SUBJECTS' CONSENT FORM Page _2_of_6 
Appr. Date: 8/4/94 TITLE: Phase I Trial, of Interleukin-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 1102) 
response rates in the range of 20% but this is not certain. Experimental 
treatments are under investigation which attempt to stimulate the immune 
system to reject the tumor, and I can be referred to physicians at other 
institutions who are conducting such trials. In some cases, proteins are 
injected which can stimulate the imm une system. Other experimental 
treatments available at the Arizona Cancer Center change from time to time 
and currently include Taxol plus etoposide phosphate, platelet factor 4, peg- 
asparaginase and LY295501. I also have the option to receive no treatment at 
this time. 
PROCEDURE 
I-D-2-a-l Within 14 days before I start the test injections, I will have a complete history 
and physical evaluation, electrocardiogram (EKG), urinalysis, blood work 
(complete blood count or CBC), differential and platelets, blood chemistries, 
pregnancy test, hepatitis test, HIV test, other special blood tests and my'-tumor 
sites will be measured, either by direct measurement or x-ray measurement. 
If I agree to participate, I will be asked to agree to the following which is 
described below: 
If I decide to take part in this study, I will receive my injections as an outpatient. 
In this study, injections of manufactured genes will be given that may help to 
fight this disease in other patients but because this treatment is experimental, 
X_D-i-c 1 may not derive any direct benefit from it. The purpose of this study is to 
determine a safe dose of a new treatment which will attempt to induce tumor 
shrinkage. Because this is new and experimental, I will be observed to 
determine the side effects of the therapy. I will also be monitored for the 
effects of this treatment on the growth of my tumor. 
By using techniques in the laboratory, it is now possible to prepare large 
amounts of human DNA or genetic material in bacteria This DNA will be mixed 
with fat bodies called lipids, and then the mixture will be put into my tumor by 
needle injection. Once introduced into the tumor, the DNA produces proteins 
which it is hoped, based on animal studies, will stimulate tumor tissue 
rejection. One protein, known as IL-2, causes the cells which will contain it 
to be recognized as "foreign enemy" by the i mm une system. The purpose of 
the study is to determine whether this treatment will induce the cells of my 
imm une system, known as lymphocytes, to attack and kill the tumor. This type 
of therapy which stimulates lymphocytes is called immunotherapy. IL-2, the 
protein produced- by the gene has been given safely to humans. It is approved 
by the FDA for the treatment of kidney cancer. By putting the gene for it 
directly into the tumor a high local concentration of IL-2 may occur in the 
tumor but little will 1 get into the blood. 
If I qualify for this study, I will have a solution containing the DNA/lipid 
complex injected directly into a tumor nodule. The injections will be made 
under sterile conditions after providing a local anesthetic (xylocaine), and 
areas within a single nodule will be injected. The time of treatment is 
approximately 30 minutes. The treatment will be given every week for a total 
Recombinant DNA Research, Volume 20 
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