Protocol Number: 03-C-0040
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 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 (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 G-CSF (a drug that helps boost white cell counts) by injection under the skin. The also receive Mesna, a drug that protects the bladder from harmful side effects of Cytoxan. -Adriamycin (doxorubicin)/Cytoxan: Patients may receive additional chemotherapy with Adriamycin and Cytoxan for a maximum of 4 cycles. Adriamycin is given as a 10-minute IV bolus and Cytoxan is infused IV over 1 hour. Cycles are usually 21 days. -Immune-depleting chemotherapy: Patients receive a final course of chemotherapy (following radiation, if needed) with Cytoxan and fludarabine to lower the immune system in preparation for receiving cells collected before the start of chemotherapy. 5. Additional vaccines: Starting 3 weeks after immune-depleting chemotherapy, patients receive a series of three monthly immunizations with a second type vaccine, called rF-EA-Tricom. Starting 10 months after the immune-depleting chemotherapy, they will get a booster shot of the same vaccine every 6 months for four doses, along with four daily injections of Sargramostim. Along with the first series of immunizations, patients receive the white cells that were collected during apheresis to boost the body's response to the vaccines. 6. Hormonal treatment: Patients whose tumors are estrogen- or progesterone-positive receive hormonal treatment, probably with Tamoxifen, after all chemotherapies are completed. The total length of treatment varies, depending on the number of cycles patients receive and whether or not they also undergo surgery or radiation therapy.
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National Institutes of Health Clinical Center
Bethesda, Maryland 20892. Last update: 09/16/2008
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