Fwn C JW — • * 5/^1) 
CLINICAL INVESTIGATION CONSENT FORM 
The Johns Hopkins Medical Institutions 
(The Johns Hopkins Hospital 
The Francis Scotl Key Medical Center, etc.) 
PHASE I STUDY OF NON-REPLICATING 
AUTOLOGOUS TUMOR CELL INJECTIONS 
USING CELLS PREPARED WITH OR WITHOUT GM-CSF GENE 
TRANSDUCTION IN PATIENTS WITH METASTATIC RENAL 
CELL CARCINOMA 
ExpferMBon ol Pro) ret to Sub)acL 
Patknt I.D. Plate 
PURPOSE OF THE STUDY : This is a study of side effects of two forms of a 
kidney cancer drug that has not been tested in humans for safety. In this 
study the drugs are shots under the skin of kidney cancer cells made from 
your cancer. The purpose of this study is to see if important side effects 
occur after injections of a person's own kidney cancer cells prepared by 
these new methods. You are being asked to take part in this study because 
you have a cancer in your kidney. Tests you had show spread of the kidney 
cancer outside the kidney. Standard treatments with surgery, 
radiation, immunotherapy , or chemotherapy are not likely to cure you. For 
this reason kidney cancer patients are asked to think about taking part in 
this research study. 
PROCEDURES : In this study there are two types of kidney cancer cell drugs. 
The side effects from each preparation are not known. This is the first 
time either type has been tested in humans. One type of cell drug is made 
when the patients kidney cancer cells are grown in a sterile dish and in 
time they make some of a factor called GM-CSF, granulocyte macrophage 
colony stimulating factor. In the other type of drug, kidney cancer cells 
are grown the same way, but the human GM-CSF gene is also put into the DNA 
of the kidney cancer cells. A gene is a piece of DNA with the message in 
it to tell a cell to make something. In this case the message is to make 
more GM-CSF. The message is carried into the kidney cancer cells in the 
dish by a engineered mouse virus which is able to deliver genes into human 
cancer cells in a dish. In both ways of making kidney cancer cell drugs, 
the cells are treated with nuclear radiation in the laboratory so they 
cannot divide anymore. Only after radiation of the cells are they then 
given as shots. In other words, this cancer cell drug should not grow under 
the skin as little cancers. 
Doctors do not know the side effects after shots from one way of 
making the cell drug or the other. To study these questions , you will 
receive one of the two forms of prepared kidney cancer. After surgery, you 
will be given one of the two kidney cancer cell drug types by 
randomization, a process similar to a flip of the coin. Neither you nor 
the doctors taking care of you in the clinic will know which of the two 
types of cell you will get until after the shots are completed or side 
effects occur preventing further injections. You will receive cells 
prepared only one wav for the entire study. Your medical care will be the 
same regardless of which cell preparation injections you receive. 
If you take part, you will first have surgery to remove the kidney 
with the cancer in it. This is where the kidney cancer cells that make up 
the shots comes from. You will be asked to sign a separate hospital 
consent form for the operation after having a chance to discuss the 
surgery. In all patients at Johns Hopkins healthy enough to take part in 
this study, surgery is routinely offered to patients as a treatment option. 
THIS CONSENT FORM CONTINUES ON THE REVERSE SIDE 
13381 
Recombinant DNA Research, Volume 17 
