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 
FOR WOMEN OF CHILDBEARING POTENTIAL: Since this research may have an adverse effect 
on any unborn children and should therefore not be done during pregnancy, it is necessary that a 
pregnancy test (using two teaspoonfuls of blood drawn from a vein by needle stick) be done first. 
You will be asked to take contraceptive measures while you are participating in this study. You will 
not be allowed to participate in this study if you are pregnant. To your knowledge, you are not 
pregnant at this time. 
FOR MEN WITH POTENTIAL TO FATHER CHILDREN: It is not yet determined whether these 
drugs can adversely affect sperm development in men and thus have an adverse effect on any future 
unborn children. Men who are sexually active must take appropriate contraceptive measures during 
their participation in this study. 
ALTERNATIVE TREATMENTS: 
Alternative treatments for your disease include chemotherapy, surgery, radiation therapy, drugs, 
standard or other investigational therapies. You may choose to receive no specific treatment and 
only symptomatic treatment for relief of your discomforts at any time. 
COSTS: 
The "GMT" will be supplied free of charge by the study sponsor. There will be no cost to vou for 
the investigational care required as part of the study. In the event that third party pavers do 
not pav for research treatments which they deam not part of the standard of care, t he sponsor 
will be responsible for the costs not covered. Information is available from the Business Office, 
(919) 684-2395, concerning costs and likely insurance coverage. 
RIGHT TO REFUSE OR WITHDRAW: 
Taking part in this study is entirely voluntary. You may decline to participate or you may withdraw 
your consent and discontinue participation in the project at any time without affecting your needed 
medical care or your relationship with your physician. You will be given a copy of this informed 
consent. 
Patient Name: 
History Number 
Consent version 5/23/94 
Patient Initials: , , T , 
Recombinant DNA Research, Volume 20 
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