Protocol ID93-008 
Page 12 
Treatment Schema 
TIL Recovery 
I 
CDS ■»TIL plus CDS + TIL 
neoRexp>anded In rll^2 
I + rIL-2 IP 
Days of Treatment 
1234 S 9 10 II 15 16 17 IS 
X 
IP rlL-2 
XXX xxxx xxxx 
5.3 General Considerations 
5.3.1 A temporary removable catheter will be placed under fluoroscopic guidance by 
an interventional radiologist. 
5.3.2 Patients with major loculation will be excluded at this time. 
5.3.3 Patients receiving TIL will be admitted for a minimum of 24-48 hours following 
I.P. TIL. In subsequent rIL-2 cycles patients may be treated as outpatients. 
5.4 rIL-2 Administration 
5.4.1 The first dose of rIL-2 (0.033 mg = 6x10^ lU) will be administered in the same 
bag as the TIL in D5 1/4 NS containing 0. 1% albumin, USP. rIL-2 must first 
be dissolved in sterile USP water before dilution in the saline albumin 
solution. 
5.4.2 rIL-2 will be given subsequently at a daily bolus dose of 0.033 mg/rrfi 
(6xl0^m2 lU) on days 2-4, 8-11, 15-18. All rIL-2 administered to patients will 
be prepared in 250 ml D5 1/4 NS + albumin 0. 1% USP. 
5.4.3 One to two liters of fluid (depending on patient size and comfort) will be 
maintained in the abdominal cavity to allow for adequate distribution of TIL + 
rll^2. 
5.4.4 Patients whose TIL do not meet the criteria for the trial will be taken off study. 
5.4.5 During the administration of rIL-2, patients will be treated with 
acetaminophen at a dose of 650 mg q 4-6 hours. Non-steroidal anti- 
inflammatory drugs may be added if necessary. In addition, Carafate will be 
administered before meals and at bedtime and at least 4 times a day. Maalox 
can be added if necessary. The concurrent use of steroids is not allowed. If 
the patient develops severe chills and fever despite this premedication, 
Benadryl or Demerol in a dose of 25 mg - 50 mg I.V. may be used q 4-6 hours. 
5.4.6 While in the hospital receiving TIL + rIL-2, patients will receive I.V. fluids as 
dictated by the patient’s fluid needs. Since hypotension may occur with rIL-2 
therapy, I.V. fluid rate will be increased if the systolic blood pressure drops 
below 90 mm Hg and the rate will be titrated to maintain the blood pr:essure 
[470] 
Recombinant DNA Research, Volume 19 
