prepared in this way is not known. Fortunately, the re-injected 
cancer cells work just as well inactivated by nuclear radiation in 
a test tube before injection into mice. A patient's RCC cells 
before final injection will be treated with nuclear radiation in 
the laboratory so they cannot divide anymore. In other words these 
cancer cells should not grow under the skin as little cancers. 
Instead they are likely to be destroyed by white blood cells that 
come into the area where they are injected. 
B. Granulocyte-Macrophage Colony Stimulating Factor 
A second aspect of this trial is the testing for safety of GM- 
CSF (granulocyte-macrophage colony stimulating factor) by the 
injected RCC cells carrying the antigens on their surfaces. When 
expanded in numbers in the technique to grow RCC cells for 
injection, the GM-CSF factor is secreted by the cells. The new 
technique of increasing the dose of these cells and injecting them 
under the skin has not been tested before for safety in human 
beings. This new technique also has not been studied as a cancer 
treatment. In the past, tumors were immediately prepared and 
injected. They were not grown to higher doses but were seen to 
produce some GM-CSF. In mice the GM-CSF factor may aid the immune 
system in "kick starting" certain white blood cells to move about 
the blood stream and to "see" the presence of cancer cells in the 
body with cancer markers — antigens — and eliminate them as the 
system eliminates cells infected with viruses like the flu. 
C. Gene Transfer of the Granulocyte-Macrophage Colony Stimulating 
Factor 
The third aspect of this trial is a laboratory finding that 
mouse RCC kidney cancer cells stimulate the immune system if the 
GM-CSF gene is put into cancer cells that do not make GM-CSF and 
then GM-CSF is made and the cells are injected under the skin. A 
gene is a piece of DNA with the instructions in it to tell a cell 
to make something. In this case the instructions to make lots of 
GM-CSF are carried into the cancer cell by a engineered mouse virus 
which is able to deliver genes well into human cancer cells. The 
inactivation of the cells with nuclear radiation does not seem to 
decrease the amount of GM-CSF made. 
The National Institutes of Health Recombinant DNA Advisory 
Committee and Food and Drug Administration have approved pilot 
studies using injections of human tumor cells genetically 
engineered to secrete other genes such as the recombinant TNF gene 
product, interleukin-2 gene product, and the interleukin-4 gene 
product in patients with advanced cancers including kidney cancer. 
Recombinant DNA Research, Volume 17 
[347] 
