Phase i study of anti-CD3 x anti-her2 Bispecific antibody in metastatic castrate resistant prostate cancer patients

Prostate Cancer

Volumn 2015, Issue , 2015, Pages

  Vaishampayan, Ulka ^a,b   Thakur, Archana ^a   Rathore, Ritesh ^c   Kouttab, Nicola ^c   Lum, Lawrence G ^a,b  

^a WAYNE STATE UNIVERSITY   (United States)

^b WAYNE STATE UNIVERSITY SCHOOL OF MEDICINE   (United States)

^c ROGER WILLIAMS MEDICAL CENTER   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

DOCETAXEL; ESTRAMUSTINE; ESTROGEN; GAMMA INTERFERON; GONADORELIN DERIVATIVE; GRANULOCYTE MACROPHAGE COLONY STIMULATING FACTOR; INTERLEUKIN 2; INTERLEUKIN 4; INTERLEUKIN 5; KETOCONAZOLE; MITOXANTRONE; OKT 3; PROSTATE SPECIFIC ANTIGEN; STEROID; TRASTUZUMAB;

AGED; ARTICLE; BONE METASTASIS; CANCER IMMUNOTHERAPY; CASTRATION RESISTANT PROSTATE CANCER; CHILL; CLINICAL ARTICLE; COHORT ANALYSIS; CYTOKINE PRODUCTION; DRUG DOSE ESCALATION; DRUG SAFETY; ENZYME LINKED IMMUNOSPOT ASSAY; HUMAN; HUMAN CELL; INFUSION; LIVER METASTASIS; LOW DRUG DOSE; LUNG METASTASIS; LYMPH NODE METASTASIS; MALAISE; MALE; OVERALL SURVIVAL; PERIPHERAL BLOOD MONONUCLEAR CELL; PHASE 1 CLINICAL TRIAL; PILOT STUDY; PRIORITY JOURNAL; SIDE EFFECT; T LYMPHOCYTE ACTIVATION; TH1 CELL; TH2 CELL; TREATMENT DURATION; VERY ELDERLY;

EID: 84931847694     PISSN: 20903111     EISSN: 2090312X     Source Type: Journal    
DOI: 10.1155/2015/285193     Document Type: Article

References (76)

