PHASE I TRIAL OF AdR SVtk VIRUS WITH GANCICLOVIR IN 
PATIENTS WITH UNRESECTABLE MALIGNANT 
MESOTHELIOMA 
UPCC 2594 
Several types of risks and discomfort can occur from videothoroscopy and chest tube placement 
a. Risks of anesthesia; The thoracic surgeon will determine with you if general or 
local anesthesia is required. If general anesthesia is required, then the risk 
(less than 1%) of severe even fatal reaction is present. Local anesthesia carries an even 
smaller risk of severe or fatal complications (allergic reactions). 
b. Bleeding: All surgical procedures will cause some degree of blood loss. It is estimated 
the amount of blood loss to be minimal (less than 100 cc or 3 tablespoons). 
c. Pain: Post operative pain/discomfort at die surgical site is expected and will be 
treated with adequate pain medicines. 
d. Fever/Infection/Pneumonia: The risk of infection after surgery is small (less than 5%). 
If this occurs, you may experience shortness of breath, fever and cough. 
e. Allergic reaction to medications: This is extremely rare (less than 1 in 1000 chance). 
Complications Caused by the Virus: 
a. Multiplication of the virus: The virus that is being used to infect the cancer cell and make 
them susceptible to ganciclovir has been made so that it cannot reproduce by itself. There 
is a very slight possibility that something may happen during the study that will allow 
the virus to multiply. The effects of this event are unknown. However, your immune 
system will likely kill the virus after it has been there for several days to weeks. 
b. Damage to other cells or lining of the lung or the chest wall: It is possible that the virus 
could injure airway cells that it enters. This has not been seen in experiments that have 
been performed on animal and human cells. If this occurs, the segment of lung that is 
used for the study could be temporarily or permanently damaged. 
c. Spread of the virus: It is possible that the virus could spread from your body to 
surroundings. The virus has been altered so that it cannot reproduce by itself. 
If, however, something should happen that the virus does spread and reproduce, 
it would likely behave no different from similar types of viruses that are already 
in the environment around us. However, if there are signs that virus is being spread, 
you may be asked to remain in the hospital longer than two weeks for further 
monitoring. 
d. Cancer The type of virus used in these studies is not the type that inserts its genes 
into the patient's own genes. The insertion of the virus gene into your genes is 
highly unlikely, the chance the virus will cause cancer is thus very small. 
e. Changes in the body's eggs or sperm: There is a remote possibility that the virus 
could change the genes in the body's eggs or sperm. For this reason, fertile men or 
women must use contraception. 
f. Participation in multiple studies may be hazardous to you: If you already are 
participating in another study, please inform us fully. You should not participate 
in multiple studies, unless you and the investigators agree that your health and the 
outcome of the study will not be jeopardized. 
Risks/Side Effects of Ganciclovir 
a. Lowering of white blood cell count: This can happen from 25 to 50% of the time. 
Lowering of the white blood cell count can place you at risk of infection, even fatal 
infection (less than 1% of the time). 
b. Effects on eyes: Retinal detachment has been described with this drug in up to 
30% of patients. However these patients had AIDS and an unusual eye infection. 
Recombinant DNA Research, Volume 20 
[417] 
