3.5 STAGE 3: LONG-TERM FOLLOW-UP 
Protocol patients will maintain scheduled long-term follow-up at the 
Johns Hopkins Oncology Center. If their disease progresses at any time during 
the trial, patients will be offered treatment with other therapies including 
IL 2 or phase I drugs under study if that is medically appropriate. They may 
also choose to remain on the study. However, they will be asked to continue 
scheduled follow-up at the Johns Hopkins Oncology for continuity of care and 
as a part of long-term follow up for this study. The timing and nature of 
routine studies including assessment of any late onset auto— immune toxicity 
are described in Section 7 . Presence and duration of patient tumor specific 
immune responses will be tested during scheduled Stage 3 clinic visits as 
described in Section 7 as well. Patients and families will have been asked 
for prior authorization for autopsy in the event of death, as described in 
Appendix 14. H. Autopsies will be performed at the Johns Hopkins Hospital 
under the direction of the study's pathologist. Dr. Audrey Lazenby. The 
strategy of the detailed clinical-pathologic analysis to be followed is 
described in Section 9. 
3.6 RATIONALE FOR STUDY DESIGN AND PREDICTED TOXICITIES 
3. 6. a. Surgery 
Surgery is essential for procurement of RCC tumor cells for 
therapeutic presentation of tumor-specific antigens in the autologous vaccine 
after short-term culture. Nephrectomy in stage III T4b and stage IV disease 
has become an essential component of RCC experimental immunotherapy strategies 
as reviewed in Section 2. Nephrectomy is also performed in this setting to 
forestall major morbidity which can attend the increasing growth of the 
primary tumor. The intra-operative mortality rate at Johns Hopkins for radical 
nephrectomy in RCC patients pre-selected by this study's eligibility criteria 
is under 2%. 
3.6.b. Randomization 
Randomization to treatment arm is blinded to both patients and 
clinical investigators in order to assign treatment impartially to plus or 
minus gene transduction one day after nephrectomy (Section 5 describes 
methodology). Randomization is not intended in this pilot study as a tool to 
eliminate all bias or to justify a type I error rate (alpha level) of 
statistical hypotheses tests. In addition, the blinded clinical investigators 
will be assisted in more objective evaluation of subjective, non-quant itative 
assessments of toxicity (minor symptoms) without biases about the type of cell 
preparation during Stage 2. of the trial. 
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