Trial Information

Peripheral Stem Cell Transplantation Protocol for Patients With Previously Treated Advanced Breast Cancer - A Phase II Pilot Study

OBJECTIVES: I. Assess the antitumor response, survival, and disease free survival following
high dose carboplatin, ifosfamide, and thiotepa with autologous peripheral blood stem cell
(PBSC) support and consolidation radiotherapy to sites of pretreatment bulk disease in
patients with previously treated advanced breast cancer. II. Assess the toxicity of high
dose chemotherapy in these patients. III. Compare the effectiveness of PBSC mobilization
with high dose cyclophosphamide and filgrastim (G-CSF) vs G-CSF alone in this patient
population.

OUTLINE: Patients are assigned to 1 of 2 peripheral blood stem cell (PBSC) mobilization
groups at the discretion of the attending physician: Group 1: Patients receive high dose
cyclophosphamide IV over 6 hours and filgrastim (G-CSF) subcutaneously (SQ) daily beginning
24 hours after completion of cyclophosphamide and continuing until 3 days after blood counts
have recovered and until PBSC are harvested. Group 2: Patients receive G-CSF SQ daily alone
until PBSC are harvested. Both groups: PBSC are harvested on days 15-19 after
cyclophosphamide infusion or when blood counts recover. Patients receive high dose
carboplatin IV continuously, ifosfamide IV over 4 hours, and thiotepa IV over 1 hour on days
-5 to -3. PBSC are reinfused beginning 48 hours after completion of combination
chemotherapy. Patients receive G-CSF SQ beginning on day 0 and continuing until 3 days after
blood counts have recovered. Sites of pretransplantation metastases greater than 3 cm are
irradiated beginning after transplantation and after blood counts recover. Patients are
followed every month for 1 year.

PROJECTED ACCRUAL: A total of 12-24 patients will be accrued for this study.