Superantigen-based immunotherapy: A phase I trial of PNU-214565, a monoclonal antibody-staphylococcal enterotoxin A recombinant fusion protein, in advanced pancreatic and colorectal cancer

Journal of Clinical Oncology

Volumn 15, Issue 5, 1997, Pages 1994-2007

  Giantonio, B J ^a   Alpaugh, R K ^a   Schultz, J ^a   McAleer, C ^a   Newton, D W ^a   Shannon, B ^a   Guedez, Y ^a   Kotb, M ^a   Vitek, L ^a   Persson, R ^a   Gunnarsson, P O ^a   Kalland, T ^a   Dohlsten, M ^a   Persson, B ^a   Weiner, L M ^a  

^a FOX CHASE CANCER CENTER   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

CA 242 ANTIGEN; HLA DR ANTIGEN; HYBRID PROTEIN; INTERLEUKIN 2; MONOCLONAL ANTIBODY; NACOLOMAB TAFENATOX; STAPHYLOCOCCUS ENTEROTOXIN A; SUPERANTIGEN; T LYMPHOCYTE RECEPTOR BETA CHAIN; TUMOR NECROSIS FACTOR ALPHA; UNCLASSIFIED DRUG;

ADULT; AGED; AREA UNDER THE CURVE; ARTICLE; CANCER IMMUNOTHERAPY; CLINICAL ARTICLE; CLINICAL FEATURE; CLINICAL TRIAL; COLORECTAL CANCER; DOSE RESPONSE; DRUG BLOOD LEVEL; DRUG HALF LIFE; DRUG TOLERANCE; FEMALE; FEVER; HUMAN; HUMORAL IMMUNITY; HYPOTENSION; INTRAVENOUS DRUG ADMINISTRATION; LYMPHOCYTE PROLIFERATION; MALE; MAXIMUM PERMISSIBLE DOSE; PANCREAS CANCER; PHASE 1 CLINICAL TRIAL; PRIORITY JOURNAL;

EID: 0031005762     PISSN: 0732183X     EISSN: None     Source Type: Journal    
DOI: 10.1200/JCO.1997.15.5.1994     Document Type: Article

References (65)

