If patients develop post-operative complications which require ongoing 
medical management that precludes experimental vaccine therapy, they will be 
assigned directly to Stage 3 of the trial. Post-operative complications 
excluding eligibility for vaccination are described in Section 4.0. 
Vaccination is scheduled to begin on Day 0 of Stage 2 of the trial, 
generally 28 days post-nephrectomy. Up to, but no more, than 42 days will be 
allowed postoperatively if additional time is required to propagate the number 
of RCC cells needed for 3 full courses of treatment. If at day 35 
postoperatively or at the upper limit allowed for 4 passages of cells in 
culture, it appears that insufficient cells will be available for all three 
vaccinations at the assigned Dose Level, the patient will be treated on day 42 
post-nephrectomy at the highest possible specified Dose Level allowing 3 
complete treatments. The overall protocol time table is shown in Figure 7. 
Patients will not be given fractions of an assigned vaccine dose. 
Technical failures of vaccine preparation resulting in RCC cell numbers 
insufficient to complete vaccination courses at the lowest Dose Level will 
force assignment of the patient to Stage 3 of the trial. 
3.4 STAGE 2: VACCINATION AND TOXICITY EVALUATION 
In Stage 2 of the trial, patients will be vaccinated on day 0. 
Evaluation for local and systemic toxicities and induction of antitumor immune 
responses will follow. Also in both Stage 2 and in Stage 3 of the trial, any 
evidence of autoimmunity will be assessed. The scope, rationale, and timing 
of these observations are delineated in Sections 7, 8, and 9. 
3. 4. a. Starting Vaccine Cell Dose and Dose Escalation Scheme 
Tumor cell dose will be escalated in 10-fold increments until Dose 
Level 4 — the upper limit feasible guided by our pre-clinical studies (Table 
12). Four Dose Levels are set. Dose Level 1 will be 4xl0 6 cells, Dose Level 
2 will be 4xl0 7 cells, Dose Level 3 will be 4xl0 8 cells, and Dose Level 4 will 
be lxlO 9 cells. No individual patient will be treated with escalating doses. 
The method of dose escalation is described in the legend for Table 12. 
Accrual and randomization will continue until every treatment position is 
evaluated on both arms of the study, or dose limiting toxicities are observed. 
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