III. PATIENT ELIGIBILITY 
1. Patients must have histologically confirmed metastatic melanoma for 
which standard curative or palliative measures do not exist or are no longer 
effective. These patients have expected survivals of six months or less. 
2. Women of child bearing potential must have a negative pregnancy test. 
3. Patients must have a negative HIV test. 
4. Patients 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^ 
b. platelet count greater than 150,000/mm^ 
c. bilirubin less than 1.6 mg/dl 
d. creatinine less than 1.6 mg/dl 
5. Patients requiring steroid therapy will be excluded. 
IV. TREATMENT PLAN 
(Note: In this protocol we have used International Units for units of 
IL-2 as recommended by NCI standardization requests. One Cetus unit is equal 
to 6 International Units). 
1. Summary - Patients receiving autologous TIL have routinely received 
2-3 X 10^^ cells and some patients have received as many as 6 x 10^^ TIL. In 
the five patients shown in Tables 5 and 6 that received combinations of LNL6 
gene-modified TIL and unmodified TIL up to 3 x 10^^ TIL were administered 
Including up to 1.45 x 10^^ gene-modified TIL subpopulations. In the protocol 
using TIL transduced with the gene coding for TNF we will perform an escalating 
dose study giving Increasing numbers of TIL along with IL-2 at three weekly 
intervals (see Appendix A). The starting dose of TIL will be l/30th to l/60th 
the number of TIL previously shown to be well tolerated by patients. 
Recombinant DNA Research, Volume 14 
[267] 
