Toxicity Change 
SGOT or alk phos >3x UNL md 350% T 
compared to preRx baseline 
Direct bili 30.2mg/dl above UNL 
Other Rx complications or medical conditions No further Rx 
which substantially T risk to patient 
Symptomatic tumor PROG requiring other 
Rx e.g. RT or chemo 
9.0 Ancillary Treatment 
Symptomatic care may be given as required with medications such as 
antiemetics and analgesics. However, administration of corticosteroids will 
require that the patient be removed from study. 
10.0 Toxicity Monitoring and Adverse Reaction Reporting 
Patients will be monitored and questioned at every visit (see Schedule of Events) 
regarding the occurrence and nature of any adverse experiences. An event is any 
change in the physiological or psychological state other than the primary condition 
that qualifies the patient for this study. 
The Investigator must report to Mr. Steven Kradjian (ph 619-453-9777, available 
24 hours.) upon occurrence of any life-threatening events (Grade IV) that may be 
attributable to administration of the study drug, all fatal events, or the first 
occurrence of any previously unknown clinical event (regardless of Grade). A 
written report is to follow within 3 working days to: 
Steven A. Kradjian, Director 
Regulatory Affairs 
Vical Inc. 
9373 Towne Centre Drive, Suite 100 
San Diego, CA 92121 
Patients will be taken off study immediately if : 
Unacceptable toxicity (Grade HI or IV) develops and is not easily corrected (refer 
to WHO toxicity sheet). 
Development of Progressive Disease (see definition) requiring the institution of 
alternative treatments such as radiation, surgery or other drug therapy. If the 
Investigator believes that the patient's best interest requires a change of therapy. 
At the patient's or guardian's request. 
Recombinant DNA Research, Volume 18 
[765] 
