Phase II study of Vigil® DNA engineered immunotherapy as maintenance in advanced stage ovarian cancer

Gynecologic Oncology

Volumn 143, Issue 3, 2016, Pages 504-510

  Oh, Jonathan ^b   Barve, Minal ^a,b   Matthews, Carolyn M ^b   Koon, E Colin ^b   Heffernan, Thomas P ^e   Fine, Bruce ^b   Grosen, Elizabeth ^f   Bergman, Melanie K ^f   Fleming, Evelyn L ^g   DeMars, Leslie R ^g   West, Loyd ^g   Spitz, Daniel L ^h   Goodman, Howard ^h   Hancock, Kenneth C ^b   Wallraven, Gladice ^c   Kumar, Padmasini ^c   Bognar, Ernest ^c   Manning, Luisa ^c   Pappen, Beena O ^c   Adams, Ned ^a   Senzer, Neil ^a,c   Nemunaitis, John ^a,b,c,d   more..

^a Mary Crowley Cancer Research Centers   (United States)

^b TEXAS ONCOLOGY   (United States)

^c GRADALIS INC   (United States)

^d MEDICAL CITY DALLAS HOSPITAL   (United States)

^e North Texas Gynecologic Oncology   (United States)

^f Cancer Care Northwest   (United States)

^g DARTMOUTH HITCHCOCK MEDICAL CENTER   (United States)

^h Florida Cancer Specialists   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

CA 125 ANTIGEN; CARBOPLATIN; COMPLEMENTARY DNA; FURIN; GAMMA INTERFERON; PACLITAXEL; RECOMBINANT GRANULOCYTE MACROPHAGE COLONY STIMULATING FACTOR; SHORT HAIRPIN RNA; ANTINEOPLASTIC AGENT; CANCER VACCINE; FANG VACCINE;

ADVANCED CANCER; ARTICLE; CANCER ADJUVANT THERAPY; CANCER IMMUNOTHERAPY; CANCER RECURRENCE; CANCER STAGING; CELL THERAPY; CLINICAL ARTICLE; CROSSOVER PROCEDURE; CYTOREDUCTIVE SURGERY; DNA ENGINEERED AUTOLOGOUS WHOLE CELL THERAPY; DRUG SAFETY; ENZYME LINKED IMMUNOSPOT ASSAY; HUMAN; IMMUNE RESPONSE; LYMPHOCYTE SUBPOPULATION; OVARY CANCER; PHASE 2 CLINICAL TRIAL; PHYSICAL EXAMINATION; PRIORITY JOURNAL; RECURRENCE FREE SURVIVAL; RNA INTERFERENCE; T LYMPHOCYTE ACTIVATION; ADULT; AGED; CARCINOMA, ENDOMETRIOID; CLINICAL TRIAL; CONTROLLED STUDY; DISEASE FREE SURVIVAL; FEMALE; MIDDLE AGED; NEOADJUVANT THERAPY; NEOPLASMS, CYSTIC, MUCINOUS, AND SEROUS; OVARIAN NEOPLASMS; PATHOLOGY; RANDOMIZED CONTROLLED TRIAL; T LYMPHOCYTE; VERY ELDERLY;

ADULT; AGED; AGED, 80 AND OVER; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; CANCER VACCINES; CARBOPLATIN; CARCINOMA, ENDOMETRIOID; CROSS-OVER STUDIES; CYTOREDUCTION SURGICAL PROCEDURES; DISEASE-FREE SURVIVAL; FEMALE; HUMANS; MIDDLE AGED; NEOADJUVANT THERAPY; NEOPLASMS, CYSTIC, MUCINOUS, AND SEROUS; OVARIAN NEOPLASMS; PACLITAXEL; T-LYMPHOCYTES;

EID: 84996553234     PISSN: 00908258     EISSN: 10956859     Source Type: Journal    
DOI: 10.1016/j.ygyno.2016.09.018     Document Type: Article

References (39)

