CONSENT FOR RESEARCH 
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 Informed Consent 
PURPOSE AND BACKGROUND 
Your doctor has explained to you that you have advanced breast cancer which cannot be cured by 
currently available standard treatments (surgery, chemotherapy, hormonal therapy or radiation 
therapy). You are being asked to participate in a research study conducted at Duke University and 
sponsored by Applied Immune Sciences, Inc., which was designed to evaluate the safety and 
effectiveness of an investigational therapy in which the immune cells are stimulated by tumor cells 
which are taken out of your body, changed by a new active immune gene delivery method 
(Avectin™), killed by irradiation ,and returned by a small injection into the skin. 
When the metastatic lesions are surgically removed as part of your needed clinical care, the tumor 
cells will be taken from the metastatic lesion and mechanically disrupted in the test tube. Your 
tumor cells will then be modified by insertion of DNA or genetic material (a "gene"). Avectin™ 
puts the naturally occurring protein substance of the gene for Interleukin 2 (IL-2) into your tumor 
cells. The Autologous Interleukin 2 Gene Modified Tumor cells ("GMT") are then used as an active 
immune therapy against your cancer. The EL-2 produced by your modified tumor cells will 
hopefully make your tumor cells more visible to your immune system and cause your immune 
system to attack your tumor cells. This research study is designed to test safety and possible 
effectiveness of this "GMT" in terms of stimulating your body's immune system to attack your 
metastatic cancer. 
The IL-2 gene, or DNA, is inserted into your tumor cells in the laboratory using genetic engineering 
techniques that have recently been developed. The IL-2 DNA is inserted into a substance 
(Avectin™) which is not a virus and does not grow, but acts as a vehicle to deliver the gene which 
would otherwise not be efficiently incorporated into your tumor cells. The gene has the capability of 
making your tumor cells express and produce human IL-2. The tumor cells will be killed with 
radiation before injection into your body. Each injection will be given in the soft tissue of your body 
(subcutaneously). Avectin™ is an experimental agent produced at Applied Immune Sciences, Inc. 
Under Dr. H. Kim Lyerly's direction, the EL-2 gene will be incorporated into your tumor cells to 
produce the "GMT". 
Patient Name: 
History Number 
Consent version 5/23/94 
Patient Initials: 
Recombinant DNA Research, Volume 20 
[ 266 ] 
