3 + Severe toxicity which requires therapeutic intervention and interrupts 
usual activities. Hospitalization may or may not be required. 
4+ Life-threatening toxicity which requires hospitalization. A toxicity 
which causes a drug-related death will be called a 4F. 
12.0 ADVERSE EXPERIENCE 
To date there have been minimal side effects from vaccinations with allogenic tumor 
cells (20). Patients have had induration and erythema at the site of the vaccination. 
There have been no reports of anaphylaxis to allogenic tumor cells in vivo. In the 
initial study of administration with genetically altered human cells to patients, no 
additional side effects were seen as a result of the procedure and no viable retrovirus 
was transmitted (17). 
Serious adverse effects of treatment will be reported to the Memorial Sloan-Kettering 
Cancer Center IRB as well as the NIH Office for Protection from Research Risks within 
24 hours and a written report will follow within ten 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 planned 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 a measurable 
endpoint. 
13.2 Design and sample size. 
Approximately twelve patients will be enrolled in this pilot study of 
tumor cell vaccinations. Two dose levels of tumor cells will be used. 
low dose: 10 million tumor cells 
high dose: 50 million tumor cells 
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 an maximum tolerated dose may 
not be established in this study. 
Recombinant DNA Research, Volume 15 
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