Aldesleukin in advanced renal cell carcinoma

References

• Storkel S, Eble JN, Adlakha K et al. Classification of renal cell carcinoma: Working Group No. 1. Union Internationale
   Google Scholar
• Zbar B, Brauch H, Talmadge C, Linehan M. Loss of alleles of loci on the short arm of chromosome 3 in renal cell carcinoma. Nature 327,721–724 (1987).
   PubMed Web of Science ®Google Scholar
• Linehan WM, Shipley WU, Parkinson DR. Cancer of the kidney and ureter. In Cancer: Principles and Practice of Oncology DeVita VT, Hellen S, Rosenberg SA (Eds), JB Lippincott, PA, USA, 1023–1051 (1993).
   Google Scholar
• Motzer RJ, Bander NH, Nanus DM. Renal cell carcinoma. N Engl. J Med. 335, 865–875 (1996).
   PubMed Web of Science ®Google Scholar
• Motzer RJ, Russo P, Nanus DM. Current Problems in Cancer: Renal Cell Carcinoma. Mosby, MO, USA 18,9–232 (1997).
   Google Scholar
• Finke JH, Rayman P, Hart L. Characterization of TIL subsets from human renal cell carcinoma: specific reactivity defined by cytotoxicity, IFN-a secretion and proliferation. ' Irnmunother. 15,91–104 (1994).
   PubMed Web of Science ®Google Scholar
• Van den Hove LE, Van Gool SW, Van Poppel H, Coorrevits L, van Damme B, Ceupens JL. Phenotype, cytokine production and cytolytic capacitiy of freh (uncultured) tumor-infiltrating T-lymphocytes in human renal cell carcinoma Clin. Exp. Immuriol. 109, 501–509 (1997).
   PubMedGoogle Scholar
• Kunische-Hoppe M, Bohle RM, Rauber K et al. Metastatic renal cell carcinoma arising in a transplant kidney. Eur. Radiol. 8, 441–442 (1998).
   Google Scholar
• Olivier RTD, Mehta A, Barnett MJ. A Phase II study of surveillance in patients with metastatic renal cell carcinoma and assessment of response of such patients to therapy on progression. Mol. Biother. 1, 14–20 (1988).
   Google Scholar
• Witt PL, Lindner DJ, D'Ainha J. Pharmacology of interferons: induced proteins, cell activation, and antitumor activity. In: Cancer Chemotherapy, and Biotherapy: Principles and Practice. Chabner BA, Longo DL (Eds), Lippencott, Williams and Wilkins, PA, USA, 585–608 (1996).
   Google Scholar
• Bukowski RM, McLain D, Finke JE Clinical pharmacokinetics of interleukin-1, 2,4, tumor-necrosis factor and macrophade colony-stimulating factor. In: Cancer Chemotherapy, and Biotherapy. Principle and Practice. Chabner BA, Longo DL (Eds), Lippencott, Williams and Wilkins, PA, USA, 612–619 (1996).
   Google Scholar
• Morgan DA, Ruscetti FW, Gallo R. Selective in vitro growth of T-lymphocytes from normal human bone marrows. Science 193,1007–1008 (1976).
   Google Scholar
• Rubin JT. Interleukin-2: its biology and clinical application in patients with cancer. Cancer Invest. 11(4), 460–472 (1993).
   Google Scholar
• Lafreniere R, Rosenberg SA. Successful immunotherapy of murine experimental hepatic metastases with lymphokine-activated killer cells and recombinant interleukin-2. Cancer Res. 45(8), 3735–3741 (1985).
   Google Scholar
• Young NT, Roelen DL, Dallman MJ, Morris PJ, Welsh KI. HLA-DRB1 amino acid disparity is the major stimulus of interleukin-2 production by alloreactive helper T-lymphocytes. Irnmunogenetics 47(4), 310–317 (1998).
   Google Scholar
• Taniguchi T, Matsui H, Fujita T et al. Structure and expression of a cloned cDNA for human interleukin-2. Nature 302(5906), 305–310 (1983).
   Google Scholar
• Rosenberg SA, Grimm EA, McGrogan M et al. Biological activity of recombinanthuman interleukin-2 produced in Ercherichia coll. Science 223(4643), 1412–1414 (1984).
   Google Scholar
• Jeal W Goa KL. Aldesleukin (recombinant IL-2): a review of its pharmacological properties, clinical efficacy and tolerability in patients with renal cell carcinoma. Rio. Drugs 7,285–317 (1997).
   Google Scholar
• Buzio C, De Palma G, Passalacqua R et al. Effectiveness of very low doses of immunotherapy in advanced renal cellcancer. Br. ' Cancer 76(4), 541–544 (1997).
   Google Scholar
• Pavone L, Andrulli S, Santi R, Majori M, Buzio C. Long-term treatment with low doses of interleukin-2 and interferon-a: immunological effects in advanced renal cell cancer. Cancer Irnmuriol. Irnmunother. 50(2), 82–86 (2001).
   Google Scholar
• Jablons D, Bolton E, Mertins S et al. IL-2-based immunotherapy alters circulating neutrophil Fc receptor expression and chemotaxis. j Irnmunol. 144(9), 3630–3636 (1990).
   Google Scholar
• Whittington R, Faulds D. Interleukin-2. A review of its pharmacological properties and therapeutic use in patients with cancer. Drugs 46(3), 446–514 (1993).
   Google Scholar
• Oppenheim MH, Lotze MT. Interleukin-2: solid-tumor therapy. Oncology51 (2), 154–169 (1994).
   Google Scholar
• Lotze MT, Matory YL, Ettinghausen SE et al. In vivo administration of purified human interleukin-2. II. Half-life, immunologic effects, and expansion of peripheral lymphoid cells in vivo with recombinant IL-2. j Irnmunol. 135 (4), 2865–2875 (1985).
   Google Scholar
• Yang JC, Rosenberg SA. An ongoing prospective randomized comparison of interleukin-2 regimens for the treatment of metastatic renal cell cancer. Cancerj Sci. Am. 3\(Suppl. 1), S79—S84 (1997).
