A Phase I and Pharmacokinetic Study of Subcutaneously-Administered Recombinant Human Interleukin-4 (rhuIL-4) in Patients with Advanced Cancer

References

• Atkins M. B., Vachino G., Tilg H. J., Karp D. D., Robert N. J., Kappler K., Mier J. W. Phase I evaluation of thrice-daily intravenous bolus interleukin-4 in patients with refractory malignancy. J. Clin. Oncol. 1992; 10: 1802–1809
   PubMed Web of Science ®Google Scholar
• Barut B. A., Cochran M. K., O'Hara C., Anderson K. C. Response patterns of hairy cell leukemia to B-cell mitogens and growth factors. Blood 1990; 76: 2091–2097
   PubMed Web of Science ®Google Scholar
• Begley C. G. Human progenitor cell assays. Cell Therapy: Stem Cell Transplantation, Gene Therapy and Cellular Immunotherapy, G. Morstyn, W. P. Sheridan. Cambridge University Press. 1996
   Google Scholar
• Blankenstein T., Li W., Muller W., Diamantstein T. Retroviral interleukin 4 gene transfer into an interleukin 4-dependent cell line results in autocrine growth but not in tumorigenicity. Eur. J. Immunol. 1990; 20: 935–938
   PubMed Web of Science ®Google Scholar
• Broxmeyer H. E., Hu L., Cooper S., Tushinski R., Mochizuki D., Rubin B. Y., Gillies S., Williams D. E. Synergistic effects of purified recombinant human and murine B cell growth factor-1/IL-4 on colony formation in vitro by hematopoietic progenitor cells. J. Immunol. 1988; 141: 3852–3862
   PubMed Web of Science ®Google Scholar
• Chakraborty N. G., Sporn J. R., Tortora A. F., Kurtzman S. H., Yamase H., Ergin M. T., Mukherji B. Immunization with a tumor-cell-lysate-loaded autologous-antigen-presenting-cell-based vaccine in melanoma. Cancer Immunol. Immunother. 1998; 47: 58–64
   PubMed Web of Science ®Google Scholar
• Coffman R. L., Ohara J., Bond M. W., Carty J., Zlotnik A., Paul W. E. B cell stimulatory factor-1 enhances the IgE response of lipopolysaccharide-activated B cells. J. Immunol. 1986; 136: 4538–4541
   PubMed Web of Science ®Google Scholar
• Colgan S. P., Resnick M. B., Parkos C. A., Delp-Archer C., McGuirk D., Bacarra A. E., Weller P. F., Madara J. L. IL-4 directly modulates function of a model human intestinal epithelium. J. Immunol. 1994; 153: 2122–2129
   PubMed Web of Science ®Google Scholar
• Crawford R., Finbloom M., Ohara J., Paul W. E., Meltzer M. B cell stimulatory factor 1 (interleukin 4) activates macrophages for increased tumoricidal activity and expression of la antigens. J. Immunol. 1987; 139: 135–141
   PubMed Web of Science ®Google Scholar
• Davis I., Maher D., Cebon J., Dyer W., McKendrick J., Begley G., Woodruff R., Green M., Fox R., Railings M., Bonnem E., Boyd A., Morstyn G. Pharmacokinetic and clinical studies of interleukin-4 (IL-4) in patients with malignancy (abstract). Proc. Am. Soc. Clin. Oncol. 1991; 10: 287
   Google Scholar
• de Vries J. E. Interleukin-4. Human Cytokines. Handbook for Basic and Clinical Research, B. B. Aggarwal, J. U. Gutterman. Blackwell Scientific Publications, Boston, MA 1992; 113–129
   Google Scholar
• DeLuca E., Sheridan W. P., Watson D., Szer J., Begley C. G. Prior chemotherapy does not prevent effective mobilisation by G-CSF of peripheral blood progenitor cells. Br. J. Cancer 1992; 66: 893–899
   PubMed Web of Science ®Google Scholar
• Dranoff G., Jaffee E., Lazenby A., Golumbek P., Levitsky H., Brose K., Jackson V., Hamada H., Pardoll D., Mulligan R. C. Vaccination with irradiated tumor cells engineered to secrete murine granulocyte-macrophage colony-stimulating factor stimulates potent, specific, and long-lasting anti-tumor immunity. Proc. Natl. Acad. Set. USA 1993; 90: 3539–3543
