(supplied by the Cetus Corporation, Emeryville, CA) (28) and will be 
administered exactly as specified in our previously approved protocols (86-C- 
183c) (41). The IL-2 will be provided as a lyophilized powder and will be 
reconstituted with 1.2 ml/vial. Each vial contains approximately 1.2 mg of 
IL-2 (specific activity 18 x 10 6 IV/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 50 ml of normal 
saline containing 5% human serum albumin and will be infused intravenously at 
a dose of 720,000 IU/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 ad- 
ministered. 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 Table 9. If this toxicity is easily r reversed by supportive 
measures then additional doses may be given. 
8. Concomitant therapy: Patients may receive concomitant medications 
to control the side effects of therapy (4,5). It is our plan to administer 
the same concomitant medications used in all previous TIL protocols. These 
include: acetaminophen (650 mg every 4 hours), indomethacin (50-75 mg every 
six hours) and ranitidine (150 mg every 12 hours) throughout the course of 
treatment. Patients may receive intravenous meperidine (25-50 mg) to 
control chills when they occur, although chills are unusual after the first 
one to two doses of IL-2. Hydroxyzine hydrochloride (25 mg every six hours) 
is given to treat pruritis. Steroids will not be used in these patients 
and if steroid are required, then the patient will immediately be taken 
off protocol therapy. 
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