Phase I study of subcutaneously administered recombinant human interleukin 12 in patients with advanced renal cell cancer

Clinical Cancer Research

Volumn 5, Issue 12, 1999, Pages 3983-3989

  Portielje, Johanna E A ^a,b,d   Kruit, Wim H J ^a,b   Schuler, Martin ^a   Beck, Joachim ^a   Lamers, Cor H J ^a,b   Stoter, Gerrit ^a,b   Huber, Christoph ^a   De Boer Dennert, Maureen ^a,b   Rakhit, Ashok ^a,c   Bolhuis, Reinder L H ^a,b   Aulitzky, Walter E ^a  

^a ERASMUS MC CANCER INSTITUTE   (Netherlands)

^b JOHANNES GUTENBERG UNIVERSITY   (Germany)

^c HOFFMANN LA ROCHE INC   (United States)

^d ERASMUS MEDICAL CENTER   (Netherlands)

Author keywords

[No Author keywords available]

Indexed keywords

LIVER ENZYME; RECOMBINANT INTERLEUKIN 12;

ADULT; ADVANCED CANCER; AGED; AREA UNDER THE CURVE; ARTICLE; BLOOD TOXICITY; CLINICAL ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DEPRESSION; DIARRHEA; DOSE RESPONSE; DRUG BLOOD LEVEL; DRUG TOLERANCE; FATIGUE; FEMALE; FEVER; HEADACHE; HUMAN; KIDNEY CANCER; MALE; MUCOSA INFLAMMATION; NAUSEA; PHASE 1 CLINICAL TRIAL; PRIORITY JOURNAL; VASCULITIS; VOMITING;

ADJUVANTS, IMMUNOLOGIC; ADULT; AGED; ANGIOGENESIS INHIBITORS; CARCINOMA, RENAL CELL; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG ADMINISTRATION SCHEDULE; FEMALE; HUMANS; INJECTIONS, SUBCUTANEOUS; INTERLEUKIN-12; KIDNEY NEOPLASMS; MALE; MIDDLE AGED; RECOMBINANT PROTEINS;

EID: 0033388981     PISSN: 10780432     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (29)

