Anticipated PCR Results 
Day 
Blood 
Skin 
Tumor 
Controls 
Pre 
<l/10l- 5 
<1/10^ 
1/10^ 
1 
I-IOO/IO^ 
It 
II 
II 
3 
If 
II 
It 
II 
6 
It 
If 
i-io/io’ 
It 
15 
II 
10-100/10^ 
II 
20 
<1/105 
It 
If 
II 
50 
<1/105 
II 
II 
II 
80 
<1/10^ 
It 
It 
II 
etc . 
1/10^ - loVio^ 
Controls will consist of transduced K562 or TIL added to graded numbers of 
lymphocytes, skin or tumor to insure that detection was possible on each day of 
assay. We expect that peripheral blood will haye only transiently detectable 
cells and that txjmor biopsies (as long as tumor is accesssable during a response) 
will have cells peristing over the period of study. We will compare our results 
with those that we previously obtained at the NCI. IF there is a suggestion of 
prolonged survival of worked TIL's at tumor sites then a subsequent randomized 
study directly comparing IL-2 and IL-2/IL-4 will need to be considered. 
7.0 RESPONSIBILITIES 
(1) Consent - Drs. Lotze/Rubin/Edington/Posner/Wolmark 
(2) IL-2/IL-4 Administration - Same/Medical and/or Surgical Oncology 
Staff 
(3) Tumor biopsy - Any member of Surgical Oncology Section 
(4) TIL growth - Drs. Whiteside/Elder and colleagues 
(5) Preparation of viral supernatants and safety testing - Dr. 
Moen/ Anderson at GTI . 
8.0 RISK AND BENEFITS 
Interleukin-2 can cause the following types of side effects: Fever, 
chills, skin rash, or other allergic reactions, headache, fatigue, weight gain, 
flu-like symptoms (fever, chills), diarrhea, shortness of breath, low blood 
pressure, low blood counts which could lead to an increased risk of bruising or 
bleeding, abnormal liver function, decrease in kidney function, and production 
of antibodies against the administered IL-2. 
There are also side effects which have been associated with the use of IL- 
2, but occur much less frequently. These include the following: extremely high 
fever, nausea, vomiting, and overproduction by the body of a certain kind of 
white blood cells called eosinophils, arthritis, and unfavorable effect on 
patients who have certain infections within their nervous systems. 
Interleukin-4 may cause flu- like symptoms such as fever, chills, fatigue, 
loss of appetite, weight loss, headache, nasal congestion, nausea, vomiting, 
gastritis or gastric \ilcer, diarrhea. IL-4 may also cause a lowering of the 
white blood cell count which may increase the risk of infection, may cause 
abnormal elevation of liver enzyme, abnormal kidney function and low blood 
pressure . 
[850] 
Recombinant DNA Research, Volume 14 