   PubMed Web of Science ®Google Scholar
• Ghosh A. K., Smith N. K., Prendiville J., Thatcher N., Crowther D., Stern P. L. A phase I study of recombinant human interleukin-4 administered by the intravenous and subcutaneous route in patients with advanced cancer: Immunological studies. Eur. Cytokine Netw. 1993; 4: 205–211
   PubMed Web of Science ®Google Scholar
• Gilleece M. H., Scarffe J. H., Ghosh A., Heyworth C. M., Bonnem E., Testa N., Stern P., Dexter T. M. Recombinant human interleukin 4 (IL-4) given as daily-subcutaneous injections - a phase I dose toxicity trial. Br. J. Cancer 1992; 66: 204–210
   PubMed Web of Science ®Google Scholar
• Golumbek P. T., Lazenby A. J., Levitsky H. I., Jaffee L. M., Karasuyama H., Baker M., Pardoll D. M. Treatment of established renal cancer by tumor cells engineered to secrete interleukin-4. Science 1991; 254: 713–716
   PubMed Web of Science ®Google Scholar
• Grimm E. A., Mazumder A., Zhang H. Z., Rosenberg S. A. Lymphokine-activated killer cell phenomenon. Lysis of natural killer-resistant fresh solid tumor cells by interleukin 2-activated autologous human peripheral blood lymphocytes. J. Exp. Med. 1992; 155: 1823–1841
   Google Scholar
• Henschler R., Mantovani L., Oster W., Lubbert M., Lindemann A., Mertelsmann R., Herrmann F. Interleukin-4 regulates mRNA accumulation of macrophage-colony stimulating factor by fibroblasts: synergism with interleukin-1 beta. Br. J. Haematol. 1990; 76: 7–11
   PubMed Web of Science ®Google Scholar
• Herrmann F., Andreeff M., Gruss H.-J., Brach M. A., Lübbert M., Mertelsmann R. Interleukin-4 inhibits growth of multiple myelomas by suppressing inter-leukin-6 expression. Blood 1991; 78: 2070–2074
   PubMed Web of Science ®Google Scholar
• Hillman G. G., Puri R. K., Kukuruga M. A., Pontes J. E., Haas G. P. Growth and major histocompatibility antigen expression regulation by IL-4, interferon-gamma (IFN-γ) and tumour necrosis factor-alpha (TNF-α) on human renal cell carcinoma. Clin. Exp. Immunol. 1994; 96: 476–483
   PubMed Web of Science ®Google Scholar
• Hoon D. S., Hayashi Y., Morisaki T., Foshag L. J., Morton D. L. Interleukin-4 plus tumor necrosis factor alpha augments the antigenicity of melanoma cells. Cancer Immunol. Immunother. 1993; 37: 378–384
   PubMed Web of Science ®Google Scholar
• Hoon D. S.B., Okun E., Banez M., Irie R. F., Morton D. L. Interleukin 4 alone and with γ-interferon or α-tumor necrosis factor inhibits cell growth and modulates cell surface antigens on human renal cell carcinomas. Cancer Res. 1991; 51: 5687–5693
   PubMed Web of Science ®Google Scholar
• Howard M., Farrar J., Hilfiker M., Johnson B., Takatsu K., Hamaoka T., Paul W. E. Identification of a T-cell derived B cell growth factor distinct from interleukin-2. J. Exp. Med. 1982; 155: 914–923
   PubMed Web of Science ®Google Scholar
• Imai Y., Nara N., Tohda S., Nagata K., Suzuki T., Nagasawa M., Murohashi I., Aoki N. Antiproliferative and differentiative effects of recombinant interleukin-4 on a granulocyte colony-stimulating factor-dependent myeloblasts leukemic cell line. Blood 1991; 78: 471–178
   PubMed Web of Science ®Google Scholar
• Ishizaka A., Sakiyama Y., Nakanishi M., Tomizawa K., Oshika E., Kojima K., Taguchi Y., Kandil E., Matsumoto S. The inductive effect of interleukin-4 on IgG4 and IgE synthesis in human peripheral blood lymphocytes. Clin. Exp. Immunol. 1990; 79: 392–396
   PubMed Web of Science ®Google Scholar
• Karray S., Kautry A. Varsat, Tsudo M., Merle H. Beral, Debre P., Galanaud P. IL-4 inhibits the expression of high affinity IL-2 receptors on monoclonal human B cells. J. Immunol. 1990; 145: 1152–1158
