SUBJECTS’ CONSENT FORM Page _3_of_6. 
Appr. Date: 8/4/94 TITLE* Phase I Trial, of Interieukin-2 Plasmid Number 
DNA DMRIE/DOPE Lipid Complex as an Immuno- SWOG: 
therapeutic Agent in Solid Malignant Tumors HSC:94-129 
or Lymphomas by Direct Gene Transfer(VCL 1 102) 
of six treatments- Blood samples (between 1-2 ounces) will be obtained weekly 
or biweekly. A CT scan will be performed before initiation of treatment and 
once or twice in the 2-month study period- My blood lymphocytes will be 
tested to see if the immune system is being boosted. My blood will also be 
tested for evidence of toxicity (side effects) from this treatment. 
At different times in the course of the protocol, tumor biopsies will be 
performed. This procedure involves the injection of a local anesthetic 
(xylocaine) under sterile conditions, followed by insertion of a needle into the 
tumor nodule and withdrawal of a sample of the tumor. This procedure will be 
performed prior to treatment and at intervals of 2 weeks up to 4 times. These 
tests will be in conjunction with the treatments. 
I will be checked regularly for any toxicity (side effects of the drug). Clinic 
visits will be required approximately every week for the first 6 weeks and 
then approximately monthly for a total of 4 months. In addition, '-small 
quantities of blood (2-6 teaspoons) for laboratory tests will be taken weekly. X- 
rays will be done every 2 months and at the end of the study. 
l_D_2-b-2 The study ma\' be ter min ated before that time by my decision, because of side 
l_D_2-b-3 effects or if medically indicated- My follow-up after study completion will be 
life-long. Therefore, the Cancer Center will maintain a current address file on 
me. If I expire, permission for autopsy will be requested. 
RISKS 
I-D-2-a-5 All current methods of anticancer treatment (whether standard or 
experimental) have potential side effects. In studies conducted thus far in ten 
patients with the direct injection of a different gene into patients’ tumor 
nodules, no serious side effects have been noted. One patient had severe pain 
in the injected nodule. However, this number of patients is so small that the 
incidence of side effects for this therapy are really not known. 
I-D-2-b-2 I will be kept informed of results from this study while I am receiving the 
drug, especially regarding any finds which might affect my willingness to 
participate. 
There are potential side effects and risks to this procedure. I may experience 
mil d or even severe discomfort from needle injections or tumor biopsies. This 
is anticipated in- 100% of the patients. I may have mild discomfort and 
bleeding from the tumor biopsy. This is anticipated in 100% of the patients. I 
will be given a local anesthetic to minimi se the discomfort. Also, if the 
injections are into nodules in the liver, bleeding may be serious and require 
surgery to stop it. If the injections are in the lung area the lung may be 
punctured requiring hospitalization or a chest tube. These are anticipated in 
1-5% of the patients. There is a risk of death due to bleeding in pneumothorax. 
Even though the DNA inserted into my tumor is considered harmless to me, 
events could occur within normal cells that allow them to become cancerous. 
Laboratory studies suggest that this possibility is very unlikely. However, this 
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Recombinant DNA Research, Volume 20 
