Vaccine Therapy, Trastuzumab, and Vinorelbine in Treating Women With Locally Recurrent or Metastatic Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: therapeutic autologous dendritic cells; trastuzumab; vinorelbine ditartrate
Intervention description: 10 μg/kg subcutaneously (sc) each day for four days or g-CSF at 5 μg/kg sc each day for four days with GM-CSF 250 μg/m2 sc each day for four days. G-CSF and/or GM- CSF will be self-administered. On the fifth day patients will have two intravenous lines placed in the apheresis area of the Blood Bank and then undergo a 15 litre apheresis collection; 4 mg/kg intravenously, every 14 days; Vinorelbine 25 mg/m2 will be administered intravenously, every 14 days
Intervention MeSH terms: Trastuzumab; Vinorelbine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 56.0
Sex: Female
Minimum age: 18 Years
Maximum age: 120 Years
Healthy volunteers: No
Keywords: recurrent breast cancer; stage IIIB breast cancer; stage IIIC breast cancer; stage IV breast cancer

Summary:

      RATIONALE: Vaccines may make the body build an immune response to kill tumor cells.
      Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or
      deliver tumor-killing substances to them without harming normal cells. Drugs used in
      chemotherapy, such as vinorelbine, work in different ways to stop tumor cells from dividing
      so they stop growing or die. Combining vaccine therapy with monoclonal antibody therapy and
      chemotherapy may kill more tumor cells.

      PURPOSE: This phase II trial is studying how well giving vaccine therapy together with
      trastuzumab and vinorelbine works in treating women with locally recurrent or metastatic
      breast cancer.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed breast cancer

               -  Locally recurrent or metastatic disease

          -  HLA-A0201 positive by DNA genotyping

          -  HER2/neu expression at least 1+ by immunohistochemistry of tumor sample

          -  Central Nervous System (CNS) metastases allowed provided on therapy for 3 months and
             stable

          -  Hormone receptor status:

               -  Not specified

        PATIENT CHARACTERISTICS:

        Age

          -  18 and over

        Sex

          -  Female

        Menopausal status

          -  Not specified

        Performance status

          -  Eastern Cooperative Oncology Group (ECOG) 0-2

        Life expectancy

          -  Not specified

        Hematopoietic

          -  Absolute neutrophil count > 1,500/mm^3

          -  Platelet count > 100,000/mm^3

          -  Hematocrit > 33%

        Hepatic

          -  Transaminases ≤ 3 times upper limit of normal

          -  Bilirubin ≤ 2 times normal

          -  Hepatitis B surface antigen negative

        Renal

          -  Creatinine < 2.0 mg/dL

        Cardiovascular

          -  Ejection fraction > 45% by multigated acquisition scan (MUGA) OR

          -  Left ventricular function normal by echocardiogram

          -  No serious cardiac condition that would preclude study participation or compliance

        Other

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

          -  HIV negative

          -  No serious medical or psychiatric condition that would preclude study participation or
             compliance

        PRIOR CONCURRENT THERAPY:

        Biologic therapy

          -  Prior biologic therapy allowed

        Chemotherapy

          -  More than 30 days since prior cytotoxic chemotherapy

          -  No other concurrent chemotherapy

        Endocrine therapy

          -  More than 30 days since prior hormonal therapy

          -  No concurrent hormonal therapy

          -  No concurrent systemic steroids

        Radiotherapy

          -  Not specified

        Surgery

          -  Not specified

        Other

          -  Concurrent bisphosphonates for bone metastases allowed