Progressive Disease (P): This rating will be assigned where there is an increase of greater than or 
equal to 25% in the product of the two longest perpendicular diameters of the lesion(s) or the 
occurrence of a new lesion(s). 
10.0 Data Submission 
The following forms must be submitted to the study chair according to the following 
schedule: 
Forms 
On-study Form 
Treatment Form 
Follow-up Form 
Schedule 
Within one week of registration 
Within one week of treatment 
Every month while receiving protocol 
Adverse Reaction Reporting Form Within five days for reportable toxic 
events 
11.0 BIBLIOGRAPHY 
1. Gabrilove JL, Jakubowski A. Hematopoietic growth factors: biology and clinical application. 
Monograph J Natl Cancer Inst. 10:73-77, 1990. 
2. Kelso A. Cytokines: structure and function and synthesis. Current Opinion in Immunology 
2(2):215-225, 1989. 
3. Borden EC, Sondel PM. Lymphokines and cytokines as cancer treatment. Immunotherapy 
realized. Cancer 65 (3 Suppl): 800-8 14, 1990. 
4. Rosenberg SA, Lotze MT, Mule JJ. New approaches to the immunotherapy of cancer. Ann 
Intern Med 108:853-864, 1988. 
5. Lotze MT, Change AE, Seipp CA, et al. High-dose recombinant interleukin-2 in the 
treatment of patients with disseminated cancer: responses, treatment-related morbidity and histologic 
findings. JAMA 256:31 17-3124, 1986. 
6. Pizza G, Viza D, De Vinci C, Paschuchi JM, Busutti L, Bergami T. Intralymphatic 
administration of interleukin-2 (IL-2) in cancer patients: a pilot study. Cytokine Research 7(l):45-48, 
1988. 
7. Sama G, Collins J, Figlin R, Robertson P, Altrock B, Abels R. A pilot study of 
intralymphatic interleukin-2. II Clinical and biological effects. J Biological Response Modifiers 
9(1):8 1-86, 1990. 
8. Gandolfi L, Solmi L, Pizza GC, Bertoni F, Muratori R, De Vinci C, Bacchini P, Morelli MC, 
Corrado G. Intratumoral echo-guided injection of interleukin-2 and cytokine-activated killer cells in 
hepatocellular carcinoma. Hepato-Gastroenterology 36(5):352-356, 1989. 
9. Bubenik J, Viotenok NN, Kieler J, Prassolov VS, Chumakov PM, Bubenikova D, Simova J, 
Jandlova T. Local administration of cells containing an inserted IL-2 gene and producing IL-2 
inhibits growth of human tumors in nu/nu mice. Immunology Letters 19(4):279-282, 1988. 
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Recombinant DNA Research, Volume 18 