   Google Scholar
• Physicians' Desk Reference. Medical Economic Co., NJ, USA, 894–898 (1999).
   Google Scholar
• Donohue JH, Rosenberg SA. The fate of interleukin-2 after in vivo administration. I17717711fla 130(5), 2203–2208 (1983).
   Google Scholar
• Schiphorst PP, Chang PC, Clar N, Schoemaker RC, Osanto S. Pharmacokinetics of interleukin-2 in two anephric patients with metastatic renal cell cancer. Ann. Oncol. 10(11), 1381–1383 (1999).
   Google Scholar
• Rosenberg SA. Immunotherapy of cancer by systemic administration of lymphoid cells plus interleukin-2. j Biol. Response Mod. 3(5), 501–511 (1984).
   Google Scholar
• Rosenberg SA. The development of new immunotherapies for the treatment of cancer using interleukin-2. A review. Ann. Surg. 208(2), 121–135 (1988).
   Google Scholar
• Fyfe G, Fisher RI, Rosenberg SA, Sznol M, Parkinson DR, Louie AC. Results of treatment of 255 patients with metastatic renal cell carcinoma who received high-dose recombinant interleukin-2 therapy. J Clin. Oncol. 13(3), 688–696 (1995).
   Google Scholar
• Rosenberg SA, Lotze MT, Muul LM et al. Observations on the systemic administration of autologous lymphokine-activated killer cells and recombinant interleukin-2 to patients with metastatic cancer. N Engl. J Med. 313(23), 1485–1492 (1985).
   Google Scholar
• Whitehead RP, Ward D, Hemingway L, Hemstreet GP III, Bradley E, Konrad M. Subcutaneous recombinant interleukin-2 in a dose escalating regimen in patients with metastatic renal cell adenocarcinoma. Cancer Res. 50 (20), 6708–6715 (1990).
   Google Scholar
• Stein RC, Malkovska V, Morgan S et al. The clinical effects of prolonged treatment of patients with advanced cancer with low-dose subcutaneous interleukin-2 Br. J Cancer63(2), 275–278 (1991).
   Google Scholar
• Stoter G, Fossa SD, Rugarli C et al. Metastatic renal cell cancer treated with low-dose interleukin-2. A phase-II multicentre study. Cancer Treat. Rev 16(Suppl. A), 111–113 (1989).
   Google Scholar
• Rosenberg SA, Lotze MT, Yang JC et al. Combination therapy with interleukin-2 and a-interferon for the treatment of patients with advanced cancer. J Clin. Oncol. 7(12), 1863–1874 (1989).
   Google Scholar
• Abrams JS, Rayner AA, Wiernik PH et al. High-dose recombinant interleukin-2 alone: a regimen with limited activity in the treatment of advanced renal cell carcinoma.j Natl Cancer Inst. 82 (14), 1202–1206 (1990).
   Google Scholar
• Bukowski RM, Goodman P, Crawford ED, Sergi JS, Redman BG, Whitehead RR Phase II trial of high-dose intermittent interleukin-2 in metastatic renal cell carcinoma: a Southwest Oncology Group study. ' Natl Cancer Inst. 82(2), 143–146 (1990).
   Google Scholar
• von der Maase H, Geertsen P, Thatcher N et al. Recombinant interleukin-2 in metastatic renal cell carcinoma — a European multicentre Phase II study. Eur. Cancer27(12), 1583–1589 (1991).
   Google Scholar
• Geertsen PF, Hermann GG, von der Maase H, Steven K. Treatment of metastatic renal cell carcinoma by continuous intravenous infusion of recombinant interleukin-2: a single-center Phase II study: J Cilia. Oncol. 10(5), 753–759 (1992).
   Google Scholar
• Negrier S, Mercatello A, Bret M et al. Intravenous interleukin-2 in patients over 65 with metastatic renal carcinoma. Br. J Cancer65(5), 723–726 (1992).
   Google Scholar
• Sleijfer DT, Janssen RA, Buter J, de Vries EG, Willemse PH, Mulder NH. Phase II study of subcutaneous interleukin-2 in unselected patients with advanced renal cell cancer on an out-patient basis. Cilia. Oncol. 10(7), 1119–1123 (1992).
   Google Scholar
• Lopez M, Carpano S, Cancrini A et al. Phase II study of continuous intravenous infusion of recombinant interleukin-2 in patients with advanced renal cell carcinoma. Ann. Oncol. 4(8), 689–691 (1993).
   Google Scholar
• Buter J, Sleijfer DT, van der Graaf WT, de Vries EG, Willemse PH, Mulder NH. A progress report on the out-patient treatment of patients with advanced renal cell carcinoma using subcutaneous recombinant interleukin-2. Semin. Oncol. 20(6 Suppl. 9), 16–21 (1993).
   Google Scholar
• Philip T, Negrier S, Lasset C et al. Patients with metastatic renal carcinoma candidate for immunotherapy with cytokines. Analysis of a single institution study on 181 patients. Br. J Cancer 68(5), 1036–1042 (1993).
   Google Scholar
• Escudier B, Ravaud A, Fabbro M et al. High-dose interleukin-2 two days a week for metastatic renal cell carcinoma: a FNCLCC multicenter study. J Irnmunother. Emphasis Tumor Irnmunol. 16(4), 306–312 (1994).
   Google Scholar
• Rosenberg SA, Yang JC, Topalian SL et al. Treatment of 283 consecutive patients with metastatic melanoma or renal cell cancer using high-dose bolus interleukin-2. JAMA 271(12), 907–913 (1994).
   Google Scholar
• Vlasveld LT, Horenblas S, Hekman A et al. Phase II study of intermittent continuous infusion of low-dose recombinant interleukin-2 in advanced melanoma and renal cell cancer. Ann. Oncol. 5(2), 179–181 (1994).
   Google Scholar
• Gore ME, Galligioni E, Keen CW et al. The treatment of metastatic renal cell carcinoma by continuous intravenous infusion of recombinant interleukin-2. Eur. I Cancer30A(3), 329–333 (1994).
   Google Scholar
• Taneja SS, Pierce W, Figlin R, Belldegrun A Immunotherapy for renal cell carcinoma: the era of interleukin-2-based treatment. Urology 45 (6), 911–924 (1995) .
