PATIENT ELIGIBILITY 
4.1 Advanced disease ovarian cancer patients who have not previously 
been exposed to Taxol and who have failed conventional dose 
therapy or induction therapy including platinum analogues and who 
therefore have an 80% chance of dying of progressive ovarian 
cancer. 
4.2 Patients must have a performance of <3 on Zubrod performance 
scale (Appendix Al) , a creatinine level <1.6 mg% , acceptable 
cardiac condition (class I or II; Appendix A2) , normal liver 
functions with bilirubin <2 mg%, and acceptable pulmonary 
condition (FEVI and DLCO >50% of predicted) . Patients should be 
free of infections at the time of treatment. 
4.3 A serum creatinine less than 1.5, a creatinine clearance of at 
least 50 cc/min/m 2 , a SGOT within the normal range, and a 
bilirubin of less than 1.5 is required. 
4.4 Patients with refractory disease must have an engrafting dose of 
a CD34 selection autologous bone marrow stored with the cells 
exposed to safety-modified retroviruses which contain the MDR-1 
cDNA in a transcriptional unit. A backup marrow or peripheral 
blood stem cell collection which is equivalent to an engrafting 
dose must to be stored. Patients must sign informed consent, 
must not be pregnant or lactating, and must be practicing 
adequate contraception if of childbearing potential. 
4.5 No patient who is unresponsive to platelet infusions will be 
eligible for this study unless a total of 8 collections of 
autologous platelets are available before therapy. 
TREATMENT PLAN 
5.1 General: All patients should be registered with the data 
management office, Ext: 2-2926. Information pertaining to 
important patient characteristics will be recorded. 
5.2 Bone marrow aspiration and collection of peripheral blood stem 
cells and storage: Marrow is to be stored using in vitro methods 
for reducing the total number of mature nucleated cells and for 
the enrichment of the stored marrow in the early progenitor 
cells, by the CellPro Ceprate Stem Cell Concentrator. The method 
of concentrating the marrow and for concentrating the marrow in 
early stem cells using the CellPro Ceprate Collector are 
summarized in Appendix B. 
The cells will then be modified by transduction with the safety- 
modified retroviruses which carry the MDR-1 cDNA in a 
transcription unit. The retroviruses are outlined in Appendix D. 
The method of transduction is outlined in Appendix D. 
The criterion for adequacy of the autologous marrow will be as 
follows: At least 2 x 10 8 /kg nucleated cells per kg, 10,000 
CFUGM/kg, 0.7 x 10 6 CD34 positive cells/kg, and a marking 
frequency of at least 1% in the marrow. If this is not 
available, an additional marrow storage will be conducted, or an 
equivalent number of progenitor cells, as measured by the CFUGM 
assay, will be collected from the peripheral blood and modified 
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