I 
1 
PStiCnt EVSlUStiOri! (Twenty line* not to exceed 75 charectert per line) 
Pre- Every When WBC Count > 1.5 K/pl 
Treat. 2-3 Davs Everv 3 Months in Remission 
History, Phys. Exam X 
CBC, differential XX X 
and platelet counts 
SMA12/PT/PTT/FIB/FSP XX X 
and electrolytes* 
BM aspirate & BX** X X 
BM cytogenetics X X 
EKG/CXR/urinalysis* X 
Pulmonary function test X 
FDA QC Tests as outlined X X 
in post therapy evaluation 
section . 
• In addition as indicated by clinical and hematologic situations. 
** Bone marrow aspirate and peripheral blood for PCR and functional evaluation of the MDR 
content of the cells at +21, +32 days post marrow reinfusion, and every three weeks 
during the first 6 months every 3 months during the first 2 years, and every 6 months 
for the first 5 years following transplant. 
The peripheral blood and bone marrow will be studied with immunohistochemical staining for 
the presence of breast cancer cells, to determine if the patient is eligible for the MDR-1 
transduction (see Appendix G) . 
1 
Miscellaneous Information: (Include any other information that you feel is pertinent to the study) 
(Three lines not to exceed 75 characters per line! . 
None 
Statistical Considerations: (Twelve Tine* not to exceed 75 characters per Gne 
We plan to initially enter 15-20 advanced breast cancer patients in this pilot trial so that 
10 patients are fully evaluable on the trial. We estimate that 100% of the patients will 
exhibit evidence of the functional viral MDR-1 sequences since chemotherapy selection in vivo 
will be used to select for the hematopoietic cells which have retained the MDR-1 retroviral 
transgenome . 
Objectives: 
(Twelve lines not to exceed 76 characters per Gne 
1 . 
2 . 
To evaluate the feasibility of introducing into early hematopoietic progenitor cells 
the MDR-1 cDNA in advanced breast cancer patients and thereby promoting the in vivo 
selection of genetically-modified hematopoietic cells which are resistant to 
chemotherapy by virtue of having been transduced by the MDR-1 cDNA containing safety- 
modified retroviruses. 
To determine the toxicity of modifying stem cells 
function following and during transplant. 
Recombinant 
with MDR viruses on hematopoietic 
DNA Research, Volume 19 