1. [1] Senzer, N., Barve, M., Kuhn, J., Melnyk, A., Beitsch, P., Lazar, M., et al. Phase I trial of “bi-shRNAi(furin)/GMCSF DNA/autologous tumor cell” vaccine (FANG) in advanced cancer. Mol. Ther. 20:3 (2012), 679–686 (Epub 2011/12/22).
2. [2] Senzer, N., Barve, M., Nemunaitis, J., Kuhn, J., Melnyk, A., Beitsch, P., et al. Long term follow up: phase I trial of “bi-shRNA furin/GMCSF DNA/Autologous Tumor Cell” immunotherapy (FANG™) in advanced cancer. Journal of Vaccines and Vaccination, 4(8), 2013, 209.
3. [3] Gadducci, A., Cosio, S., Conte, P.F., Genazzani, A.R., Consolidation and maintenance treatments for patients with advanced epithelial ovarian cancer in complete response after first-line chemotherapy: a review of the literature. Crit. Rev. Oncol. Hematol. 55:2 (2005), 153–166 (Epub 2005/05/14).
4. [4] Markman, M., Liu, P.Y., Wilczynski, S., Monk, B., Copeland, L.J., Alvarez, R.D., et al. Phase III randomized trial of 12 versus 3 months of maintenance paclitaxel in patients with advanced ovarian cancer after complete response to platinum and paclitaxel-based chemotherapy: a Southwest Oncology Group and Gynecologic Oncology Group trial. J. Clin. Oncol. 21:13 (2003), 2460–2465 (Epub 2003/06/28).
5. [5] Stuart, G.C., First-line treatment regimens and the role of consolidation therapy in advanced ovarian cancer. Gynecol. Oncol. 90:3 Pt 2 (2003), S8–15 (Epub 2003/09/18).
6. [6] Sabbatini, P., Harter, P., Scambia, G., Sehouli, J., Meier, W., Wimberger, P., et al. Abagovomab as maintenance therapy in patients with epithelial ovarian cancer: a phase III trial of the AGO OVAR, COGI, GINECO, and GEICO—the MIMOSA study. J. Clin. Oncol. 31:12 (2013), 1554–1561 (Epub 2013/03/13).
7. 2) administered to patients with advanced ovarian cancer who attained a complete response to primary platinum-paclitaxel: follow-up of a Southwest Oncology Group and Gynecologic Oncology Group phase 3 trial. Gynecol. Oncol. 114:2 (2009), 195–198 (Epub 2009/05/19).
8. [8] Burger, R.A., Brady, M.F., Bookman, M.A., Fleming, G.F., Monk, B.J., Huang, H., et al. Incorporation of bevacizumab in the primary treatment of ovarian cancer. N. Engl. J. Med. 365:26 (2011), 2473–2483 (Epub 2011/12/30).
9. [9] Perren, T.J., Swart, A.M., Pfisterer, J., Ledermann, J.A., Pujade-Lauraine, E., Kristensen, G., et al. A phase 3 trial of bevacizumab in ovarian cancer. N. Engl. J. Med. 365:26 (2011), 2484–2496 (Epub 2011/12/30).
10. [10] Mei, L., Chen, H., Wei, D.M., Fang, F., Liu, G.J., Xie, H.Y., et al. Maintenance chemotherapy for ovarian cancer. Cochrane Database Syst. Rev., 6, 2013, CD007414 (Epub 2013/07/03).
11. [11] Messori, A., Fadda, V., Maratea, D., Trippoli, S., Maintenance chemotherapy in ovarian cancer: a trial-sequential analysis. J. Cancer Ther. 4 (2013), 1242–1243.
12. [12] Lesnock, J.L., Farris, C., Krivak, T.C., Smith, K.J., Markman, M., Consolidation paclitaxel is more cost-effective than bevacizumab following upfront treatment of advanced epithelial ovarian cancer. Gynecol. Oncol. 122:3 (2011), 473–478 (Epub 2011/06/15).
