transduced cells at least four weeks post transduction to assay for the presence of 
replication competent virus before reinfusion of the cells into the patients. In addition, 
we plan to irradiate the cells prior to injection and thus will not assay for oncogenic 
events. 
Murine Safety Studies 
The kbalb-STK and PA-1 STK cell lines are being tested for safety by inoculation 
into Balb/c mice. The kbalb-STK (Group I) cell was irradiated and then 2 x 107 tumor 
cells were inoculated I.P.. Mice have been observed for 30 days with no evidence of 
adverse effects. The PA-1 STK cell line was irradiated and 2 x 107 cells were 
inoculated I.P (Group II). These mice received ganciclovir therapy. This procedure 
has been repeated a second time in the mice, three weeks after the first injection, with 
no evidence of adverse effects 30 days post initiation of therapy (Table III). 
Table III 
Group 
# of mice 
RX 
Davs 
Adverse Effects 
1 
20 
1 H 1 
30 
■ - 
II 
10 
GCV 
30 
4.0 Objectives of the Study 
4.1 To evaluate the safety and side effects of treatment with a Gene- 
Modified Ovarian Cancer Vaccine which is administered 
intraperitoneally and activated with ganciclovir. 
4.2 To determine a maximum cell number of the vaccine which can safely 
be administered intraperitoneally. 
4.3 To evaluate the immunologic response to this vaccine program. 
4.4 To observe for clinical effects on the residual ovarian cancer. 
Recombinant DNA Research, Volume 15 
[593] 
