Immunization of colorectal cancer patients with recombinant baculovirus-derived KSA (Ep-CAM) formulated with monophosphoryl lipid a in liposomal emulsion, with and without granulocyte-macrophage colony-stimulating factor

Vaccine

Volumn 22, Issue 5-6, 2004, Pages 773-780

  Neidhart, Jeffrey ^a   Allen, Karen O ^a   Barlow, Daunte L ^a   Carpenter, Mark ^a   Shaw, Denise R ^a   Triozzi, Pierre L ^a   Conry, Robert M ^a  

^a UNIVERSITY OF ALABAMA AT BIRMINGHAM   (United States)

Author keywords

Colorectal cancer; Granulocyte macrophage colony stimulating factor; Monophosphoryl lipid A

Indexed keywords

CANCER VACCINE; EPITHELIAL CELL ADHESION MOLECULE; GAMMA INTERFERON; LIPOSOME; MINERAL OIL; PHOSPHORYL LIPID A; RECOMBINANT GRANULOCYTE COLONY STIMULATING FACTOR; RECOMBINANT GRANULOCYTE MACROPHAGE COLONY STIMULATING FACTOR; RECOMBINANT VACCINE; TUMOR ANTIGEN; UNCLASSIFIED DRUG;

ACTIVE IMMUNIZATION; ADULT; AGED; ALLERGIC REACTION; ANTIBODY RESPONSE; ARTICLE; AUTOIMMUNE DISEASE; BACULOVIRUS; CELLULAR IMMUNITY; CLINICAL ARTICLE; CLINICAL TRIAL; COLORECTAL CANCER; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DELAYED HYPERSENSITIVITY; DRUG EFFECT; DRUG FORMULATION; DRUG SAFETY; DRUG SCREENING; DRUG TOLERABILITY; EMULSION; ENZYME LINKED IMMUNOSPOT ASSAY; FEMALE; FEVER; HUMAN; HUMORAL IMMUNITY; HYPERGLYCEMIA; INJECTION SITE; LIVER TOXICITY; LUNG DISEASE; LYMPHADENOPATHY; LYMPHOCYTE PROLIFERATION; MALE; PRIORITY JOURNAL; RANDOMIZATION; RANDOMIZED CONTROLLED TRIAL; SKIN TEST; THYROID DISEASE;

EID: 1642493613     PISSN: 0264410X     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.vaccine.2003.08.021     Document Type: Article

References (52)