1. E. J. Small, P. F. Schellhammer, C. S. Higano et al., "Placebo-controlled phase III trial of immunologic therapy with Sipuleucel-T (APC8015) in patients with metastatic, asymptomatic hormone refractory prostate cancer," Journal of Clinical Oncology, Vol. 24, no. 19, pp. 3089-3094, 2006.
2. Y. Nishio, Y. Yamada, H. Kokubo et al., "Prognostic significance of immunohistochemical expression of the HER-2/neu oncoprotein in bone metastatic prostate cancer," Urology, Vol. 68, no. 1, pp. 110-115, 2006.
3. C. Ricciardelli, M. W. Jackson, C. S. Choong et al., "Elevated levels of HER-2/neu and androgen receptor in clinically localized prostate cancer identifies metastatic potential," Prostate, Vol. 68, no. 8, pp. 830-838, 2008.
4. T. Okegawa, M. Kinjo, K. Nutahara, and E. Higashihara, "Pretreatment serum level of HER2/nue as a prognostic factor in metastatic prostate cancer patients about to undergo endocrine therapy," International Journal of Urology, Vol. 13, no. 9, pp. 1197-1201, 2006.
5. S. Signoretti, R. Montironi, J. Manola et al., "Her-2-neu expression and progression toward androgen independence in human prostate cancer," Journal of the National Cancer Institute, Vol. 92, no. 23, pp. 1918-1925, 2000.
6. I. A. Osman, H. Scher, M. Drobnjak, M. Fazzari, and C. Cordon-Cardo, "HER-2/neu membrane overexpression in prostate cancer," Proceedings of the American Association for Cancer Research, Vol. 41, Article ID 4572a, 2000.
7. N. Craft, Y. Shostak, M. Carey, and C. L. Sawyers, "A mechanism for hormone-independent prostate cancer through modulation of androgen receptor signaling by the HER-2/neu tyrosine kinase," Nature Medicine, Vol. 5, no. 3, pp. 280-285, 1999.
8. P. N. Lara Jr., K. G. Chee, J. Longmate et al., "Trastuzumab plus docetaxel in HER-2/neu-positive prostate carcinoma: final results from the California Cancer Consortium Screening and Phase II Trial," Cancer, Vol. 100, no. 10, pp. 2125-2131, 2004.
9. M. J. Morris, V. E. Reuter, W. K. Kelly et al., "HER-2 profiling and targeting in prostate carcinoma," Cancer, Vol. 94, no. 4, pp. 980-986, 2002.
10. A. C. Ochoa, G. Gromo, B. J. Alter, P. M. Sondel, and F. H. Bach, "Long-term growth of lymphokine-activated killer (LAK) cells: role of anti-CD3, beta-IL 1, interferon-gamma and -beta," The Journal of Immunology, Vol. 138, no. 8, pp. 2728-2733, 1987.
11. P. M. Anderson, F. H. Bach, and A. C. Ochoa, "Augmentation of cell number and LAK activity in peripheral blood mononuclear cells activated with anti-CD3 and interleukin-2-preliminary results in children with acute lymphocytic leukemia and neuroblastoma," Cancer Immunology Immunotherapy, Vol. 27, no. 1, pp. 82-88, 1988.
12. B. P. Chen, M. Malkovsky, J. A. Hank, and P. M. Sondel, "Nonre-stricted cytotoxicity mediated by interleukin 2-expanded leukocytes is inhibited by anti-LFA-1 monoclonal antibodies (MoAb) but potentiated by anti-CD3 MoAb," Cellular Immunology, Vol. 110, no. 2, pp. 282-293, 1987.
13. E. Lotzova, C. A. Savary, R. B. Herberman, K. B. McCredie, M. J. Keating, and E. J. Freireich, "Augmentation of antileukemia lytic activity by OKT3 monoclonal antibody: synergism of OKT3 and interleukin-2," Natural Immunity and Cell Growth Regulation, Vol. 6, no. 5, pp. 219-223, 1987.
14. S. C. Yang, K. D. Fry, E. A. Grimm, and J. A. Roth, "Successful combination immunotherapy for the generation in vivo of antitumor activity with anti-CD3, interleukin 2, and tumor necrosis factor α," Archives of Surgery, Vol. 125, no. 2, pp. 220-225, 1990.
