CLINICAL PROTOCOL 
Product: VCL-1102 
August 10. 1994 
VICAL INC. 
9373 Towne Centre Dr., Ste. 100 
San Diego, CA 92121 
12.0 STATISTIC CONSIDERATIONS 
The primary goal of this protocol is to determine the safety, side effects, toxicity and 
maximum tolerated dose (MTD) of direct intratumoral injection of increasing doses of 
VCL-1102 in patients with solid tumors or lymphomas. Three patients will be 
evaluated at potentially four dose levels. The MTD will be defined as the highest dose 
which does not result in Grade 3 or higher toxicity in any of the patients treated at that 
dose (it is recognized that the MTD may not be reached). Toxicities and side effects at 
each dose level will be tabulated. 
This design is based on the traditional design for early phase I studies. Although newer 
approaches have preferred properties from a statistical perspective, the application of 
these approaches to this study is limited because they typically require a much larger 
number of potential doses (42) or prior information about the dose-toxicity relationship 
(43, 44). We have therefore chosen to retain the traditional design. 
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