protocol, relapsed patients receiving vinblastine 
chemotherapy and G-CSF will have peripheral blood and 
bone marrow collected after cycles 1 and 3 for analysis 
as described above to study the effects of chemotherapy 
and growth factors on the presence of Neo-marked cells. 
6.7 An additional 10 ml of blood will be obtained every 
three months for the first year, and every six months 
thereafter for Western blot analysis of anti-retroviral 
antibodies . 
6.8 5 ml of serum will be obtained at one month and three 
months post-transplantation for an ELISA assay of anti- 
murine immunoglobulins and anti-avidin immunoglobulins. 
6.9 Upon the death of a patient, an autopsy will be 
requested and multiple organ sites will be analysed by 
PCR for the presence of the Neo gene, tumor-specific 
markers, and helper virus genome. The importance of 
obtaining an autopsy- will be discussed with patient 
prior to entry into the protocol. 
7.0 HAZARDS AND DISCOMFORTS 
We would classify this genetic marking amendment as offering 
no direct benefit to patients enrolled on it, but posing 
little risk in addition to that already inherent to 
autologous transplantation. Information obtained from this 
pilot gene transfer study could benefit future patients with 
breast cancer, CML and multiple 'myeloma undergoing 
autologous transplantation or tumor-directed genetic 
therapy, as well as patients with a wide variety of 
hematologic and other diseases amenable to genetic therapy. 
The theoretical risks posed by insertion of marker gene into 
the patient's genome were discussed in Section 3.5. None of 
the approximately 20 patients that have thus far received 
retrovirally transduced bone marrow, peripheral blood or 
tumor infiltrating cells have had any adverse events noted 
that could be attributed to the gene transfer procedure. 
The patients will not experience any direct or immediate 
extra discomforts as a result of being enrolled in this 
protocol amendment. The minimal extra blood and bone marrow 
necessary for analysis of gene transfer will be obtained 
during blood draws and bone marrow aspirations required to 
monitor engraftment and tumor relapse after autologous 
transplantation . 
8.0 TOXICITY MONITORING AND REPORTING 
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