6.2 Baseline Tests And Evaluations Prior To Treatment 
6.2.1 An interval medical history will be obtained and recorded 
on the case report forms. Any other treatments/ 
medications/biologicals/blood products the patient is 
receiving at the time of enrollment, or has received 30 
days prior to the baseline visit and during therapy, will be 
recorded on data collection forms. 
6.2.2 A complete medical history and physical examination, 
including evaluation of Karnofsky Performance Status, 
vital signs and weight. 
6.2.3 A CBC with differential and platelet count. 
6.2.4 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. 
6.2.5 Prothrombin Time (PT) and Partial Thromboplastin Time 
(PTT) if clinically indicated. 
6.2.6 A urinalysis including: color, pH, specific gravity, protein, 
glucose, ketones, bilirubin and a microscopic examination. 
6.2.7 Chest X-ray (P/A and lateral). 
6.2.8 Electrocardiogram 12-lead. 
6.2.9 Sedimentation Rate 
If clinically indicated, testing may be done for anti- 
lymphocyte toxicity. 
6.2.12 Delayed type hypersensitivity testing. 
6.2.13 In Vitro analysis of immunological function. 
6.2.14 Clinical assessment of breast tumor burden including: 
CT scan of chest, abdomen, or pelvis, if indicated. 
Bone marrow biopsy, if indicated. 
Tumor biopsy or sampling of ascites or effusion. 
6.2.15 Hepatitis B surface antigen. 
6.2.16 Serum frozen and stored for analysis of antibody to rIL-2, 
if indicated. 
6.2.17 Autologous breast cancer cells will be isolated and 
propagated from clinically or surgically obtained biopsies 
or aspirations, gene modified and characterized. 
6.3 Tests And Evaluations During And After Treatment 
Study evaluations should be conducted according to the 
Schedule of Activities. All blood should be drawn before 
autologous IL-2 GMT administration. 
6.3.1 An interval history will be taken and a physical 
examination (including Karnofsky) will be performed at 
weeks 0, 1, 2, 4, 5, 8, 9, 12, 13, 16, and 24. 
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