procedures in the Diagnostic Radiology Suite at Saint Mary's Hospital. 
The needle is inserted under direct sonographic visualization. A constant 
volume of 4ml lipid preparation will be used at all DNA concentrations. 
7.4 Amounts of DNA in 4ml of lipid to be injected: 
Schedule A 
Group 
Number of Patients 
pg of DNA 
A-l 
3 
10|ig day 1 only 
A-2 
3 
50pg day 1 only 
A-3 
3 
250pg day 1 only 
Schedule B 
(Will be initiated after safety of schedule A at 50|ig has been established) 
Group 
Number of Patients 
pg of DNA 
B-l 
3 
lOpg day 1 and 15 
B-2 
3 
lOpg day 1, 15 and 30 
7.5 Criteria for re-treatment: Patients with a partial response at 4 weeks after 
the last injection of their initial course may receive an additional course of 
treatment identical to the first treatment, i.e., on Schedule A, at 4 weeks a 
responding patient may receive a second injection at the same dose 
initially given; on Schedule B, 4 weeks after two injections (B-l) and 4 
weeks after three injections (B-2), responding patients may receive a 
second course identical to their first course. 
7.6 The primary objectives of this investigation are to determine the 
feasibility and safety of intralesional injections of DNA/lipids into liver 
metastases. Patients will be entered in groups of 3 at each dose level and 
observed for at least 4 weeks before entry of additional patients. 
Number of patients with 2 Instructions for entry of additional 
grade 3 toxicity (World Health patients 
Organization [WHO]) 
0 
Escalate to next volume level. 
1 
Enter 3 more patients at same volume 
level. 
2 or 3 
Discontinue further patient entry at 
that level and enter 3 more patients at 
the previous level. 
8.0 Treatment Modification Based on Toxicity 
[764] 
Recombinant DNA Research, Volume 18 
