Status 
(Open/ 
Closed) 
P/FDA 
Open 
P/FDA 
■o 
1 
0 
Open 
P/FDA 
P/FDA 
and NIH 
P/FDA 
and NIH 
< 
| 
# 
Deaths 
CU 
o 
CU 
- 
CU 
CU 
CU 
CU 
cu 
Adverse 
Effects 
cu 
No 
cu 
No 
cu 
cu 
cu 
cu 
cu 
Problems 
with Gene 
Transfer 
cu 
No 
cu 
No 
cu 
cu 
cu 
cu 
cu 
In Vivo 
Evidence 
of Gene 
Transfer 
(Human) 
cu 
No 
cu 
No 
a* 
cu 
cu 
cu 
cu 
Patient 
Accrual 
To 
Date 
© 
o 
- 
o 
o 
o 
o 
o 
Maximum 
Patient 
Accrual 
10 
(5- ABM 
5-PBL) 
15 
(3 groups 
of 5) 
12 
(4 groups 
of 3) 
- 
15 (if + 
response- 
additional 
15 may be 
accrued) 
8 
fS 
00 
Vector 
Supplier 
LLO 
Viagene 
Vical 
MSKCC 
GTI 
GTI 
MA 
and 
GTI 
Case 
Western 
Reserve 
U. of 
Miami 
GTI 
Packag- 
ing Cell 
PA317 
D-17 
CU 
► 
GP + env 
AM12 
PA317 
PA317 
GP + env 
AM 12 
NA 
VN 
PA317 
Vector/ 
Gene 
GIGc 
[HIV-IT(V)] 
(Rev M10) 
(ARevMlO) 
and 
(RSV-tar/ 
Rev M10) 
(RSV-tar/ 
Rev M10) 
12-28-93 
(NAPAD- 
IL2) 
5-11-93 
(GlNaCvi2) 
GlTlcSvNa 
pHAMDRl/ 
A 
pAnti-IGF-I 
(EBV 
derived) 
pBMG-Neo- 
hIL2/BPV 
derived 
(liposomes) 
G1MD 
Date 
First 
Patient 
Treated 
CU 
8-10-93 
CU 
1-4-93 
CU 
CU 
IU 
CU 
CU 
Patients 
Gaucher 
Disease 
+ 
tS 
X 
hiv(+) 
Cancer/ 
glio- 
blastoma 
Cancer/ 
Astro- 
cytoma 
Cancer/ 
Breast, 
Ovarian, 
and Brain 
Cancer/ 
Brain 
Cancer/ 
Small cell 
lung cancer 
Cancer/ 
Breast 
M/T 
H 
H 
H 
H 
H 
H 
|h 
x Is 
< 
9-3-93 
9-3-93 
9-3-93 
12-28-93 
5-ll-93 c 
9-3-93 
9-3-93 
CU 
CU 
10-7-93 
RAC 
Approval 
Date 
6-7-93 
6-7-93 
6-7-93 
N/A 
€6-8-9 
6-8-93 
i 
9-9-93 
9-9-93 
Institution 
HIN 
USC and 
UCLA 
U. of MI 
SDRCC 
Children's 
Hosp., LA 
and LA 
Methodist 
Columbia 
U. 
Case 
Western 
Reserve 
U. of 
Miami 
HIN 
t/1 
Cu 
J 
V 
1 
o 
C _ s 
a « 
«3 
O 
Nabel 
Sobol, et. al. 
1 ** 
1 ■= 
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Hesdorffer, 
et. al. 
Ilan 
Cassilcth, 
et. al. 
3 S’! 
to ® I 
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Protocol # 
1 
9306-049 
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1 
9306-051 
9309-053 
9309-054 
[586] 
Recombinant DNA Research, Volume 18 
