SUBJECTS' CONSENT FORM Page _4_of_6. 
Appr. Date: 8/4/94 TITLE: Phase I Trial, of Interleukin-2 Plasmid Number 
DNA DMRIE/DOPE Lipid Complex as an Imm uno- SWOG: 
therapeutic Agent in Solid Malignant Tumors HSC:94-129 
or Lymphomas by Direct Gene Transfer(VCL 1102) 
is a new procedure and it is not known whether cells could become abnormal 
After long periods of time. In animal studies, the development of cancer cells 
has not been observed in any animals tested. The inserted DNA will contain a 
gene that inactivates certain antibiotics in bacteria. This protein is not likely 
to be made in humans, and many other antibiotics that are not inactivated will 
be available and effective in treating any potential bacterial infections. As 
stated above, the gene for IL-2 causes the cancer cells to produce IL-2. When 
large amounts of IL-2 itself is given to patients they may have side effects of 
fever, chills, loss of appetite, weakness, fatigue or tiredness and low blood 
pressure. My doctors do not think this will happen here because the amount 
of IL-2 produced in the tumor is tiny. 
It has been explained to me that this procedure, called direct gene transfer, 
has been used before in human patients only in two pr elimin ary clinical trials 
in about 10 patients. Because this procedure is new, it is possible that despite 
our extensive efforts, other unforeseen problems may arise, including the 
very remote possibility that death may occur. 
I will undergo biopsy of tumor and other tissue, on several occasions before 
and after injection. Blood and tissue specimens will be taken where possible to 
follow the duration and effects of IL-2 expression. As noted below, the patient 
may withdraw from the study at any time. My doctors do not believe there will 
be any adverse consequences of such a withdrawal. 
D-2-a-A BENhfllS 
This is a phase I study and therefore toxicity and biological acitivty are the 
main objectives and benefit may well not occur. If it does we believe it will be 
in under 20 % of the patients. 
This phase I study should provide the information needed to subsequently 
conduct a phase II study to detennine if this approach will lead to responses. 
The injections I will receive may induce an immune response to my tumor and 
a remission (meaning a shrinkage of the cancer for weeks to months). 
•D-2-b-4 CONFIDENTIALITY 
Medical information about me and my progress in this study will remain 
confidential. Should the results of this study be reported or published, no 
individual patient .names will be used. In accord with the requirements of the 
Food and Drug Administration (FDA), occasionally medical records of patients 
may be reviewed by medical monitors of sponsoring agencies whose duty it is 
to oversee this research to verify its accuracy. This may include the 
sponsoring compahy (Vi cal Inc. San Diego, California), the National Cancer 
Institute and the FDA In addition, the ACC will inform the media that a gene 
therapy protocol is being conducted but they will fully protect the privacy of 
the patients and their confidentiality 
Recombinant DNA Research, Volume 20 
[623] 
