Vaccine and Chemotherapy for Previously Untreated Metastatic Breast Cancer
Status:
Terminated
Trial end date:
2011-06-01
Target enrollment:
Participant gender:
Summary
This study will evaluate the effectiveness of chemotherapy and a combination of vaccines to
treat metastatic breast cancer (breast cancer that has spread beyond the breast) in patients
whose cancer cells have a protein called carcinoembryonic antigen (CEA) on their surface.
Patients who require surgery or radiation therapy, or both, will receive these treatments as
well.
Patients 18 years of age and older with previously untreated metastatic breast cancer may be
eligible for this study. Newly diagnosed patients may not have received prior chemotherapy.
Patients previously diagnosed with local disease may have received chemotherapy or radiation
therapy at least 18 months before entering the current study. Patients may have received
hormonal therapy for stage IV disease. Candidates are screened with a medical history and
physical examination, blood and urine tests, x-rays, heart and lung tests, and a test to
determine the presence of CEA on their tumor cells.
Participants undergo the following procedures:
1. Central venous line: Under local or general anesthesia, an intravenous catheter (plastic
tube) is inserted into a major vein in the chest. It is used to give chemotherapy and
other medications and to withdraw blood samples.
2. Apheresis: Before beginning treatment and at various times before and after
chemotherapy, patients undergo apheresis to collect white blood cells for later
re-infusion at the time of immunizations and to evaluate the body's response to the
vaccines. For this procedure, blood is collected through the central venous catheter and
circulated through a machine that separates the white cells from the rest of the blood.
The white cells are removed and frozen for later use. The rest of the blood is returned
to the patient through the catheter.
3. First vaccine: Before starting chemotherapy, patients receive one subcutaneous (under
the skin) injection of a vaccine called rV-CEA-Tricom, along with subcutaneous
injections of granulocyte macrophage colony stimulating factor (GM-CSF) (Sargramostim),
a drug that stimulates the bone marrow to release white blood cells and white cell
precursors into the bloodstream.
4. Chemotherapy:
- Taxol (paclitaxel)/Cytoxan (cyclophosphamide): Patients receive three to five
cycles of Taxol and Cytoxan. Taxol is given as a continuous 72-hour intravenous
(intravenous (IV), through a vein) infusion and Cytoxan is given daily for 3 days,
intravenously, over 1 hour. Cycles are 21 to 42 (usually 28) days. After each
cycle, patients also receive growth colony stimulating factor (G-CSF) (a drug that
helps boost white cells.