eosinophilia; anemia; capillary leak syndrome with fluid retention, weight gain, congestive heart failure, 
and hypotension; pruritus; transient liver and renal function abnormalities; nasal congestion and 
glossitis; mental status changes; rash; thrombocytopenia; oliguria; hair loss; myocardial infarction and 
cardiac arrhythmias; arthritis; and visual abnormalities. 
Any previously unknown ECOG grade 2 and 3 adverse reactions will be reported in writing within 
10 working days to our IRB, the FDA, and the NCI. 
Any grade 4 adverse reaction or patient death while on gene therapy treatment will be reported to 
our IRB, the FDA, and the NCI by phone within 24 hours, with a written report to follow within 10 
working days. 
6.0 CRITERIA FOR CLINICAL EVALUATION AND DEFINITION OF RESPONSE 
Complete Remission: Complete disappearance of all measurable and evaluable disease. No new 
lesions. No disease-related symptoms. No evidence of non-evaluable disease, including normalization 
of abnormal laboratory values. Status must be maintained for one month to qualify. 
Partial Remission: Greater than or equal to a 50% decrease from baseline in the sum of products 
of perpendicular diameters of all measurable lesions. No progression of evaluable, but non-measurable 
disease. No new lesions. Status must be maintained for one month to qualify. 
Stable Disease/No Response: Disease status not defined by criteria for Complete or Partial 
Remission (above) or Progressive Disease (below). 
Progressive Disease: 50% increase in the sum of the products of measurable lesions over the 
smallest sum observed (or over baseline status if no intervening decrease), or reappearance of a lesion 
which had disappeared, or worsening of evaluable, non-measurable disease, or appearance of any new 
lesion/site. 
7.0 STUDY PARAMETERS 
Test/Eval 
Before 
ChemoRx 
During 
ChemoRX 
Before 
GeneRX 
During 
GeneRX 
After 
GeneRx 
History, PE, 
PS 
X 
Q 3 wks 
X 
Weekly 
Monthly 
CBC,Diff,Plts 
X 
Weekly 
X 
Weekly 
Monthly 
ALT, AST, LDH, Aik. 
P’ase, Bilirubin 
X 
Q 3 wks 
X 
Weekly 
Monthly 
Creat.,Uric Acid 
X 
Q 3 wks 
X 
Weekly 
Monthly 
Na,K, Cl, Calcium 
X 
Q 3wks 
X 
Weekly 
Monthly 
Chest X-ray 
X 
Q 3 wks 
X 
Monthly 
Monthly 
Bone Scan 
X 
CT of Brain 
X 
CT of Chest 
X 
at end 
X 
at end 
prn 
CT of Abdomen 
X 
at end 
X 
prn 
prn 
MUGA SCAN 1 
X 
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Recombinant DNA Research, Volume 18 
