3.0 OBJECTIVES 
Primary Objective: 
To evaluate the safety of treating patients with autologous breast cancer 
cells transduced with the gene for human Interleukin 2 (IL-2). 
Secondary Objectives: 
To evaluate clinical response and duration of response to treatment. 
To evaluate the effects of treating patients with IL-2 gene modified 
tumor cells on CTL. 
4.0 STUDY DESIGN 
This will be a phase I safety study administering IL-2 gene modified 
autologous tumor (GMT) to patients with refractory or recurrent 
metastatic breast cancer. Three additional, escalating doses of IL-2 
GMT, will be performed one month part. The study will be conducted 
exclusively at Duke University Medical Center and will enroll a 
maximum of 20 patients. A sample size of 20 will be required in order 
to allow for the detection of significant toxicity with 90% power and a 
5% significance level. The study will be stopped early should an 
unacceptable toxicity rate be observed. 
In addition, prior to treatment and at selected times during and after 
treatment, all patients will be evaluated for immune responses and 
survival, although not all of these evaluations will be measurable end 
points. 
4.1 Accrual 
We expect to accrue 10 patients a year to this study. In the first 
stage, 10 eligible patients will be entered. If 3 or more toxic 
events are observed, the study will be closed to further accrual. If 
2 or less toxic events are observed in the first 10 patients, an 
additional 10 patients will be accrued to this study (for a total of 
20). Therefore, this study should reach the total accrual goal of 
20 patients in approximately 24 months. 
4.2 Study Duration 
All patients will receive up to four cycles of GMT if sufficient 
numbers of cells are recovered and available. It is estimated that 
the study will take 30 months for completion of a six month 
study period for all 20 evaluable patients. All patients will be 
followed for safety of the GMT treatment until death. 
5.0 STUDY PATIENT POPULATION 
This study will enroll patients eligible for Protocol treatment of 
metastatic breast cancer. A minimum of ten and a maximum of 
twenty patients with metastatic breast cancer will be enrolled. 
5.1 Inclusion Criteria 
Patients must meet all of the following criteria: 
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