   Google Scholar
• Whitehead RP, Wolf MK, Solanki DL et al. A Phase II trial of continuous-infusion recombinant interleukin-2 in patients with advanced renal cell carcinoma: a Southwest Oncology Group study. ' Irnmunother. Emphasis Tumor II77177111701. 18(2), 104–114 (1995).
   Google Scholar
• Escudier B, Farace F, Theodore C et al. Treatment of metastatic kidney neoplasms with a new interleukin-2 protocol: the experience of the Gustave-Roussy Institute. Bull. Cancer 82(4), 296–302 (1995).
   Google Scholar
• Tourani JM, Lucas V, Mayeur D et al. Subcutaneous recombinant interleukin-2 (rIL-2) in out-patients with metastatic renal cell carcinoma. Results of a multicenter SCAPP1 trial. Ann. Oncol. 7(5), 525–528 (1996).
   Google Scholar
• Nieken J, Sleijfer DT, Buter J et al. A Phase II trial of dose-intensive interleukin-2 in metastatic renal cell carcinoma. J Cancer Res. Clin. Oncol. 125(2), 101–108 (1999).
   Google Scholar
• Dillman RO, Wiemann MC, VanderMolen LA, Bury MJ, DePriest C, Church C. Hybrid high-dose bolus/continuous infusion interleukin-2 in patients with metastatic melanoma: a Phase II trial of the Cancer Biotherapy Research Group (formerly the National Biotherapy Study Group). Cancer Biother. Radiopharrn. 12(4), 249–255 (1997).
   Google Scholar
• Oleksowicz L, Dutcher JP. A Phase II trial of dose-intensive interleukin-2 in metastatic renal cell carcinoma. J Cancer Res. Clin. Oncol. 125(2), 101–108 (1999).
   Google Scholar
• Escudier B, Chevreau C, Lasset C et al. Cytokines in metastatic renal cell carcinoma: is it useful to switch to interleukin-2 or interferon after failure of a first treatment? Groupe Francais d'Immunotherape. j Cilia. Oncol. 17(7), 2039–2043 (1999).
   Google Scholar
• Bordin V, Giani L, Meregalli S et al. Five-year survival results of subcutaneous low-dose immunotherapy with interleukin-2 alone in metastatic renal cell cancer patients. Urol Int. 64(1), 3–8 (2000).
   Google Scholar
• Gitlitz BJ, Hoffman DM, Moldawer N, Belldegrun A, Figlin RA.Treatment of metastatic renal cell carcinoma with high-dose bolus interleukin-2 in a non-intensive care unit: an analysis of 124 consecutively treated patients. Cancer 7(2), 112–120 (2001).
   Google Scholar
• Lissoni P, Bordin V, Vaghi M et al. Ten-year survival results in metastatic renal cell cancer patients treated with monoimmunotherapy with subcutaneous low-dose interleukin-2. Anticancer Res. 22(2B), 1061–1064 (2002).
   Google Scholar
• Yang JC, Rosenberg SA. An ongoing prospective randomized comparison of interleukin-2 regimens for the treatment of metastatic renal cell cancer. Cancerj Sd. Am. 3\(Suppl. 1), S79—S84 (1997).
   Google Scholar
• Yang JC, Sherry RM, Steinberg SM et al. Randomized study of high-dose and low- dose interleukin-2 in patients with metastatic renal cancer. J Clin. Oncol. 21(16), 3127–3132 (2003).
   Google Scholar
• Lissoni P Effects of low-dose recombinant interleukin-2 in human malignancies Cancer Sd. Am. 3\(Suppl. 1), S115—S120 (1997).
   Google Scholar
• Dutcher JP. Interleukin-2 based therapy for kidney cancer. Cancer Treat Res. 116, 155–172 (2003).
   PubMedGoogle Scholar
• Margolin K, Rayner AA, Hawkins M. Toxicity of Interleukin-2 and lymphokine-activated killer (LAK) cell therapy. JOncol. 7,486-489(1989).
   Google Scholar
• Belldegrun A, Webb DE, Austin HA III et al. Effects of interleukin-2 on renal function in patients receiving immunotherapy for advanced cancer. Ann. Intern. Med. 106,817-822 (1987).
   Google Scholar
• Dutcher J, Atkins MB, Margolin K et al. Kidney cancer: the Cytokine Working Group experience (1986–2001). Part II: management of IL-2 toxicity and studies with other cytokines. Med. Oncol. 18, 209–219 (2001).
   Google Scholar
• Locker GJ, Kapiotis S, Veitl M et al. Activation of endothelium by immunotherapy with interleukin-2 in patients with malignant disorders. Br. J Haernatol. 105(4), 912–919 (1999).
   Google Scholar
• Cormier JN, Hurst R, Vasselli J et al. A prospective randomized evaluation of the prophylactic use of low-dose dopamine in cancer patients receiving interleukin-2. I Immunother. 20(4), 292-300(1997).
   Google Scholar
• Kim H, Rosenberg SA, Steinberg SM, Cole DJ, Weber JS. A randomized double-blinded comparison of the anti-emetic efficacy of ondansetron and droperidol in patients receiving high-dose interleukin-2. j Irnmunother. Emphasis Tumor II77177111701. 16(1), 60–65 (1994).
   Google Scholar
• West WH, Tauer KW, Yannelli JR et al. Constant-infusion recombinant interleukin-2 in adoptive immunotherapy of advanced cancer. N Engl. J. Med. 316(15), 898–905 (1987). patients: a Phase I study. JOncoL 7(11), 1726–1732 (1989). Phase I clinical trial of interleukin-2 and a-interferon: toxicity and immunologic effects. Cancer Res. 49(22), 6432–6436 (1989).
   Google Scholar
• West WH. Clinical application of continuous infusion of recombinant interleukin-2. Eur. J Cancer Clin. OncoL 25 (Suppl. 3), S11—S15 (1989).
   Google Scholar
• West WH. Continuous infusion recombinant interleukin-2 (rIL-2) in adoptive cellular therapy of renal carcinoma and other malignancies. Cancer Treat. Rev 16 (Suppl. A), 83–89 (1989).
