Form 
M-03 
DUKE UNIVERSITY MEDICAL CENTER 
A PHASE I TRIAL of HUMAN GAMMA 
INTERFERON TRANSDUCED AUTOLOGOUS 
TUMOR CELLS in PATIENTS with 
DISSEMINATED MALIGNANT MELANOMA 
(Page 2 of 5 ) 
IRB# 1456 92-12 
Extra blood tests will be done because of this research. The blood 
will be obtained by venipuncture (needle stick in a blood vessel in 
the arm) . This is the standard method for obtaining blood and is 
momentarily painful. There is a small risk of fainting, of some 
bruising (bleeding under the skin), and a rare (1/1000) risk of 
infection. The blood will be drawn at each treatment with a total 
of 300 cc. over the twenty-one (21) months of this study. You will 
be followed annually after the completion of the study for 
progress. This follow up will continue for the rest of your life. 
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SIDE EFFECTS: It is possible that this vaccination may cause 
allergic reactions, such as rash, skin tenderness, swelling, fever 
or hives. In addition, you have approximately a 1/5 chance of 
developing a lump at the injection site(s) . These lumps may become 
hard and inflamed or may become ulcerated or require draining by 
your physician. The lumps may persist as long as you are receiving 
the treatment; however, they should resolve within a few weeks to 
months after discontinuing therapy. Rarely, a more severe allergic 
reaction could occur, such as severe shortness of breath, low blood 
pressure or fainting. It is also possible that you could get a 
viral infection which may cause serious illness. In addition, the 
treatment solution could contain viruses which may have not been 
identified in our tests. Receiving injections of these solutions 
could also result in other serious side effects of which we are 
currently unaware. Indeed, unknown side effects are possible as 
this treatment preparation has not yet been tested in humans. The 
side effects may be experienced in varying degrees. Any of the 
above side effects requiring hospitalization for management 
intervention will neccesitate removal from the treatment program. 
You will be asked to contact Dr. Seigler at (919) 684-3942, should 
any side effects occur or should you have any other 
questions/problems at any time during this treatment. 
I 
Patients Initials 
[650] 
Recombinant DNA Research, Volume 17 
