This is a Phase I open-label multi-center study in which fifteen patients per center will 
be enrolled for direct injections with lipid-formulated HLA-B7 plasmids. Each center 
will enter patients with one tumor type. The Arizona Cancer Center will enroU patients 
with melanoma. There will be two study arms, single injections (arm 1) and multiple 
injections (arm 2). Eligible patients will have one solid tiunor nodule injected with the 
study drug (in the single-dose phase of the study), whereas patients enrolled in the 
repeated-dose phase of the study wiU have either two or three nodules injected. 
Increasing doses of the study drug will be administered in the single-dose phase of the 
study. Three dosage groups with three patients each will be studied sequentially with 
at least one month of observation post-injection on the first patient in the dosage group 
prior to advancing to the next higher dosage. 
Initially, Arm 1 patients will receive a single injection of 10 pg of the study drug. 
Following completion of the first dosage group of three patients, a second single dosage 
group of three patients will be treated at the second level and the repeated dose arm of 
the study will be initiated. Group II will receive a five-fold higher concentration of 
study drug (50 pg). Following completion of the second single dosage group of three 
patients, a third group of three patients will be treated. Group in will receive a 5-fold 
higher dose (250 pg) than Group H patients. 
The dose will be raised to the next higher level if none of the three patients exhibit any 
toxidties of grade El or higher. If a patient displays toxidties of grade m or higher, 
then that dose will be repeated on three additional patients. This arm of the study is 
summcu-ized in the following table; 
ARM 1 
Dosage 
Group 
No. of patients 
per group 
Dose per 
treatment 
Total no. of 
treatments per 
patient 
I 
3 
10 pg 
1 
n 
3 
50 pg 
1 
m 
3 
250 Hg 
1 
Patients in arm 2 will receive repeated injections of 10 pg of the study drug. The dose 
schedule given below will be carried out and second and third doses will be 
administered to each subject in whom no grade DI or greater toxidties are observed. 
Second and third doses wUl be administered in different tumors than the first dose if 
such are available. If not, they will be administered in the same tumor nodule. 
ARM 2 
Recombinant DNA Research, Volume 19 
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