3.2 THREE STAGE PHASE I TRIAL 
This trial will be conducted in three stages. In the surgical stage 
(Stage 1), nephrectomy will be followed by vaccine preparation. In Stage 2 of 
the trial, eligible patients following surgery will be treated with cell 
therapy and evaluated for acute toxicities and induction of immune responses 
in the short-term. In Stage 3 of the trial, patients will be evaluated over 
the long-term (including autopsy) for late onset toxicities and correlation of 
immune response assays with clinical course. If patients show progression of 
their disease in Stage 2 or 3 of the trial, they may elect IL-2 therapy if 
they have not previously received it, treatment with other investigational 
agents, or best supportive care provided at the Johns Hopkins Oncology Center. 
In all cases, however, patients will continue scheduled follow-up for the 
observational stage of this trial. 
3.3 STAGE 1: SURGERY, RECOVERY, AND CELL PREPARATION 
Stage 1 of the trial will involve clinical and laboratory evaluation, 
and determination that candidate Stage III T 4b and Stage IV RCC patients are 
safe surgical candidates. Pathologic diagnosis and staging of disease will be 
completed during surgery (Figure 7). Surgical and medical eligibility 
criteria are delineated in Section 4.0. Prior to final enrollment, patients 
will sign informed consent in accordance with the institutional procedures for 
clinical investigation at the Johns Hopkins Oncology Center. 
Provided the diagnosis of RCC is histologically confirmed at resection, 
one day after nephrectomy, patients will be randomized to cell preparation 
either with non-transduced tumor vaccine cells or with tumor vaccines 
transduced with the GM-CSF gene. Autologous vaccine will be prepared 
accordingly at Somatix Therapy Corporation for patients during their recovery 
from surgery. Blinded randomization will occur in the Biostatistics Office of 
the Johns Hopkins Oncology Center by the methods described in Section 5. 
Neither patients nor doctors will know prior to surgery which treatment arm 
will be assigned. Randomization is designed only to assign patients 
impartially to either treatment arm — not to equalize for all patient 
characteristics. After randomization, patients and their physicians will be 
blinded until conclusion of Stage 2 is completed for the individual patient. 
At the completion of stage 2, both patient and clinical investigator will be 
informed of assigned cell preparation for the individual patient. 
During the post operative recovery period, vaccine cells plus or minus 
GM-CSF gene transfer will be expanded and ultimately lethally irradiated as 
described in Appendix 14. C. If the post-operative recovery is uncomplicated, 
each patient will be completely re-evaluated seven days before planned 
vaccination (day -7). If still eligible by all criteria in Section 4.0, the 
patients will receive pretreatment staging CT scans of metastatic disease 
sites and baseline immune function testing as described in Section 7. 
If patients develop post-operative complications which require ongoing 
medical management that precludes experimental vaccine therapy, they will be 
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