1. Bolhuis RL, Lamers CH, Goey SH, et al: Adoptive immunotherapy of ovarian carcinoma with bs-MAb-targeted lymphocytes: A multicenter study. Int J Cancer 7:78-81, 1992
2. Weiner LM, Clark JI, Davey M, et al: Phase I trial of 2B1, a bispecific monoclonal antibody targeting c-erbB-2 and FcγRIII. Cancer Res 55:4586-4593, 1995
3. Valone FH, Kaufman PA, Guyre PM, et al: Phase Ia/Ib trial of bispecific antibody MDX-210 in patients with advanced breast or ovarian cancer that overexpress the proto-oncogene HER-2/neu. J Clin Oncol 13:2281-2292, 1995
4. Nitta T, Sato K, Yagita H, et al: Preliminary trial of specific targeting therapy against malignant glioma. Lancet 335:368-371, 1990
5. Boon T, Cerottini JC, van den Eynde B, et al: Tumor antigens recognized by T lymphocytes. Ann Rev Immunol 12:337-365, 1994
6. Restifo NP, Spiess PJ, Karp SE, et al: A nonimmunogenic sarcoma transduced with the cDNA for interferon gamma elicits CD8+ T cells against the wild-type tumor: Correlation with antigen presentation capability. J Exp Med 175:1423-1431, 1992
7. Flyer DC, Burakoff SJ, Faller DV: Retrovirus-induced changes in major histocompatibility complex antigen expression influence susceptibility to lysis by cytotoxic T lymphocytes. J Immunol 135:2287-2292, 1985
8. Ward PL, Koeppen HK, Hurteau T, et al: MHC class I and unique antigen expression by tumors that escaped from CD8+ T cell-dependent surveillance. Cancer Res 50:3851-3858, 1990
9. Van der Bruggen P, Traversari C, Chomez P, et al: A gene encoding an antigen recognized by cytolytic T lymphocytes on a human melanoma. Science 254:1643-1647, 1991
10. Restifo NP, Esquivel F, Kawakami Y, et al: Identification of human cancers deficient in antigen processing. J Exp Med 177:265-272, 1993
11. Leach DR, Krummel MF, Allison JP: Enhancement of antitumor immunity by CTLA-4 blockade. Science 271:1734-1736, 1996
12. Marrack P, Kappler J: The staphylococcal enterotoxins and their relatives. Science 248:705-711, 1990
13. Kotb M: Bacterial pyrogenic exotoxins as superantigens. Clin Micro Rev 8:411-426, 1995
14. Fraser JD: High affinity binding sites of staphylococcal enterotoxins A and B to HLA-DR. Nature 339:221-224, 1989
15. Fischer H, Dohlsten M, Lindvall M, et al: Binding of staphylococcal enterotoxin A to HLA-DR on B cell lines. J Immunol 142:3151-3155, 1989
16. Dellabona P, Peccoud J, Kappler J. et al: Superantigens interact with MHC class II molecules outside of the antigen groove. Cell 62:1115-1121, 1990
17. Jardetzky TS, Brown JH, Gorga JC, et al: Three-dimensional structure of a human class II histocompatibility molecule complexed with superantigen. Nature 368:711-718, 1994
18. Fleischer B, Gerardy-Schan R, Metzroth B, et al: An evolutionary conserved mechanism of T cell activation by microbial toxins. Evidence for different affinities of T cell receptor-toxin interaction. J Immunol 146:11-17, 1991
19. Irwin MJ, Hudson KR, Fraser JD, et al: Enterotoxin residues determining T-cell receptor Vβ binding specificity. Nature 359:841-843, 1992
20. Gascoigne NRJ, Ames KT: Direct binding of secreted T-cell receptor β chain to superantigen associated with class II major histocompatibility complex protein. Proc Natl Acad Sci USA 88:613-616, 1991
21. Lafon M, Lafage M, Martinez-Arcnds A, et al: Evidence for a viral superantigen in humans. Nature 358:507-510, 1992
22. White J, Herman A, Pullen AM, et al: The Vβ-speciric superantigen staphylococcal enterotoxin B: Stimulation of mature T cells and clonal deletion in neonatal mice. Cell 56:27-35, 1989
23. Choi Y, Kotzin B, Herron L, et al: Interaction of Staphylococcus aureus toxin "superantigens" with human T cells. Proc Natl Acad Sci USA 86:8941-8945, 1989
24. Dohlsten M, Lando PA, Hedlund G, et al: Targeting of human cytotoxic T lymphocytes to MHC class II expressing cells by staphylococcal enterotoxins. Immunology 71:96-100, 1990
25. Lando P, Hedlund G, Dohlsten M, et al: Bacterial superantigens as anti-tumor agents: Induction of tumor cytotoxicity in human lymphocytes by staphylococcal enterotoxin. Cancer Immunol Immunother 33:231-237, 1991
26. Lando P, Dohlsten M, Kalland T, et al: The TCR-CD3 complex is required for activation of human lymphocytes with staphylococcal enterotoxin A. Scand J Immunol 31:133-138, 1990
27. Fischer H, Dohlsten M, Andersson U, et al: Production of TNF-α and TNF-β by staphylococcal enterotoxin A activated human t cells. J Immunol 144:4663-4669, 1990
28. Kalland T, Dohlsten M, Lind P, et al: Monoclonal antibodies and superantigens: A novel therapeutic approach. Med Oncol Tumor Pharmacother 10:37-47, 1993
29. Fleischer B, Schrezenmeier H: Stimulation by staphylococcal enterotoxins. Clonally variable response and requirement for MHC class II molecules on accessory target cells. J Exp Med 167:1697-1708, 1988
30. Kalland T, Hedlund G, Dohlsten M, et al: Staphylococcal enterotoxin-dependent cell-mediated cytotoxicity. Curr Top Microbiol Immunol 174:81-92, 1991
31. Herrman T, Maryanski JL, Romero P, et al: Activation of MHC class I restricted CD8+ CTL by microbial T cell mitogens. Dependence upon MCH class II expression of the target cells and Vβ usage of the responder T cell. J Immunol 144:1181-1186, 1990
32. Hedlund G, Dohlsten M, Lando PA, et al: Staphylococcal enterotoxins direct and trigger CTL killing of autologous HLA-DR+ mononuclear leukocytes and freshly prepared leukemia cells. Cell Immunol 129:426-434, 1990
