CLINICAL PROTOCOL 
Product; VCL-1102 
July 7, 1994 
VICAL INC. 
9373 Towne Centre Dr., Ste. 100 
San Diego, CA 92121 
the first occurrence of any previously unknown clinical event (regardless of 
Grade). A written report is to follow within 3 working days to: 
Susan M. Stahl, Director of Clinical Projects 
Vical Inc. 
9373 Towne Centre Drive, Suite 100 
San Diego, CA 92121 
8.3 Patients will be taken off study immediately if : 
8.3.1 Unacceptable toxicity (Grade III or IV) develops and is not easily corrected (refer 
to WHO toxicity sheet. Appendix m). 
8.3.2 Development of Progressive Disease (see definition 9.2.4) requiring the 
institution of alternative treatments such as radiation, surgery or other drug 
therapy. 
8.3.3 If the Investigator believes that the patient's best interest requires a change of 
therapy. 
8.3.4 At the patient's or guardian's request. 
9.0 EFFICACY CRITERIA 
9.1 Pharmacologic/Immunologic Studies 
As part of the measurement of the efficacy of this study, successful gene transfer and 
expression will be evaluated by molecular and immunological analyses. The following 
parameters will be measured to evaluate the tumor transfection and expression of IL-2 
of VCL-1102: 
9.1.1 The presence of DNA from the IL-2 gene will be assessed by PCR amplification 
of cells obtained by biopsy of the treated site on various days after the injection 
of the study drug (see Schedule of Events, Appendix I). 
9.1.2 Immunohistochemical staining of tumor biopsy samples will be used to assess 
immunologic response and soluble IL-2 expression. 
9.1.3 Serum IL-2 levels will be measured. 
9.1.4 PCR analysis of peripheral blood samples will be used to test for the presence of 
plasmid DNA. 
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