5. 
Patients must have a performance status less than 2 and must be free 
of active systemic infections and other major medical illnesses of the 
cardiovascular and respiratory systems. They should have the following 
laboratory values: 
a. white blood cell count greater than 3000/mm 3 
b. platelet count greater than 150,000/mm 3 
c. bilirubin less than 1.7 mg/dl 
d. creatinine less than 1.7 mg/dl 
6. Patients requiring steroid therapy will be excluded. 
7 . Patients who have received therapy with cytotoxic agents, steroids, 
other biologies, or radiotherapy in the 4 weeks prior to cell inoculation will 
be excluded . 
IV. TREATMENT PLAN 
1. Summary . Tissue culture lines will be established from resected 
tumors during the course of normal patient treatment. The gene for 
IL-2 will be inserted into these tumor cells using e ith er retroviral mediated 
gene transduction or by trancf e ction te c hniques usin g c a - i -c ium phosphate or 
- microin j a ctio n-. Patients that develop advanced untreatable metastatic cancer 
find have failed all other effective treatments will be offered the possibility 
of joining this protocol. After signing an informed consent the patients will 
be registered in the protocol and will receive the injection of the gene 
modified tumor cells into the mid thigh. Up to 2 x 10 s gene modified tumor 
cells will be injected in 1 ml subcutaneously and three centimeters lateral or 
vertical from this site the patient will receive two intradermal injections of 
2 x 10 7 gene modified tumor cells in 0.1 ml each. These sites will then be 
carefully monitored. At three weeks the patient will undergo resection of 
several lymph nodes from the draining superficial inquinal area. These lymph 
nodes will be used to grow lymphocytes for adoptive cellular therapy of that 
patient. As predicted by animal models, it is not expected that tumor will 
grow at the local injection site. If, however, tumor does grow then the soft 
tissue in the area of the tumor injection will be resected when a tumor has 
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