   Google Scholar
• Geertsen PF, Gore ME, Negrier S, Tourani JM, von der Maase H. Safety and efficacy of subcutaneous and continuous intravenous infusion rIL-2 in patients with metastatic renal cell carcinoma. Br. J Cancer90(6), 1156–1162 (2004).
   Google Scholar
• Lotze MT, Line BR, Mathisen DJ. The in vivo distribution of autologous human and murine lymphoid cells. j I17717711fla 125,1487–1493 (1980).
   Google Scholar
• Weber JS, Rosenberg SA. Modulation of murine tumor major histocompatibility antigens by cytokines in vivo and in vitro. Cancer Res. 48(20), 5818–5824 (1988).
   Google Scholar
• Rubin JT, Elwood LJ, Rosenberg SA, Lotze MT. Immunohistochemical correlates of response to recombinant interleukin-2-based immunotherapy in humans. Cancer Res. 49(24 Pt 1), 7086–7092 (1989).
   Google Scholar
• Itoh K, Shiiba K, Shimizu Y, Suzuki R, Kumagai K. Generation of activated killer (AK) cells by recombinant interleukin-2 (rIL-2) in collaboration with interferon-y (IFN-y). Inznzunol. 134(5), 3124–3129 (1985).
   Google Scholar
• Masucci G, Ragnhammar P, Wersall P, Mellstedt H. Granulocyte—monocyte colony-stimulating-factor augments the interleukin-2-induced cytotoxic activity of human lymphocytes in the absence and presence of mouse or chimeric monoclonal antibodies (mAb 17-1A). Cancer Irnmunol. Immunother. 31 (4), 231–235 (1990).
   Google Scholar
• Steger GG, Kaboo R, deKernion JB, Figlin R, Belldegrun A. The effects of granulocyte-macrophage colony-stimulating factor on tumour-infiltrating lymphocytes from renal cell carcinoma. Brj Cancer 72(1), 101–107 (1995).
   PubMedGoogle Scholar
• Romani N, Gruner S, Brang D et al. Proliferating dendritic cell progenitors in human blood. J Exp Med. 180(1), 83–93 (1994).
   Google Scholar
• Szabolcs P, Moore MA, Young JVV. Expansion of immunostimulatory dendritic cells among the myeloid progeny of human CD34+ bone marrow precursors cultured with c-kit ligand, granulocyte-macrophage colony-stimulating factor, and TNF-a. J.Immunol. 154(11), 5851–5861 (1995).
   Google Scholar
• Tamura T, Sasaki Y, Shinkai T et al. Phase I study of combination therapy with interleukin-2 and I3-interferon in patients with advanced malignancy. Cancer Res. 49(3), 730–735 (1989).
   Google Scholar
• Paolozzi F, Zamkoff K, Doyle M et al. Phase I trial of recombinant interleukin-2 and recombinant I3-interferon in refractory neoplastic diseases. J Biol. Response Mod. 8(2), 122–139 (1989).
   Google Scholar
• Lee KH, Talpaz M, Rothberg JM et al. Concomitant administration of recombinant human interleukin-2 and recombinant interferon-a2a in cancer patients: a Phase I study. J. Clin. Oncol. 7(11), 1726–1732 (1989).
   Google Scholar
• Budd GT, Osgood B, Barna B et al. Phase I clinical trial of interleukin-2 and a-interferon: toxicity and immunologic effects. Cancer Res. 49(22), 6432–6436 (1989).
   Google Scholar
• Bukowski RM, Murthy S, Sergi J et al. Phase I trial of continuous infusion recombinant interleukin-2 and intermittent recombinant interferon-a2a: clinical effects. BioL Response Mod. 9(6), 538–545 (1990).
   Google Scholar
• Mittelman A, Huberman M, Puccio C et al. A Phase I study of recombinant human interleukin-2 and a-interferon-2a in patients with renal cell cancer, colorectal cancer, and malignant melanoma Cancer 66(4), 664–669 (1990).
   Google Scholar
• Hirsh M, Lipton A, Harvey H et al. Phase I study of interleukin-2 and interferon-a2a as out-patient therapy for patients with advanced malignancy. J OncoL 8(10), 1657–1663 (1990).
   Google Scholar
• Huberman M, Bering H, Fallon B et al. A Phase I study of an out-patient regimen of recombinant human interleukin-2 and a2a-interferon in patients with solid tumors. Cancer68(8), 1708–1713 (1991).
   Google Scholar
• Rosso R, Sertoli MR, Queirolo P et al. An out-patient Phase I study of a subcutaneous interleukin-2 and intramuscular a2a-interferon combination in advanced malignancies. Ann. Oncol. 3(7), 559–563 (1992).
   Google Scholar
• Ratain MJ, Priest ER, Janisch L, Vogelzang NJ. A Phase I study of subcutaneous recombinant interleukin-2 and interferon-a2a. Cancer 71(7), 2371–2376 (1993).
   Google Scholar
• Marincola FM, White DE, Wise AP, Rosenberg SA. Combination therapy with interferon-a2a and interleukin-2 for the treatment of metastatic cancer. j Clin. OncoL 13(5), 1110–1122 (1995).
   Google Scholar
• Cause BL, Sznol M, Kopp WC et al. Phase I study of subcutaneously administered interleukin-2 in combination with interferon-a2a in patients with advanced cancer. J Clin. OncoL 14(8), 2234–2241 (1996).
   Google Scholar
• Atzpodien J, Kirchner H, de Mulder P et al. Subcutaneous recombinant interleukin-2 and a-interferon in patients with advanced renal cell carcinoma: results of a multicenter Phase II Study. Cancer Biother. 8(4), 289–300 (1993).
   Google Scholar
• Atzpodien J, Lopez Hanninen E et al. Multiinstitutional home-therapy trial of recombinant human interleukin-2 and interferon-a2a in progressive metastatic renal cell carcinoma. JOncol. 13(2),497-501 (1995).
