surgical site infections following nephrectomy prior to final eligibility on 
day -7 for Stage 2 of the trial. Postoperative complications, including deep 
venous thrombosis or pulmonary embolism, will exclude eligibility for Stage 2 
and result in assignment to Stage 3 of the trial. Any other postoperative 
medical problem of sufficient severity to require ongoing medical management 
and make experimental therapy unduly hazardous will be grounds for exclusion 
of Stage 2 (decision on day-7) and assignment to Stage 3 of the trial. 
4.9 Prior to enrollment, investigators must inform both patients and 
family members that in the event of a death on the study at anytime, 
permission will be sought for autopsy. Patient or family refusal or 
indecision is in no way an exclusion criteria for enrollment. 
4.10 Patient must have no other pre-existing medical problems of 
sufficient severity to limit full compliance with the study or expose them to 
undue risk. 
5.0 BIOSTATISTICS 
5.1 Study Design 
The design of this study is somewhat unusual for a Phase I dose 
escalation. In particular, we intend to randomly assign patients to one of 
two treatment groups: one with GM-CSF gene transduction of cells and one 
without. Randomization is frequently used both to reduce bias and to justify 
the type I error rate (alpha level) of statistical hypothesis tests. In this 
study, the purpose of randomization is to insure that patients are assigned to 
the respective treatment groups impartially with regard to "gene therapy" — not 
to justify statistical hypothesis tests. 
5.2 Sample Size and Accrual 
This trial employs a simple Phase I dose escalation scheme. The lowest 
two doses (4 x 10 6 and 4 x 10 7 cells) will accrue only two patients in each 
group. This is because we do not expect serious toxicities at these Dose 
Levels. The remaining two groups will employ three patients per treatment 
group. In addition, in the gene transfer group at the highest dose (1 x 10 9 
cells), three additional patients will be accrued to obtain additional 
experience. In the event that 2 dose limiting toxicities are observed at any 
dose, three additional patients will be accrued at the next lower dose as 
described in Section 3. The rate of accrual on this study is limited by the 
capability to prepare multiple vaccines simultaneously. We expect to be able 
to treat 6-8 patients per month. Thus, Stage 2 of the trial will last for 
approximately 6 to 8 months depending on toxicities observed. 
5.3 Randomization 
The study will employ equal randomization between the two treatment 
groups. All matters concerning registration, randomization, and treatment 
assignment will be conducted through the Oncology Biostatistics Office in the 
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