13. [13] Burger, R.A., Brady, M.F., Bookman, M.A., Fleming, G.F., Monk, B.J., Huang, H., et al. Incorporation of bevacizumab in the primary treatment of ovarian cancer. N. Engl. J. Med. 365:26 (2011), 2473–2483 (Epub 2011/12/30).
14. [14] Aghajanian, C., Blank, S.V., Goff, B.A., Judson, P.L., Teneriello, M.G., Husain, A., et al. OCEANS: a randomized, double-blind, placebo-controlled phase III trial of chemotherapy with or without bevacizumab in patients with platinum-sensitive recurrent epithelial ovarian, primary peritoneal, or fallopian tube cancer. J. Clin. Oncol. 30:17 (2012), 2039–2045 (Epub 2012/04/25).
15. [15] Pujade-Lauraine, E., Hilpert, F., Weber, B., Reuss, A., Poveda, A., Kristensen, G., et al. Bevacizumab combined with chemotherapy for platinum-resistant recurrent ovarian cancer: the AURELIA open-label randomized phase III trial. J. Clin. Oncol. 32:13 (2014), 1302–1308 (Epub 2014/03/19).
16. [16] Liu, J.F., Cannistra, S.A., Emerging role for bevacizumab in combination with chemotherapy for patients with platinum-resistant ovarian cancer. J. Clin. Oncol. 32:13 (2014), 1287–1289 (Epub 2014/03/19).
17. [17] Kandalaft, L.E., Powell, D.J. Jr., Singh, N., Coukos, G., Immunotherapy for ovarian cancer: what's next?. J. Clin. Oncol. 29:7 (2011), 925–933 (Epub 2010/11/17).
18. [18] Bristow, R.E., Baldwin, R.L., Yamada, S.D., Korc, M., Karlan, B.Y., Altered expression of transforming growth factor-beta ligands and receptors in primary and recurrent ovarian carcinoma. Cancer 85:3 (1999), 658–668 (Epub 1999/03/26).
19. [19] Soares, K.C., Rucki, A.A., Kim, V., Foley, K., Solt, S., Wolfgang, C.L., et al. TGF-beta blockade depletes T regulatory cells from metastatic pancreatic tumors in a vaccine dependent manner. Oncotarget 6:40 (2015), 43005–43015 (Epub 2015/10/31).
20. [20] Karyampudi, L., Lamichhane, P., Scheid, A.D., Kalli, K.R., Shreeder, B., Krempski, J.W., et al. Accumulation of memory precursor CD8 T cells in regressing tumors following combination therapy with vaccine and anti-PD-1 antibody. Cancer Res. 74:11 (2014), 2974–2985 (Epub 2014/04/15).
21. [21] Ghisoli, M., Barve, M., Mennel, R., Lenarsky, C., Horvath, S., Wallraven, G., Three year follow up of Vigil™ immunotherapy in metastatic advanced Ewing's sarcoma. Mol. Ther., 2016 (in press).
22. [22] Markman, M., Liu, P.Y., Rothenberg, M.L., Monk, B.J., Brady, M., Alberts, D.S., Pretreatment CA-125 and risk of relapse in advanced ovarian cancer. J. Clin. Oncol. 24:9 (2006), 1454–1458 (Epub 2006/03/22).
23. [23] Jemal, A., Siegel, R., Ward, E., Hao, Y., Xu, J., Thun, M.J., Cancer statistics, 2009. CA Cancer J. Clin. 59:4 (2009), 225–249.
24. [24] Sheikh, N.A., Petrylak, D., Kantoff, P.W., Dela Rosa, C., Stewart, F.P., Kuan, L.Y., et al. Sipuleucel-T immune parameters correlate with survival: an analysis of the randomized phase 3 clinical trials in men with castration-resistant prostate cancer. Cancer Immunol. Immunother. 62:1 (2013), 137–147 (Epub 2012/08/07).
25. [25] Li, X., Ye, F., Chen, H., Lu, W., Wan, X., Xie, X., Human ovarian carcinoma cells generate CD4(+)CD25(+) regulatory T cells from peripheral CD4(+)CD25(−) T cells through secreting TGF-beta. Cancer Lett. 253:1 (2007), 144–153 (Epub 2007/03/14).