   Google Scholar
• Facendola G, Locatelli MC, Pizzocaro G et al. Subcutaneous administration of interleukin-2 and interferon-a2a in advanced renal cell carcinoma: a confirmatory study. Br. J Cancer 72(6), 1531–1535 (1995).
   Google Scholar
• Clark JI, Gaynor ER, Martone et al. Daily subcutaneous ultra-low-dose interleukin-2 with daily low-dose interferon-a in patients with advanced renal cell carcinoma. Clin. Cancer Res. 5(9), 2374–2380 (1999).
   Google Scholar
• Locatelli MC, Facendola G, Pizzocaro G et al. Subcutaneous administration of interleukin-2 and interferon-a2b in advanced renal cell carcinoma: long-term results. Cancer Detect Prey 23 (2), 172–176 (1999).
   Google Scholar
• Schmidinger M, Steger GG, Wenzel C et al. Sequential administration of interferon-y and interleukin-2 in metastatic renal cell carcinoma: results of a Phase II trial. Austrian Renal Cell Carcinoma Study Group. Cancer Irnmunol. Irnmunother. 49(7), 395–400 (2000).
   Google Scholar
• Ryan CW, Vogelzang NJ, Dumas MC, Kuzel T, Stadler WM. Granulocyte—macrophage-colony stimulating factor in combination immunotherapy for patients with metastatic renal cell carcinoma: results of two Phase II clinical trials. Cancer 88(6), 1317–1324 (2000).
   PubMed Web of Science ®Google Scholar
• Rogers E, Bredin H, Butler M et al. Combined subcutaneous recombinant a-interferon and interleukin-2 in metastatic renal cell cancer: results of the Multicentre All Ireland Immunotherapy Study Group. Eur. UroL 37(3), 261–266 (2000).
   Google Scholar
• Hotton KM, Khorsand M, Hank JA et al. A Phase lb/II trial of granulocyte-macrophage-colony stimulating factor and interleukin-2 for renal cell carcinoma patients with pulmonary metastases: a case of fatal central nervous system thrombosis. Cancer88(8), 1892–1901 (2000).
   Google Scholar
• Schmidinger M, Steger G, Wenzel C et al. Sequential administration of interferon-y, GM-CSF, and interleukin-2 in patients with metastatic renal cell carcinoma: results of a phase II trial. j Irninunother. 24(3), 257–262 (2001).
   Google Scholar
• Buzio C, Andrulli S, Santi R et al. Long-term immunotherapy with low-dose interleukin-2 and interferon-CL in the treatment of patients with advanced renal cell carcinoma. Cancer 92(9), 2286–2296 (2001).
   Google Scholar
• Ravaud A, Delva R, Gomez F et al. Subcutaneous interleukin-2 and interferon-CL in the treatment of patients with metastatic renal cell carcinoma. Less efficacy compared with intravenous interleukin-2 and interferon-a. Results of a multicenter Phase II trial from the Groupe Francais d'Immunotherapie. Cancer 95(11), 2324–2330 (2002).
   Google Scholar
• Clark JI, Kuzel TM, Lestingi TM et al. A multi-institutional Phase II trial of a novel in-patient schedule of continuous interleukin-2 with interferon-a2a in advanced renal cell carcinoma: major durable responses in a less highly selected patient population. Ann. OncoL 13(4), 606–613 (2002).
   Google Scholar
• Tourani JM, Pfister C, Tubiana N et al. Subcutaneous interleukin-2 and interferon-CL administration in patients with metastatic renal cell carcinoma: final results of SCAPP III, a large, multicenter, Phase II, nonrandomized study with sequential analysis design-the Subcutaneous Administration Propeukin Program Co-operative Group. JOncoL 21(21),3987–3994 (2003)
   Google Scholar
• Verra N, Jansen R, Groenewegen G et al. Immunotherapy with concurrent subcutaneous GM-CSF, low-dose IL-2 and IFN-a in patients with progressive metastatic renal cell carcinoma. Br. J Cancer88(9), 1346–1351 (2003).
   Google Scholar
• Palmer PA, Atzpodien J, Philip T et al. A comparison of 2 modes of administration of recombinant interleukin-2: continuous intravenous infusion alone versus subcutaneous administration plus interferon-CL in patients with advanced renal cell carcinoma. Cancer Biother. 8 (2), 123–136 (1993).
   Google Scholar
• Atkins MB, Sparano J, Fisher RI et al. Randomized Phase II trial of high-dose interleukin-2 either alone or in combination with interferon-a2a in advanced renal cell carcinoma. J Clin. Oncol. 11(4), 661–670 (1993).
   Google Scholar
• Lissoni P, Barni S, Ardizzoia A et al. A randomized study of low-dose interleukin-2 subcutaneous immunotherapy versus interleukin-2 plus interferon-CL as first line therapy for metastatic renal cell carcinoma. Tumor] 79(6), 397–400 (1993).
   Google Scholar
• Witte RS, Leong T, Ernstoff MS et al. A Phase II study of interleukin-2 with and without I3-interferon in the treatment of advanced renal cell carcinoma. Invest. New Drugs. 13(3), 241–247 (1995).
   Google Scholar
• Lummen G, Goepel M, Mollhoff S, Hinke A, Otto T, Rubben H. Phase II study of interferon-y versus interleukin-2 and interferon-a2a in metastatic renal cell carcinoma. J Uml. 155(2), 455–458 (1996).
   Google Scholar
• Boccardo F, Rubagotti A, Canobbio L et al. Interleukin-2, interferon-CL and interleukin-2 plus interferon-CL in renal cell carcinoma. A randomized Phase II trial. Tumor]. 84(5), 534–539 (1998).
   Google Scholar
• Negrier S, Escudier B, Lasset C et al. Recombinant human interleukin-2, recombinant human interferon-a2a, or both in metastatic renal-cell carcinoma. Groupe Francais d'Immunotherapie. N Eng]j Med. 338(18), 1272–1278 (1998).
   Google Scholar
• Lissoni P, Mengo S, Bucovec R et al. Clinical and biological effects of interleukin-2 with or without a concomitant administration of granulocyte—macrophage colony-stimulating factor in metastatic cancer patients. In vivo. 17(1), 73–75 (2003).
