This will help determine the best way to reduce the chance of 
relapse: increased intensity of systemic therapy versus more 
extensive cleansing procedures for the peripheral blood or 
marrow. 
These cleansed and marked peripheral blood and marrow cells 
will be used to restore normal marrow function after intensive 
therapy. Bone marrow will be taken (about two quarts) from 
the pelvis and possible sternum under general anesthesia. A 
small amount of extra blood (one tablespoon full) may be 
removed for studies after the transplant to follow the marking 
procedure, but this will not require additional venipunctures 
over and above that which is already required to follow 
transplant recovery. Peripheral blood cells will be removed 
from the peripheral blood by a machine called a cell 
separator. Thirty percent of the stored marrow cells will be 
mixed with a specially engineered mouse virus which cannot 
cause an infection in the body. This virus will mark cells 
with a bacterial gene that makes it possible to find these 
cells. This "marked" marrow will be added to the rest of the 
marrow and returned to the circulation after intensive 
therapy. A second mouse v;Lrus will be used to mark the 
peripheral blood the same way. 
The therapy will be given during the transplant and in the 
event of relapse would be the same as if the patient had not 
been given the marrow marked with the virus. Ten patients 
will participate in this clinical research study. 
4. RISKS, SIDE EFFECTS AND DISCOMFORTS TO PARTICIPANTS: 
Extensive study of this virus marking procedure has been 
undertaken in mice and monkeys. This virus and another like 
it are currently being studied at other institutions. No 
adverse effects have been observed in all of this study 
. because the virus is modified so that it cannot cause an 
infection in the cells of the body. It only marks a small 
number of blood cells in the autologous marrow. 
Risks, however, which may not yet have been observed, are 
possible. These are "theoretical risks" since they have not 
yet been seen. It is possible that the virus could change the 
cells which are marked so as to grow in an abnormal pattern, 
and even cause cancer or leukemia. This risk is much lower 
than damage to the cells by chemotherapy and irradiation. The 
marker might also produce a protein which might inactivate 
certain antibiotics but alternative antibiotics are available 
so that this does not constitute a risk or threat for patients 
during therapy. 
4a. This clinical research may involve unforeseeable risks to 
the participant during treatment. To help prevent injury 
to unborn children, upon recommendation by the attending 
physician, the participants should practice adequate 
Recombinant DNA Research, Volume 15 
[875] 
