RECOMBINANT DNA ADVISORY COMMITTEE (RAC) 
DATA MANAGEMENT REPORT - JUNE 1993 
Attachment II - Page 1 
Protocol 
Status 
(Open/ 
Closed) 
C 
8. 
o 
Open 
Open 
Closed 
Open 
Open 
Open 
Open 
Open 
Open 
Open 
Open 
Open 
Number 
of 
Patient 
Deaths 
00 
O 
r- 
O 
- 
fO 
NA 
- 
<N 
- 
o 
o 
Adverse 
Effects 
O 
Z 
No 
No 
No 
No 
No 
ND-1 
failure 
to 
engraft 
NA 
No 
No 
No 
No 
No 
Problems 
with Gene 
Transfer 
Procedure 
No 
No 
No 
No 
No 
No 
No 
NA 
No 
No 
No 
No 
No 
§ 
> 
C 
Evidence 
of Gene 
Transfer 
(Human) 
Yes 
Yes 
Yes 
Yes 
Yes 
0* 
Yes 
NA 
No 
Yes - 2 
patients 
7 c 
1 V 
1/3 •“ 
£ a. 
Yes - 1 
patient 
No 
Patient 
Accrual To 
Date 
O 
o 
1—* 
<N 
SO 
00 
O 
<N 
<0 
(N 
vO 
Maximum 
Patient 
Accrual 
Unlimited 
o 
50 
<N 
O 
o 
o 
vO 
20 
vn 
•o 
Vector 
Supplier 
GTI 
GTI 
GTI 
GTI/ 
Chiron 
GTI 
GTI 
GTI 
GTI 
LID 
GTI 
GTI/ 
Chiron 
GTI 
Univ. of 
PA. Med. 
Center 
Univ. of 
Michigan 
Packaging 
Cell 
PA317 
PA317 
PA317 
PA317 
PA317 
PA317 
PA317 
PA317 
PA317 
PA317 
PA317 
PA317 
Y-crip 
NA 
Vector/ 
Gene 
* 
o 
o 
Z 
2 
LASN-ADA 
GINaSvAd 
^2 
la 
is 
P Cl. 
si 
o 
u 
Z 
si 
o 
;z 
2 
* 
o 
§> 
Z 
si 
o 
iz 
si 
0 
IZ 
si 
0 
;z 
j 
% ^ 
la 
is 
P 3> 
GlNaCVi2 
(IL-2) 
CMV-BA- 
(h)LDLR 
Cationic 
liposomes/ 
HLA-B7 
cDNA 
Date 
First 
Patient 
Treated 
5-22-89 
9-14-90 
5-13-93 
1-29-91 
9-9-91 
1-27-92 
1-16-92 
7-31-92 
0* 
3-3-92 
10-8-91 
3-12-92 
6-5-92 
6-4-92 
Patient 
Population 
Cancer 
SCID due 
to ADA 
Deficiency 
Cancer 
AML 
NBL 
NBL 
CML 
Acute 
Hepatic 
Failure 
Melanoma 
Cancer 
Cancer 
FH 
Cancer 
M/T 
2 
H 
H 
2 
2 
2 
2 
2 
H 
H 
H 
H 
N1H 
Approval 
Date 
o \ 
°P 
<N 
9-6-90 
4-22-92 
(Amend) 
9-6-90 
7-12-91 
7-12-91 
7-12-91 
7-12-91 
7-12-91 
1-17-92 
10-15-91 
10-15-91 
11-14-91 
4-17-92 
C 
< 
Approval 
Date 
10-3-88 
7-31-90 
2-10-92 
(Amend) 
7-31-90 
r— < 
o 
5-31-91 
5-31-91 
5-31-91 
5-30-91 
5-30-91 
10-7-91 
10-7-91 
10-8-91 
2-10-92 
Institution 
HIN 
NIH 
HIN 
St. Jude 
Children’s 
St. Jude 
Children's 
St. Jude 
Children's 
MD 
Anderson 
Baylor 
College of 
Medicine 
Univ. of 
Pittsburgh 
NIH 
NIH 
Univ. of 
PA. Med. 
Center 
Univ. of 
Michigan 
PI(s) 
Rosenberg 
Blaese 
Rosenberg 
Brenner, 
et. al. 
Brenner, 
et. al. 
Brenner, 
et. al. 
Deisseroth 
Ledley, 
et. al. 
Lotze 
Rosenberg 
Rosenberg 
Wilson 
Nabel 
* 
£ 
CL 
8810-001* 
9007-002* 
9007-003 
9102-004* 
9105-005* 
9105-006* 
9105-007* 
9105-008 
9105-009* 
9110-010* 
9110-011 
<N 
| 
5 
9202-013* 
Recombinant DNA Research, Volume 17 
[603] 