1. Zeh H.J., Stavely-O'Carroll K., Choti M.A. Vaccines for colorectal cancer. Trends Mol. Med. 7:2001;307-313.
2. Gottlinger R.D., Funke I., Johnson J.P.et al. The epithelial cell surface antigen 17-1A, a target for antibody-mediated tumor therapy: its biochemical nature, tissue distribution and recognition by different monoclonal antibodies. Int. J. Cancer. 38:1986;47-53.
3. Herlyn D., Steplewski Z., Herlyn M., Koprowski H. Colorectal carcinoma-specific antigen: detection by means of monoclonal antibodies. Proc. Natl. Acad. Sci. U.S.A. 76:1979;1438-1442.
4. Shetye S.F., Frodin J.-E., Christensson B.et al. Immunohistochemical monitoring of metastatic colorectal carcinoma in patients treated with monoclonal antibodies (MAb 17-01A). Cancer Immunol. Immunother. 27:1988;154-162.
5. Herlyn D., Herlyn M., Ross A.H., Ernst C., Atkinson B., Koprowski H. Efficient selection of tumor growth-inhibiting monoclonal antibodies. J. Immunol. Methods. 73:1984;157-167.
6. Herlyn D., Koprowski H. IgG2a monoclonal antibodies inhibit human tumor growth through interaction with effector cells. Proc. Natl. Acad. Sci. U.S.A. 79:1982;4761-4765.
7. Herlyn D., Steplewski Z., Herlyn M., Koprowski H. Inhibition of colorectal carcinoma tumor growth in nude mice by monoclonal antibody. Cancer Res. 40:1980;717-721.
8. Herlyn D., Sears H.F., Ernst C.S., Iliopoulos D., Steplewski Z., Koprowski H. Initial clinical evaluation of two murine IgG2a monoclonal antibodies for immunotherapy of gastrointestinal carcinoma. Am. J. Clin. Oncol. 14:1991;371-378.
9. Riethmuller G., Schneider-Gadicke E., Schlimok G.et al. Randomized trial of monoclonal antibody for adjuvant therapy of resected Dukes' C colorectal carcinoma. Lancet. 343:1994;1177-1183.
10. LoBuglio A.F., Saleh M.N., Lee J.et al. Phase I trial of multiple large doses of murine monoclonal antibody C017-1A. I. Clinical aspects. J. Natl. Cancer Inst. 80:1988;932-936.
11. Herlyn D., Wettendorff M., Schmoll E.et al. Anti-idiotype immunization of cancer patients: modulation of the immune response. Proc. Natl. Acad. Sci. U.S.A. 84:1987;8055-8059.
12. Loibner H, Plot R, Rot AW, et al. Immunoreactivity of a patient with colorectal cancer metastasis after immunization with anti-idiotypes. Lancet 1990;335:171.
13. Herlyn D., Benden A., Kane M.et al. Anti-idiotype cancer vaccines: pre-clinical and clinical studies. In Vivo. 5:1991;615-624.
14. Samonigg H., Wilders-Truschnig M., Loibner H.et al. Immune response to tumor antigens in a patient with colorectal cancer after immunization with anti-idiotype antibody. Clin. Immunol. Immunopathol. 65:1992;271-277.
15. Herlyn D., Harris D., Zaloudik J.et al. Immunoregulatory activity of monoclonal anti-idiotypic antibody to anti-colorectal carcinoma antibody CO17-1A in animals and patients. J. Immunother. 15:1994;303-311.
16. Somasundaram R., Zaloudik J., Jacob L.et al. Induction of antigen-specific T and B cell immunity in colon carcinoma patients by anti-idiotypic antibody. J. Immunol. 155:1995;3253-3261.
17. Maruyama H., Zaloudik J., Li W.et al. Cancer vaccines: single-epitope anti-idiotype vaccine versus multiple-epitope antigen vaccine. Cancer Immunol. Immunother. 49:2000;123-132.
18. Staib L., Birebent B., Somasundaram R.et al. Immunogenicity of recombinant GA733-2E antigen (CO17-1A, EGP, KS1-4, KSA, Ep-CAM) in gastro-intestinal carcinoma patients. Int. J. Cancer. 92:2001;79-87.
19. De Becker G., Moulin V., Pajak B.et al. The adjuvant monophosphoryl lipid A increases the function of antigen-presenting cells. Int. Immunol. 12:2000;807-815.
20. Moore A., McCarthy L., Mills K.H. The adjuvant combination monophosphoryl lipid A and QS21 switches T cell responses induced with a soluble recombinant HIV protein from Th2 to Th1. Vaccine. 17:1999;2517.
21. Ismaili J., Rennesson J., Aksoy E.et al. Monophosphoryl lipid A activates both human dendritic cells and T cells. J. Immunol. 168:2002;926-932.
22. Zhou F., Huang L. Monophosphoryl lipid A enhances specific CTL induction by a soluble protein antigen entrapped in liposomes. Vaccine. 11:1993;1139-1144.
23. O'Hagan D.T., MacKichan M.L., Singh M. Recent developments in adjuvants for vaccines against infectious diseases. Biomol. Eng. 18:2001;69-85.
24. Ulrich T. MPLr immunostimulant: adjuvant formulations. In: O'Hagan DT, editor. Vaccine adjuvants: preparation methods and research protocols. Totowa, NJ: Humana Press; 2000:273-82.
25. Harris D.T., Matyas G.R., Mastrangelo M.J.et al. Inducing immunity to prostate specific antigen (PSA) in prostate cancer patients. Proc. Am. Soc. Clin. Oncol. 18:1999;1693.
26. Warren T.L., Weiner G.J. Uses of granulocyte-macrophage colony-stimulating factor in vaccine development. Curr. Opin. Hematol. 7:2000;168-173.
27. Dranoff G., Jaffee E., Lazenby A.et al. 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. Sci. U.S.A. 90:1993;3539-3543.
28. Soiffer R., Lynch T., Mihm M.et al. Vaccination with irradiated autologous melanoma cells engineered to secrete human granulocyte-macrophage colony-stimulating factor generates potent antitumor immunity in patients with metastatic melanoma. Proc. Natl. Acad. Sci. U.S.A. 95:1998;13141-13146.
