maximum tolerated dose (MTD) (up to 1 x 10^ cells per dose) of genetically 
modified tumor cells will be determined. If the MTD has not been determined by 
four groups of patients, an additional group could be added at an appropriately 
higher dose. Four patients will initially receive 3 x 10^ HSV- 
TK positive tumor cells I.P on day 0. Approximately twenty-four hours 
after the I.P. infusion the patient will be started on a seven day course of 
ganciclovir. Two weeks after the termination of ganciclovir therapy the patient 
will be reevaluated in terms of side effects from treatment and disease state. If 
no adverse toxicity occurred from the previous I.P. tumor injection and 
ganciclovir therapy and there appears to be no evidence of progressing tumor 
which would require chemotherapy, then the patient will 
be eligible for the next dose. This schedule will continue for doses of 1 x 10®, 3 
x 10 s for Group 1. If no adverse side effects warranting the stoppage of therapy 
are reported in Group 1 then Group 2 patients will at one dose level higher as 
shown in sec. 8.2 and this pattern will continue through the 4 groups. If a 
patient has to drop out of the study for reasons other than toxicity, then another 
patient may be added to the group and will begin therapy at the lowest dose for 
that group. By entering patients at each dose level, we shall attempt to address 
the question of the maximum tolerated dose (MTD). 
7.0 Patient Registration 
Patients may enter this study by completing a consent form. Their eligibility will 
be confirmed by the data manager at the University of Rochester Cancer 
Center. Patient’s will be assigned to Groups by the data manager. Participation 
or non- participation in this clinical study will not affect other therapy for which 
the patient is eligible. 
8.0 Treatment Plan 
8.1 The patent’s will be admitted to the hospital for the first eight days of each 
cycle. The vaccine is given on day 1 and ganciclovir on days 2-8. The 
treatment is repeated at 3 week intervals for a total of 3 cycles of 
treatment. At the completion of treatment, patients will be followed 
regularly until their is progression of disease. 
8.2 Vaccine and administration. Patients will be assigned in order of 
entrance on study to one of the four treatment schedules below. The 
dose escalates with each treatment unless any toxicity of grade II or 
higher level has occurred (Appendix B). For Grade II toxicity (except for 
neutropenia or thrombocytopenia) the dose is repeated but physician 
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