.lEDlCAL RECORD 
— 
CONTINUATION SHEET for either: 
NIH 2514-1, Consent to Participate In A Clinical Research Study 
NIH 2514-2, Minor Patient's Assent to Participate In A Clinical Research Study 
STUDY NUMBER: CONTINUATION: page _JL of _L pages. 
can occur, Including Irregular heart beat, low blood pressure, and heart attack. Some 
patients have had their colon torn, resulting in abdominal inflammation and infection 
that required surgery to co'rrect. 
It is very unlikely, though possible, that this treatment could kill you. In previous 
studies many of these side effects disappeared or were alleviated after halfing the IL-2 
administration. Other unknown side effects may occur. 
Tumor Infiltrating Cells 
The administration of the TIL may cause fever, chills, and shortness of breath. Based 
on our previous experience, these side effects are expected and should only last a few 
hours. Because these lymphocytes are grown from your tumor, it is possible that the 
lymphocytes we return to you may contain tumor cells. This may make your condition 
worse, but we will carefully examine the lymphocytes that you are given to decrease the 
chance that this may occur. 
i 
The purpose of this study is to determine the maximum doses of 'a treatment consisting 
of your own gene-modified immune lymphocytes and interleukin-2 that can be administered 
to patients. Since this is a new, experimental treatment, we will monitor the effects of 'i 
treatment on the growth of your tumor. I 
•I 
Although treatment with the tumor infiltrating lymphocytes (TIL) can shrink tumors in some! 
patients, many patients do not respond to treatment and even those that exhibit shrinkage 
may show regrowth of the tumor after a short period of time (months). Recent scientific i 
advances have made it possible to modify the genetic makeup of the TIL in an effort to ! 
make the TIL more effective. The scientific advance is called "retroviral-mediated j 
gene transfer” and allows us to Insert a gene into some of your lymphocytes, stimulating ! 
them to produce a hormone called tumor necrosis factor (TNF). This hormone is naturally | 
produced in the body in small amounts. TNF is thought to play a role in body defenses ! 
against cancer. Giving too much TNF may be dangerous and may cause life-threatening j 
low blood pressure. TNF can also cause fever, chills, low urine output, weight loss, ! 
nausea, vomiting and fatigue. The Introduction of this gene may or may not improve j 
the anti-cancer effects of the TIL. It is even possible that it could decrease the ' 
anti-cancer effects of the lymphocytes although this is considered unlikely; we cannot ' 
tell at this time. The gene-modified TIL may have more dangerous side-effects, such as 
causing low blood pressure, than would unmodified TIL. | 
If you decide to participate in this part of the study, a gene will be inserted into a 
portion of your lymphocytes by a special laboratory technique. These special lymphocytes j 
are referred to as "marked” lymphocytes (or "marked” TIL), A gene is a part of a 
chromosome (hereditary material) that contains the information a cell needs to make 
proteins. By Inserting a gene into your tumor Infiltrating lymphocytes, we will be I 
able to distinguish these marked lymphocytes from all other cells in your body. Thus, 
we will be able to study some Important aspects of their life span and function. i 
The following procedure will be used to Insert the gene into your lymphocytes. Your j 
PATIENT IDENTIFICATION | CONTINUATION SHEET for either: 
[300] Recombinant DNA Research, Volume 14 
I iMin-i;si4.2 (10-84) 
P A ; 09-25-0099 
