Phase II Trial of Interleukin-2 and Interferon-ce in Patients with Renal Cell Carcinoma: Clinical Results and Immunologic Correlates of Response

Journal of Immunotherapy

Volumn 20, Issue 4, 1997, Pages 301-311

  Bukowski, Ronald M ^a   Olencki, Thomas ^a   Wan, Qm ^a   Peereboom, David ^a   Thomas Budd, G ^a   Elson, Paul ^a   Sandstrom, Kate ^a   Tuason, Laurie ^a   Rayman, Patricia ^a   Tubbs, Raymond ^a   McLain, Denise ^a   Klein, Eric ^a   Novick, Andrew ^a   Finke, James ^a  

^a LERNER RESEARCH INSTITUTE   (United States)

Author keywords

Interferon; Interleukin 2; Metastatic renal cell carcinoma; Phase II; Renalcell carcinoma

Indexed keywords

CD3 ANTIGEN; HLA DR ANTIGEN; INTERLEUKIN 2 RECEPTOR; RECOMBINANT ALPHA2B INTERFERON; RECOMBINANT INTERLEUKIN 2; T LYMPHOCYTE ANTIGEN;

ADULT; AGED; ARTICLE; CANCER IMMUNOTHERAPY; CANCER SURVIVAL; CHILL; CLINICAL ARTICLE; CLINICAL TRIAL; CONTINUOUS INFUSION; FEMALE; FEVER; GASTROINTESTINAL TOXICITY; HUMAN; HUMAN CELL; HYPOCALCEMIA; INTRAVENOUS DRUG ADMINISTRATION; KIDNEY CARCINOMA; LIVER TOXICITY; LUNG TOXICITY; LYMPHOCYTE PROLIFERATION; MALE; METASTASIS; NEUROTOXICITY; ORAL DRUG ADMINISTRATION; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; SIGNAL TRANSDUCTION; SUBCUTANEOUS DRUG ADMINISTRATION; T LYMPHOCYTE SUBPOPULATION; TUMOR ASSOCIATED LEUKOCYTE; TUMOR REGRESSION;

ADULT; AGED; ANTIGENS, CD; CARCINOMA, RENAL CELL; FEMALE; HUMANS; INTERFERON ALFA-2B; INTERLEUKIN-2; KIDNEY NEOPLASMS; LYMPHOCYTES, TUMOR-INFILTRATING; MALE; MIDDLE AGED;

EID: 0031463916     PISSN: 15249557     EISSN: 15374513     Source Type: Journal    
DOI: 10.1097/00002371-199707000-00007     Document Type: Article

References (43)

