Trial Information

A Phase I Trial of Vaccination With Autologous, Lethally Irradiated Breast Cancer Cells Engineered by Adenoviral Mediated Gene Transfer to Secrete Granulocyte-Macrophage Colony Stimulating Factor 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.