my cancer. Follow-up studies will also include blood tests at each visit. Approximately 100 cc ( 5-10 
tablespoons) of blood will be obtained at these visits. Radiology studies such as x-rays or CT scans will 
be performed after the third injection. 
Men and Women Who Can Have Children 
I understand that both men and women who participate in this study must agree to to use an effective 
contraception method (such as condoms, the pill, diaphragm or intrauterine device) to prevent 
reproduction for the duration of the experimental treatment. 
Because this is a new medication and it has not been given to pregnant women, it is not known how it 
j! would affect the unborn baby. If I am pregnant, breast feeding or think I might become pregnant, I can't 
! be in this research study. If I am not pregnant and if I am using a method of birth control approved by 
i my doctor, I can be in this research study. If I cannot have children because of menopause or surgical 
; sterilization, I can be in the research study. 
I' 
Medications 
Before taking any drug other than the study injections, I should first discuss it with the study physician. 
This includes over-the-counter medications such as pain relievers and antacids. 
I 
I will tell my study physician or research assistant about the medications I am taking, including why and 
I how often I take the medicine, and the strength of these medications. 
{ 
! I understand that I should not drive or operate complicated machinery if drowsiness or sedation results 
from any of my treatments. 
Risks And Discomforts 
Participation in this study may involve some added risks or discomforts. These include: 
I 1. There may be pain, itching or a rash at the injection sites. These complications will be treated 
' with medications, should they occur. If these side-effects at the injection sites are severe and do not 
respond to medications it may be necessary to surgically remove the affected tissues at the injection sites. 
Surgical removal of this tissue may be associated with pain, bleeding, infection and scar formation. 
i 
2. I may experience an allergic reaction to the injected materials. Allergic reactions may include 
symptoms such as fever, chills, rash, itching and low blood pressure. In some patients, these allergic 
reactions may be so severe as to be life-threatening. These allergic reactions will be treated in the event 
that they develop. Because this is a new and untried treatment, it is possible that other risks not 
mentioned and not presently known could occur. 
i 3. The injections may induce immune responses against normal cells in the brain and cause 
I encephalitis. Immune responses directed against normal tissues are termed "autoimmune reactions". 
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Recombinant DNA Research, Volume 19 
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