stem Cell Collector (see Appendix B) and one half of these cells 
(1/2 X 10^/kg) will be exposed to safety-modified retroviruses 
which carry the MDR-1 cDNA in transcriptional unit as outlined in 
Appendix D. These cells must be negative for breast cancer cells 
by the immunostaining tests outlined in Appendix G. A backup 
marrow or peripheral blood stem cell collection which is 
equivalent to an engrafting dose will be made for breast cancer 
patients . 
5.3 Treatment Plan: All patients should be treated in the Protected 
Environment if available. 
a. The preparative ablative regimen, which is given a single 
time before the transplantation of MDR-1 modified and 
unmodified peripheral blood stem cells, will consist of the 
following systemic chemotherapy: 
Cyclophosphamide: 1.5 g/m^ qd on days -8,-7, and -6, for a total 
dose of 4.5 gms/m^ over the three days, Mesna, 500 mg/m^, will be 
given IV 1/2 hour before the first dose of cyclophosphamide, then 
2 gms/m^ will be given as a continuous infusion over each 24 hour 
period during the cyclophosphamide infusion. 
Thiotepa at a dose of 200 mg/m^ qd x 3 days, will be diluted in 
normal saline, and given IVPB over 4 hours on days -8,-7, and -6 
at a total dose for the three days of 600 mg/m^. 
BCNU at a dose of 150 mg/m^ will be dissolved in 100 cc of D5W 
and given dIV piggyback on days -8,-7, and -6 over 40 minutes 
(total dose 450 mg/m^) . 
b. Subsequently, MDR-1 virally unmodified and modified 
autologous peripheral blood stem cells will be reinfused on 
day 0, which is 5 days after the last dose chemotherapy so as 
to protect the marrow from metabolites of the chemotherapy. 
Premedication with benadryl 25 mg and solucortef 100 mg ivb 
30 minutes before reinfusion to prevent anaphylactic 
reactions. 
c. Treatment of patients in the Protected Environment on the 
12th floor of the Lutheran Pavilion is strongly urged. 
Patients will remain there until the attainment of 500 
granulocytes /mm^. 
d. Patients will receive bactrim DS po BID and ketoconazole 200 
mg po q8h as antibiotic prophylaxis or other antibiotics 
specified by the Infectious Disease group while hospitalized 
to protect patients against overwhelming infection. 
e. All blood products will be irradiated from the start of 
treatment and for three months following the transplant. 
f. GCSF (5 mcg/kg) will be given SC qd starting on day 1 after 
marrow harvesting and until the ANC is >10,000//xd. 
Recombinant DNA Research, Volume 19 
[529] 
