9.3.5. Vital signs will be obtained every 15 minutes during the TIL infusion, and 
30 minutes after completion of the infusion. Fluid balance will be 
monitored during the rIL-2 infusion. Patients will be instructed to record 
their weight daily and to report a weight gain in excess of 5 lbs per day 
or 20 lbs total for the duration of the rIL-2 infusion. 
10. TREATMENT OF SIDE EFFECTS AND TOXICITY MANAGEMENT 
10.1 Recombinant Interleukin-2 Toxicity 
a) Human Studies: Previously documented side effects of rIL-2 at a dose of 
3 x 10 6 U/m 2 /day include: severe flu-like symptoms, diarrhea, cardiac 
arrhythmias, hypotension, weight gain, thrombosis, congestive heart 
failure, short term memory loss, pruritis, abdominal cramps, leg 
weakness, knee tenderness and infection. These toxicides are described 
in Appendix VIII. 
10.2 Treatment of Possible Toxicity and Side Effects of Recombinant Interleukin-2 
10.2.1 Toxicity criteria are given in Appendix III. 
a) Dose Modification: Recombinant IL-2 may be utilized at a 50 percent 
lower dose level. 
b) The development of life threatening toxicity (Grade 3) will require 
withholding of rIL-2 until toxicity returns to less than grade 1 or to 
baseline, at which time rIL-2 will be resumed at 50 percent of the initial 
dose level. If Grade 2 or Grade 3 toxicity occurs after the resumption at 
50 percent of the initial dose rIL-2 will again be discontinued until a 
return to baseline value or Grade 1 toxicity. Resumption of the rIL-2 will 
be at 10 percent of the initial dose. These patients will be withdrawn from 
the study, however, if Grade 2 or Grade 3 toxicity occurs after resumption 
at 10 percent of the initial dose. 
10.2.2 Treatment Regimen 
Acetaminophen 650 mg q 6 hours prophlactically for chill. For some 
study subjects it may be necessary to maintain a q 4 hours schedule. 
Diphenhydramine, 50 mg IV prior to the rIL-2 infusion and q 4 hours pm. 
Compazine 10 mg IV or PRN q 4 hours pm for nausea. 
Recombinant DNA Research, Volume 15 
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