5.1.1 The patients entering the active immunotherapy must 
have a histologically confirmed metastatic breast cancer 
that has failed conventional chemotherapy or hormonal 
therapy. 
5.1.2 If gene modified tumor cells cannot be generated for 
therapy, the patients will not be enrolled. 
5.1.3 The patient must have one or more measurable lesions by 
physical examination or non-invasive radiologic 
procedure. Measurable is defined as detectable in length 
(physically or radiographically) in two dimensions. 
5.1.4 Estimated life expectancy of at least 6 months. 
5.1.5 Complete recovery from effects of prior major surgery 
before initiating study participation. 
5.1.6 Adequate hematologic, renal, and hepatic function. 
Patients must have the following clinical laboratory 
parameters: 
a) WBC > 3500/ mm3 
b) Hgb > 10 gm/dl 
c) platelets > 60,000/ mm3 
d) absolute neutrophil count > 1500/mm3 
e) prothrombin time < 1.5 X normal 
f) creatinine < 2.0 mg/dl 
g) bilirubin < 1.5 mg/dl 
h) AST and ALT < 4 X upper limit of normal 
5.1.7 Failure, defined by lack of regression, or progression of 
disease despite conventional chemotherapy, hormonal 
therapy or radiation therapy. Conventional chemotherapy 
includes patients who have undergone autologous bone 
marrow transplantation following high dose 
chemotherapy. 
5.1.8 Complete recovery from effects of prior therapy before 
initiating study participation. 
5.1.9 Patients must be >18 years. 
5.1.10 The patient must be HIV-seronegative as determined by 
ELISA or Western blot. 
5.1.11 Signed informed consent. 
5.2 Exclusion Criteria 
5.2.1 Medical or psychological impediment to probable 
compliance with the protocol. 
5.2.2 Pregnant or lactating women. Women of child bearing 
potential must have a negative pregnancy test prior to 
entrance into the study. Participants must commit to use 
effective contraception for the duration of the study. 
5.2.3 Concurrent chemotherapy, radiation therapy or 
immunotherapy. 
Recombinant DNA Research, Volume 20 
[251] 