   Google Scholar
• Smith JVV II, Kurt RA, Baher AG et al. Immune effects of escalating doses of granulocyte-macrophage colony-stimulating factor added to a fixed, low-dose, in-patient interleukin-2 regimen: a randomized Phase I trial in patients with metastatic melanoma and renal cell carcinoma. J Irninunother. 26(2), 130–138 (2003).
   Google Scholar
• Atzpodien J, Kirchner H, Hanninen EL, Deckert M, Fenner M, Poliwoda H. Interleukin-2 in combination with interferon-CL and 5-fluorouracil for metastatic renal cell cancer. Ear. J Cancer 29A\(Suppl. 5) S6—S8 (1993).
   Google Scholar
• Atzpodien J, Kirchner H, Duensing S et al. Biochemotherapy of advanced metastatic renal-cell carcinoma: results of the combination of interleukin-2, CL-interferon, 5-fluorouracil, vinblastine, and 13-ds-retinoic acid. World Uml. 13(3), 174–177 (1995).
   Google Scholar
• Joffe JK, Banks RE, Forbes MA et al. A Phase II study of interferon-a, interleukin-2 and 5-fluorouracil in advanced renal carcinoma: clinical data and laboratory evidence of protease activation. Br. UroL 77(5), 638–649 (1996).
   Google Scholar
• Hofmockel G, Langer W, Theiss M, Gruss A, Frohmuller HG. Immunochemotherapy for metastatic renal cell carcinoma using a regimen of interleukin-2, interferon-CL and 5-fluorouracil. j UroL 156(1), 18–21 (1996).
   Google Scholar
• Lopez Hanninen E, Kirchner H, Atzpodien J. Interleukin-2 based home therapy of metastatic renal cell carcinoma: risks and benefits in 215 consecutive single institution patients. UroL 155(1), 19–25 (1996).
   Google Scholar
• Hofmockel G, Theiss M, Gruss A, Langer W Frohmuller H. Immunochemotherapy of metastatic renal cell carcinoma with interleukin-2, interferon-CL and 5-fluorouracil. Urologe A 36(1), 45–49 (1997).
   Google Scholar
• Ellerhorst JA, Sella A, Amato RJ et al. Phase II trial of 5 -fluorouracil, interferon-CL and continuous infusion interleukin-2 for patients with metastatic renal cell carcinoma. Cancer 80 (11), 2128–2132 (1997).
   Google Scholar
• Tourani JM, Pfister C, Berdah JF et al. Out-patient treatment with subcutaneous interleukin-2 and interferon-CL administration in combination with fluorouracil in patients with metastatic renal cell carcinoma: results of a sequential nonrandomized Phase II study. Subcutaneous Administration Propeukin Program Co-operative Group. J OncoL 16(7), 2505–2513 (1998).
   Google Scholar
• Ravaud A, Audhuy B, Gomez F et al. Subcutaneous interleukin-2, interferon-a2a, and continuous infusion of fluorouracil in metastatic renal cell carcinoma: a multicenter Phase II trial. Groupe Francais d'Immunotherapie. Clin. OncoL 16(8), 2728–2732 (1998).
   Google Scholar
• Samland D, Steinbach F, Reiher F, Schmidt U, Gruss A, Allhoff ER Results of immunochemotherapy with interleukin-2, interferon-a2a and 5-fluorouracil in the treatment of metastatic renal cell cancer. Eur. UroL 35(3), 204–209 (1999).
   Google Scholar
• Elias L, Binder M, Mangalik A et al. Pilot trial of infusional 5-fluorouracil, interleukin-2, and subcutaneous interferon-CL for advanced renal cell carcinoma. Am. J Clin. OncoL 22(2), 156–161 (1999).
   Google Scholar
• Elias L, Lew D, Figlin RA et al. Infusional interleukin-2 and 5-fluorouracil with subcutaneous interferon-CL for the treatment of patients with advanced renal cell carcinoma: a Southwest Oncology Group Phase II study. Cancer 89(3), 597–603 (2000).
   Google Scholar
• van Herpen CM, Jansen RL, Kruit WH et al. Immunochemotherapy with interleukin-2, interferon-CL and 5-fluorouracil for progressive metastatic renal cell carcinoma: a multicenter Phase II study. Dutch Immunotherapy Working Party. Br. Cancer 82 (4), 772–776 (2000).
   Google Scholar
• Allen MJ, Vaughan M, Webb A et al. Protracted venous infusion 5-fluorouracil in combination with subcutaneous interleukin-2 and a-interferon in patients with metastatic renal cell cancer: a Phase II study. Br. .1. Cancer 83 (8), 980–985 (2000).
   Google Scholar
• Dutcher JP, Logan T, Gordon M et al. Phase II trial of interleukin-2, interferon a, and 5-fluorouracil in metastatic renal cell cancer: a cytokine working group study. Clin. Cancer Res. 6(9), 3442–3450 (2000).
   Google Scholar
• Olencki T, Peereboom D, Wood L et al. Phase I and II trials of subcutaneously administered rIL-2, interferon-a2a, and fluorouracil in patients with metastatic renal carcinoma. .1. Cancer Res. Clin. One& 127(5), 319–324 (2001).
   Google Scholar
• Soon i G, Dillman RO, Wiemann MC et al. Phase II trial of subcutaneous interleukin-2, subcutaneous interferon-a, 5-fluorouracil and cis-retinoic acid in the treatment of renal cell carcinoma: final results of cancer biotherapy research group 94–10. Cancer Biother. Radiopharnt. 17(2), 165–173 (2002).
   Google Scholar
• Ryan CW, Vogelzang NJ, Stadler WM. A Phase II trial of intravenous gemcitabine and 5-fluorouracil with subcutaneous interleukin-2 and interferon-a in patients with metastatic renal cell carcinoma. Cancer 94(10), 2602–2609 (2002).
   Google Scholar
• Gez E, Rubinov R, Gaitini D et al. Interleukin-2, interferon-a, 5-fluorouracil, and vinblastine in the treatment of metastatic renal cell carcinoma: a prospective Phase II study: the experience of Rambam and Lin Medical Centers 1996–2000. Cancer 95(8), 1644–1649 (2002).
