condition to deteriorate could be encountered. You will be closely 
monitored for such side effects. 
Treatment will continue as long as there is sufficient possibility 
of response to warrant the risks of side effects encountered. Your 
physicians feel that the risks of your disease are much greater than the 
risks of treatment as outlined above. Furthermore, you physicians have 
considered your individual situation and have concluded that, at this 
time, no other therapeutic approaches such as surgery, radiation 
therapy, or other chemotherapeutic treatments are clinically indicated 
as being more effective. At some later time, should these alternatives 
be clinically indicated, they will be discussed with you because this 
study does not preclude their use. 
II. POTENTIAL RISKS AND BENEFITS: 
Risks and Side Effects 
There are potential side effects and risks to this procedure. 
First, you may experience mild discomfort from the needle injections or 
tumor biopsies. You may have mild discomfort and bleeding from the 
tumor biopsy. You will be given a local anesthetic to minimize the 
discomfort. Second, even though the DNA inserted into your tumor is 
considered harmless to you, events could occur within normal cells that 
allow them to become cancerous. Laboratory studies suggest that this 
possibility is unlikely. However, this is a new procedure and we do not 
know whether cells could be come abnormal after long periods of time. 
In animal studies, we have not observed the development of cancer cells 
in any animals tested. Third, the inserted DNA will contain a gene that 
inactivates certain antibiotics in bacteria. This protein is not likely 
to be made in humans, and many other antibiotics that are not 
inactivated will be available and effective in treatment any potential 
bacterial infections. Finally, there could be bruising at the site 
where you will be getting your blood drawn as well as possible 
inflammation or infection of the vein. Of course, care will be taken to 
avoid these complications. 
We emphasize that this procedure, called direct gene transfer, has 
been used in only a few human patients. Because this procedure is new, 
it is possible that despite our extensive efforts, other unforeseen 
problems may arise, including the very remote possibility that death may 
occur. This new form of therapy may attract considerable attention from 
the media and scientific community; however, your identity will be 
protected from the media and from scientific publication. 
No data exists regarding the effects of this therapy on human 
reproductive function. Therefore, you should use adequate contraception 
to avoid the pregnancy of you or your spouse during the course of this 
treatment. 
III. ALTERNATIVE THERAPIES; 
There are no known cures for patients with your disease. Other 
alternative treatments available to you can control local symptoms. 
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