Patient Name: 
CONSENT FOR RESEARCH History Number 
Consent version 5/23/94 
STUDY TITLE: AIS-1061-9406 
A PILOT STUDY OF AUTOLOGOUS HUMAN 
INTERLEUKIN 2 GENE MODIFIED TUMOR CELLS IN 
PATIENTS WITH REFRACTORY OR RECURRENT 
METASTATIC BREAST CANCER 
IRB # 302-94-3 
If you choose to enter this program, you will be injected with "GMT" every four weeks at weeks 0, 
4, 8, and 12 until you have received up to four (4) total injections. The duration of this study will be 
24 weeks on an out-patient basis, although you will be followed for the rest of your life for clinical 
evaluation. The "GMT" will be prepared under stringent conditions and will be tested for sterility 
before injection. 
Similar modified tumor cells have been tested in mice and have been found to have some ability to 
counteract the growth of tumor. Several studies involving laboratory animals have shown an 
increased immune response and reduction of tumor size with these preparations. Several trials in 
humans for skin and kidney cancers using a different active immune delivery system for GMT 
than vou will receive in this study have begun, including one at Duke, and the results are not 
known at this time. It is not known if the response seen in laboratory animals will be seen in 
humans. 
PROCEDURES: 
Blood tests will be done to evaluate the safety and effectiveness of this research. These tests 
include: a complete blood count, urinalysis, blood chemistry, and coagulation testing, sedimentation 
rate, HIV antibody testing, and Hepatitis B testing. We will also be doing other laboratory or 
radiologic studies (chest x-ray, CT scan or MRI, bone marrow biopsy or tumor biopsy) that would 
also be done for your breast cancer check-up. All tests are considered standard care and no 
additional tests will be done that are not part of your standard care. Your blood will be obtained by 
venipuncture (needle stick in a blood vessel in arm) and will total 300cc over the course of this 
study, which is 3/5 of a pint. This is the standard method for obtaining blood and is momentarily 
painful. There is a small risk of fainting, of some bruising (bleeding under the skin), and a rare 
(1/1000) risk of infection. 
You will be followed for the rest of your life. Should you move, you should provide the investigator, 
Dr. H. Kim Lyerly (681-8350) with your new address. 
Patient Initials: 
Recombinant DNA Research, Volume 20 
[ 267 ] 
