FEE-24-’ 94 THU 14:39 ID:HEnHTQLOGY-ONCOLOGY FAX NO: 602-626-2225 
tt444 P06 
SUBJECTS' CONSENT FORM 
TITLE; Ph:ise I Srudy of Immunochempy 
of Malignant Melanoma by 
Direct Gene Transfer 
Page _3.of_5_ 
Appr. Date: 11/23/93 
Re%T 1/13/94 
Number. 
SWCG; 
KSC; 93-175 
RISKS 
All current methods of anticancer treatment (whether standard or experimental) 
have potential side effects. In studies thus far conducted in a few patients, no side 
effects have been noted. However, this is so small that the incidence of side effects 
for this therapy are really not known. Padent follow-up after study completion will 
be life-long. 
I will be kept infcrmed of results from this study while I am receiving the drug, 
especially regarding my finds which might affect m.y willingness to parddpace. 
There are potential side effects and risks to this procedure. Firsd I may experience 
miid discomfort from needle injections or rumor biopsies. I may have mild discomfort 
and bleeding from the tumor biopsy. I will be given a local anesdietic to minimize 
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 rube. There is a risk of heath 
due to bleeding in pneumothora.x. ^ Second, even though the DNA inserted into my 
tumor is considered harmless to me, es'ents could occur within normal cells that allow 
them to become cuncerous. Laboratory studies suggest that das possibility is 
unlikely. Hcw'ever. this is a new procedure and it is not known whether ceils could 
become abnormal after long periods of time. In animal studies, the development of 
cancer cells has nc: been observed in any animals tested. Third, the inserted DNA 
will contain a gene that inactivates certain antibiotics in baccena. This protein is 
not likely to be made in humans, and many ocher antibiotics that are not inactivated 
will be available and effective in treating any potential bacterial infections. 
It has been e.xplained to me that this procedure, called direct gene transfe.". has been 
used before in human patients only in one preliminary clinical trial. Because this 
procedure is new, it is possible that despite our e.xtensive efforts, other unforeseen 
problems may arise, including the ver>' 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 HLA-B7 e.xpresslon. If this is successful, I will be immunized 
to the HLA-37 protein. In the event that I should require an organ transplant, I 
would not be able to receive an organ from an individual who makes this protein, 
which occurs in approximately 15% of donors. 
This study should provide the informarion needed to subsequendy conduct a phase II 
study CO determine if this approach will lead to responses TTie injections I will 
receive may induce an immune response to my tumor and a remission (meaning a 
shrinkage of the cancer for wee.ks to months). 
Medical information about me and my progress in this study will remain 
confrdential. Should the results of this study be reported or published, no individual 
.cobiFiDEyn’^iin 
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Recombinant DNA Research, Volume 19 
