9.0 Study Parameters (revised) 
Parameters 
r - 
Pre- Study 1 
Physical exam X 
History X 
Performance Status X 
Tumor Staging and/or 
Nodule Imaging X 
Chemistry Survey^ X 
Vital Signs X 
Weight X 
CBC , Diff, Platelet X 
PT , PTT X 
EKG X 
CPK + isoenzymes X 
CXR X 
U/A and Culture X 
Hb s Ag , HIV X 
Brain CT or MRI X 
Assess for adverse 
events status X 
PCR on PBL and serum 
to detect HLA-B7 gene X 
Tumor biopsy X 
Assay for HLA-B7 
cytotoxic T cells X 
Assay for HLA-B7 
antibody X 
Pregnancy test 
(if relevant) X 
Anti-DNA antibodies X 
ds DNA 
ss DNA 
CT scan of brain 
(if relevant) X 
CT of chest & abdomen X 
Quantitate size of lesion X 
ANA, ESR, CH50 , CRP X 
* 
X 
X 
X 
X 
X 
X 
X 
X 
**x 
During Treatment 
Day 
Week 
I I 
3 14 28 6 8 
X X X X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X X 
X X 
X X 
X X 
X X 
X 
X X 
X 
* An additional sample will be taken several minutes after injection to 
examine for the presence of plasmid DNA. 
** To be performed on nodules 1 week prior to treatment. Nodules will be 
between 0.25 and 4 cm in size. 
^ Routine laboratory tests include uric acid, calcium, phosphate, 
SGOT, SGPT, alkaline phosphatase, LDH, bilirubin, BUN, creatinine, total 
protein, glucose, amylase, lipase 
Recombinant DNA Research, Volume 17 
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