order to decrease the likelihood of cancer cell contamination. In 
the unlikely event that your tumor recurs as a result of reinfusion 
of contaminating gene transduced cancer cells we can always treat 
you with other non-MDR responsive drugs. It is not known whether 
the gene transduction process interferes with the recovery of 
normal bone marrow function. To avoid any possibility of this 
occurring you will receive sufficient untransduced marrow at the 
time of marrow infusion to guarantee the success of the transplant. 
2. The risks of high dose chemotherapy and ABMT are the same in 
this study as those if you were not in the study. The major 
problems relate to the risk of infection which may occur as a 
result of the ablative effects of the high doses of chemotherapy. 
In addition, there are toxicities due to the drugs used that affect 
organs other than the marrow. These are listed in the attached 
table and involve predominantly the heart, kidneys, liver, bladder 
and nervous system. In addition, it is likely that you will develop 
significant nausea and vomiting around the time the chemotherapy is 
administered although you will receive medications to limit this 
problem. In order to minimize the risk of infection you will be 
kept isolated in a room especially equipped with a clean air HEPA 
filter. Visitors will be limited to no more than two people; both 
visitors and medical personnel will wear protective clothing, and 
all food you receive will be specially treated to decrease the 
possibility of transmitting any infection to you. In addition, you 
will receive prophylactic therapy for viral, fungal and bacterial 
organisms. If you are unable to eat you will receive intravenous 
feeding. Finally, you will receive blood and platelet transfusions 
in order to maintain a normal hemoglobin and to prevent bleeding. 
Six weeks after the marrow is reinfused you will undergo a series 
of tests designed to evaluate the response of your tumor to the 
high dose chemotherapy as well as to determine whether the marrow 
with the added MDR gene is present and is functioning normally. The 
presence and activity of this gene would indicate that your marrow 
may be more resistant to certain anti-cancer drugs such as taxol 
you might receive at this time or later. Further treatment with 
such drugs is not part of this protocol, and will be left to 
decisions made by you and your physician at the appropriate time 
following ABMT. 
Almost all of the tests you will undergo would be done even if you 
did not participate in the study. However, it may be necessary to 
do an additional bone marrow or blood test to evaluate the results 
of this new treatment. The following blood tests and marrow samples 
will be required if you participate in this study: 
A. Blood and marrow - 6 weeks after ABMT. 
B. Blood weekly after each dose of chemotherapy and blood and bone 
marrow at 3 month intervals should you receive additional 
chemotherapy after ABMT. 
C. Marrow every 6 months after ABMT or once all other therapy for 
recurrent disease is discontinued. 
These tests are necessary to determine the presence and function of 
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