hour to identify any side-effects of treatment. Subsequently, I will be contacted daily for 
three days following each injection and I will come to the clinic to be examined if redness 
or swelling develops at the injection sites. I will also be examined every two weeks during 
the first 8 weeks of the study, once a month for three months and every 3 months for one 
year after the completion of therapy and at least yearly thereafter to identify any side- 
effects of treatment and to evaluate the effects of these injections on my cancer. Follow- 
up studies will also include blood tests at each visit. Approximately 100 to 200 cc (10-20 
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 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 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. 
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 will tell my study physician or research assistant about the medications I am taking, 
including why and 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: 
1. There may be some pain, bleeding or infection at the skin biopsy site. These 
potential complications are rarely severe. The biopsy site will be closed with one or two 
stitches which will be removed approximately 10 days after the biopsy. 
Recombinant DNA Research, Volume 18 
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