thoracoscope. This includes bleeding, infection, and collapse of the lung. All 
of these complications are unusual and are easily treated. The risks of general 
anesthesia are minimal and include pneumonia and heart attack. I may have to 
stay in the hospital 3-4 days after this procedure. 
The risks of vaccination with my own tumor cells may include a soreness at the 
injection site. Local inflammation and /or discomfort due to lymph node 
enlargement may occur. On occasion, persons reacting strongly to the vaccine 
might develop local ulceration or infection. 
Interleukin-4 may cause flu- like symptoms, elevation of liver enzymes , fatigue, 
loss of appetite, weight loss, headache, nasal congestion, nausea, vomiting, 
stomach ulcers, 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 kidney 
function and low blood pressure. 
There is a slight risk that this treatment may cause a second cancer in my body, 
although the chance of this is low. The tumor cells and fibroblasts will be 
pretreated with X-rays to prevent their growth after being injected into my skin. 
The mouse virus used to put a new gene into my fibroblasts has been treated in 
such a way that it is nearly impossible that it could infect other cells in my 
body or cause a new tumor to grow. 
ALTERNATIVE TREATMENTS: 
Alternatives that could be considered in my treatment include experimental 
chemotherapeutic drugs alone or in combination. The principal investigators of 
this study have provided me with detailed information about my disease, and the 
benefits and risks of other available treatments. I should feel free to discuss 
my disease and my prognosis with the investigators. 
The physician involved in my care will be available to answer any questions I may 
have regarding this program. 
NEW INFORMATION : 
Any new information that comes to the attention of the investigators during the 
course of this research that might affect mv choice to continue as a research 
subject will be provided to me. This includes new information about the nature 
of the experimental procedure or the physical reactions experienced by other 
patients involved in this study. 
COSTS AND PAYMENTS: 
The vaccine, special research blood tests, clinic visits, and vaccine biopsies 
required for this study will be provided to me at no charge. All other 
laboratory, physician, or hospital costs not related to the performance of 
research during this treatment protocol, including thoracoscopic removal of lung 
metastases and admission to the hospital for complications of therapy, will be 
charged to me or my insurance company. I have been informed of the possible cost 
of treatment on this protocol, although I understand that this is only an 
Patient's Signat’""-' 
Recombinant DNA Research, Volume 16 
[517] 
