Schedule B 
(Will be initiated after safety of Schedule A at SOmcg has been established) 
Number of Patients 
Group 
B-1 3 
B-2 3 
meg of DNA 
lOmcg day 1 and 15 
lOmcg day 1, 15 and 30 
Schedul e A 
A 1 to 3 REG Rx (day 1) 4 wks Re- 
evaluation 
PR may be 
retreated once 
< PR Observation 
Schedule B 
B-1 Rx 
REG (day 1) 
B-2 Rx 
REG (day 1) 
PR - cycle of 2 
injections 15 days 
apart may be 
repeated once 
Rx 4 wk Re- 
(day 15) evaluation 
< PR no Rx 
Observation 
PR - cycle of 3 
injections each 15 
days apart may 
be repeated once 
Rx Rx 2 wk Re- 
(day 15) (day 30) evaluation 
< PR - no Rx 
Observation 
1.0 Background 
1.1 Overview 
Cancer is a disease in which certain cells grow uncontrolled by the body's normal self- 
regulatory mechanisms. Traditional chemotherapy seeks to control cancer by killing 
rapidly dividing cells or by preventing cells from entering cell cycle and dividing. 
However, a number of non-malignant cells in the body such as bone marrow cells and 
intestinal epithelium cells, are also rapidly dividing and hence are highly susceptible to the 
toxicity of chemotherapy. Doses sufficient to induce remission in the cancer cannot be 
administered without life-threatening side effects in 5-10% of the patients and the overall 
mortality from chemotherapy is 0.5%. A therapeutic approach that selectively kills tumor 
Recombinant DNA Research, Volume 19 
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