Any adverse effects of treatment will be reported within 24 hours to the IRB 
of the UIC Cancer Center as well as the Office for Protection from Research 
Risks of the National Institutes of Health. A written report will follow 
within 10 days to the Office of Recombinant DNA Activities, Building 31, Room 
4B11, Bethesda, MD, 20892. 
13.0 Biostatistical considerations 
13.1 The endpoint of this pilot study has been defined as clinical toxicity. 
As indicated in Section 7, six patients are to be injected at each dose level. 
If three patients develop grade III or IV toxicity (as defined by the Common 
Toxicity Criteria) , then a maximum tolerated dose will be defined, and the 
study will be ended. All patients will be evaluated for immune response as 
described in section 9.0, although this evaluation will not be the only 
measurable endpoint. 
13.2 Design and sample size 
Twelve patients will be enrolled in this pilot study of allogeneic 
tumor cell immunization. Two dose levels of tumor cells will be used. 
ft 7 
Low Dose: 5 x 10 intramuscular + 2 x 10 (2) intradermal 
q o 
High Dose: 5 x 10 intramuscular + 2 x 10 (2) intradermal 
13.3 The maximum tolerated dose will be defined as the dose of vaccine for 
which three or more patients have grade III or IV toxicity. The trial will be 
stopped at the determination of maximum tolerated dose or the completion of 
both dose levels. It is anticipated that a maximum tolerated dose may not be 
established in this study. 
Recombinant DNA Research, Volume 18 
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