discretion could lower the dose if overall toxicity is of concern. For 
Grade III or IV toxicity, the dose is lowered one level. 
Patients first dose second dose third dose 
1-4 
3 x 10 7 
1 x 10 8 
3 x 10 8 
5-8 
1 x 10 8 
3 x 10 8 
1 x 10 9 
9-12 
3 x 10 8 
1 x 10 9 
3 x 10 9 
13-16 
1 X 10 9 
3 x 1 0 9 
1 X 1 0 1 0 
The vaccine is prepared in 1000 cc of normal saline and administered 
through a small intraperitoneal catheter which is inserted 
on the day of treatment and removed after the 1 hour infusion. Catheter 
placement and diffusion of fluid will be checked by a technitian flow study 
prior to the vaccine. 
8.3 Vaccine side effects. Irradiated tumor cells have been administered as 
vaccines at intradermal sites in previous studies. At intradermal sites, the 
local side effects are usually only a transient non-tender bump and even 
this side effect is largely determined by the adjuvant used rather than the 
tumor cells. The side effects from intraperitoneal vaccine administration 
are unknown. The ganciclovir activation of the tumoricidal effect could 
lead to some local inflammatory response which may be a beneficial 
antitumor effect. However, whether symptoms will occur is unknown. For 
this reason the study is designed with an escalating dose plan, the 
patients will be hospitalized and monitored daily for side effects. 
8.4 Ganciclovir is a nucleoside analog. It’s an FDA approved drug for the 
treatment of cytomegalovirus infection. It is excreted by the kidney and a 
creatinine clearance is a required pretreatment test. Granulocytopenia 
and thrombocytopenia are common side effects during the 2 to 3 week 
course for CMV infections. We will only be giving a 7 day course but mild 
cytopenias can be expected. Pain and phlebitis at the site of 
administration may occur. Anemia, fever, rash, and abnormal liver 
enzymes have also been reported. 
Reconstitution and administration. It is supplied as a sterile powder and 
is reconstituted with sterile water. It is not compatible with bacteriostatic 
water. For IV administration it is prepared in 100 cc of normal saline or 
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Recombinant DNA Research, Volume 15 
