Patients who have had congestive heart failure or coronary artery 
disease or who have an ejection fraction of less than 50% (by 
Cardiac Muga Scan) will not be eligible for this protocol. 
4.2 Patients must have a performance of <2 on Zubrod performance I 
scale (Appendix Al) , a creatinine level <1.6 mg%, normal I 
creatinine clearance, acceptable cardiac condition (class I or I 
II; Appendix A2) , normal liver functions (the SCOT should be I 
within the normal range) with bilirubin <2 mg%, and acceptable I 
pulmonary function tests (FEVI and DLCO >50% of predicted) . I 
Patients should be free of infections at the time of treatment. I 
4.3 Patients who have a history of bowel obstruction or greater than I 
Grade I neuropathies will be excluded. Patients should have had I 
a recent marrow exam and have had no evidence of involvement I 
with breast cancer. In addition, the peripheral blood aned marrow | 
must be negative for breast cancer cells by the I 
immunohistochemical assays summarized in Appendix G. I 
4.4 Patients with refractory disease must have an engrafting dose of I 
a CD34 selected autologous peripheral blood stem cells stored one i 
half of which have been CD3 4 selected, and then exposed to I 
safety-modified retroviruses which contain the MDR-1 cDNA in a I 
transcriptional unit. A dose of backup marrow or peripheral I 
blood stem cell collection which is equivalent to an engrafting I 
dose must be stored. Patients must sign informed consent, must I 
not be pregnant or lactating, and must be practicing adequate I 
contraception if of childbearing potential. I 
4.5 No patient who is unresponsive to platelet infusions will be | 
eligible for this study unless a total of 8 collections of I 
autologous platelets are available before therapy. I 
Before post transplantation Taxol therapy is initiated, the I 
patients must have an ANC of 1800/cu mm, and a platelet count and I 
hemoglobin equal to or greater than 100,000/cu mm and 8 g/dl, I 
respectively. These levels must also be imposed for eligibility | 
for the protocol. | 
5.0 TREATMENT PLAN i 
5.1 
5.2 
General: All patients should be registered with the data j 
management office. Ext: 2-2926. Information pertaining to ifi 
important patient characteristics will be recorded. •, 
Bone marrow aspiration and collection of peripheral blood stem 
cells and storage: In these breast cancer patients, two 
engrafting doses of autologous peripheral blood or marrow cells 
(one engrafting dose of which is CD34 selected peripheral blood 
stem cells) will be collected in the early phases of 
hematopoietic recovery from conventional dose cyclophosphamide 
chemotherapy (4 gms/m^) under GCSF stimulation (5 mcg/kg/day) . 
The adequacy of a peripheral blood stem cell collection (2 
engrafting doses) will be 4 x 10® nucleated cells/kg or 20,000 
CFUGM/kg or 1 X 10®/kg CD34 positive cells. These peripheral 
blood stem cells will be CD34 selected and by the CellPro Ceprate 
1 
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Recombinant DNA Research, Volume 19 
