Deceatrer 1-2, 1994, Data Management Report -- Page 
Attadnent IV - F&ge 4 
Protocol 
Status 
Addi t ional 
patients 
will not 
be entered 
until 
current 
data Is 
analysed 
Open 
Closed 
10-19-94 
Open 
Open 
f Deaths 
1 
disease 
relapse 
8 
PO 
(0 autop. ) 
7 
P0 
(0 autop.) 
o 
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41 t. £ 4- 4. (- C 
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Tes 
Grade 1 
induration/ 
erythema/ 
pruritus/ 
nausea/fever/ 
fatigue 
o 
Problems 
Associated 
With Gene 
Transfer 
s 
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Z 2 
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£ i sr 
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No 
No 
Tes 
Low 
transduction 
efficiency 
(<1X) 
Evidence Of 
Biological 
Activity 
VN 
Tes 
Stable 
disease in 1 
patient 
Yes 
Stable 
disease in 5 
patients 
< 
Z 
In Vivo Evidence Of 
Gene Transfer And 
Expression In 
Target Celts 
a. 
« 
4) 
>~ 
o 
« 
41 
>- 
M-P 
VN-A 
VN-A 
N-Yes 
* >18 months 2/6 in 
granulocytes and 
lymphocytes 
Patients 
Entered On 
Study 
in 
2 evaluable 
(4 entered) 
"C 
CM 
'S* 
s 
© *- 
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Patient 
Accrual 
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eg x 
OJ X 
12 
(M/F) 
Divided 
between NIH 
and U. HA 
Vector 
Seller 
GTI 
GTl 
MSKCC 
HSKCC 
GTI 
Vector Construct 
Packaging Cell Line 
(Delivery Vehicle) 
GllkSvNa 
PAJ17 
(Retrovirus) 
8 
Z 
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f 1 
N K L 
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5 2 5 
Dates of 
Treatment: 
(1) First Patient 
(2) Host Recent 
Patient 
(1) 12-7-92 
(2) 
(1) 12-17-93 
(2) 1-4-94 
(1) 2-17-93 
(2) 10-19-94 
(1) 3-17-93 
(2) 10-12-94 
(1) 10-28-92 
(2) 10-15-94 
5 
T/C 
(Brain Tunors) 
H/BM/PB 
(CHL) 
T/V/C 
(Melanoma) 
T/V/C 
(Renat Cell) 
M/BM/PB 
(Multiple 
Myeloma) 
Approval Oates 
RAC/ 
NIH/ 
FDA/ 
RAC/6-1-92 
MIH/8- 14-92 
FDA/ 
RAC/6-2-92 
N1M/8- 14-92 
FDA/1 -5-93 
eg 
8 ? rg 
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N S S 
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RAC/6-2-92 
NIH/8- 14-92 
FDA/10-92 
RAC/6-2-92 
HIH/8- 14-92 
FDA/12-92 
PI/ 
Institution 
Oldfield/ 
NIH 
Oelsseroth/ 
HD Anderson 
lT 
4» 
h « 
s *. a 
• V) 
O 4) z 
Gansbscher, 
et. si./ 
MSKCC 
Dieibar/ 
NIH, U. HA 
a a 
i * 
i s 
w 
£ 
© n 
8 ? 
O' w 
0 
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9206-021 
(4590) 
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