3. 
OBJECTIVES 
3.1 To evaluate the sensitivity, specificity, and accuracy of capturing CD8(+) and 
CD4(+) TIL and PBL. 
3.2 To evaluate the safety and efficacy of the in vitro expansion of bulk, CD8( + ) and 
CD4(+) TIL and PBL in the presence of rIL-2 for infusion into the patient of 
origin. 
3.3 To evaluate the safety and efficacy of genetically "marking" bulk, CD8(+) and 
CD4(+) TIL and PBL using replication-defective retroviral vectors. 
3.4 To evaluate the toxicity and possible efficacy of genetically-engineered bulk, 
CD8(+), CD4( + ) TIL and PBL in combination with a continuous infusion of 
rIL-2 (melanoma). 
3.5 To evaluate the toxicity and possible efficacy of genetically-engineered bulk 
CD8(+) CD4(+) TIL and PBL in combination with IFNorA and a continuous 
infusion of rIL-2 (renal cell). 
3.6 To document and compare possible antitumor activity for melanoma and renal cell 
carcinoma observed following treatment. 
3.7 To examine the immunological and biological mechanisms associated with the 
tumor response and/or non-response to the treatment. 
3.8 To examine trafficking patterns and life span of administered bulk, CD8(+), 
CD4( + ) TIL and PBL. 
4. BACKGROUND 
The objective of the biological therapy of cancer is to obtain an immune response specific 
to autologous tumor. In a variety of murine models, therapy with recombinant 
interleukin-2 (rIL-2) has been observed to effect significant tumor regression 1 . Potential 
mechanisms involved in this anti-tumor effect are: 1) the activation of lymphokine 
activated killer (LAK) cells 2 , 2) stimulation and activation of cytotoxic T-lymphocytes 
against the tumor, and 3) secondary induction of other cytokines including tumor 
necrosis factor alpha (TNF) or gamma interferon. 0 
In recent clinical trials 3 cancer patients treated with LAK cells and high doses of rIL-2 
have experienced complete or partial responses reported in the range of 20 percent in 
melanoma, 30 percent in renal carcinoma 10 percent in colorectal carcinoma. In clinical 
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