CLINICAL PROTOCOL 
Product: VCL-1102 
July 7, 1994 
VICAL INC. 
9373 Towne Centre Dr., Ste. 100 
San Diego, CA 92121 
2.1 
[604] 
the drug in patients with malignant melanoma, (Dr. Evan M. Hersh, 
Principal Investigator), the University of Chicago is testing the drug in 
patients with metastatic renal cell carcinoma, (Dr. Nicholas J. Vogelzang, 
Principal Investigator), and the Mayo Clinic is administering the drug to 
patients with metastatic colorectal carcinoma, (Dr. Joseph Rubin, Principal 
Investigator). The study began in May 1994 and as of June 30, 1994 eight 
patients have undergone treatment with a single injection of 10-50 ug of 
DNA intratumorally No adverse events attributable to the drug were 
observed. 
In the VCL 1102 Phase I study proposed in this protocol, Vical intends to 
test for safety and dose optimization of the direct gene transfer approach 
for delivering the IL-2 gene directly into solid tumors and lymphomas. 
High dose parenteral IL-2 therapy is FDA approved as a cancer 
immunotherapy, and has shown some promise for treating rertal cell 
carcinoma and malignant melanoma, but the serious, often life threatening 
side effects of the treatments have prompted investigators to seek 
additional methods to rally the immune system to produce tumor specific 
killer cells. 
2.0 OBJECTIVES 
The objectives of this Phase I study include: 
To determine in patients with metastatic malignancies the safety, side 
effects, toxicity and maximum tolerated dose (MTD) of direct intratumoral 
injection of increasing doses of a DNA/lipid mixture: VCL-1102 (IL-2/ 
DMRIE/DOPE) designed to introduce the IL-2 gene into patients 
with solid tumors or lymphomas. 
2.2 To confirm in vivo expression of the IL-2 gene in the tumor 
cells. 
2.3 To determine the biological activity and pharmacokinetics of the 
treatment including: 
• Intratumoral gene transfection and transcription by PCR 
analysis. 
• Intratumoral inflammatory or immune response by 
immunohistochemistry of tumor biopsies. 
Recombinant DNA Research, Volume 20 