   PubMed Web of Science ®Google Scholar
• Lahm H., Schnyder B., Wyniger J., Borbenyi Z., Yilmaz A., Car B. D., Fischer J. R., Givel J.-C., Ryffel B. Growth inhibition of human colorectal-carcinoma cells by interleukin-4 and expression of functional interleukin-4 receptors. Int. J. Cancer 1994; 59: 440–447
   PubMed Web of Science ®Google Scholar
• Leach M. W., Snyder E. A., Sinha D. P., Rosenblum I. Y. Safety evaluation of recombinant human interleukin-4. I. Preclinical studies. Clin. Immunol. Immunopathol. 1997; 83: 8–11
   PubMedGoogle Scholar
• Lotze M. T., Rubin J. T., Carty S., Edington H., Ferson P., Landreneau R., Pippin B., Posner M., Rosenfelder D., Watson C., Carlos T., Kirkwood J., Lembersky B., Logan T., Rosenstein M., Rybak M. E., Whiteside T., Elder E., Moen R. C., Jacob W., Chen Y., Rinkus R. L., Bryant J. Gene therapy of cancer: a pilot study of IL-4-gene-modified fibroblasts admixed with autologous tumor to elicit an immune response. Human Gene Ther. 1994; 5: 41–55
   PubMed Web of Science ®Google Scholar
• Lotze M. T., Shurin M., Davis I., Amoscato A., Storkus W. J. Dendritic cell based therapy of cancer. Dendritic Cells in Fundamental and Clinical Immunology, P. Ricciardi-Castagnoli. Plenum Press, New York 1997; 551–569
   Google Scholar
• Maher D., Boyd A., McKendrick J., Begley G., Lieschke M., Green M., Fox R., Railings M., Bonnem E., Morstyn G. Rapid response of B-cell malignancies induced by interleukin-4 (IL-4) (abstract). Blood 1990a; 76: 152a
   Google Scholar
• Maher D. W., Pike B. L., Boyd A. W. The response of human B cells to interleukin 4 is determined by their stage of activation and differentiation. Scand. J. Immunol. 1990b; 32: 631–640
   PubMed Web of Science ®Google Scholar
• Maher D. W., Davis I., Boyd A. W., Morstyn G. Human interleukin-4: an immunomodulator with potential therapeutic applications. Prog. Growth Factors Res. 1991; 3: 43–56
   PubMedGoogle Scholar
• Margolin K., Aronson F. R., Sznol M., Atkins M. B., Gucalp R., Fisher R. L, Sunderland M., Doroshow J. H., Ernest M. L., Mier J. W., et al. Phase II studies of recombinant human interleukin-4 in advanced renal cancer and malignant melanoma. J. Immunother, Emphasis Tumor Immunol. 1994; 15: 147–153
   PubMed Web of Science ®Google Scholar
• Markowitz A., Kleinerman E., Hudson M., Itoh K., LaPushin R., Stewart M., Gutterman J. Phase I study of recombinant human interleukin-4 (rhuIL-4) in patients with advanced cancer (abstract). Blood 1989; 74(Suppl. I)146a
   Google Scholar
• Miller A. B., Hoogstraten B., Staquet M., Winkler A. Reporting results of cancer treatment. Cancer 1981; 47: 207–214
   PubMed Web of Science ®Google Scholar
• Mitchell P. L.R., Clutterbuck R. D., Powles R. L., Lord C. D., Morilla R., Hiorns L. R., Titley J., Catovsky D., Millar J. L. Interleukin-4 enhances the survival of SCID mice engrafted with human B-cell precursor leukaemia. Blood 1996; 87: 4797–4803
   PubMed Web of Science ®Google Scholar
• Modesti A., Masuelli L., Modica A., D'Orazi G., Scarpa S., Bosco M. C., Forni G. Ultrastructural evidence of the mechanisms responsible for interleukin-4-activated rejection of a spontaneous murine adenocarcinoma. Int. J Cancer 1993; 53: 988–993
   PubMed Web of Science ®Google Scholar
• Morisaki T., Yuzuki D. H., Lin R. T., Foshag L. J., Morton D. L., Hoon D. S.B. Interleukin 4 receptor expression and growth inhibition of gastric carcinoma cells by interleukin 4. Cancer Res. 1992; 52: 6059–6065
   PubMed Web of Science ®Google Scholar
