To infuse the TIL they will be thawed and grown for one to three addi- 
tional weeks using the same procedures detailed above. For infusion TIL are 
reharvested. At the time of cell collection, one liter of saline for injection 
is pumped through the collection chamber and the centrifuge is stopped. TILs 
are resuspended in the collection bag, the centrifuge is started again, and 
another liter of saline is pumped through to fully wash the TILs free of tissue 
culture medium components. The cells are then filtered through a platelet 
administration set into 600 ml transfer packs (Fenwal), and 50 ml of 25% albumin 
and 450,000 lU of IL-2 are added to the 200 to 300 ml volume of cells in saline. 
The TIL are infused over 30 to 60 minutes through a central venous catheter. 
3. Interleukin-2. The recombinant IL-2 used in this trial will be pro- 
vided by the Division of Cancer Treatment, National Cancer Institute (supplied 
by the Cetus Corporation, Emeryville, CA)(28). The IL-2 will be provided as a 
lyophilized powder and will be reconstituted with 1.2 ml/vial. Each vial con- 
tains approximately 1.2 mg of IL-2 (specific activity 18 x 10^ lU/mg). Less 
than 0.04 ng of endotoxin are present per vial as measured by the limulus 
amebocyte assay. Each vial also contains 5% mannitol and approximately 130- 
230 ug of sodium dodecyl sulfate/mg of IL-2. Following reconstitution the IL-2 
will be diluted in 15 ml of D 5 W containing 5% human serum albumin and will be 
infused intravenously at a dose of 180,000 lU/kg over a 15 minute period every 
8 hr, beginning from two to 24 hr after the TIL infusion. IL-2 will be given 
for up to five consecutive days as tolerated. Under no circumstances will more 
than 15 doses of IL-2 be administered. The same toxicity criteria will be used 
as in our previous protocol (86-C-183c). Doses may be skipped depending on 
patient tolerance. Doses will be skipped if patients reach grade III or grade 
IV toxicity as detailed in Appendix B. If this toxicity is easily reversed by 
supportive measures then additional doses may be given. 
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