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 
A biopsy is usually associated with a small amount of post operative pain. This is usually 
controlled with a mild pain medica tion, such a s acetaminophen (Tylenol). The biopsy can be 
complicated bv bleeding or infection Bleeding is often controlled bv applvingpressureon.the 
incision. Infections are unusual; however, if an infection does occur, it mav require the 
administration of antibiotics. Sometimes an infection requires the removal of vour_stitclies and 
dressing changes applied to vour incision for a period of time, often for a period of a few 
weeks. 
Thoracentesis or removal of fluid from vour chest bv placing a needle into vour chest cavity to 
withdraw fluid that mav contain tumor cells from vour chest mav be complicated bv the needle 
injuring the lung. If the lung is injured, it mav collapse requiring insertion of a larger tube to 
allow the lung to re-exoand. and to drain large amounts of fluid. Thoracentesis can be 
complicated bv bleeding or an infection. Bleeding or infection are usually treated bv placing 
pressure on the puncture site or treating with antibiotics. 
Paracentesis or removal of fluid from vour abdominal cavity, involves placing a needle into 
vour abdominal cavity to withdraw fluid that mav contain tumor cells from vour abdomen. 
This mav be complicated bv the needle injuring the contents of vour abdomen which includes 
vour intestine. Bleeding and infection mav complicate paracentesis. Bleeding or infection are 
usually_treated bv placing pressu re on the puncture site or treating with antibiotics. In some 
cases, the abdominal fluid mav continue to leak from the puncture site. This usually resolves 
spontaneously. In s ome cases, patients mav require further surgery to correct the injury of a 
lung or the abdominal contents following thoracentesis or paracentesis. 
POTENTIAL BENEFITS 
The potential benefit to you is that your tumor may temporarily shrink in size or completely 
disappear. No guarantees, however, can be offered that your cancer will respond to the treatment. 
Knowledge may be gained from the experiment that will benefit others. 
Patient Initials: 
Recombinant DNA Research, Volume 20 
[ 269 ] 
