« So 
■s ^ 
0 ^ 
0 5 
Open 
Open 
a 
a 
a 
a 
a 
a 
a 
a 
* 3 
o 
04 
- 
- 
r«* 
•o 
'O 
o 
Adverse 
EfTccu 
No 
No 
No 
Yes-fever, 
nausea, 
vomiting, 
abdominal 
pain 
No 
No 
•*«s. 
« a 
i S •= 1 
>• j= 2 S. 
No 
Yes-Grade 1 
induration 
and 
erythema 
, No 
Probkms 
with Geae 
Transfer 
No 
No 
Sustained 
Marking 
No 
No 
No 
® 1 c 
> *= e ? 
c ** U 
^ c er 
c ® 5 
1^1 
8 
£ *£ 
3 n 
a 2 
No 
No 
No 
o| 
.1^ 
flj " 
Yes 
(Published) 
NA 
NA 
No 
VN 
No 
3 
>• 
NA 
Yes-stable 
disease in 1 
patient 
Ycs-siabic 
disease in 2 
patients 
1 
VN 
in Vivo Evidence of 
Gene Tnnsfer 
0. 
3 
o 
3 
> 
M-Yei 
M-Yes 
T-NE 
M-Ycs 
(Transient Only) 
V-NA 
(Transient Only) 
0. 
3 
o 
3 
> 
M-P 
V-NA 
V-NA 
M-Yea 
(low efficiency) 
FatienU 
Entered onto 
Study 
7/5 evaluable 
(4 AML and 
1 ALL) 
O' 
04 
3(1 NHL 
BMT recipient 
and 2 non- 
BMT) 
a 
o 
00 
00 
Maximum 
Patient 
Accrual 
04 
20 
(10 AML 
and 10 
ALL) 
40(20 
Melanoma 
and 20 
Renal Cell) 
a 
30 
(15 NHL/ 
H1V+ and 
15 HFV + ) 
04 
a 
o 
04 
04 
04 
V«ior 
Supplier 
Vial 
GTI 
GTl 
U. 
Rocheaier 
TOC 
GTl 
on 
GTl 
MSKCC 
MSKCC 
GTl 
3 (3 
Z £ 
NA 
PA317 
PA317 
PA317 
PA317 
PA317 
PA317 
PA317 
GP+cnv 
AM12 
GP+env 
AM12 
PA317 
Vector 
04 ^ 
3 
E 
111 
IE'-' 
x: 
8 
m 
Z 
5 
cd 
8 
2 o 
J 'O 
c 
• 
HSV-TK 
HyTK 
04 
<5 
m 
Z 
5 
m 
z 
1 
3 
x: 
8 
z 
5 
NAPAD/1L2 
NAPAD/1L2 
■o 
So: 
4 8 
85. 
i 5 
Date First 
Padcot Treated 
6-3-92 
s: 
4 
M9-93 
R 
a2> 
R 
§ 
O' 
12-7-92 
? 
S ' 
2-17-93 
3-17-93 
10-28-92 
Pilienu 
Cancer 
BMM/ 
AML 
ALL 
■o 
li® 
(31 S 
Cancer/ 
Ovarian 
♦ 
S' 
X 
Cancer/ 
NB 
Cancer/ 
Brain 
BMM and PBM/ 
CML • 
t E 
« S 
^ -5 
•32 
Cancer/ 
Renal Cell 
BMM and PBM/ 
Multiple Myeloma 
M/T 
H 
2 
2 
2 
H 
h 
2 
t- 
2 
NIH 
Appiovil 
Date 
s: 
fi 
4 
4-17-92 
4-17-92 
2-5-93 
4-17-92 
10-7-93*’ 
8-14-92 
1 
oi) 
8-14-92 
8-14-92 
8-14-92 
8-14-92 
RAC 
Approval 
Date 
s; 
A 
2-11-92 
2-11-92 
S 
? ■£! 
s 5 
6-1-92 
6-1-92 
6-2-92 
6-2-92 
6-2-92 
6-2-92 
'S* 9 
Nabel/ 
U. Ml 
Cornelia/ 
IN U. 
Freeman/ 
Tulane U. 
m 
3 U 
H 
u 
E 
O 
“m 
mJ U 
« 1 
e 
c 
t! 
CQ 
Oldfield/ 
NIH 
l| 
uT 
iy8 
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o 
U 
•6 yu 
5 •• UJ 
1 “2 
o 
Dunbar/ 
NIH artd U. MA 
Prococol # 
T, 
1 
1 
9202-013 
9202-016* 
1 
9206-018 
O' 
9206-020* 
1 
1 
9206-023* 
