Chemotherapy and Progenitor Cell Transplantation to Treat Inflammatory Breast Cancer
Status:
Completed
Trial end date:
2014-06-20
Target enrollment:
Participant gender:
Summary
This study will evaluate the effectiveness of combination chemotherapy with paclitaxel
(Taxol) and cyclophosphamide (Cytoxan), followed by high-dose melphalan and etoposide for
treating inflammatory breast cancer. Patients also receive infusions of their own previously
collected progenitor cells (primitive cells that can make new cells to replace ones destroyed
by chemotherapy).
Patients 18 years of age or older with stage IIIB inflammatory breast cancer that has not
metastasized (spread beyond the breast) may be eligible for this study. Candidates are
screened with a medical history and physical examination, blood and urine tests, and chest
x-ray. They have computed tomography (CT) of the head, chest, abdomen and pelvis as well as a
bone scan to determine the extent of disease, and a nuclear medicine scan called MUGA to
examine the heart's pumping ability. They may receive a rehabilitation medicine evaluation.
Participants undergo the following tests and procedures:
- Central venous line placement: Patients have a central venous line (plastic tube) placed
into a major vein in the chest before beginning treatment. The line remains in the body
throughout treatment and is used to give chemotherapy and other medications and to
withdraw blood samples. The line is usually placed under local anesthesia in the
radiology department or the operating room.
- Chemotherapy: Patients receive two or more cycles of paclitaxel and cyclophosphamide.
Paclitaxel is given intravenously (I.V., through a vein) for 72 hours using a portable
pump. Cyclophosphamide is given daily for 3 days I.V. over 1 hour. The cycles may be 28
days apart. A drug called Mesna is given with this treatment to protect the bladder from
irritation from cyclophosphamide. Patients who have not previously been treated with
doxorubicin (Adriamycin) may receive a maximum of four cycles of doxorubicin and
cyclophosphamide by vein on a single day during each cycle, with cycles 21 days apart.
When all the paclitaxel/cyclophosphamide cycles are completed, patients receive
melphalan and etoposide, both drugs I.V. over 1 to 8 hours for three consecutive days.
- G-CSF treatment: After each paclitaxel/cyclophosphamide cycle and after the
melphalan/etoposide treatment, patients are given a drug called G-CSF. G-CSF, injected
under the skin, stimulates production of infection-fighting white blood cells.
- Apheresis: This is a procedure to collect progenitor cells for later reinfusion. For
this procedure, blood is collected through a catheter (plastic tube) placed in an arm
vein. The blood is circulated through a cell-separating machine, where the white cells,
including the progenitor cells, are extracted, and the red cells are returned to the
patient through another catheter in the other arm. Apheresis is done after each of two
cycles of paclitaxel/cyclophosphamide.
- Progenitor cell transplant: Progenitor cells are reinfused after melphalan/etoposide
treatment.
- Glucose infusion: A salt solution with chemically modified glucose is infused I.V. over
a period of from 12 to 48 hours, with subsequent donation of blood cells for blood and
immune system studies. Patients have a maximum of two glucose infusions, separated by at
least 3 months.
- Tumor biopsy: Some patients have a biopsy of their tumor (removal of a small piece of
tumor tissue for microscopic study) before starting chemotherapy.
- Blood tests: Blood is drawn frequently to monitor safety and treatment response, and for
research purposes.
- Dental consultation: Some patients may have a dental consultation before the progenitor
cell transplant.