7.5 Amounts of DNA to be injected: 
Number of 
Patients 
meg of DNA 
A-1 
3 
lOmcg day 1 only 
A-2 
3 
50mcg day 1 only 
A-3 
3 
250 meg day 1 only 
Schedule B 
(Will be initiated after safety of schedule A at 50mcg has been established) 
Number of 
Patients 
mgg gf DNA 
B-1 
3 
lOmcg day 1 and 15 
B-2 
3 
lOmcg day 1, 15 and 30 
7.6 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-1) and 4 weeks after 
three injections (B-2), responding patients may receive a second course 
identical to their first course. 
7.7 The primary objectives of this investigation are to determine the feasibility 
and safety of intralesional injections of DNA/lipids into patients with renal 
cell carcinoma. 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 
grade 3 toxicity (World Instructions for entry of 
Health Organization fWHOh additional patients 
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 
Toxicity 
(For liver metastases only) 
SCOT, SGPT or alk phos >3x 
baseline 
Direct bili 0.2mg/dl above 
Dose Reduction 
50% 
50% 
UNL 
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Recombinant DNA Research, Volume 19 
