CLINICAL PROTOCOL 
Product: VCL-1102 
July 7, 1994 
VICAL INC. 
9373 Towne Centre Dr., Ste. 100 
San Diego, CA 92121 
below 80 mm Hg, the injection will be terminated immediately and the patient will be 
closely monitored or treated appropriately until blood pressure is normalized. 
Patients will be closely monitored for toxicity for 2- 4 hours, 24 hours and 7 days after 
the first and second injections. For injections 3-6, patients will be monitored 7 days 
post injection as long as they have experienced no toxicity at the 4 and 24 hour 
observation periods following injections 1 and 2. 
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 toxicities from the prior 
injection and injected with the next dose only if no Grade 3 or higher toxicity occurs. All 
toxicities will be graded according to the World Health Organization (WHO) 
recommendations (see Appendix III). 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. 
At the 16 week visit, a tumor sizing will be done. After the 12 week visit, patients will 
be evaluated a minimum of every 4 months. The Schedule of Events chart (Appendix I) 
defines the specific blood tests and other procedures to be performed at each follow-up 
visit. 
7.0 SAFETY AND EFFICACY 
No more than two weeks prior to entry into the study, and several times during the 
study according to the Schedule of Events chart (Appendix I), all patients will have the 
following studies performed to assess their disease status: 
7.1 Physical exam and medical history including height, weight, vital signs, 
performance status and tumor measurements (tumor staging and by physical 
exam (when accessible). 
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Recombinant DNA Research, Volume 20 
