CLINICAL PROTOCOL 
Product: VCL-1102 
July 7, 1994 
VICAL INC. 
9373 Towne Centre Dr., Ste. 100 
San Diego, CA 92121 
Schedule for Post-Injection Patient Monitoring 
Treatment # 
3-4 Hrs 
24 Hrs. 
7 Days 
14 Days 
1 
X 
X 
X 
— 
2 
X 
X 
X 
— 
3 
X 
— 
X 
— 
4 
X 
— 
X 
— 
5 
X 
— 
X 
— 
6 
X 
— 
X 
X 
Before each subsequent injection, patients will be evaluated for toxicides 
from the prior injection and injected with the next dose only if no Grade 3 
or higher toxicity occurs. A tumor sizing will be done at each intramural 
injection of the nodule and if the tumor shrinks to a point where it can no 
longer be injected, subsequent doses will be administered into different 
tumor nodules if any are present. 
After the 6th injection, patient follow-up will include evaluations at weeks 
8, 12 and 16 weeks. Tumor sizing will be done at each intramural injection 
and at the 8 and 16 week post injection visit. After the 16 week visit, 
patients will be evaluated a minimum of every 4 months. 
If a patient experiences a partial response at 4 weeks after the last injection 
of their initial course, he/she may receive an additional course of 
treatment identical to the first course of treatment as long as the patient 
still meets the eligibility criteria. 
The highest dose that does not yield Grade 3 or higher toxicities will be 
considered the maximum tolerable dose. An additional 5 patients will be 
recruited and tested with the maximum tolerable dose. 
4.0 PATIENT ELIGIBILITY 
Patients will be carefully selected based on their past medical history and 
present status. The Investigator and the patient will make a joint decision 
regarding the appropriate treatment with conventional therapy. Patients 
will be considered eligible for this study if they have failed conventional 
therapy or if conventional therapy is not indicated and they meet the 
inclusion criteria listed below in Section 4.1 
[606] 
Recombinant DNA Research, Volume 20 
