6.3. 1.1 Records of concomitant medications and blood 
products administration will be kept. 
6.3. 1.2 Patients will be continually evaluated for signs 
and symptoms characteristic of infections, 
neoplasms, or autoimmune disease. 
6.3. 1.3 Laboratory tests will be reviewed and assessed for 
adverse experiences. Injection sites will be 
inspected at the time of physical exam. 
6.3.2 CBC with differential and platelet count at weeks 0, 4, 8, 
12. 16, and 24. 
6.3.3 Serum chemistries (identical to section 6.2.5) at weeks 0, 4, 
8. 12. 16, and 24. 
6.3.4 Sedimentation rate (identical to Section 6.2.11) at weeks 0, 
4. 8. 12. 16, and 24. 
6.3.5 In Vitro analysis of immune function at weeks 0, 4, 8, 12, 
16, and 24. 
6.3.6 Clinical assessment of breast tumor burden-as clinically 
indicated (identical to section 6.2.14) at weeks 0, 12, and 24. 
6.3.7 Urinalysis (identical to section 6.2.7) at weeks 0, 12, and 24. 
6.3.8 Serum for rIL-2 antibodies should be drawn and stored at 
weeks 0, 4, 8, 12, 16, and 24. 
6.4 Long Term Tests And Evaluations 
6.4.1 Recurrence or Refractory Metastatic Breast Carcinoma 
6.4.1. 1 Dose and administration of previous therapy will 
be recorded. 
6.4.1.2 If breast cancer is refractory or if breast cancer 
recurs following a response, this will be 
documented by pathologic assessment (histology 
or cytology). 
6.4.1 Long Term Clinical Follow-up Evaluations 
6.4. 1.1 Following 24 weeks, patients will be seen every 3 
months for the remainder of the first year, every 6 
months for year 2 and yearly thereafter, until 
death. 
6.4. 1.2 At each visit an interim history including vital 
signs will be taken and the following recorded: 
a. Signs and symptoms of disease progression 
and secondary illnesses or malignancies. 
b. Kamofsky performance score 
c. CBC (differential, platelet count and MCV) 
d. Chemistry panel (serum creatinine, BUN, 
bilirubin (total), SGPT, SGOT, alkaline 
phosphatase, LDH, CPK, and amylase) 
e. Urinalysis 
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