   Google Scholar
• Roigas J, Deger S, Taymoorian K et al. Effects of 13-cis-retinoic acid on chemoimmunotherapy of metastatic renal cell carcinoma-results of a retrospective analysis. Cancer Biother. Radiopharrn. 18 (2), 157–163 (2003).
   Google Scholar
• Ravaud A, Trufflandier N, Ferriere JM et al. Subcutaneous interleukin-2, interferon-a2a and 5-fluorouracil in metastatic renal cell carcinoma as second-line treatment after failure of previous immunotherapy: a Phase II trial. Br. .1. Cancer 89(12), 2213–2218 (2003).
   Google Scholar
• Rathmell WK, Malkowicz SB, Holroyde C, Luginbuhl W, Vaughn DJ. Phase II trial of 5-fluorouracil and leucovorin in combination with interferon-a and interleukin-2 for advanced renal cell cancer. Am.j Clin. Oncol. 27(2), 109–112 (2004).
   Google Scholar
• Indrova M, Bubenik J, Jakoubkova J et al. Subcutaneous interleukin-2 in combination with vinblastine for metastatic renal cancer: cytolytic activity of peripheral blood lymphocytes. Neoplasnta 41(4), 197–200 (1994).
   Google Scholar
• Pectasides D, Varthalitis J, Kostopoulou M et al. An out-patient Phase II study of subcutaneous interleukin-2 and interferon-a2b in combination with intravenous vinblastine in metastatic renal cell cancer. Oncology 55 (1), 10–15 (1998).
   Google Scholar
• Gez E, Mekori T, Struminger L et al. T-cell subpopulation in patients with metastatic renal cell carcinoma treated by recombinant interleukin-2, recombinant interferon-a, 5-fluorouracil, and vinblastine. Cancer Invest. 17(4), 259–263 (1999).
   Google Scholar
• Lindemann A, Hoeffken K, Schmidt RE et al. A multicenter trial of interleukin-2 and low-dose cyclophosphamide in highly chemotherapy-resistant malignancies. Cancer Treat. Rev 16(Suppl. A), 53–57 (1989).
   Google Scholar
• Buter J, Janssen RA, Martens A, Sleijfer DT, de Leij L, Mulder NH. Phase I/II study of low-dose intravenous OKT3 and subcutaneous interleukin-2 in metastatic cancer. Ear. .1. Cancer 29A (15), 2108–2113 (1993).
   Google Scholar
• Mertens WC, Bramwell VH, Banerjee D et al. Sustained oral indomethacin and ranitidine with intermittent continuous infusion interleukin-2 in advanced renal cell carcinoma. Cancer Biother. 8(3), 229–233 (1993).
   Google Scholar
• Wersall JP, Masucci G, Hjelm AL et al. Low dose cyclophosphamide, a-interferon and continuous infusions of interleukin-2 in advanced renal cell carcinoma. Med. Oncol. Tumor Pharrnacother. 10(3), 103–111 (1993).
   Google Scholar
• Deckert M, Franzke A, Buer J et al. Linomide and interleukin-2 in patients with advanced renal cell carcinoma. Cancer Biother Radiopharnt. 11(5), 319–324 (1996).
   Google Scholar
• Stadler WM, Kuzel T, Dumas M, Vogelzang NJ. Multicenter Phase II trial of interleukin-2, interferon-a, and 13-cis-rennoic acid in patients with metastatic renal-cell carcinoma. .1. Clin. Oncol. 16(5), 1820–1825 (1998).
   Google Scholar
• Creagan ET, Hestorff RD, Suman VJ et al. Combined levamisole with recombinant interleukin-2 (IL-2) in patients with advanced renal cell carcinoma: a Phase II study. Am. .1. Clin. Oncol. 21(2), 139–141 (1998).
   Google Scholar
• Lissoni P, Rovelli F, Baiocco N, Tangini G, Fumagalli L. A Phase II study of subcutaneous low-dose interleukin-2 plus erythropoietin in metastatic renal cell carcinoma progressing on interleukin-2 alone. Anticancer Res. 21(1B), 777–779 (2001).
   Google Scholar
• Donskov F, von der Maase H, Henriksson R et al. Out-patient treatment with subcutaneous histamine dihydrochloride in combination with interleukin-2 and interferon-a in patients with metastatic renal cell carcinoma: results of an open single-armed multicentre Phase II study. Ann. Oncol. 13(3), 441–449 (2002).
   Google Scholar
• Naglieri E, Lopez M, Lelli G et al. Interleukin-2, interferon-a and medroxyprogesterone acetate in metastatic renal cell carcinoma. Anticancer Res. 22 (5), 3045–3051 (2002).
   Google Scholar
• Lissoni P, Malugani F, Bordin V, Conti A, Maestroni G, Tancini G. A new neuroimmunotherapeutic strategy of subcutaneous low-dose interleukin-2 plus the long-acting opioid antagonist naltrexone in metastatic cancer patients progressing on interleukin-2 alone. Neuro. Endocrinol. Lett. 23(3), 255–258 (2002).
   Google Scholar
• Neri B, Doni L, Gemelli MT et al. Phase II trial of weekly intravenous gemcitabine administration with interferon and interleukin-2 immunotherapy for metastatic renal cell cancer. j Urol. 168(3), 956–958 (2002).
   Google Scholar
• Kedar I, Mermershtain W, Ivgi H. Thalidomide reduces serum C-reactive protein and interleukin-6 and induces response to IL-2 in a fraction of metastatic renal cell cancer patients who failed IL-2-based therapy. Int. .1. Cancer 110(2), 260–265 (2004).
   Google Scholar
• Hrushesky WJ, Murphy GP. Current status of the therapy of advanced renal cell carcinoma. .1. Surg. Oncol. 277–288 (1977).
   Google Scholar
• Blay .pr, Negrier S, Combaret V et al. Serum level of interleukin-6 as a prognosis factor in metastatic renal cell carcinoma. Cancer Res. 52(12), 3317–3322 (1992).
