8. RCR will be assayed for using the attached FDA supervised tests at 
Somatix Therapy Corporation under IND BB5229. 
9. RCR has not been detected in either production lots for vaccine 
generation or transduced melanoma cells. 
10. Sensitivity of testing for Somatix Therapy Corporation IND BB5229 
is attached. 
C Clinical Protocol 
1. Irradiated, GM-CSF transduced tumor cells have been demonstrated 
to be active in multiple murine tumor model systems including the 
B16 melanoma, RENCA renal cell carcinoma, CMS-5 fibrosarcoma, 
Lewis lung carcinoma, WP-4 fibrosarcoma, CT-26 colon carcinoma, 
C1300 neuroblastoma, Dunning prostate carcinoma, MBT-2 bladder 
carcinoma. 
2. This is a Phase I study designed to determine the dose limiting 
toxicity and maximum tolerated dose of autologous, irradiated 
melanoma cells engineered to express GM-CSF. 
3. No. 
4. The proposed study is similar to the RAC approved Phase I renal 
cell carcinoma trial, protocol # 9303-040. The major differences are: 
(1) the tumor target is melanoma rather than renal cell carcinoma, 
(2) all patients will receive GM-CSF transduced cells as vaccines, and 
(3) the vaccine schedule will be 1 x lO' 7 cells per injection varied 
from every month to every week (the total dose of cells 
administered is within the range tested in the renal cell trial). 
Recombinant DNA Research, Volume 20 
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