• Nair S. K., Boczkowski D., Morse M., Cumming R. I., Lyerly H. K., Gilboa E. Induction of primary carcinoembryonic antigen (CEA)-specific cytotoxic T lymphocytes in vitro using human dendritic cells transfected with RNA. Nature Biotechnol. 1998; 16: 364–369
   PubMed Web of Science ®Google Scholar
• Nestle F. O., Alijagic S., Gilliet M., Sun Y., Grabbe S., Dummer R., Burg G., Schadendorf D. Vaccination of melanoma patients with peptide-or tumor lysate-pulsed dendritic cells. Nature Med. 1998; 4: 328–332
   PubMed Web of Science ®Google Scholar
• Newcom S. R., Ansari A. A., Gu L. Interleukin-4 is an autocrine growth factor secreted by the L-428 Reed-Stemberg cell. Blood 1992; 79: 191–197
   PubMed Web of Science ®Google Scholar
• Noma Y., Sideras P., Naito T., Bergstedt-Lindquist S., Azuma C., Severinson E., Tanabe T., Kinashi T., Matsuda F., Yaoita Y., Honjo T. Molecular cloning of cDNA encoding the murine IgGl induction factor by a novel strategy using SP6 promoter. Nature 1986; 319: 640–656
   PubMed Web of Science ®Google Scholar
• Ohe Y., Podack E. R., Olsen K. J., Miyahara Y., Ohira R., Miura K., Nishio K., Saijo N. Combination effect of vaccination with IL2 and IL4 cDNA transfected cells on the induction of a therapeutic immune response against Lewis lung carcinoma cells. Int. J. Cancer 1993; 53: 432–437
   PubMed Web of Science ®Google Scholar
• Okabe M., Kuni-Eda Y., Sugiwura T., Tanaka M., Miyagishima I. T., Saiki I., Minagawa T., Kurosawa M., Itaya T., Miyazaki T. Inhibitory effect of interleukin-4 on the in vitro growth of Phi-positive acute lymphoblastic leukemia cells. Blood 1991; 78: 1574–1580
   PubMed Web of Science ®Google Scholar
• Olencki T., Finke J., Tubbs R., Tuason L., Greene T., McLain D., Swanson S. J., Herzog P., Stanley J., Edinger M., Budd G. T., Bukowski R. M. Immunomodulatory effects of interIeukin-2 and interleukin-4 in patients with malignancy. J. Immunother. Emphasis Tumor Immunol. 1996; 19: 69–80
   PubMed Web of Science ®Google Scholar
• Park L. S., Friend D., Sassenfeld H. M., Urdal D. L. Characterization of the human B cell stimulatory factor 1 receptor. J. Exp. Med. 1987; 166: 476–488
   PubMed Web of Science ®Google Scholar
• Paul W. E. Interleukin-4: a prototypic immunoregulatory lymphokine. Blood 1991; 77: 1859–1870
   PubMed Web of Science ®Google Scholar
• Pippin B. A., Rosenstein M., Jacob W. F., Chiang Y., Lotze M. T. Local IL-4 delivery enhances immune reactivity to murine tumors: gene therapy in combination with IL-2. Cancer Gene Therapy 1994; 1: 35–42
   PubMed Web of Science ®Google Scholar
• Platzer C., Richter G., äberia K., Hock H., Diamantstein T., Blankenstein T. Interleukin-4-mediated tumor suppression in nude mice involves interferon-γ. Eur. J. Immunol. 1992; 22: 1729–1733
   PubMed Web of Science ®Google Scholar
• Rubin J. T., Lotze M. T. Acute gastric mucosal injury associated with the systemic administration of IL-4. Surgery 1992; 111: 274–280
   PubMed Web of Science ®Google Scholar
• Sallusto F., Lanzavecchia A. Efficient presentation of soluble antigen by cultured human dendritic cells is maintained by granulocyte/macrophage colony-stimulating factor plus interleukin 4 and down-regulated by tumor necrosis factor α. J. Exp. Med. 1994; 179: 1109–1118
   PubMed Web of Science ®Google Scholar
• Smeland E. B., Blomhoft H. K., Funderud S., Shalaby M. R., Espevik T. Interleukin 4 induces selective production of interleukin 6 from normal human B lymphocytes. J. Exp. Med. 1989; 170: 1463–1468
   PubMed Web of Science ®Google Scholar
