Vaccination With Autologous Breast Cancer Cells Engineered to Secrete Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) in Metastatic Breast Cancer Patients

After the patient has given their consent to participate in the trial, a series of tests will
be performed to determine if the patient is eligible. These tests may take place up to 21
days before the surgery to remove a tumor sample or cancer-containing fluid, which will be
used to create the vaccines. The tumor cells or fluid is then brought to a special, certified
laboratory where the vaccine is made. Specially trained laboratory technicians then use a
method known as adenoviral mediated gene transfer, which adds a new gene to the cancer cells.
This gene causes the cells to make GM-CSF, a powerful hormone that stimulates the immune
system. The cells are then given radiation so that they will not grow. Participants will
start receiving vaccine on day 1, 8, 15, 29, and then every two weeks until the supply of
vaccine has run out. The amount of the vaccine depends upon the total amount of cells that
are obtained from the breast cancer tumor or fluid. Each time the patient is vaccinated, they
will be given injections that will be placed underneath the skin. A different place will be
used for each injection. If there are enough cells from the patient's tumor sample, the
patient will be given an injection of non-transduced irradiated cells (the gene was not
added) . These cells will help to measure how the patient's immune system is reacting to the
tumor cells. This is called Delayed-Type Hypersensitivity (DTH). With vaccine #1 and #5, the
patient will also receive a DTH injection. Two to three days after the vaccine and DTH
injection, skin biopsies will be taken of both sites. At week 10 in the study treatment, or
earlier if necessary, the patient will have a chest, abdomen, and pelvic CT scan to determine
if the vaccine therapy has had an effect on their disease. A brain MRI will be performed if
there were any abnormalities on the first brain MRI or if new symptoms have developed.
Patients may participate in this study until one of the following happens: All vaccine
created from the tumor has been given to the patient; the patient's disease worsens; the
patient experiences an unacceptable and/or harmful side effect; the patient is unable to
follow the study plan; or the patient's doctor feels it is no longer in the best interest of
the patient to continue.

Inclusion Criteria:

- Histologically confirmed Stage IV breast cancer

- Prior banked malignant effusion or significant malignant effusion for tumor harvest or
surgically-accessible tumor nodule of at least 2cm in greatest diameter by physical
exam, magnetic resonance imaging (MRI) or computed tomography (CT) scan

- Must have received at least one prior regimen of chemotherapy for metastatic disease

- Patients with HER2 positive tumors must have received at least one prior
trastuzumab-based therapy in the metastatic setting, and may not receive trastuzumab
therapy and vaccine treatment concurrently

- Patients may receive concurrent bisphosphonate therapy and/or erythropoetin therapy at
any point while on study

- ECOG performance status 0 or 1

- Estimated life expectancy of greater than or equal to 6 months

- 18 years of age or older

- Greater than 4 weeks from immunotherapy, or systemic glucocorticoid therapy

- Adequate recovery from drug-related toxicities from prior systemic therapies

- Adequate recovery from recent surgery and radiation therapy

- Greater than 6 months since bone marrow or peripheral blood stem cell transplant

Exclusion Criteria:

- Urgent need for cytotoxic chemotherapy, radiotherapy, or surgery in the next 60 days

- Uncontrolled active infection or illness

- Psychiatric illness/social situation that would limit study compliance

- Pregnant or nursing mothers

- Evidence of HIV infection

- Previous participation in an adenovirus-based trial

- Concurrent invasive malignancy