3055484975 
DIU. OF HEM/ONC 
F-400 T-119 P-008/007 HUG 20 ’93 16: 
Informed Consent - 2 Podack/Cassileth 
Risks and Discomforts 
If an additional biopsy is required, the local or general anesthesia and/or the biopsy itself can 
rarely cause fatal or serious complications, including bleeding, infection and post-operative pain. 
Significant side effects from this treatment approach are not expected for a number of reasons. 
As mentioned previously, the amount of lnterleukin-2 produced locally by the tumor cells that have 
been injected into my forearm is unlikely to have side effects. I will nevertheless be monitored 
for the development of side effects that have been reported when lnterleukin-2 is administered 
in high doses, such as fever, nausea and/or vomiting, diarrhea, shortness of breath, anemia, low 
blood pressure and shock, heart failure, weight gain and fluid retention, itching, abnormalities in 
liver and kidney function tests, rashes, abnormal blood counts, and visual, mental, and heart 
rhythm disturbances. 
The cancer cells returned to me will be treated with radiation before they are returned to me 
which should prevent them from reproducing. Nevertheless, there is an unlikely possibility that 
my cancer cells could grow at the sites of reinjection or that combination of the papilloma virus 
material with my cancer cells will produce a new kind of cancer locally at the injection sites or 
which could spread throughout my body. There is a remote possibility that the portion of the 
genetic material in the tumor cells obtained from a part of the bovine papilloma virus could 
recombine with human genetic material and lead to active viral infection. It has been explained 
to me that this is highly unlikely because the papilloma virus of cows is usually specific for cows 
and does not infect humans and because only a fragment of the whole virus is involved in this 
gene therapy technique. Nevertheless, because of the potential for infectious virus becoming 
established, my physicians have strongly urged me to employ contraception throughout this 
therapy to avoid transmitting virus to a developing fetus. Since this therapy is intended to 
stimulate my immune system, it is remotely possible that an immune attack on my normal cells 
and tissues could occur. 
My doctor will be watching me closely to see if side effects are occurring. Routine blood and 
urine tests, scans and x-rays will be done to check the effects of treatment. I understand that in 
an investigational study of this nature there is always the risk of very uncommon or previously 
unknown side effects occurring. I understand that my doctor will treat any side effects that occur. 
I have been told that the institution is not financially responsible for the added cost for treatment 
of side effects that may occur from this research study. 
Contact Persons 
For more information concerning the research and research-related risks or Injuries, I can notify 
Dr. , the investigator in charge at (306) . 
In addition, I may contact at (305) 
for information regarding patients' rights in research studies. 
Benefits 
It is not possible to predict whether or not any personal benefit will result from the use of this 
treatment program. I have been told that should my disease become worse, side effects become 
severe, or that my doctor feel that this treatment is no longer in my best interest the treatment 
will be stopped. Further treatment will be discussed. 
Recombinant DNA Research, Volume 18 
[265] 
