CLINICAL PROTOCOL 
Product: VCL-1102 
July 7, 1994 
VICAL INC. 
9373 Towne Centre Dr., Ste. 100 
San Diego, CA 92121 
• Systemic immune activation as measured by baseline 
peripheral blood mononuclear cell (PBMC) thymidine 
incorporation, NK cell activity and CTL activity against 
utologous tumor cells. 
2.4 To characterize the clinical response to the study drug by serially 
assessing the size of the injected tumor and of other tumor 
masses that may be present and evaluable. 
3.0 STUDY DESIGN 
This is a Phase I open-label single-center study in which up to 25 patients 
will be enrolled for injections directly into tumor nodules with the lipid- 
formulated IL-2 plasmid complex, VCL-1102. Solid tumors and 
lymphomas are the tumor types to be evaluated. 
Eligible patients will have one or more tumor nodules injected several 
times at specified intervals with a specified dose of the study drug (see 
Table 1 below). There will be four groups with 5 patients each with an 
additional group of 5 patients treated at the MTD dose, or at 300 ug if the 
MTD is not reached. 
TABLE 1 
Dosage 
Group 
No. of 
patients per 
group 
Dose per 
treatment 
Total no. of 
treatments 
per patient 
Days 
between 
treatments 
I 
5 
10 ug 
6 
7 
n 
5 
30 PS 
6 
7 
m 
5 
100 pg 
6 
7 
IV 
5 
300 pg 
6 
7 
V 
5 
MTD 
6 
7 
Patients will be closely monitored for toxicity for 3-4 hours post injection 
then 24 hours and 7 days after the first and second injections. For 
injections 3-6, patients will be monitored for 3-4 hours post injection then 
7 days post injection as long as they have experienced no toxicity during 
the 4 and 24 hour observation periods following injections 1 and 2. 
Recombinant DNA Research, Volume 20 
[605] 
