One week after the first injection, I will have the same procedure done except that I will not be injected with the 
fibroblasts NOT secreting interleukin- 12. This injection will be repeated two weeks after the first injection and three 
weeks after the first injection. 
Twenty eight days after the first injections, two injection sites will be biopsied (a small piece of tissue removed) 
under local anesthesia. These biopsies will each require a few skin stitches. The pieces of skin that are removed will 
be examined to see if this treatment is working. I will also have a physical examination at this time. 
Lastly, I understand that I must return to the Pittsburgh Cancer Institute Outpatient Services one and two months 
after the last injections to evaluate my progress. 
A total of 18 patients with cutaneous (skin) cancer lesions will be enrolled in the first part of this study which will 
be looking to see the highest dose humans can tolerate. All patients will be treated on the Pittsburgh Cancer 
Institute Inpatient or Outpatient Units. 
RISKS AND BENEFITS : The potential benefit of this treatment lies in the possibility that my tumor will shrink 
or disappear. If this happens, I may or may not live longer. Symptoms caused by my tumors may get better after 
therapy. It is not possible to predict whether I will receive any personal benefit from my participation in this study. 
There is a small risk associated with skin biopsy that includes infection, bleeding, and delayed healing. Both of 
these complications are easily treated. The risks of injections with my own skin cells may include soreness and/or 
bleeding at the injection site. Local inflammation and/or discomfort due to lymph node enlargement may occur. On 
occasion, persons reacting strongly to the preparation might develop local ulcers or infection. 
Interleukin- 12 could cause an elevation in transaminase, an enzyme secreted by my liver, decreased white blood cells, 
which may increase my risk of infection; decreased platelets, which may cause problems with blood clotting, 
increasing my risk of bruising or bleeding; increased protein and albumin, which may cause swelling, extra- 
medullary hematopoiesis, which means my blood cells may form outside my bone marrow. Anemia, weight loss, 
decreased appetite are rare, but may occur. 
There is a slight risk that this treatment may cause a second cancer in my body, although the chance of this is low. 
The 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. 
In the event of death, wheather from accident, injury or illness, I have been informed that an autopsy will be 
requested. My close relatives have been informed of my wishes. 
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 U-eatments. 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 : If any information, either good or bad, comes to the attention of the investigators which 
may relate to my willingness to continue to participate, it will be provided to me. I have been told that should my 
disease become worse, should new scientific developments occur that indicate this treatment is not in the best 
interest, or should my physician feel that this treatment is no longer in my best interest, the treatment will be 
stopped. Further treatment would be discussed. 
COSTS AND PAYMENTS : The gene transfection procedure and biopsies necessary for this study will be supplied 
free of charge. This institution will bear the acute costs of non-negligent injuries arising out of the experiment. 
Cost will not be a factor in determining who will be treated. 1, or my insurance company, will be responsible for 
payments for all routine and subsequent care, any sickness or problems that may arise out of the nature of my 
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Patient's Initials 
Recombinant DNA Research, Volume 19 
