INFORMED CONSENT 
UAB 9405 
March 16, 1994 
Participation in this study will require that I have laboratory studies and x-rays including CT scan 
of the abdomen to assess the extent of my metastatic tumor. I will also have blood drawn for the 
various immunology studies. It may be necessary to draw up to one unit of blood (400 ml) 
monthly for two months for these special studies. My body should regenerate this blood within 
four weeks in the same fashion as would occur if I had donated blood. This therapy should not 
be given if I am pregnant and I will take measures to prevent pregnancy during the two study 
months. 
The entire study will be conducted in the out-patient department and I will not be hospitalized 
unless problems - either due to the vaccination or otherwise - require admission to the hospital. 
The duration of the study will be eight weeks from initial vaccination. 
RISKS AND DISCOMFORTS 
This form of gene therapy and this particular polynucleotide vaccine have not been given to 
patients previously. However, studies in mice, rats, and monkeys have noted no toxicity or side 
effects associated with this type of vaccine administration. In animals, these vaccines have 
induced immune responses which are protective against challenge with infectious agents and 
some types of cancer cells. Possible side effects include those seen with vaccinations in general 
including local tenderness, discomfort or pain at the injection site, swelling and possible 
tenderness of regional lymph nodes (in arm pit). In addition to these side effects, it is 
theoretically possible that I could develop an immune response to CEA or CEA-like molecules in 
normal tissues which could cause unexpected toxicity to circulating white cells, lining of the 
colon or liver dysfunction. The likelihood of these risks cannot be identified because the vaccine 
is a new treatment. Animal studies and trials in humans with a different CEA vaccine have 
revealed no unexpected problems due to developing an immune response to CEA. There may be 
other risks which have not been encountered and cannot be anticipated. 
Risks of having blood drawn include bleeding at the needle puncture site, leading to 
discoloration of the skin and possible iron deficiency. I will take an iron supplement during the 
trial. 
The potential acute or long-term side effects of having a gene inserted into my muscle cells are 
unknown. The insertion of a gene into some of my muscle cells is considered harmless to me; 
however, events could possibly occur in muscle cells or other normal cells in the body that allow 
them to be cancerous. Laboratory studies suggest that this is highly unlikely and has not been 
observed in pre-clinical animal studies. However, this is a new procedure and we do not know 
whether cells could become abnormal after long periods of time. A second factor is that the 
vaccine also contains a gene that inactivates a certain antibiotic (kanamycin) in bacteria. This 
protein is not likely to be made in humans and many other antibiotics that are not inactivated by 
this protein are available and effective in treating potential bacterial infections. Finally, it is 
possible that this expression of the gene in my muscle cells could trigger an immune response 
that could lead to an autoimmune disease such as arthritis or inflammatory muscle disorders. 
Animal studies suggest that this is very unlikely. 
Patient’s Initials 
[418] 
Recombinant DNA Research, Volume 19 
