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 
STATEMENT OF NEW FINDINGS: 
During your treatments, you will also be notified of any additional information that becomes 
available which might influence your decision to continue in the study. 
EMERGENCY TREATMENT AND COMPENSATION FOR INJURY: 
In the event vou sustain iniurv as a result of vour active participation in this research project, 
immediate medical care is available. If immediate medical care is not covered bv third party 
pavers, the sponsor will cover the cost. However, neither the sponsor nor Duke will be liable 
for any other damages or costs, exclusive of the cost of immediate medical care for injuries vou 
might suffer as a result of vour participation in the project. F urther information concerning this 
and your rights as a research subject can be obtained from the Hospital Risk Management Office 
(919) 684-3277. 
TERMINATION OF STUDY: 
Your participation in this research may be ended without your consent for the following reasons: 
1. If your physician determines it is not in your best interests to continue participation in this 
study, your physician may discontinue this treatment. 
2. If you experience side effects which your physician considers unacceptable. 
3. If you refuse to have treatment or tests recommended by your physician or disregard 
requirements of the study. 
4. The sponsor terminates the study. 
PRIVACY: 
The confidentiality of this study's records identifying you will be maintained within Duke University 
Medical Center. Your identity will remain confidential if material from the record is used for 
publication or for educational purposes. However, you should be aware that hospital personnel, the 
sponsor, Applied Immune Sciences, Inc., the Food and Drug Administration (FDA), and/or the 
National Cancer Institute (NCI) may inspect the records. 
Patient Initials: 
Recombinant DNA Research, Volume 20 [271] 
Patient Name: 
History Number 
Consent version 5/23/94 
