Autologous Vaccination With Lethally Irradiated, Autologous Breast Cancer Cells Engineered to Secrete GM-CSF in Women With Operable Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: Autologous, Lethally Irradiated Breast Cancer Cells
Intervention description: Vaccination with autologous tumor cells engineered by adenoviral mediated gene transfer to secrete GM-CS
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 8.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: autologous vaccination; GM-CSF; adenoviral mediated gene transfer; Stage IV breast cancer

Summary:

      The purpose of this trial is to test the safety of a vaccine made from a patient's own breast
      cancer cells, and determine if this vaccine will delay or stop the growth of the cancer. The
      vaccine is made by genetically modifying a patient's own tumor cells to secrete
      granulocyte-macrophage colony-stimulating factor (GM-CSF) to activate the immune response
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically or cytologically confirmed invasive breast cancer, pre-operative stages
             II-III per AJCC 6th edition, based on baseline evaluation by clinical examination
             and/or breast imaging

          -  Cohort 1: At least 2cm of residual disease in sum of diameters by clinical or
             radiographic findings following their preoperative chemotherapy

          -  Cohort 2: Patients who have not received preoperative chemotherapy must have at least
             4cm of disease in the largest diameter by clinical or radiographic findings

          -  Prior therapy for Cohort 1 only: Must have completed preoperative (neoadjuvant)
             chemotherapy with either a standard regimen (containing an anthracycline and/or a
             taxane) or on a clinical trial

          -  HER2 positive tumors must have received at least one prior trastuzumab-based therapy,
             and may not receive concurrent trastuzumab therapy and vaccination

          -  Must initiate hormonal therapy (if indicated), including ovarian suppression, at least
             4 weeks prior to initiation of vaccinations

          -  Must have completed definitive resection of primary tumor with adequated excision of
             gross disease. Surgery should have occured more than 28 days but within 12 weeks prior
             to enrollment

          -  May receive concurrent hormonal therapy, such as tamoxifen, ovarian suppression, and
             aromatase inhibitors

          -  Must have had prior banked tumor of sufficient cellular yield for vaccination

          -  ECOG Performance Status 0 or 1

          -  18 years of age or older

          -  Greater than 4 weeks from immunotherapy, or systemic glucocorticoid therapy

          -  Adequate recovery from recent surgery and radiation therapy

        Exclusion Criteria:

          -  Uncontrolled active infection or illness

          -  Other medical or psychiatric illness or social situation that would limit study
             compliance

          -  Pregnancy or nursing mothers

          -  Evidence of HIV infection

          -  Previous participation in an adenovirus-based trial

          -  Concurrent invasive malignancies