1. Chikkala NF, Lewis I, Ulchaker J, Stanley J, Tubbs R, Finke JH. Interactive effects of α-interferon A/D and interleukin-2 on murine lymphokine-activated killer activity: analysis at the effector and precursor level. Cancer Res 1990;50:1176-82.
2. Rosenberg SA, Schwarz SL, Spiess PJ. Combination immunotherapy for cancer: synergistic antitumor interactions of interleukin-2, alpha interferon, and tumor-infiltrating lymphocytes. J Natl Cancer Inst 1988;80:1393-7.
3. Stahl M, Wilke HJ, Seeber S, Schmoll HJ. Cytokines and cytotoxic agents in renal cell carcinoma: a review. Semin Oncol 1992;19:70-9.
4. Keilholz U, Scheibenbogen C, Tilgen W, et al. Interferon-a and interleukin-2 in the treatment of metastatic melanoma. Cancer 1993;72:607-14.
5. Sparano JA, Fisher RI, Sunderland M, et al. Randomized phase III trial of treatment with high-dose interleukin-2 either alone or in combination with interferon alfa-2a in patients with advanced melanoma. J Clin Oncol 1993;11:1969-77.
6. Marineóla FM, Venzon D, White D, et al. HLA association with response and toxicity in melanoma patients treated with interleukin-2 based therapy. Cancer Res 1992;52:6561-6.
7. Favrot MC, Combaret V, Negrier S, et al. Functional and immunophenotypic modifications induced by interleukin-2 did not predict response to therapy in patients with renal cell carcinoma. J Biol Response Mod 1990;9:167-77.
8. Pichert G, Jost LM, Fierz W, Stahel RA. Clinical and immune modulatory effects of alternative weekly interleukin-2 and interferon alfa-2a in patients with advanced renal cell carcinoma and melanoma. Br J Cancer 1991;63:287-92.
9. Atzpodien J, Kirchner H, Korfer A, et al. Expansion of peripheral blood natural killer cells correlates with clinical outcome in cancer patients receiving recombinant subcutaneous inter-leukin-2 and interferon α-2. Tumor Biol 1993;14:354-9.
10. Janssen RAJ, Sleijfer DT, Heijn AA, Mulder NH, The TH, de Leij L. Peripheral blood lymphocyte number and phenotype prior to therapy correlate with response in subcutaneously applied rIL-2 therapy of renal cell carcinoma. Br J Cancer 1992; 66:1177-9.
11. 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 alpha in patients with advanced renal cell carcinoma. Cancer Biother 1993;8:123-36.
12. Bergmann L, Fenchel K, Weidmann E, et al. Daily alternating administration of higher dose alpha-2b-interferon and inter-leukin-2 bolus infusion in metastatic renal cell cancer: A phase II study. Cancer 1993;72:1733-42.
13. Rubin JT, Elwood LJ, Rosenberg SA, Lotze MT. Immunohis-tochemical correlates of response to recombinant interleukin-2 based immunotherapy in humans. Cancer Res 1989; 49:7086-92.
14. Budd GT, Osgood B, Barna B, et al. Phase I clinical trial of interleukin-2 and interferon-alpha: toxicity and immunologic effects. Cancer Res 1989;49:6432-6.
15. Budd GT, Murthy S, Finke J, et al. Phase I trial of high-dose bolus interleukin-2 and interferon alfa-2a in patients with metastatic malignancy. J Clin Oncol 1989;10:804-9.
16. Bukowski RM, Murthy S, Sergi JS, et al. Phase I trial of continuous infusion recombinant interleukin-2 and intermittent recombinant interferon-alpha-2a: toxicity and immunologic effects. J Biol Response Mod 1990;9:538-45.
17. Budd GT, Finke JH, Tubbs RR, et al. Phenotypic and functional analysis of lymphoid cells in the peripheral blood and tumor of cancer patients treated with recombinant interleukin-2 plus interferon-a. In: Klein EA, Finke JH, Bukowski RM. Renal cell carcinoma: Immunotherapy and cellular biology. New York: Marcel Dekker, 1993:273-96.
18. Finke JH, Rayman P, Edinger M, et al. Characterization of a human renal cell carcinoma specific cytotoxic CD8+ T cell line. J Immunother 1991;11:1-11.
19. Finke JH, Rayman P, Hart L, et al. Characterization of tumor infiltrating lymphocyte subsets from human renal cell carcinoma: Specific reactivity defined by cytotoxicity, interferon y secretion, and proliferation. J Immunother 1994;15:91-104.