15. M. Ueda, I. D. Joshi, M. dan et al., "Preclinical studies for adoptive immunotherapy in bone marrow transplantation: generation of anti-CD3 activated cytotoxic T cells from normal donors and autologous bone marrow transplant candidates," Transplantation, Vol. 56, no. 2, pp. 351-356, 1993.
16. J. P. Uberti, I. Joshi, M. Ueda, F. Martilotti, L. L. Sensenbrenner, and L. G. Lum, "Preclinical studies using immobilized OKT3 to activate human T cells for adoptive immunotherapy: optimal conditions for the proliferation and induction of non-MHC-restricted cytotoxicity," Clinical Immunology and Immunopathology, Vol. 70, no. 3, pp. 234-240, 1994.
17. P. M. Anderson, B. R. Blazar, F. H. Bach, and A. C. Ochoa, "Anti-CD3 + IL-2-stimulated murine killer cells. In vitro generation and in vivo antitumor activity," The Journal of Immunology, Vol. 142, no. 4, pp. 1383-1394, 1989.
18. + interleukin-2 stimulation of marrow and blood: comparison of proliferation and cytotoxicity," Blood, Vol. 80, no. 7, pp. 1846-1853, 1992.
19. C.-C. Ting, M. E. Hargrove, and Y. S. Yun, "Augmentation by anti-T3 antibody of the lymphokine-activated killer cellmediated cytotoxicity," Journal of Immunology, Vol. 141, no. 3, pp. 741-748, 1988.
20. A. C. Ochoa, D. E. Hasz, R. Rezonzew, P. M. Anderson, and F. H. Bach, "Lymphokine-activated killer activity in long-term cultures with anti-CD3 plus interleukin 2: identification and isolation of effector subsets," Cancer Research, Vol. 49, no. 4, pp. 963-968, 1989.
21. H. E. Lum, M. Miller, D. Van Epps, and L. G. Lum, Targeting Prostate Cancer Cells with T Cells Armed with Two Novel Bispecific Antibodies (OKT3 x 9187 and OKT3 x 9189), 29th edition, 2001.
22. L. G. Lum, R. Rathore, and H. E. Lum, Targeting of Prostate Cancer with T Cells Armed with OKT3 x Anti-HER2/New Bispecific Monoclonal Antibodies(Biabs), 29 edition, 2001.
23. P. A. Davol and L. G. Lum, "How important is HER2/neu amplification and expression when selecting patients for HER2/neutargeted therapies?" Clinical Breast Cancer, Vol. 5, no. 1, pp. 70-71, 2004.
24. + tumors," Journal of Hematotherapy & Stem Cell Research, Vol. 10, no. 2, pp. 247-260, 2001.
25. A. Thakur, D. Schalk, S. H. Sarkar, Z. Al-Khadimi, F. H. Sarkar, and L. G. Lum, "A Th1 cytokine-enriched microenvironment enhances tumor killing by activated T cells armed with bispecific antibodies and inhibits the development of myeloid-derived suppressor cells," Cancer Immunology, Immunotherapy, Vol. 61, no. 4, pp. 497-509, 2012.
26. A. Thakur, O. Norkina, and L. G. Lum, "In vitro synthesis of primary specific anti-breast cancer antibodies by normal human peripheral blood mononuclear cells," Cancer Immunology, Immunotherapy, Vol. 60, no. 12, pp. 1707-1720, 2011.
27. A. Thakur, P. Littrup, E. N. Paul, B. Adam, L. K. Heilbrun, and L. G. Lum, "Induction of specific cellular and humoral responses against renal cell carcinoma after combination therapy with cryoablation and granulocyte-macrophage colony stimulating factor: a pilot study," Journal of Immunotherapy, Vol. 34, no. 5, pp. 457-467, 2011.
28. A. Thakur, D. Schalk, S. H. Sarkar, Z. Al-Khadimi, F. H. Sarkar, and L. G. Lum, "A Th1 cytokine-enriched microenvironment enhances tumor killing by activated T cells armed with bispecific antibodies and inhibits the development of myeloid-derived suppressor cells," Cancer Immunology, Immunotherapy, Vol. 61, no. 4, pp. 497-509, 2012.
29. 2 dependent pathway," Journal of Translational Medicine, Vol. 11, no. 1, article 35, 2013.
30. R. C. Grabert, L. P. Cousens, J. A. Smith et al., "Human T cells armed with Her2/neu bispecific antibodies divide, are cytotoxic, and secrete cytokines with repeated stimulation," Clinical Cancer Research, Vol. 12, no. 2, pp. 569-576, 2006.