• Sosman J. A., Fisher S. G., Kefer C., Fisher R. I., Ellis T. M. A phase I trial of continuous infusion interleukin-4 (IL-4) alone and following interlcukin-2 (IL-2) in cancer patients. Ann. Oncol. 1994; 5: 447–452
   PubMed Web of Science ®Google Scholar
• Spits H., Yssel H., Paliard X., Kastelein R., Figdor C., de Vries J. E. IL-4 inhibits IL-2-mediated induction of human lymphokine-activated killer cells but not the generation of antigen-specific cytotoxic T lymphocytes in mixed leukocyte cultures. J. Immunol. 1988; 141: 29–36
   PubMed Web of Science ®Google Scholar
• Taylor C. W., Grogan T. M., Salmon S. E. Effects of interleukin-4 on the in vitro growth of human lymphoid and plasma cell neoplasms. Blood 1990; 75: 1114–1118
   PubMed Web of Science ®Google Scholar
• Tepper R. L., Coffman R. L., Leder P. Aneosinophil-dependent mechanism for the antitumor effect of interleukin-4. Science 1992; 257: 548–551
   PubMed Web of Science ®Google Scholar
• Tepper R. L., Pattengale P. K., Leder P. Murine interleukin-4 displays potent anti-tumor activity in vivo. Cell 1989; 57: 503–512
   PubMed Web of Science ®Google Scholar
• Thornhill M. H., Haskard D. O. IL-4 regulates endothelial cell activation by IL-1, tumor necrosis factor, or IFN-γ. J. Immmunol. 1990; 145: 865–872
   PubMed Web of Science ®Google Scholar
• Thornhill M. H., Kyan-Aung U., Haskard D. O. IL-4 regulates endothelial cell adhesiveness for T cells but not for neutrophils. J. Immunol. 1990; 144: 3060–3065
   PubMed Web of Science ®Google Scholar
• Toi M., Bicknell R., Harris A. L. Inhibition of colon and breast carcinoma cell growth by interleukin-4. Cancer Res. 1992; 52: 275–279
   PubMed Web of Science ®Google Scholar
• Totpal K., Aggarwal B. B. Interleukin 4 potentiates the antiproliferative effects of tumor necrosis factor on various cell lines. Cancer Res. 1991; 51: 4266–4270
   PubMed Web of Science ®Google Scholar
• Trehu E. G., Isner J. M., Mier J. W., Karp D. D., Atkins M. B. Possible myocardial toxicity associated with interleukin-4 therapy. J. Immunother. 1993; 14: 348–351
   PubMed Web of Science ®Google Scholar
• Tulpule A., Joshi B., DeGuzman N., Espina B. M., Mocharnuk R., Prakash O., Templeton D., Levine A. M., Gill P. S. Interleukin-4 in the treatment of AIDS-related Kaposi's sarcoma. Ann Oncol. 1997; 8: 79–83
   PubMed Web of Science ®Google Scholar
• Vitetta E. S., Ohara J., Myers C. D., Layton J. E., Krammer P. H., Paul W. E. Serological biochemical and functional identity of B cell-stimulatory factor 1 and B cell differentiation factor for IgG1. J. Exp. Med. 1985; 162: 1726–1731
   PubMed Web of Science ®Google Scholar
• Vokes E. E., Figlin R., Hochster H., Lotze M., Rybak M. E. A phase II study of recombinant human interleukin-4 for advanced or recurrent non-small cell lung cancer. Cancer J. Sci. Am. 1998; 4: 46–51
   PubMed Web of Science ®Google Scholar
• Wong H. L., Lotze M. T., Wahl L. M., Wahl S. M. Administration of recombinant IL-4 to humans regulates gene expression, phenotype, and function in circulating monocytes. J. Immunol. 1992; 148: 2118–2125
   PubMedGoogle Scholar
• Yokota T., Otsuka T., Mosmann T., Banchereau J., Defrance T., Blanchard J., DeVries E., Lee F., Arai K.-I. Isolation and characterization of a human interleukin cDNA clone, homologous to mouse B-cell stimulatory factor-1, that expresses B-cell-and T-cell-stimulating activities. Proc. Natl. Acad. Sci. USA 1986; 83: 5894–5898
   PubMed Web of Science ®Google Scholar
• Yu J. S., Wei M. X., Chiocca E. A., Martuza R. L., Tepper R. Treatment of glioma by engineered interleukin 4-secreting cells. Cancer Res. 1993; 53: 3125–3128
   PubMed Web of Science ®Google Scholar