Schema 
Prior to discussing protocol entry with the patient, call the Randomization Center to insure that a place 
m the protocol is open to the patient. j 
Escalating doses will be evaluated. Groups of patients will receive either escalating doses of an 
intralesional injection of the test agent into one metastatic lesion in the liver in a single session! 
(schedule A) or repeated injections at the same dose (schedule B). 
Schedule A 
Group Number of Patients pg of DNA 
A-l 3 lOpg 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 50pg has been established) 
Group Number of Patients pg of DNA 
B-l 3 10pg day 1 and 15 
B-2 3 lOpg hay 1, 15 and 30 
Schedule A 
□ PR — > may be retreated once 
REG Rx (day 1) 
Schedule B 
2 PR -» cycle of 2 injections 15 days 
apart may be repeated once. 
Bj Rx — » Rx 4 wks Eval 
REG (day 1) (day 15) 
< PR — > no Rx — > Obs 
I 
2 PR — > cycle of 3 injections each 15 days 
apart may be repeated once. 
— » Eval 
(day 30) 
2PR — » no Rx — » Obs 
B 2 Rx — > Rx 2 wks Rx 
JEG (day 1) (day 15) 
— > 4 wks Eval 
< no Rx — » Obs 
" 
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Recombinant DNA Research, Volume 18 
