2. Cells from your tumor (called autologous tumor cells) are killed and injected 
in the skin (given 4 times), 
3. Cells from the ovarian cancer used in your treatment are killed and injected 
in the skin (given 4 times), 
4. two types of control tumor cells (a kidney cancer line and another ovarian 
cancer line) are killed and injected in the skin (given 4 times). 
Gene-modified cells : one purpose of this study is to determine an acceptable dose 
of the treatment. You will receive the treatment 3 times. There will be at least 
four groups of patients. Each group will begin with a different starting or initial 
dose of the gene-modified cells. You will be assigned to one of the 4 starting 
doses. After the first treatment, the dose is raised three fold for the second 
treatment, and then another three fold higher for the third treatment. The gene- 
modified cells are prepared in the laboratories of the University of Rochester 
Cancer Center. The gene-modified cells are radiated to kill the cancer and prevent 
any future growth. It is given by placing a catheter through the abdominal wall 
into the abdominal cavity. The gene-modified cells are given in 1000 cc (1 liter - 
slightly more than 1 quart) of fluid through this catheter, over 30-60 minutes. 
Then the catheter is withdrawn. If you have a surgically-placed permanent catheter, 
this will be used. 
Ganciclovir : Approximately 30 hours after the treatment with the gene-modified 
cells, the first dose of this drug is given by intravenous infusion over 1 hour. 
The drug is then given in this same manner every 12 hours for a total of 7 days. 
Patients are hospitalized to receive the gene-modified cells and Ganciclovir, for an 
8 day period. The tests and treatment are repeated at 3 week intervals for a total 
of 3 treatments. 
RISKS AND DISCOMFORTS 
Cancer treatments often have side effects. The treatment in this program may cause 
all, some or none of the side effects listed. In addition there is always the risk 
of unknown side effects occurring. 
Skin Tests are for the purpose of evaluating the effects of the treatment. There 
may be swelling, redness, and slight tenderness for 2-3 days following these tests. 
Some of these tests contain a small amount of human serum, which could conceivably 
transmit infections such as hepatitis or AIDS. This has never occurred to our 
knowledge. The human serum is tested by the producer in a manner approved by the 
Food and Drug Administration in order to minimize the likelihood of a transmitted 
infection. 
The gene-modified ovarian cancer cells were prepared by using a virus to transfer 
the new gene into the cancer cells. The virus used is defective and does not grow 
or multiply; however, we cannot completely eliminate the possibility of 
circumstances that might result in virus growth in which case there would be a small 
danger of the virus causing cancer or an infection. When the gene-modified cells 
are given into the abdomen and the cells are killed by the Ganciclovir, symptoms 
such as abdominal pain, cramping, or diarrhea could occur, or other unforseen side 
effects, since there is no previous experience with this treatment in humans. 
Recombinant DNA Research, Volume 15 
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