33. Hedlund G, Dohlsten M, Petersson C, et al: Superantigen based tumor therapy: In vivo activation of cytotoxic T cells. Cancer Immunol Immunother 36:89-93, 1993
34. Todd JK, Fishaut M, Kapral F, et al: Toxic-shock syndrome associated with phage group-I Staphylococci. Lancet 2:1116-1118, 1978
35. Schlievert PM, Shands KN, Dan BB, et al: Identification and characterization of an exotoxin from Staphylococcus aureus associated with toxic-shock syndrome. J Infect Dis 143:509-516, 1981
36. Johnson H, Russell J, Pontzer C: Superantigens in human disease. Sci Am 266:92-101, 1992
37. Kotzin BL, Leung DY, Kappler J, et al: Superantigens and their potential role in human disease. Adv Immunol 54:99-166, 1993
38. Kalland T, Dohlsten M, Lando PA, et al: Antibody targeted superantigens in experimental tumor therapy, in Thibodeau J, Sekaly R-P (eds): Bacterial Superantigens: Structure, Function and Therapeutic Potential. Austin, TX, Landes Co, 1995, pp 219-238
39. Dohlsten M, Abrahmsen L, Bjork P, et al: Monoclonal antibody-superantigen fusion proteins: Tumor specific agents for T-cell based tumor therapy. Proc Natl Acad Sci USA 91:8945-8949, 1994
40. Dohlsten M, Hedlund G, Akerblom E, et al: Monoclonal antibody-targeted superantigens: A different class of anti-tumor agents. Proc Natl Acad Sci USA 88:9287-9291, 1991
41. Dohlsten M, Sundstedt A, Borklund M, et al: Superantigen-induced cytokines suppress growth of human colon-carcinoma cells. Int J Cancer 54:482-488, 1993
42. Lando PA, Dohlsten M, Hedlung G, et al: T cell killing of human colon carcinomas by monoclonal-antibody targeted superantigens. Cancer Immunol Immunother 36:223-228, 1993
43. Lando PA, Hedlund G, Dohlsten M, et al: Bacterial superantigens as anti-tumor agents: Induction of tumor cytotoxicity in human lymphocytes by staphylococcal enterotoxin A. Cancer Immunol Immunother 3:231-237, 1991
44. Kalland T, Dohlsten M, Lind P, et al: Monoclonal antibodies and superantigens: A novel therapeutic approach. Med Oncol Tumor Pharmacother 10:37-47, 1993
45. Dohlsten M, Hansson J, Ohlsson L, et al: Antibody-targeted superantigens are potent inducers of tumor-infiltrating T lymphocytes in vivo. Proc Natl Acad Sci USA 92:9791-9795, 1995
46. Dohlsten M, Lando PA, Bjork P, et al: Immunotherapy of human colon cancer by antibody-targeted superantigens. Cancer Immunol Immunother 41:162-168, 1995
47. a epitope on distinct core proteins. J Biol Chem 266:21537-21547, 1991
48. Ouyang Q, Vilien M, Ravn-Juhl B, et al: CEA and carbohydrate antigens in normal and neoplastic colon mucosa. An immunohistochemical study. Acta Pathol Microbiol Immunol Scand 95:177-183, 1987
49. Johansson C, Nilsson O, Baeckstrom D, et al: Novel epitopes on the CA50-carrying antigen: Chemical and immunochemical studies. Tumor Biol 12:159-170, 1991
50. Haglund C, Lindgren J, Roberts PJ, et al: Tissues expression of the tumor-associated antigen CA242 in benign and malignant pancreatic lesions. A comparison with CA50 and CA19-9. Br J Cancer 60:845-851, 1989
51. Litton MJ, Dohlsten M, Lando PA, et al: Antibody-targeted superantigen therapy induces tumor-infiltrating lymphocytes, excessive cytokine production, and apoptosis in human colon carcinoma. Eur J Immunol 26:1-9, 1996
52. Miller A, Hoogstraten B, Staquet M, et al: Reporting results of cancer treatment. Cancer 47:207-214, 1981
53. Tomai MA, Aelion JA, Dockter ME, et al: T cell receptor V gene usage by human T cells stimulated with the superantigen streptococcal M protein. J Exp Med 174:285-288, 1991
54. Kotb M, Watanabe-Ohnishi R, Wang B, et al: Analysis of the TCR Vβ specificities of bacterial superantigens using PCR. Immunomethods 2:33-40, 1993
55. Walsh PS, Metzger DA, Higuchi R: Chelex 100 as a medium for simple extraction of DNA for PCR-based typing from forensic material. BioTechniques 10:506-513, 1991
56. Olerup O, Zetterquist H: HLA-DR typing by PCR amplification with sequence-specific primers (PCR-SSP) in 2 hours: An alternative to serological DR typing in clinical practice including donor-recipient matching in cadaveric transplantation. Tissue Antigens 39:225-235, 1992
57. Olerup O, Zetterquist H: DR "low resolution" PCR-SSP typing - A correction and an update. Tissue Antigens 41:55-56, 1993
58. Herman A, Labrecque N, Thibodeau J, et al: Identification of the staphylococcal enterotoxin A superantigen binding site in the beta 1 domain of the human histocompatibility antigen HLA-DR. Proc Natl Acad Sci USA 88:9954-9958, 1991
59. Zimmerman TJ: Topical ophthalmic beta blockers: A comparative review. J Ocular Pharm 9:373-384, 1993
60. Newton DW, Dohlsten M, Olsson C, et al: Mutations in the MHC class II binding domains of staphylococcal enterotoxin A differentially affect T-cell receptor Vβ specificity. J Immunol 157: 3988-3994, 1996
61. Weiner LM: Applications of gamma-interferon in cancer therapy. A review. Mol Biother 3:186-191, 1991
62. Rosenberg SA, Lotze MT, Muul LM, et al: A progress report on treatment of 157 patients with advanced cancer using lymphokine activated killer cells and interleukin-2 or high-dose interleukin-2 alone. N Engl J Med 316:889-897, 1987
63. Weiner LM, Padavic-Shaller K, Kitson J, et al: Phase I evaluation of combination therapy with interleukin 2 and γ-interferon. Cancer Res 51:3910-3918, 1991
64. Dillman RO: Monoclonal antibodies for treating cancer. Ann Intern Med 111:592-603, 1989
65. Weiner LM, Harvey E, Padavic-Shaller K, et al: Phase II multicenter evaluation of prolonged murine monoclonal antibody 17-1A therapy in pancreatic carcinoma. J Immunol 13:110-116, 1993