A Phase I study of the combination of these two agents has found that the 
doses being administered in this protocol have been well tolerated in a small 
number of patients. More severe or new toxicities may be encountered with 
combinations of these agents. 
Individual patients may benefit by having their tumors shrink or disappear. 
Symptoms related to cancer may improve if shrinkage of tumor is achieved. The 
population of patients with cancer may benefit from this trial which may define 
the role of combination IL-2 and lL-4 alone or with TIL in the treatment of 
cancer . 
9.0 COST AND PAYMENTS 
Patients and/or their insurance carriers will be expected to pay for the 
cost of treatment and evaluation. IL-2 and IL-4 will be supplied free of charge 
through the National Cancer Institute. Every effort will be made to ensure that 
payment will be forthcoming prior to enrolling patients. The growth of TIL's 
will be paid for by outside sources of funding. 
10.0 REFERENCES 
1. Lotze, M.T. , Strausser, J.L., and Rosenberg, S.A.: In vitro growth of 
cytotoxic hximan lymphocytes II. Use of T cell growth factor (TCGF) to 
clone hiaman T cells. J. Immunol. 124:2972-2978. 1980. 
2. Lotze, M.T. : IL-2 - Basic principles. In: Principles and Practice 
of Biologic Therapy. Devlta, V,, Heilman, S., and Rosenberg, S.A. ed. 
Lippincott, Philadelphia, 1990. 
3. Kawakami, Y. , Custer, M.C., Rosenberg, S.A., and Lotze, M.T.: IL-4 
regulates IL-2 induction of lymphokine- activated killer activity 
from human lymphocytes. J. Immunol. 142:3452-3461, 1989. 
4. Kawakami, Y. , Rosenberg, S.A., and Lotze, M.T. : Interleukin-4 promotes 
the growth of t\amor- infiltrating lymphocytes cytotoxic for 
human autologous melanoma. J. Exp. Med. 168: 2183-2191, 1988. 
5. Chazen, G.D. , Pereira, G.M.B., LeGros , G. , Gillis, S., and Shevach, 
E.M. : Interleukin-7 is a T-cell growth factor. Proc. Natl. Acad. 
Sci. USA 86: 5923-5927, 1989. 
6. Armitage, R.J., Namen, A.E. , Sassenfeld, H.M. , and Grabstein, K.H. : 
Regulation of human T cell proliferation by IL-7. J. Immunol. 144: 
938-941, 1990. 
7. Okazaki, H. , Ito, M. , Sudo, T. , Hattori, M. , Kano, S., Katsura, Y. , 
Recombinant DNA Research, Volume 14 
[851] 