20. Schendel DJ, Gansbacher B, Oberneder R, et al. Tumor specific lysis of human renal cell carcinomas by tumor-infiltrating lymphocytes. I. HLA-A2-restricted recognition of autologous and allogeneic tumor lines. J Immunol 1993; 151:4209-20.
21. Finke JH, Rayman P, Alexander J, et al. Characterization of the cytolytic activity of CD4+ and CD8 + TIL subsets in human renal cell carcinoma. Cancer Res 1990;50:2363-70.
22. Miescher S, Stoeck M, Qiao L, Barras C, Barrelet L, von Fliedner V. Preferential clonogenic deficit of CD8-positive T-lymphocytes infiltrating human solid tumors. Cancer Res 1988;48:6992-8.
23. Alexander JP, Kudoh S, Melsop KA, et al. T-cells infiltrating renal cell carcinoma display a poor proliferative response even though they can produce interleukin-2 and express interleukin-2 receptors. Cancer Res 1993;53:1380-7.
24. Ick in T-cells infiltrating human renal cell carcinoma. Cancer Res 1993;53:5613-6.
25. +) tumor infiltrating lymphocytes in β cell non-Hodgkin’s lymphomas. Leuk Lymphoma 1993;9:91-4.
26. Sheibani K, Tubbs K. Enzyme immunohistochemistry: technical aspects. Semin Diagn Pathol 1984;1:235-50.
27. Li X, Liu J, Park JK, et al. T-cells from renal cell carcinoma patients exhibit an abnormal pattern of κ B-specific DNA binding activity: a preliminary report. Cancer Res 1994; 54:5424-9.
28. Wilcoxon R. Individual comparisons by ranking methods. Bio-metrics 1945;1:80-3.
29. Kaplan EL, Meier P. Nonparametric estimation from incomplete observations. J Am Stat Assoc 1958;53:457-81.
30. Rosenberg SA, Lotze MT, Yang JC, et al. Combination therapy with interleukin-2 and alpha-interferon for treatment of patients with advanced cancer. J Clin Oncol 1989;7:1863-74.
31. Ilson DH, Motzer RJ, Kradin RL, et al. A phase II trial of interleukin-2 and interferon alfa-2α in patients with advanced renal cell carcinoma. J Clin Oncol 1992;10:1124-30.
32. Figlin RA, Belldegrun A, Moldawer N, et al. Concomitant administration of recombinant interferon alfa-2A: an active outpatient regimen in metastatic renal cell carcinoma. J Clin Oncol 1992;10:414-21.
33. Atzpodien J, Kirchener H, de Mulder P, et al. Subcutaneous recombinant interleukin-2 and α-interferon in patients with advanced renal cell carcinoma: results of a multicenter phase II study. Cancer Biother 1993;8:289-300.
34. Vogelzang NJ, Lipton A, Figlin RA. Subcutaneous interleukin-2 plus interferon alfa-2α in metastatic renal cancer: an outpatient multicenter trial. J Clin Oncol 1993;11:1809-16.
35. Atkins MK, Sparano J, Fisher RI, et al. Randomized phase II trial of high-dose interleukin-2 either alone or in combination with interferon alfa-2b in advanced renal cell carcinoma. J Clin Oncol 1993;11:661-70.
36. Sherry RM, Pass HI, Rosenberg SA, et al. Surgical resection of metastatic renal cell carcinoma and melanoma after response to interleukin-2-based immunotherapy. Cancer 1992;69:1850-5.
37. Elson PJ, Witte RS, Trump DL. Prognostic factors for survival in patients with recurrent or metastatic renal cell carcinoma. Cancer Res 1988;48:7310-3.
38. Jones M, Philip T, Palmer P, et al. The impact of interleukin-2 on survival in renal cancer: A multivariate analysis. Cancer Biother 1993;8:275-88.
39. 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 1994;271:907-13.
40. Fyfe G, Fisher FI, Rosenberg SA, et al. Results of treatment of 255 patients with metastatic renal cell carcinoma who received high-dose recombinant interleukin-2 therapy. J Clin Oncol 1995;13:688-96.
41. Dorval T, Mathiot C, Chosidow O, et al. IL-2 phase II trial in metastatic melanoma: analysis of clinical and immunological parameters. Biotechnol Ther 1992;3:63-79.
42. Mizoguchi H, O’Shea JJ, Longo DL, et al. Alterations in signal transduction molecules in T-lymphocytes from tumor-bearing mice. Science 1992;258:1795-8.
43. Salvadori S, Gansbacher B, Pizzimenti AM, Zier KS. Abnormal signal transduction by T cells of mice with parental tumors is not seen in mice bearing IL-2-secreting tumors. J Immunol 1994;153:5176-82.