29. Jaffee E.M., Hruban R.H., Biedrzycki B.et al. Novel allogeneic granulocyte-macrophage colony-stimulating factor-secreting tumor vaccine for pancreatic cancer: a phase I trial of safety and immune activation. J. Clin. Oncol. 19:2001;145-156.
30. Leong S.P.L., Enders-Zohr P., Zhou Y.M.et al. Active specific immunotherapy with GM-CSF as an adjuvant to autologous melanoma (AM) vaccine in metastatic melanoma. Proc. Am. Soc. Clin. Oncol. 15:1996;437.
31. Disis M.L., Grabstein K.H., Sleath P.R., Cheever M.A. Generation of immunity to the HER-2/neu oncogenic protein in patients with breast and ovarian cancer using a peptide-based vaccine. Clin. Cancer Res. 5:1999;1289-1297.
32. Bendandi M., Gocke C.D., Kobrin C.B.et al. Complete molecular remissions induced by patient specific vaccination plus granulocyte-macrophage colony-stimulating factor against lymphomas. Nat. Med. 5:1999;1171-1177.
33. Marshall J.L., Hoyer R.J., Toomey M.A.et al. Phase I study in advanced cancer patients of a diversified prime-and-boost vaccination protocol using recombinant vaccinia virus and recombinant nonreplicating avipox virus to elicit anti-carcinoembryonic antigen immune responses. J. Clin. Oncol. 18:2000;3964-3973.
34. Ragnhammar P., Fagerberg J., Frodin J.E., Wersall P., Hansson L.O., Mellstedt H. Granulocyte/macrophage-colony-stimulating factor augments the induction of antibodies, especially anti-idiotypic antibodies, to therapeutic monoclonal antibodies. Cancer Immunol. Immunother. 40:1995;367-375.
35. Meidenbauer N., Harris D.T., Spitler L.E., Whiteside T.L. Generation of PSA-reactive effector cells after vaccination with a PSA-based vaccine in patients with prostate cancer. Prostate. 43:2000;88-100.
36. Conry R.M., Curiel D.T., Strong T.V.et al. Safety and immunogenicity of a DNA vaccine encoding carcinoembryonic antigen and hepatitis B surface antigen in colorectal carcinoma patients. Clin. Cancer Res. 8:2002;2782-2787.
37. Grun J.L., Maurer P.H. Different T helper cell subsets elicited in mice utilizing two different adjuvant vehicles: the role of endogenous interleukin 1 in proliferative responses. Cell Immunol. 121:1989;134-145.
38. Allison A.C., Gregoriadis G. Liposomes as immunological adjuvants. Nature. 252:1974;252.
39. Allison A.C., Byars N. Vaccine technology: adjuvants for increased efficacy. Biotechnology. 5:1987;1043-1045.
40. Alving C.R. Liposomes as carriers of antigens and adjuvants. J. Immunol. Methods. 140:1991;1-13.
41. Gupta R.K., Siber G.R. Adjuvants for human vaccines - current status. Vaccine. 13:1995;1263-1276.
42. Muderhwa J.M., Matyas G.R., Spitler L.E., Alving C.R. Oil-in-water liposomal emulsions: characterization and potential use in vaccine delivery. J. Pharm. Sci. 88:1999;1332-1339.
43. Ismaili J., Rennesson J., Aksoy E.et al. Monophosphoryl lipid A activates both human dendritic cells and T cells. J. Immunol. 168:2002;926-932.
44. Daro E., Pulendran B., Brasel K.et al. Polyethylene glycol-modified GM-CSF expands CD11b(high)CD11c(high) but not CD11b(low)CD11c(high) murine dendritic cells in vivo: a comparative analysis with Flt3 ligand. J. Immunol. 165:2000;49-58.
45. Samanci A., Yi Q., Fagerberg J.et al. Pharmacological administration of granulocyte/macrophage-colony-stimulating factor is of significant importance for the induction of a strong humoral and cellular response in patients immunized with recombinant carcinoembryonic antigen. Cancer Immunol. Immunother. 47:1998;131-142.
46. Simmons S.J., Tjoa B.A., Rogers M.et al. GM-CSF as a systemic adjuvant in a phase II prostate cancer vaccine trial. Prostate. 39:1999;291-297.
47. von Mehren M., Arlen P., Gulley J.et al. The influence of granulocyte-macrophage colony-stimulating factor and prior chemotherapy on the immunological response to a vaccine (ALVAC-CEA B7.1) in patients with metastatic carcinoma. Clin. Cancer Res. 7:2000;1181-1191.
48. Liebrich W., Schlag P., Manasterski M.et al. In vitro and clinical characterization of a Newcastle disease virus-modified autologous tumor cell vaccine for treatment of colorectal cancer patients. Eur. J. Cancer. 27:1991;703-710.
49. Hoover H.C. Jr., Brandhorst J.S., Peters L.C.et al. Adjuvant active specific immunotherapy for human colorectal cancer: 6.5 year median follow-up of a phase III prospectively randomized trial. J. Clin. Oncol. 11:1993;390-399.
50. Berinstein N.L. Carcinoembryonic antigen as a target for therapeutic anticancer vaccines: a review. J. Clin. Oncol. 20:2002;2197-2207.
51. Zbar A.P., Lemoine N.R., Wadhwa M., Thomas H., Snary D., Kmiot W.A. Biological therapy: approaches in colorectal cancer. Strategies to enhance carcinoembryonic antigen (CEA) as an immunogenic target. Br. J. Cancer. 77:1998;683-693.
52. MacLean G.D., Reddish M.A., Koganty R.R., Longenecker B.M. Antibodies against mucin-associated sialyl-Tn epitopes correlate with survival of metastatic adenocarcinoma patients undergoing active specific immunotherapy with synthetic STn vaccine. J. Immunother. Emphasis Tumor Immunol. 19:1996;59-68.