1. Kobayashi, M., Fitz, L., Ryan, M., Hewick, R. M., Clark, S. C., Chan, S., Loudon, R., Sherman, F., Perussia, B., and Trinchieri, G. Identification and purification of natural killer cell stimulatory factor, a cytokine with multiple biological effects on human lymphocytes. J. Exp. Med., 170: 827-845, 1989.
2. Perussia, B., Chan, S. H., D'Andrea, A., Tsuji, K., Santoli, D., Pospisil, M., Young, D., Wolf, S. F., and Trinchieri, G. Natural killer (NK) cell stimulatory factor or IL-12 has differential effects on the proliferation of TCR-αβ +, TCR-γδ+ T lymphocytes, and NK cells. J. Immunol., 149: 3495-3502, 1992.
3. Chan, S. H., Perussia, B., Gupta, J. W., Kobayashi, M., Pospisil, M., Young, H. A., Wolf, S. F., Young, D., Clarkm S. C., and Trinchieri, G. Induction of interferon-γ production by natural killer cell stimulatory factor: characterization of the responder cells and synergy with other inducers. J. Exp. Med., 173: 869-879, 1991.
4. Manetti, R., Parronchi, P., Giudizi, M. G., Piccinni, M. P., Maggi, E., Trinchieri, G., and Romagnani, S. Natural killer cell stimulatory factor (interleukin 12) induces T helper type 1 (Th1)-specific immune responses and inhibits the development of IL-4 producing Th cells. J. Exp. Med., 177: 1199-1204, 1993.
5. Wu, C. Y., Demeure, C., Kiniwa, M., Gately, M., and Delespesse, G. IL-12 induces the production of IFN-γ by neonatal human CD4 T cells. J. Immunol., 151: 1938-1949, 1993.
6. Scott, P. IL-12: initiation cytokine for cell-mediated immunity. Science (Washington DC), 260: 496-497, 1993.
7. Voest, E. E., Kenyon, B. M., O'Reilly, M. S., Truitt, G., D'Amato, R. J., and Folkman, J. Inhibition of angiogenesis in vivo by interleukin 12. J. Natl. Cancer Inst., 87: 581-586, 1995.
8. Sgadari, C., Angiolillo, A. L., and Tosato, G. Inhibition of angiogenesis by interleukin-12 is mediated by the interferon-inducible protein-10. Blood, 87: 3877-3882, 1996.
9. Brunda, M. J., Luistro, L., Warrier, R., Wright, R. B., Hubbart, B. R., Murphy, M., Wolf, S. F., and Gately, M. K. Antitumor and antimetastatic activity of interleukin-12 against murine tumors. J. Exp. Med., 178: 1223-1230, 1993.
10. Nastala, C. L., Edington, H. D., McKinney, T. G., Tahara, H., Nalenik, M. A., Brunda, M. J., Gately, M. K., Wolf, S. F., Schreiber, R. D., Storkus, W. J., and Lotze, M. T. Recombinant IL-12 administration induces tumor regression in association with IFN-γ production. J. Immunol., 153: 1697-1706, 1994.
11. Fujiwara, H., and Hamaoka, T. Antitumor and antimetastatic effects of interleukin-12 Cancer Chemother. Pharmacol., 38 (Suppl): S22-S26, 1996.
12. Sarmiento, U. M., Riley, J. H., Knack, P. A., Lipman, J. M.,Becker, J. M., Gately, M. K., Chizzonite, R., and Anderson, T. D. Biologic effects of recombinant human interleukin-12 in squirrel monkeys. Lab. Invest., 71: 862-873, 1994.
13. Bree, A. G., Schlerman, F. J., Kaviani, M. D., Hastings, R. C., Hitz, S. L., and Goldman, S. J. Multiple effects on peripheral hematology following administration of recombinant human interleukin 12 to non-human primates. Biochem. Biophys. Res. Commun., 204: 1150-1157, 1994.
14. Motzer R. J., Bander N. H., and Nanus, D. Renal cell carcinoma. N. Engl. J. Med., 335: 865-875, 1996.
15. Motzer, R. J., Rakhit, A., Schwartz, L. H., Olencki, T., Malone, T. M., Sandstrom, K., Nadeau, R., Parmar, H., and Bukowski, R. Phase I trial of subcutaneous recombinant human interleukin-12 in patients with advanced renal cell carcinoma. Clin. Cancer Res., 4: 1183-1191, 1998.
16. Atkins, M. B., Robertson, M. J., Gordon, M., Lotze, M. T., DeCoste, M., DuBois, J. S., Ritz, J., Sandler, A. B., Edington, H. D., Garzone, P. D. Mier, J. W., Canning, C. M., Battiato, L., Tahara, H., and Sherman, M. L. Phase I evaluation of intravenous recombinant human interleukin 12 in patients with advanced malignancies. Clin. Cancer Res., 3: 409-417, 1997.
17. Bajetta, E., Del Vecchio, M., Mortarini, R., Nadeau, R., Rakhit, A., Rimassa, L., Fowst, C., Borri, A., Anchinin, A., and Parmiani, G. Pilot study of subcutaneous recombinant human interleukin 12 in metastatic melanoma. Clin. Cancer Res., 4: 75-85, 1997.
18. Denicoff, K. D., Rubinow, D. R., Papa, M. Z., Simpson, C., Seipp, C. A., Lotze, M. T., Chang, A. E., Rosenstein, D., and Rosenberg, S. A. The neuropsychiatric effects of treatment with interleukin-2 and lymphokine activated killer cells. Ann. Intern. Med., 107: 293-300, 1987.
19. Renault, P., Hoofnagle, J., and Park, Y. Psychiatric complaints of long term interferon-alfa therapy. Arch. Intern. Med., 147: 1577-1580, 1987.
20. Coughlin, C. M., Wysocka, M., Trinchieri, G., and Lee, W. M. F. The effect of interleukin 12 desensitization on the antitumor efficacy of recombinant interleukin 12. Cancer Res., 57: 2460-2467, 1997.
21. Leonard, J. P., Sherman, M. L., Fisher, G. L., Buchanan, L. J., Larsen, G., Atkins, M. B., Sosman, J. A., Dutcher, J. P., Vogelzang, N. J., and Ryan, J. L. Effects of single-dose interleukin-12 exposure on interleukin-12-associated toxicity and interferon-γ production. Blood, 90: 2541-2548, 1997.
22. Naume, B., Gately, M. K., Desai, B. B., Sundan, A., and Espevik, T. Synergistic effects of interleukin 4 and interleukin 12 on NK cell proliferation. Cytokine, 5: 38-46, 1993.
23. Rogge, L., and Sinigaglia, F. Early events controlling T-helper cell differentiation: the role of the IL-12 receptor. Chem. Immunol., 68: 38-53, 1997.
24. Cohen, J. IL-12 deaths: explanation and a puzzle. Science (Washington DC), 270: 908, 1995.
25. Sacco, S., Heremans, H., Echtenacher, B., Buurman, W. A., Amraoui, Z., Goldman, M., and Ghezzi, P. Protective effect of a single interleukin-12 (IL-12) predose against the toxicity of subsequent chronic IL-12 in mice: role of cytokines and glucocorticoids. Blood, 90: 4473-4479, 1997.
26. Quesada, J. R. Biologic therapy with interferon-γ. In: V. T. De Vita, Jr., S. Hellman, and S. A. Rosenberg (eds.). Biologic Therapy of Cancer, Ed. 2, pp. 435-442. Philadelphia: J. B. Lippincott, 1995.
27. Thompson, J. A., Cox, W. W., Lindgren, C. G., Collins, C., Neraas, K. A., Bonnem, E. M., and Fefer, A. Subcutaneous recombinant γ interferon in cancer patients: toxicity, pharmacokinetics, and immunomodulatory effects. Cancer Immunol. Immunother., 25: 47-53, 1987.
28. Lamers, C., Gratama, J., Ogilvie, A., Goey, H., Kruit, W., Peschel, C., Aulitzky, W., Tinetti, A., Huber, C., Stoter, G., and Bolhuis, R. Exogenous IL-12 induces in vivo IL-10 production, followed by downregulation of IL-12 activities. Proc. Am. Soc. Clin. Oncol., 6: 435a, 1997.
29. Coughlin, C. M., Wysocka, M., Kurzawa, H. L., Lee, W. M. F., Trinchieri, G., and Eck, S. L. B7-1 and interleukin-12 synergistically induce effective anti-tumor immunity. Cancer Res., 55: 4980-4987, 1995.