Exclusion Criteria: 
A. Medical or psychological impediment to probable compliance with the 
protocol. 
B. Pregnant or lactating women. Women of child bearing potential must have a 
negative pregnancy test prior to entrance into the study. 
C. Male and female participants must commit to use effective contraception for 
the duration of the study. 
D. Concurrent chemotherapy, radiation therapy or immunotherapy. 
E. Concurrent treatment with corticosteroids or treatment with corticosteroids 
within 1 week of first treatment. 
F. Concurrent second malignant tumor other than in situ carcinoma of the cervix. 
G. Autoimmune diseases such as, but not restricted to, systemic lupus 
erythematosus, multiple sclerosis or anklosing spondylitis. 
H. HIV positive. 
4.4 PRE-STUDY EVALUATIONS: 
A. History and physical exam within 2 weeks prior to first treatment. 
B. Diagnostic procedures to be done within 2 weeks prior to first treatment 
include: 
(1) Complete blood counts and liver function studies; 
(2) Electrocardiogram; 
(3) Baseline blood draws for immunological testing; 
(4) Scans and x-rays include: 
a. Staging computerized tomography of the head, chest and 
abdomen within 4 weeks of first treatment; 
b. Chest x-ray within 4 weeks prior to the first treatment. All 
scans and x-rays will be used to document measurable or evaluable 
lesions. 
4.5 REGISTRATION: 
Registration is defined as the date of entry onto the study and requires that the patient 
has met all eligibility criteria, has no exclusion criteria, and has signed a consent form. 
4.6 STUDY DESIGN: 
[640] 
Recombinant DNA Research, Volume 17 