31. E. J. Small, N. Sacks, J. Nemunaitis et al., "Granulocyte macrophage colony-stimulating factor-secreting allogeneic cellular immunotherapy for hormone-refractory prostate cancer," Clinical Cancer Research, Vol. 13, no. 13, pp. 3883-3891, 2007
32. P. W. Kantoff, T. J. Schuetz, B. A. Blumenstein et al, "Overall survival analysis of a phase II randomized controlled trial of a poxviral-based PSA-targeted immunotherapy in metastatic castration-resistant prostate cancer," Journal of Clinical Oncology, Vol. 28, no. 7, pp. 1099-1105, 2010.
33. M. S. Hayden, P. S. Linsley, M. A. Gayle et al., "Single-chain mono- and bispecific antibody derivatives with novel biological properties and antitumour activity from a COS cell transient expression system," Therapeutic Immunology, Vol. 1, no. 1, pp. 3-15, 1994.
34. M. R. Shalaby, H. M. Shepard, L. Presta et al., "Development of humanized bispecific antibodies reactive with cytotoxic lymphocytes and tumor cells overexpressing the HER2 protooncogene," Journal of Experimental Medicine, Vol. 175, no. 1, pp. 217-225, 1992.
35. HER2 overexpressing tumor cells," International Journal of Cancer, Vol. 62, no. 3, pp. 319-324, 1995.
36. M. Kuwahara, M. Kuroki, F. Arakawa et al., "A mouse/humanchimeric bispecific antibody reactive with human carcinoembryonic antigen-expressing cells and human T-lymphocytes," Anticancer Research, Vol. 16, no. 5, pp. 2661-2667, 1996.
37. + helper/killer T cells for the application to adoptive tumour immunotherapy," British Journal of Cancer, Vol. 66, no. 1, pp. 20-26, 1992.
38. N. D. James, P. J. Atherton, J. Jones, A. J. Howie, S. Tchekmedyian, and R. T. Curnow, "A phase II study of the bispecific antibody MDX-H210 (anti-HER2 x CD64) with GM-CSF in HER2+ advanced prostate cancer," British Journal of Cancer, Vol. 85, no. 2, pp. 152-156, 2001.
39. E. J. Small, P. F. Schellhammer, C. S. Higano et al., "Placebo-controlled phase III trial of immunologic therapy with Sipuleucel-T (APC8015) in patients with metastatic, asymptomatic hormone refractory prostate cancer," Journal of Clinical Oncology, Vol. 24, no. 19, pp. 3089-3094, 2006.
40. Y. Nishio, Y. Yamada, H. Kokubo et al., "Prognostic significance of immunohistochemical expression of the HER-2/neu oncoprotein in bone metastatic prostate cancer," Urology, Vol. 68, no. 1, pp. 110-115, 2006.
41. C. Ricciardelli, M. W. Jackson, C. S. Choong et al., "Elevated levels of HER-2/neu and androgen receptor in clinically localized prostate cancer identifies metastatic potential," Prostate, Vol. 68, no. 8, pp. 830-838, 2008.
42. T. Okegawa, M. Kinjo, K. Nutahara, and E. Higashihara, "Pretreatment serum level of HER2/nue as a prognostic factor in metastatic prostate cancer patients about to undergo endocrine therapy," International Journal of Urology, Vol. 13, no. 9, pp. 1197-1201, 2006.
43. S. Signoretti, R. Montironi, J. Manola et al., "Her-2-neu expression and progression toward androgen independence in human prostate cancer," Journal of the National Cancer Institute, Vol. 92, no. 23, pp. 1918-1925, 2000.
44. I. A. Osman, H. Scher, M. Drobnjak, M. Fazzari, and C. Cordon-Cardo, "HER-2/neu membrane overexpression in prostate cancer," Proceedings of the American Association for Cancer Research, Vol. 41, Article ID 4572a, 2000.
45. N. Craft, Y. Shostak, M. Carey, and C. L. Sawyers, "A mechanism for hormone-independent prostate cancer through modulation of androgen receptor signaling by the HER-2/neu tyrosine kinase," Nature Medicine, Vol. 5, no. 3, pp. 280-285, 1999.
46. P. N. Lara Jr., K. G. Chee, J. Longmate et al., "Trastuzumab plus docetaxel in HER-2/neu-positive prostate carcinoma: final results from the California Cancer Consortium Screening and Phase II Trial," Cancer, Vol. 100, no. 10, pp. 2125-2131, 2004.
