5.2.4 Evidence of brain metastases by CT scan or MRI. 
5.2.5 Concurrent treatment with corticosteroids or treatment 
with corticosteroids within 4 weeks of first treatment with 
GMT cells. 
5.2.6 Concurrent second malignant tumor other than in situ 
carcinoma of the cervix or non-melanoma skin cancer. 
5.2.7 Autoimmune diseases such as, but not restricted to, 
systemic lupus erythematosus, multiple sclerosis or 
ankylosing spondylitis. 
5.2.8 Previous treatment with rIL-2. 
6.0 SCHEDULE OF ACTIVITIES 
6.1 Screening Tests And Evaluations 
The patients will be thoroughly informed of the overall aspects 
and procedures involved in the study to ensure their 
willingness to comply with the visit and schedule of activities. 
6.1.1 A medical history and physical examination, including 
evaluation of Karnofsky Performance Status, vital signs 
and weight will be obtained and recorded on the case 
report forms. Specific emphasis will be placed on history 
relevant to the presentation and prior therapy of breast 
cancer. 
The history and physical exam and the availability of 
autologous tumor tissue will be used to determine 
eligibility for the study. 
Informed Consent must be signed prior to the following 
screening procedures: 
6.1.2 CBC with differential and platelet count. 
6.1.3 Serum chemistries including: 
albumin, alkaline phosphatase, magnesium, total 
bilirubin, bicarbonate, BUN, calcium, chloride, 
cholesterol, creatinine, total protein, glucose, LDH, 
phosphorus, potassium, AST, ALT, and sodium. 
6.1.4 Prothrombin Time (PT) and Partial Thromboplastin Time 
(PTT) 
6.1.5 A urinalysis including: color, pH, specific gravity, protein, 
glucose, ketones, bilirubin and a microscopic examination. 
6.1.6 Autologous tumor tissue sampling for gene modification. 
6.1.7 A serum (beta-HCG) pregnancy test (if pre-menopausal 
female and of childbearing age) 
6.1.8 Brain CT or MRI to rule out metastases-if not previously 
documented. 
6.1.9 Histologic confirmation of refractory or recurrent breast 
cancer must be documented. 
6.1.10 Serum for HIV ELISA or Western Blot. 
6.1.11 Measureable lesion by physical exam or x-ray. 
[252] 
Recombinant DNA Research, Volume 20 
