Toxicity will be graded and classified according to Common Toxicity Criteria by the 
following outline: 
0 No toxicity 
1+ Mild toxicity, usually transient, requiring no special treatment and 
generally not interfering with usual daily activities. 
2+ Moderate toxicity ameliorated by simple maneuvers. 
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 allogeneic tumor 
cells (23). Patients have had induration and erythema at the site of the vaccination. 
There have been no reports of anaphylaxis to allogeneic tumor cells in vivo. In the 
initial study of giving genetically altered human cells to patients, no additional side 
effects were seen as a result of the procedure and no viable retrovirus was transmitted 
( 20 ). 
Serious adverse effects of treatment (defined as grade III or IV toxicity) will be reported 
to the Memorial Sloan-Kettering IRB as well as the NIH Office for the Protection from 
Research Risks within 24 hours and a written report will follow in ten days to the Office 
of Recombinant DNA Activities, Building 31, Room 4B11, Bethesda, MD. 
13.0 BIOST ATISTIC AL CONSIDERATIONS 
13.1 The endpoint of this pilot study has been defined as clinical toxicity. As 
indicated in Section 7.0, six patients will be treated 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 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. 
Twelve patients will be enrolled in this pilot study of tumor cell 
vaccinations. Two dose levels of tumor cells will be used. 
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