26. [26] Milne, K., Kobel, M., Kalloger, S.E., Barnes, R.O., Gao, D., Gilks, C.B., et al. Systematic analysis of immune infiltrates in high-grade serous ovarian cancer reveals CD20, FoxP3 and TIA-1 as positive prognostic factors. PLoS ONE, 4(7), 2009, e6412 (Epub 2009/07/31).
27. [27] Page, R.E., Klein-Szanto, A.J., Litwin, S., Nicolas, E., Al-Jumaily, R., Alexander, P., et al. Increased expression of the pro-protein convertase furin predicts decreased survival in ovarian cancer. Cellular Oncology: The Official Journal of the International Society for Cellular Oncology 29:4 (2007), 289–299 (Epub 2007/07/21).
28. [28] Yamaguchi, Y., Tsumura, H., Miwa, M., Inaba, K., Contrasting effects of TGF-beta 1 and TNF-alpha on the development of dendritic cells from progenitors in mouse bone marrow. Stem Cells 15:2 (1997), 144–153.
29. [29] Joshi, N.S., Cui, W., Chandele, A., Lee, H.K., Urso, D.R., Hagman, J., et al. Inflammation directs memory precursor and short-lived effector CD8(+) T cell fates via the graded expression of T-bet transcription factor. Immunity 27:2 (2007), 281–295 (Epub 2007/08/29).
30. + T-cell function during systemic chemotherapy in advanced ovarian cancer. Cancer Res. 65:15 (2005), 7000–7006 (Epub 2005/08/03).
31. [31] Hato, S.V., Khong, A., de Vries, I.J., Lesterhuis, W.J., Molecular pathways: the immunogenic effects of platinum-based chemotherapeutics. Clin. Cancer Res. 20:11 (2014), 2831–2837 (Epub 2014/06/01).
32. [32] Geissmann, F., Revy, P., Regnault, A., Lepelletier, Y., Dy, M., Brousse, N., et al. TGF-beta 1 prevents the noncognate maturation of human dendritic Langerhans cells. J. Immunol. 162:8 (1999), 4567–4575.
33. [33] Takeuchi, M., Alard, P., Streilein, J.W., TGF-beta promotes immune deviation by altering accessory signals of antigen-presenting cells. J. Immunol. 160:4 (1998), 1589–1597.
34. [34] Dranoff, G., Jaffee, E., Lazenby, A., Golumbek, P., Levitsky, H., Brose, K., 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. 90:8 (1993), 3539–3543.
35. [35] Zeng, G., Wang, X., Robbins, P.F., Rosenberg, S.A., Wang, R.F., CD4(+) T cell recognition of MHC class II-restricted epitopes from NY-ESO-1 presented by a prevalent HLA DP4 allele: association with NY-ESO-1 antibody production. Proc. Natl. Acad. Sci. U. S. A. 98:7 (2001), 3964–3969.
36. [36] Banchereau, J., Briere, F., Caux, C., Davoust, J., Lebecque, S., Liu, Y.J., et al. Immunobiology of dendritic cells. Annu. Rev. Immunol. 18 (2000), 767–811.
37. [37] Young, J.W., Inaba, K., Dendritic cells as adjuvants for class I major histocompatibility complex-restricted antitumor immunity. J. Exp. Med. 183:1 (1996), 7–11.
38. [38] Shen, Z., Reznikoff, G., Dranoff, G., Rock, K.L., Cloned dendritic cells can present exogenous antigens on both MHC class I and class II molecules. J. Immunol. 158:6 (1997), 2723–2730.
39. [39] Yamaguchi, H., Furukawa, K., Fortunato, S.R., Livingston, P.O., Lloyd, K.O., Oettgen, H.F., et al. Human monoclonal antibody with dual GM2/GD2 specificity derived from an immunized melanoma patient. Proc. Natl. Acad. Sci. U. S. A. 87:9 (1990), 3333–3337.