47. M. J. Morris, V. E. Reuter, W. K. Kelly et al., "HER-2 profiling and targeting in prostate carcinoma," Cancer, Vol. 94, no. 4, pp. 980-986, 2002.
48. A. C. Ochoa, G. Gromo, B. J. Alter, P. M. Sondel, and F. H. Bach, "Long-term growth of lymphokine-activated killer (LAK) cells: role of anti-CD3, beta-IL 1, interferon-gamma and -beta," The Journal of Immunology, Vol. 138, no. 8, pp. 2728-2733, 1987.
49. P. M. Anderson, F. H. Bach, and A. C. Ochoa, "Augmentation of cell number and LAK activity in peripheral blood mononuclear cells activated with anti-CD3 and interleukin-2-preliminary results in children with acute lymphocytic leukemia and neuroblastoma," Cancer Immunology Immunotherapy, Vol. 27, no. 1, pp. 82-88, 1988.
50. B. P. Chen, M. Malkovsky, J. A. Hank, and P. M. Sondel, "Nonre-stricted cytotoxicity mediated by interleukin 2-expanded leukocytes is inhibited by anti-LFA-1 monoclonal antibodies (MoAb) but potentiated by anti-CD3 MoAb," Cellular Immunology, Vol. 110, no. 2, pp. 282-293, 1987.
51. E. Lotzova, C. A. Savary, R. B. Herberman, K. B. McCredie, M. J. Keating, and E. J. Freireich, "Augmentation of antileukemia lytic activity by OKT3 monoclonal antibody: synergism of OKT3 and interleukin-2," Natural Immunity and Cell Growth Regulation, Vol. 6, no. 5, pp. 219-223, 1987.
52. S. C. Yang, K. D. Fry, E. A. Grimm, and J. A. Roth, "Successful combination immunotherapy for the generation in vivo of antitumor activity with anti-CD3, interleukin 2, and tumor necrosis factor α," Archives of Surgery, Vol. 125, no. 2, pp. 220-225, 1990.
53. M. Ueda, I. D. Joshi, M. dan et al., "Preclinical studies for adoptive immunotherapy in bone marrow transplantation: generation of anti-CD3 activated cytotoxic T cells from normal donors and autologous bone marrow transplant candidates," Transplantation, Vol. 56, no. 2, pp. 351-356, 1993.
54. J. P. Uberti, I. Joshi, M. Ueda, F. Martilotti, L. L. Sensenbrenner, and L. G. Lum, "Preclinical studies using immobilized OKT3 to activate human T cells for adoptive immunotherapy: optimal conditions for the proliferation and induction of non-MHC-restricted cytotoxicity," Clinical Immunology and Immunopathology, Vol. 70, no. 3, pp. 234-240, 1994.
55. P. M. Anderson, B. R. Blazar, F. H. Bach, and A. C. Ochoa, "Anti-CD3 + IL-2-stimulated murine killer cells. In vitro generation and in vivo antitumor activity," The Journal of Immunology, Vol. 142, no. 4, pp. 1383-1394, 1989.
56. + interleukin-2 stimulation of marrow and blood: comparison of proliferation and cytotoxicity," Blood, Vol. 80, no. 7, pp. 1846-1853, 1992.
57. C.-C. Ting, M. E. Hargrove, and Y. S. Yun, "Augmentation by anti-T3 antibody of the lymphokine-activated killer cellmediated cytotoxicity," Journal of Immunology, Vol. 141, no. 3, pp. 741-748, 1988.
58. A. C. Ochoa, D. E. Hasz, R. Rezonzew, P. M. Anderson, and F. H. Bach, "Lymphokine-activated killer activity in long-term cultures with anti-CD3 plus interleukin 2: identification and isolation of effector subsets," Cancer Research, Vol. 49, no. 4, pp. 963-968, 1989.
59. H. E. Lum, M. Miller, D. Van Epps, and L. G. Lum, Targeting Prostate Cancer Cells with T Cells Armed with Two Novel Bispecific Antibodies (OKT3 x 9187 and OKT3 x 9189), 29th edition, 2001.
60. L. G. Lum, R. Rathore, and H. E. Lum, Targeting of Prostate Cancer with T Cells Armed with OKT3 x Anti-HER2/New Bispecific Monoclonal Antibodies(Biabs), 29 edition, 2001.
