1 . Pretreatment 
a. Complete physical examination noting in detail the exact 
size and location of any lesions that exist. 
b. Complete chemistry survey including electrolytes, liver 
function tests, calcium, magnesium, creatinine, BUN, CPK. 
c. CBC differential count, PT, PTT< platelet count. 
d. Urine analysis and culture. 
e. Hepatitis screen. 
f. HIV screen. 
g. Pregnancy test if woman between the ages of 16 and 50. 
h. Chest x-ray. 
i. Electrocardiogram. 
j . Baseline x-rays and nuclear medicine scans to evaluate the 
status of disease. 
k. CT scan or MRI scan of brain. 
l. 45 ml of clotted blod for serum storage and 45 ml of anti- 
coagulated blood for mononuclear cell cryopreservaton. 
Selected patients may undergo pretreatment lymphocytapheresis . 
m. Biopsy of tumor, if possible with minimal morbidity. 
2. During Treatment. Patients will have a complete blood count and 
chemistry analysis panel at least every other day and a chest x-ray performed 
each week during treatment. 
During the infusion of the transduced cells, patients will be monitored 
closely. Vital signs including blood pressure, pulse, and respirations will be 
measured every 15 minutes during the cell infusion and every 30 minutes for at 
least four hours or until the patient is stable. A pulse oximeter may be used 
for on-line measurement of oxygen saturation during and for the four hours after 
cell infusion as well. If the systolic blood pressure drops below 80mm/Hg, or 
the oxygen saturation drops below 90% during the cell infusion, the cell infusion 
will be terminated immediately. 
3. Post -Treatment Complete evaluation of evaluable lesions with physical 
examination, biopsy, if feasible, and appropriate x-rays and/or scans prior to 
each cell infusion cycle and at approximately eight weeks after the end of 
treatment to evaluate response to treatment. Which studies will be done will in 
part by dictated by known sites of disease, but will at least include a CT scan 
of the chest and abdomen. Biopsies of skin, tumor and lOcc of blood for 
evaluation of TIL homing & persistence will be carried out at 1- 3- 6- 15- 20- 
davs and then monthly if possible. The major goal of this study is to determine 
whether TIL*s can home and persist at tumor sites. 
Western blot analysis of patient serum to determine possible exposure to 
retrovirus envelope proteins will be performed at 7 to 8 weeks after treatment 
in patients receiving transduced TILs . 
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Recombinant DNA Research, Volume 14 
