) before receiving high-dose
      chemotherapy. You will need to have enough stem cells before transplantation.

      The drugs G-CSG, tacrolimus, and methotrexate will be given to ease side effects and help
      blood counts return to normal after the transplant. G-CSF is given as a shot under the skin,
      starting the day from transplant and continuing until the white blood cell count is normal.
      Tacrolimus is given by vein or by mouth for 4 to 7 months; during the last month it is given,
      the dose will be tapered off. Methotrexate is given by vein on days 1, 3, and 6 after
      transplant. Day 11 of methotrexate is given additionally if a donor is unrelated. Blood
      transfusions may be needed also.

      Antithymocyte globulin will be given to patients who receive blood or bone marrow from donors
      whose cells do exactly match the patients or from unrelated donors.

      Sometimes the transplanted cells attack the normal cells in the patient's body instead of the
      cancer cells. This is called graft-vs-host disease (GVHD). The drug methylprednisolone will
      be given by vein or by mouth to fight GVHD is it occurs.

      Patients must stay in the hospital for about 3 to 4 weeks. Patients must stay in the Houston
      area for about 100 days after the transplant. Blood tests will be done daily while the
      patient is in the hospital. Blood and urine tests and chest x-rays, computer tomography (CT)
      scans, and/or bone scans will be done during the 100 days.

      If there are no signs of disease after 100 days, treatment will stop. Patients must return to
      the clinic for check-ups once a month for the first year, 3 times a year for 4 years, and
      once a year after that. If disease is till present after 100 days, but the patient does not
      have GVHD, the patient may receive an infusion of donor lymphocytes by vein. This treatment
      may be repeated up to 3 times with 8 weeks between infusions. If no disease is found or if
      GVHD occurs, treatment will stop.

      Before treatment starts, patients will have a complete exam including blood and urine tests.
      An EKG (heart function test) and a heart scan will be done. Patients will have a dental exam.
      A test of lung function will be done. A sample of breast tissue will be taken. This is done
      with a hollow needle while the doctor looks at a CT scan or with a lighted tube placed
      through a cut in the breast while the patient is under anesthesia.

      Herceptin will be given every week, if you have Human Epidermal growth factor Receptor 2
      (HER-2)/neu-overexpressing tumor. Prior to this an infusion heart test will be done.

      This is an investigational study. Docetaxel, Melphalan, and Herceptin are approved by the US
      Food and Drug Administration for use against breast cancer. About 40 patients will take part
      in the study.
    

Intervention name(s): Fludarabine; Melphalan; Stem Cell Infusion
Intervention type(s): Drug; Drug; Procedure
Intervention description(s): 30 mg/m^2 intravenously Daily for 5 Days; 70 mg/m^2 intravenously Daily for 2 Days; Stem Cell Infusion on Day 0.
Other intervention name(s): mini-allogeneic PBPC transplantation; Stem Cell Transplant; SCT
Intervention MeSH terms: Fludarabine; Melphalan
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Breast Cancer; PBPC Transplantation; Stem Cell Infusion; Fludarabine; Melphalan