61. P. A. Davol and L. G. Lum, "How important is HER2/neu amplification and expression when selecting patients for HER2/neutargeted therapies?" Clinical Breast Cancer, Vol. 5, no. 1, pp. 70-71, 2004.
62. + tumors," Journal of Hematotherapy & Stem Cell Research, Vol. 10, no. 2, pp. 247-260, 2001.
63. A. Thakur, D. Schalk, S. H. Sarkar, Z. Al-Khadimi, F. H. Sarkar, and L. G. Lum, "A Th1 cytokine-enriched microenvironment enhances tumor killing by activated T cells armed with bispecific antibodies and inhibits the development of myeloid-derived suppressor cells," Cancer Immunology, Immunotherapy, Vol. 61, no. 4, pp. 497-509, 2012.
64. A. Thakur, O. Norkina, and L. G. Lum, "In vitro synthesis of primary specific anti-breast cancer antibodies by normal human peripheral blood mononuclear cells," Cancer Immunology, Immunotherapy, Vol. 60, no. 12, pp. 1707-1720, 2011.
65. A. Thakur, P. Littrup, E. N. Paul, B. Adam, L. K. Heilbrun, and L. G. Lum, "Induction of specific cellular and humoral responses against renal cell carcinoma after combination therapy with cryoablation and granulocyte-macrophage colony stimulating factor: a pilot study," Journal of Immunotherapy, Vol. 34, no. 5, pp. 457-467, 2011.
66. A. Thakur, D. Schalk, S. H. Sarkar, Z. Al-Khadimi, F. H. Sarkar, and L. G. Lum, "A Th1 cytokine-enriched microenvironment enhances tumor killing by activated T cells armed with bispecific antibodies and inhibits the development of myeloid-derived suppressor cells," Cancer Immunology, Immunotherapy, Vol. 61, no. 4, pp. 497-509, 2012.
67. 2 dependent pathway," Journal of Translational Medicine, Vol. 11, no. 1, article 35, 2013.
68. R. C. Grabert, L. P. Cousens, J. A. Smith et al., "Human T cells armed with Her2/neu bispecific antibodies divide, are cytotoxic, and secrete cytokines with repeated stimulation," Clinical Cancer Research, Vol. 12, no. 2, pp. 569-576, 2006.
69. E. J. Small, N. Sacks, J. Nemunaitis et al., "Granulocyte macrophage colony-stimulating factor-secreting allogeneic cellular immunotherapy for hormone-refractory prostate cancer," Clinical Cancer Research, Vol. 13, no. 13, pp. 3883-3891, 2007
70. P. W. Kantoff, T. J. Schuetz, B. A. Blumenstein et al, "Overall survival analysis of a phase II randomized controlled trial of a poxviral-based PSA-targeted immunotherapy in metastatic castration-resistant prostate cancer," Journal of Clinical Oncology, Vol. 28, no. 7, pp. 1099-1105, 2010.
71. M. S. Hayden, P. S. Linsley, M. A. Gayle et al., "Single-chain mono- and bispecific antibody derivatives with novel biological properties and antitumour activity from a COS cell transient expression system," Therapeutic Immunology, Vol. 1, no. 1, pp. 3-15, 1994.
72. M. R. Shalaby, H. M. Shepard, L. Presta et al., "Development of humanized bispecific antibodies reactive with cytotoxic lymphocytes and tumor cells overexpressing the HER2 protooncogene," Journal of Experimental Medicine, Vol. 175, no. 1, pp. 217-225, 1992.
73. HER2 overexpressing tumor cells," International Journal of Cancer, Vol. 62, no. 3, pp. 319-324, 1995.
74. M. Kuwahara, M. Kuroki, F. Arakawa et al., "A mouse/humanchimeric bispecific antibody reactive with human carcinoembryonic antigen-expressing cells and human T-lymphocytes," Anticancer Research, Vol. 16, no. 5, pp. 2661-2667, 1996.
75. + helper/killer T cells for the application to adoptive tumour immunotherapy," British Journal of Cancer, Vol. 66, no. 1, pp. 20-26, 1992.
76. N. D. James, P. J. Atherton, J. Jones, A. J. Howie, S. Tchekmedyian, and R. T. Curnow, "A phase II study of the bispecific antibody MDX-H210 (anti-HER2 x CD64) with GM-CSF in HER2+ advanced prostate cancer," British Journal of Cancer, Vol. 85, no. 2, pp. 152-156, 2001.