two hours prior to the TIL infusion during the first week of treatment. Patients 
may receive a second four week course of therapy of rIL-2 following a two week 
rest period. Continued treatment for responders and/or patients with stable 
disease, will be decided on an individual basis. Patients demonstrating 
unacceptable toxicity will be withdrawn. 
9.2 Administration of IFNaA 
Eligible renal cell patients will receive at least one course of therapy, where each 
course consists of four consecutive weeks of IFNa, 6X10 6 U/m 2 /day, by 
intramuscular (IM) or subcutaneous (SC) injection on days one and 4 of each 
week. Patients may receive a second four week course of IFNcxA therapy 
following a two week rest period. Continued treatment for responders and 
patients with stable disease, will be decided on an individual basis. Patients 
demonstrating unacceptable toxicity will be withdrawn. 
9.3 Administration of TIL and PBL 
The number of rIL-2 activated bulk CD8(+) and/or CD4(+) TIL and/or PBL to 
be administered during a single infusion is 10 9 to 10 u This range of TIL cells has 
already been administered safely in a single infusion 9 and represents a volume of 
medium which can be processed in one day. The cells will be administered 
intravenously through a large peripheral vein or central venous catheter. The TIL 
infusion will begin one to two hours after the initiation of the rIL-2 infusion 
during the first week of treatment. A single infusion of 10 9 to 10" cells in 5 
percent normal Human Serum Albumin will be performed over a two hour period 
in an outpatient setting. The administration regimen is as follows: 
9.3.1 The TIL will be resuspended in 5 percent normal Human Serum Albumin 
for single infusion. TIL and PBL will be infused sequentially. 
9.3.2 All 10 9 to 10“ will be infused after microbiological testing is completed 
and concurrently with immunological testing. TIL cultures that are 
contaminated with microorganisms will not be infused into the patient. 
9.3.3. No filters will be used in the infusion line. 
9.3.4. The cells will be mixed gently in the infusion bag every 5 minutes to 
prevent the cells from clumping together. 
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Recombinant DNA Research, Volume 15 
