CLINICAL PROTOCOL 
Product: VCL-1102 
July 7, 1994 
VICAL INC. 
9373 Towne Centre Dr., Ste. 100 
San Diego, CA 92121 
conditions (DNA -20°C, DMRIE/DOPE 4°C). The materials will be supplied by Vical 
Inc. 
5.1 VCL 1102 (IL-2 Plasmid DNA/DMRIE/DOPE). This study drug is composed of 
plasmid DNA coding for IL-2 formulated with the cationic lipid mixture DMRIE/DOPE 
(lipid complex formulation). The DNA concentration is 1.0 mg/mL (see Investigator's 
brochure for complete details of product characteristics and preparation). 
5.2 Normal Saline: 
Sterile solution included in the drug formulationkit provided by Vical to the study site. 
6.0 STUDY DRUG ADMINISTRATION AND TOXICITIES TO BE 
MONITORED 
DNA/lipid complexes are prepared immediately prior to administration. DNA is 
supplied in 1.0 mg/mL concentration in normal saline solution. Lipid (DMRIE/DOPE) 
is supplied as a dry film. Each vial containing DMRIE/DOPE is resconstituted with 
normal saline by vortexing until homogenous. The contents of the lipid vial is 
transferred into the DNA vial and mixed well be repeated inversion. The amount 
injected into each tumor will be based on the algorithm outline below. The doses 10, 30, 
100 and 300 jig will be prepared and formulated as dilutions with normal saline. After 
injection of the drug and with the needle wtill inplace, the dead space will be flushed 
with 0.25 -0.5 ml of normal saline. 
Tumor diameter (cm) 
1.0 - 1.5 
1 . 6 - 2.0 
2.1 - 3.0 
3.1 - X 
Volume of injection (cc) 
1.0 
2.0 
3.0 
4.0 
Tumor lesions will be selected for treatment if they are accessible to intratumor 
administration by direct needle injection. These metastatic lesions will be located at any 
accessible site such as skin, nodes, lung, liver, soft tissues etc.. If necessary, the study 
drug will be injected v with the aid of sonographic or CAT scan visualization of the 
metastasis. Prior to injection, following placement of the needle, gentle aspiration will 
be applied to the syringe to ensure that no material is injected intravenously. Vital 
signs will be measured every 15 minutes at the start of, during, and after the injection 
for at least 2 hours or until the patient is stable. If the systolic blood pressure drops 
Recombinant DNA Research, Volume 20 
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