FIGURE 7 STUDY TIME COURSE 
BASIC INVESTIGATION 
CLINICAL INVESTIGATION 
PATHOLOGY 
•28 Pathologic 
confirmation of 
CELL THERAPY 
preparation 
immune response 
1 DEPARTMENT OF UROLOGY 
STUDIES 
1 PRE-OPERATIVE evaluation 
•28 .28 
Calls cultured Immune Parameters 
+ or- GM-CSFgene *-ctl Cloning 
OTH -2 
OTH-0 
BX +3 
ax +7 
I 
o> 
ax +se 
ax +«3 
DTH + S2 
DTH+M K 
ro 
03 
Cn 
O) 
Decision 1 . Enrollment 
•28 SURGERY 
•27 RANDOMIZATION 
t r 1 * 
- GM-C3F Gene Transfer + GM-CSF Gene Transfer 
JOHNS HOPMNS ONCOLOGY CENTER 
Decision 2. Eligible Post Surgery 
■u 
to 
ro 
oo 
CO 
cn 
ro 
A 
to 
cn 
O) 
cn 
co 
-u 
o 
3 - 
CTScan 
Decision 3. If Dose limiting toxicity observed 
IF YES STAGE 3 
CTScan 
"►cT 1 
L- CTScan 
UROLOGICAL ONCOLOGY CUN1C 
SCHEDULED LONG TEAM FOLLOW-UP 
IN DAYS POST CONCLUSION OF STAGE 2 
TREATMENT WITH OTHER 
MODAUT1E3 (1L-2, PHASE I AGENTS) 
T = Treatment 
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