Appr. Date: 8/4/94 
SUBJECTS' CONSENT FORM 
TITLE: Phase I Trial, of Interleukin-2 Plasmid 
DNA DMRLE/DOPE Lipid Complex as an Imm uno 
therapeutic Agent in Solid Malignant Tumors 
or Lymphomas by Direct Gene Transfer(VCL 1 102) 
Page _l_of_ 
Number: 
SWOG: 
HSC:94-129 
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1AM ARE BEING ASKED TO READ THE FOLLOWING MATERIAL TO ENSURE THAT I 
AM INFORMED OF THE NATURE OF THIS RESEARCH STUDY AND OF HOW I WILL 
PARTICIPATE IN IT, IF I CONSENT TO DO SO. SIGNING THIS FORM WILL INDICATE 
THAT I HAVE BEEN SO INFORMED AND THAT I GIVE MY CONSENT. FEDERAL 
REGULATIONS REQUIRE WRITTEN INFORMED CONSENT PRIOR TO PARTICIPATION 
IN THIS RESEARCH STUDY SO THAT I KNOW THE NATURE AND THE RISKS OF MY 
PARTICIPATION AND CAN DECIDE TO PARTICIPATE OR NOT PARTICIPATE IN A 
FREE AND INFORMED MANNER. 
PURPOSE 
[_D_l_c I am being invited to voluntarily participate in the above-titled research 
L-D-l-d project. I have a minimum of 24 hours to decide if I wish to participate and 
[_D_2-a-l may take as long as 2 weeks. The purpose of this project is to evaluate the 
[_D_2-a-3 toxicity (side effects) and safety of gene therapy of cancer by introducing a 
manufactured gene substance into a cancer tumor nodule in my body- It is 
hoped to induce immunity to the. cancer. However, this is a phase I study 
which means it is designed to test the safety of 4 different doses of the gene 
and has no assurance that it will have any benefit, although any effect on 
tumor, size will be evaluated. I will not be eligible for conventional therapy 
during this study. 
SELECTION CRITERIA 
I am being invited to participate because I have metastatic cancer which 
means that the tumor (cancer) has spread to lymph nodes (glands) or internal 
organs such as liver or lung. Furthermore, my tumor is no longer or not 
amenable to conventional treatment with surgery, radiation or approved 
drugs. 
I must be HIV negative and hepatitis B negative. This is determined by a blood 
test. 
l-D-2-b-l If I am female I must not be pregnant or nursing. Men and women of child- 
bearing age and capacity must use effective birth control during study 
participation (condoms are highly encouraged). This is because the effect on 
a developing fetus is not known. 
A total of 25 patients whose response can be evaluated will be enrolled at the 
Arizona Cancer Center. 
I-D-2-a-2 
STANDARD TREAT 
DCSJ 
There are no known cures for patients with my disease. Also, before being 
eligible for this protocol I will have failed on or been unable to take front line 
chemotherapy which has a response rate which varies from 10-70% 
depending on the type of cancer. Alternative treatments available to me 
include the delivery of x-ray treatment to sites of local disease (50% response 
rate), medication to control pain (close to 100% response rate) and certain 
established chemotherapy treatments or experimental drugs are being 
evaluated at other centers to which I can be referred. These could have 
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Recombinant DNA Research, Volume 20 
