5.2 All patients will have a double lumen apheresis Hickman placed prior to PBSC 
harvest. This will be used during the administration of high dose chemotherapy, 
PBSC and marrow reinfusion and during the period of myelosuppression. 
5.3 Patients with metastatic breast cancer will be treated with 4-5 cycles of induction 
chemotherapy on an NCI Medicine Branch Treatment protocol with either FLAC (5- 
fluorouracil, leucovorin, doxorubicin, cyclophosphamide) with GM-CSF versus 
pIXY321 or with taxol/cyclophosphamide and G-CSF. Patients achieving at least a 
partial response with induction chemotherapy will be eligible for transplant. Patients 
who have not achieved a PR but who are responding after 4-5 cycles may be treated 
with additional cycles in an attempt to achieve a PR. Such patients will be eligible for 
transplant if a PR is obtained. Patients who have achieved a PR after 4-5 cycles and 
who continue to respond may be treated with additional cycles until a CR or best 
response is achieved. Patients who achieve an early CR will also receive 4-5 cycles of 
induction chemotherapy. A maximum of 9 induction cycles will be administered. 
5.4 After bone marrow recovery from induction chemotherapy has occurred (ANC 
>2000/mm 3 and platelets > 100,000/mm 3 ), patients will undergo first bone marrow 
harvest and then PBSC harvest. At least two weeks will elapse from recovery of the 
blood counts after induction therapy to bone marrow harvest. 
5.4.1 PBSC Mobilization and Harvest - see Section 6. 1 for details of apheresis 
procedure. Throughout, patients will receive standard antiemetic regimens and 
intravenous hydration to maintain urine output >100cc/hr and to normalize 
electrolytes. PBSC mobilization and harvest will be conducted on the inpatient 
13E or 12W oncology units and in the NIH Transfusion Medicine Department. 
Day 1: Begin intravenous hydration 3 liters/M 2 /day normal saline. 
Continue x 24 hours. If urine output is less than lOOcc/hr, consider 
furosemide. 
At least 4 hours after beginning hydration, cyclophosphamide 4 g/M 2 
will be diluted to a final volume of 500mL with NS and infused I.V. over 2 
hours. 
MESNA 800mg/M 2 I.V. over 30 minutes at 3, 6, 9, 12, 15, 18, 21, 
24, 27, 30, 33, and 36 hours post-cyclophosphamide. In addition, 800mg/M 2 
Mesna will be added to the cyclophosphamide and will be infused over the 2 
hours. 
Day 2: Begin G-CSF at a dose of 10 pg/kg/day subcutaneously. 
When the total white blood cell count recovers to >2000/mm 3 begin 
daily leukapheresis, continued until at least 3 x 10 8 nucleated cells/kg are 
collected. G-CSF will be discontinued after the final leukapheresis. 
5.4.2 At least 4 weeks will elapse from the time of WBC and platelet recovery 
following PBSC harvest to bone marrow harvest. For bone marrow harvest to 
take place, patients' ANC must be > 1500/mm 3 and platelets > 100,000/mm 3 . 
Bone marrow will then be harvested as in Appendix II. 
5.5 ICE Chemotherapy Regimen 
5.5.1 Drug Schedule 
Drugs: Davs 1 2 3 4 5 
Ifosfamide x x x x 
4 g/M 2 /day I.V. q.d. 
days 1 to 4 (4 days) 
CBDCA xxxxxxxxxxxxxxxxxxx 
600 mg/M 2 /day CIV 
days 1 to 4 (72 hours) 
Etoposide xx xx xx 
250 mg/M 2 /ql2 hrs I.V. 
on days 1 to 3 (6 doses) 
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