a manner which is similar to any blood transfusion. The recovery of full marrow function 
(with normal blood counts) will require 3-4 weeks in the hospital. During this time, IV 
fluids and antibiotics may be necessary. 
(D) When the bone marrow (with the genetically- modified cells) has recovered to a 
normal level, Taxol will be given by intravenous infusion. Taxol is a drug which is 
effective against breast cancer, particularly at the late stages. Although the Taxol is 
expected to kill tumor cells, it is possible that the bone marrow cells that have been 
modified by the MDR-1 gene will be protected from being killed by the Taxol. The dose 
of Taxol which will be administered every three to four weeks will depend on how 
rapidly the white blood cell counts recover after each infusion. 
(E) The patients participating on this trial will be followed for 5 years in remission or 
until relapse. 15-20 participants will be entered in this trial. In case of death, the 
patient’s family will be asked for an autopsy because an accurate documentation of the 
precise cause of death may be important to all future patients. 
4. RISKS, SIDE EFFECTS AND DISCOMFORTS TO PARTICIPANTS: 
The side effects of the cyclophosphamide, BCNU, and thiotepa include fever, loss of 
hair, nausea and vomiting, infections, mouth sores, lung failure, cardiac failure, diarrhea 
and bladder inflammation, discoloration of the skin, skin ulceration, and bleeding. The 
side effects of Taxol include suppression of marrow function and neurological changes. 
The treatment related risk of death from the cyclophosphamide is estimated to be less 
than 5%. It is possible that the toxicity of the Taxol could be increased immediately 
following the transplant, but the dose of Taxol has been reduced to minimize this 
toxicity. 
Risks, however, which may not yet have been identified, 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. 
4a. This clinical research may involve unforeseeable risks to the participant (or to the 
embryo or fetus, if the participant is or may become pregnant during treatment). 
To help prevent injury to unborn children, upon recommendation by the attending 
physician, the participants should practice adequate methods of birth control 
throughout the period of their involvement in this clinical research study. 
5. POTENTIAL BENEFITS: The use of chemotherapy resistant cells may potentially allow 
the use of higher doses of chemotherapy, therefore increasing the chances to destroy the 
breast cancer cells. 
6. ALTERNATE PROCEDURES OR TREATMENTS: Participation in this marking study 
is voluntary. Other treatment options for this disease include conventional dose 
chemotherapy without modified cells. Taxol is a drug which is moderately active for the 
(540] 
Recombinant DNA Research, Volume 19 
