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. (C) Following 
recovery of the modified marrow, a chemotherapy drug which is 
affected by the chemotherapy pump, Taxol, will be given by 
intravenous infusion. Taxol is a drug which is very effective 
against ovarian cancer, particularly at the late stages. This 
will be administered every three to four weeks depending on 
how rapidly the white blood cell counts recover after each 
infusion. The marrow cells will be protected from the Taxol 
by the chemotherapy pump, but the tumor cells which do not 
contain the pump, will die. (D) 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 . 
4. RISKS, SIDE EFFECTS AND DISCOMFORTS TO PARTICIPANTS: 
The side effects of the cyclophosphamide and thiotepa include 
fever, loss of hair, nausea and vomiting, infections, mouth 
sores, reversible cardiac failure, diarrhea and bladder 
inflammation and bleeding. The side effects of Taxol include 
suppression of marrow function and neurological changes. The 
treatment related mortality of the cyclophosphamide and 
thiotepa is estimated to be less than 5%, since no patient 
died receiving this regimen, and the dose of one of the drugs 
(cyclophosphamide) has been further reduced. It is possible 
that the toxicity of the Taxol could be increased immediately 
following the transplant, but the dose of the Taxol has been 
reduced to prevent this toxicity. 
Extensive study of the use of safety-modified viruses to 
introduce new information into cells has already been 
accomplished in animal models (mice, dogs, and small subhuman 
primates) . This virus and another like it are currently being 
studied at other institutions. No toxic 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 inserts new information into a small number of blood 
cells in the marrow or blood. 
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. 
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Recombinant DNA Research, Volume 17 
