11.5 Clinical Response 
The limited number of patients to be accrued (20) together with their varied 
histologies (4) will limit the generalizability of the response rates that will 
be observed. Rates of response will be tabulated £nd compared to relevant norms, 
but no formal statistical analysis will be carried out. 
■12.0 ETHICAL CONSIDERATIONS 
Dr. Rosa Lynn Pinkus (Medical Ethics) will assist in developing and reviewing all 
protocol consent documents with the principal investigators. Every attempt will 
be made to protect the patients' and their family's privacy. Informed consent 
in this project is considered to be a process of shared decision-making between 
patient and physician. All written consents will be discussed with this concept 
in mind. 
13.0 RESPONSIBILITIES 
13.1 Consent- Drs . Lotze or Rubin. 
13.2 Tumor harvesting from lung- Drs. Ferson or Landrene.au 
13.3 Tumor harvesting from subcutaneous sites- Drs. Lotze, Rubin, Posner, 
or Edington 
13.4 Biopsy of vaccination sites- Drs. Lotze, Rubin, Posner, or Edington 
13.5 Preparation of tumor cell suspensions, culturing of fibroblasts, 
retroviral gene transduction, and preparation of vaccine- Immunologic 
Monitoring and Cellular Therapy Laboratories 
13.6 Administration of vaccine- Drs. Lotze, Rubin, Posner, or Edington 
13.7 Preparation of viral supernatants and safety testing- GTI/PCI 
14.0 RISKS AND BENEFITS 
Systemic interleukin-4 may cause flu- like symptoms such as fever, chills, 
fatigue, loss of appetite, weight loss, headache, nasal congestion, nausea, 
vomiting, gastritis or gastric ulcer, and diarrhea. IL-4 may cause a lowering 
of the white blood cell count that could increase the risk of infection; it may 
cause abnormal elevation of liver enzymes, abnormal kidney function and low blood 
pressure. It is unlikely that any of these toxicities will be induced by the low 
levels of IL-4 elaborated locally by the vaccine. 
Individual patients may benefit by having their tumors shrink or disappear. 
Symptoms related to cancer may improve if shrinkage of tumor is achieved. The 
population of patients with cancer may benefit from this trial which may define 
the role tumor vaccines using cells genetically modified to produce cytokines 
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