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 
RISKS/DISCOMFORTS 
It is possible that the "GMT" when administered may cause allergic reactions, such as rash, skin 
tenderness, swelling, fever or hives. In addition, you have approximately a 1/5 chance of developing 
a lump at the injection site(s) (granuloma). Such granulomas may become hard, tender and inflamed 
or may become ulcerated or require draining by your physician. The granulomas may persist as long 
as you are still being injected, however, they usually resolve within a few weeks after discontinuing 
therapy. The appearance of a granuloma is not necessarily an unwanted side effect and may actually 
indicate that you are responding at a slightly greater level to the treatment. Rarely, more severe 
allergic reactions could occur, such as severe shortness of breath, low blood pressure or fainting. It 
is also possible that you may develop disease in which your immune system attacks normal cells as 
well as cancer cells, or so called auto-immune disease. Auto-immune disease, such as arthritis or 
lupus, can lead to new medical problems that would require treatment. It is possible that the 
materials could cause toxic effects of which we are currently unaware. Because the tumor cells from 
your body are altered with a human Interleukin 2 gene using this new active immune therapy 
delivery method , unknown toxic side effects are possible as this delivery method fAvectinI M) has 
not been previously tested in humans. 
Side effects may be experienced in varying degrees: it is unlikely that you would experience all, or 
even most, of the side effects described above. Your doctor will do everything that is possible to 
prevent or reduce any discomfort or risk. As with any new drug, not all side effects may be known 
at the present time. You will be asked to contact your physician or Dr. H. Kim Lyerly, M.D. at (919) 
681-8350 to report any side effects, as well as any problems, or questions at any time during your 
treatment so that early treatment to try to prevent or minimize the development of severe 
complications can be carried out. 
Patient Name: 
History Number 
Consent version 5/23/94 
Patient Initials: 
Recombinant DNA Research, Volume 20 
[268] 
