CONSENT TO ACT AS A SUBJECT IN AN INVESTIGATIONAL STUDY 
TITLE: The Treatment of Patients with Advanced Cancer Using 
Interleukin- 2 , Interleukin-4 and Tumor Infiltrating 
Lymphocytes 
Principal Investigator: Michael T. Lotze, M.D. 
Professor of Surgery 
Chief, Section of 
Oncologic Surgery 
University of Pittsburgh 
Associate Director 
Pittsburgh Cancer Institute 
Purpose of the Study: 
Your disease has spread to portions of your body such that conventional methods 
of therapy such as drug therapy, surgery, and radiotherapy are no longer felt to 
be beneficial. Treatments being offered to you may be helpful to your disease 
although these are experimental therapies and it is not possible to determine the 
likelihood of benefit at this time. The purpose of this study is to determine the 
maximum doses of a treatment consisting of your own gene-modified immune 
lymphocytes and IL-2 and IL-4 that can be administered to patients. Since this 
is a new, experimental treatment, we will carefully monitor the effects of 
treatment on the growth of your tumor. You will receive the administration of two 
substances into your bloodstream. These substances are interleukin-4 (IL-4) and 
interleukin-2 (IL-2). IL-2 and IL-4 are biological substances normally produced 
by the body in small amounts. Using new biotechnology techniques they can be 
produced in large amounts in yeast. These substances have been purified and will 
be injected into your bloodstream. 
Description: 
Your physicians will conduct a history, and physical examination at the 
beginning of each treatment week. In addition, blood tests (2 tablespoons of 
blood) will be performed just before your treatment and three times during 
therapy to determine the safety of continuing your treatment. Routine x-rays 
such as computed axial tomographic cans (CAT scans) of your brain, chest, and 
abdomen, bone scan and a chest x-ray will be performed prior to beginning this 
treatment. In addition a -blood test for the AIDS and hepatitis viruses will be 
conducted. A bone scan, chest x-ray and CAT scans of the chest and abdomen will 
be repeated every 6-8 weeks to determine the response of your tumor to the 
treatment. Heart tests such as an ECG will be performed. If you are over 45 or 
have any risk factor for coronary artery disease (hardening of the arteries) you 
will be asked to have a stress test performed to determine whether you can 
tolerate this treatment. This test will require you to walk on a treadmill while 
your heart is being monitored. If you have any history of lung problems a 
pulmonary function test will be performed to determine whether you can tolerate 
this treatment. Pulmonary function test is an examination during which you blow 
into a machine which measures the volume of your lungs and their ability to 
oxygenate your blood. A sample of blood may be taken from your artery in your 
wrist to determine the amount of oxygen your blood during the examination. 
You will receive the IL-4 with the IL-2 every eight hours for up to five days. 
/PI 
Recombinant DNA Research, Volume 14 
[857] 