   Google Scholar
• Witte RS, Leong T, Ernstoff MS et al. A Phase II study of interleukin-2 with and without I3-interferon in the treatment of advanced renal cell carcinoma. Invest. New Drugs 13(3), 241–247 (1995).
   Google Scholar
• Takahashi A, Sasaki H, Kim SJ et al. Markedly increased amounts of messenger RNAs for vascular endothelial growth factor and placenta growth factor inrenal cell carcinoma associated with angiogenesis. Cancer Res. 54,4233–4237 (1994).
   PubMed Web of Science ®Google Scholar
• Bonfanti A, Lissoni P, Bucovec R, Rovelli F, Brivio F, Fumagalli L. Changes in circulating dendritic cells and IL-12 in relation to the angiogenic Factor VEGF during IL-2 immunotherapy of metastatic renal cell cancer. Int. J Biol. Markers15 (2), 161–164 (2000).
   Google Scholar
• Lissoni P, Bolis S, Brivio F, Fumagalli L. A Phase II study of neuroimmunotherapy with subcutaneous low-dose IL-2 plus the pineal hormone melatonin in untreatable advanced hematologic malignancies. Anticancer Res. 20(3B), 2103–2105 (2000).
   Google Scholar
• Lissoni P, Barni S, Tancini G et al. Immunoendocrine therapy with interleukin-2 (IL-2) and medroxyprogesterone acetate (MPA): a randomized study with or without MPA in metastatic renal cancer patients during IL-2 maintenance treatment after response or stable disease to IL-2 subcutaneous therapy. Tumori79(4), 246–249 (1993).
   Google Scholar
• Henriksson R, Nilsson S, Colleen S et al. Survival in renal cell carcinoma-a randomized evaluation of tamoxifen vs. interleukin-2, a-interferon (leucocyte) and tamoxifen. Br J. Cancer 77(8), 1311–1317 (1998).
   Google Scholar
• Naglieri E, Gebbia V, Durini E et al. Standard interleukin-2 (IL-2) and interferon-a immunotherapy versus an IL-2 and 4-epirubicin immuno-chemotherapeutic association in metastatic renal cell carcinoma. Anticancer Res. 18(3B), 2021-2026 (1998).
   Google Scholar
• Atzpodien J, Kirchner H, Jonas U et al. Interleukin-2- and interferon-a2a-based immunochemotherapy in advanced renal cell carcinoma: a prospectively randomized trial of the German Co-operative Renal Carcinoma Chemoimmunotherapy Group (DGCIN). j Clin. Oncol. 22 (7), 1188–1194 (2004).
   Google Scholar
• Negrier S, Caty A, Lesimple T et al. Treatment of patients with metastaticrenal carcinoma with a combination of subcutaneous interleukin-2 and interferon-a with or without fluorouracil. Groupe Francais d'Immunotherapie, Federation Nationale des Centres de Lutte Contre le Cancer. JOncol. 18(24),4009-4015 (2000).
   Google Scholar
• Atzpodien J, Kirchner H, Illiger HJ et al. IL-2 in combination with IFN á and 5-FU versus tamoxifen in metastatic renal cell carcinoma: long-term results of a controlled randomized clinical trial. Br. J. Cancer 85(8), 1130–1136 (2001).
   Google Scholar
• Motzer RJ, Bacik J, Schwartz LH et al. Prognostic factors for survival in previously treated patients with metastatic renal cell carcinoma. J. Clin. Oncol. 22(3), 454–463 (2004).
   Google Scholar
• Koretz MJ, Lawson DH, York RM et al. Randomized study of interleukin-2 (IL-2) alone vs. IL-2 plus lymphokine-activated 898–903 (1991).
   Google Scholar
• Weiss GR, Margolin KA, Aronson FR et al. A randomized Phase II trial of continuous infusion interleukin-2 or advanced renal cell carcinoma. Arch. Surg. 126(7), 898–903 (1991).
   Google Scholar
• Rosenberg SA, Lotze MT, Yang JC et al. Prospective randomized trial of high-doseinterleukin-2 alone or in conjunction with lymphokine-activated killer cells for the treatment of patients with advanced cancer. J Nat] Cancer Inst. 85 (8), 622–632 (1993).
   Google Scholar
• Law TM, Motzer RJ, Mazumdar M et al. Phase III randomized trial of interleukin-2with or without lymphokine-activated killer cells in the treatment of patients with advanced renal cell carcinoma. Cancer 76(5), 824–832 (1995).
   Google Scholar
• Fenton RG, Steis RG, Madara K et al. A Phase I randomized study of subcutaneous adjuvant IL-2 in combination with an autologous tumor vaccine in patients with advanced renal cell carcinoma. J Irmnunother. Emphasis Tumor I17717711fla 19(5), 364–374 (1996).
   Google Scholar
• Figlin RA, Thompson JA, Bukowski RM et al. Multicenter, randomized, Phase III trialof CD8(+) tumor-infiltrating lymphocytes in combination with recombinant interleukin-2 in metastatic renal cell carcinoma. J Cilia. Oncol. 17(8), 2521–2529 (1999).
   Google Scholar
• Clark JI, Atkins MB, Urba WJ et al. Adjuvant high-dose bolus interleukin-2 for patients with high risk renal cell carcinoma — a Cytokine Working Group randomized trial.j Clin. Oncol. 21,3133-3140 (2003).
   Google Scholar
• Donskov F, Bennedsgaard KM, Von der Maase H et al. Intratumoural and peripheral blood lymphocyte subsets in patients with metastatic renal cell carcinoma undergoing interleukin-2 based immunotherapy: association to objective response and survival. Br. J Cancer 87(2), 194–201 (2002).
   Google Scholar
• Atkins M, McDermott D, Regan M et al. Carbonic Anhydrase IX (CAIX) expression predicts for renal cell cancer wcq patient response and survival to IL-2 therapy. Proc. Am. Soc. Clin. Oncol. Ann. (2004) (Abstract 4512).
   Google Scholar
• Yang JC, Haworth L, Sherry RM et al. A randomized trial of bevacizumab, an antivascular endothelial growth factor antibody, for metastatic renal cancer. N Engl. J. Med. 349(5), 427–434 (2003).
   Google Scholar