Protocol ID93-008 
Page 13 
between 80 mm-90 mm Hg. In the unlikely event that hypotension develops 
to a level below 80 mm Hg and is not responsive to an initial challenge ofl.V. 
fluids, it will be treated with low dose dopamine administration at a rate of 3-5 
mcg/kg/minute. 
5.5 Administration of TIL 
5.5. 1 An attempt will be made to administer the maximum TIL number of 10 ^ cells. 
A minimum number of 1x10 ^0 cells will be acceptable. 
5.5.2 TIL will be suspended in 300-500 ml D5 1/4 NS for injection and 0.1% 
albumin. rIL-2 at a dose of .033 mg is added to the saline-albumin solution 
prior to administration. 
5.5.3 An initial infusion of approximately 10^ cells in the saline solution will be 
performed followed by the remainder of the cells over approximately 20 - 60 
minutes (with constant mixing of bag contents). 
5.5.4 No filters are used in the infusion line. 
5.5.5 Vital signs will be obtained before the infusion, every 15 minutes during the 
infusion. 30 minutes after the end of the infusion and then resumed every 4 
hours. An emergency cart will be available at the bedside during and for one 
hour following administration of TIL + rIL-2 . 
6.0 PATIENT EVALUATION 
The clinical and laboratory studies that are pertinent to the therapy protocol ID92-015 
are described on pages 14-20. 
Tumor and tissue biopsies, PEL and peritoneal cells will be obtained according to the 
schedule shown below. 
Schedule for Samples During Treatment Course 
Day 12 3 4 
IP treatment 
(i) TIL X 
(ii) rll^2 X X X X 
Tissue samples 
Tumor 
Normal peritoneum 
Omentum 
Lymph node 
Peripheral blood X 
Peritoneal fluid X 
8 
9 
10 
11 
15 
16 
17 
18 
X 
X 
X 
X 
X 
X 
X 
X 
X X 
X X 
1 mo. 
X 
X 
X 
X 
X 
X 
7.0 EVALUATION AND MANAGEMENT OF TOXICITY 
All toxicity will be graded. Previous unknown or severe toxicities must be reported to the NCI 
(Section 11.0). 
8.0 CRITERIA FOR RESPONSE 
Clinical response criteria are described in the treatment protocol BD92-015 (T92-0093). 
