CLINICAL PROTOCOL 
Product: VCL-1102 
July 7, 1994 
VICAL INC. 
9373 Towne Centre Dr., Ste. 100 
San Diego, CA 92121 
o Increase in tumor size of > 25% in the sum of the products of all diameters 
of measurable lesions. 
o Significant clinical deterioration that cannot be attributed to treatment or 
other medical conditions and is assumed to be related to increased tumor 
burden. 
o Worsening of tumor-related symptoms deemed clinically significant by 
physician. 
10.0 INFORMED CONSENT AND IRB A PPROVAL 
10.1 Informed Consent 
The Principal Investigator will write an Informed Consent Document and submit it to 
the study site IRB. The principles of informed consent described in FDA Regulations 21 
CFR Part 50 will be followed to comply with Food and Drug Administration, 
regulations. Additionally, the informed consent document will include the specific 
information requested by the Recombinant Advisory Committee and approved by the 
committee in June 1994 for gene therapy protocols. 
Regarding verbal communication about the study to potential participants, patients will 
be solicited for participation by their primary physician and referred to the study 
investigators at the Arizona Cancer Center. Every effort will be made to eliminate any 
conflict of interest if the study investigator is also treating the patient. In a private 
discussion with a study investigator or the investigator's designate (study research 
nurse or coordinator) at the Arizona Cancer Center, patients will be given a detailed 
explanation about the experimental study using non-technical language and a 
dispassionate demeanor. The patient will be told about possible alternative therapies 
and given the informed consent to take home and read. Patients will be allowed no less 
than 24 hours to decide to participate, however, they may elect to sign the informed 
consent form sooner. 
The informed consent document itself includes a description of the purpose of the study 
and the procedures associated with the conduct of the study in non-technical language, 
alternative therapies available, a statement informing the patient that study 
participation is completely voluntary, a description of possible risks, discomforts and 
side effects as well as possible benefits of the treatment., a statement about how many 
other similar gene therapy studies have been undertaken, a review of the institution's 
policy regarding study costs, the fact that both male and female participants are 
required to use barrier contraception during participation in the study, provisions for 
long term follow-up and the requirement that patient's provide a current address and 
contact person, a section stating that the investigator will request that an autopsy be 
performed in the event of the patient's death and a section defining who will have 
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