A phase I trial of SD-9427 (progenipoietin) with a multipeptide vaccine for resected metastatic melanoma

Clinical Cancer Research

Volumn 9, Issue 4, 2003, Pages 1301-1312

  Pullarkat, Vinod ^a   Lee, Peter P ^b   Scotland, Ronaldo ^a   Rubio, Valerie ^b   Groshen, Susan ^a   Gee, Conway ^a   Lau, Roy ^a   Snively, Jolie ^a   Sian, Shirley ^a   Woulfe, Susan L ^c   Wolfe, Richard A ^c   Weber, Jeffrey S ^a,d  

^a UNIVERSITY OF SOUTHERN CALIFORNIA   (United States)

^b STANFORD UNIVERSITY SCHOOL OF MEDICINE   (United States)

^c PFIZER INC   (United States)

^d UNIVERSITY OF SOUTHERN CALIFORNIA   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

CHIMERIC PROTEIN; EPITOPE; FLT3 LIGAND; FREUND ADJUVANT; GAMMA INTERFERON; GLYCOPROTEIN GP 100; GRANULOCYTE COLONY STIMULATING FACTOR; MELAN A; MONOPHENOL MONOOXYGENASE; PROGENIPOIETIN; SD 9427; UNCLASSIFIED DRUG;

ADULT; AGED; ARTICLE; CLINICAL ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CYTOKINE RELEASE; CYTOTOXIC T LYMPHOCYTE; DRUG TOLERABILITY; FATIGUE; FEMALE; GRANULOMA; HUMAN; IMMUNE RESPONSE; IMMUNIZATION; INJECTION PAIN; LEUKAPHERESIS; LEUKOPENIA; MAJOR HISTOCOMPATIBILITY COMPLEX; MALE; MELANOMA; METASTASIS; NEUTROPENIA; PHASE 1 CLINICAL TRIAL; PRIORITY JOURNAL; RELAPSE; SKIN TEST;

ADULT; AGED; AGED, 80 AND OVER; ANTIGENS, NEOPLASM; CANCER VACCINES; COLONY-STIMULATING FACTORS; CYTOKINES; DENDRITIC CELLS; EPITOPES; FEMALE; FLOW CYTOMETRY; HUMANS; IMMUNOHISTOCHEMISTRY; LEUKAPHERESIS; MALE; MELANOMA; MEMBRANE GLYCOPROTEINS; MIDDLE AGED; MONOPHENOL MONOOXYGENASE; NEOPLASM PROTEINS; PEPTIDES; RECOMBINANT PROTEINS; TIME FACTORS; TREATMENT OUTCOME; VACCINES; VACCINES, SUBUNIT;

EID: 0037390262     PISSN: 10780432     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (33)

1. Boon, T., Coulie, P. G., and Van den Eynde, B. Tumor antigens recognized by T cells. Immunol. Today, 18: 267-268, 1997.
2. Rosenberg, S. A. Identification of cancer antigens: impact on development of cancer immunotherapies. Cancer J. Sci. Am., 6: S200-S207, 2000.
3. Darrow, T. L., Slingluff, C. L., Jr., and Seigler, H. F. The role of HLA class I antigens in recognition of melanoma cells by tumor-specific cytotoxic T lymphocytes. Evidence for shared tumor antigens. J. Immunol., 142: 3329-3335, 1989.
4. Renkvist, N., Castelli, C., Robbins, P. F., and Parmiani, G. A listing of tumor antigens recognized by T cells. Cancer Immunol. Immunother., 50: 3-15, 2001.
5. Kawakami, Y., Eliyahu, S., Jennings, C., Sakaguchi, K., Kang, X., Southwood, S., Robbins, P. F., Sette, A., Appella, E., and Rosenberg, S. A. Recognition of multiple epitopes in the human melanoma antigen gp100 by tumor-infiltrating T lymphocytes associated with in vivo tumor regression. J. Immunol., 154: 3961-3968, 1995.
6. Parkhurst, M. R., Salgaller, M. L., Southwood, S., Robbins, P. F., Sette, A., Rosenberg, S. A., and Kawakami, Y. Improved induction of melanoma-reactive CTL with peptides from the melanoma antigen gp100 modified at HLA-A*0201-binding residues. J. Immunol., 157: 2539-2548, 1996.
7. Kawakami, Y., Eliyahu, S., Sakaguchi, K., Robbins, P. F., Rivoltini, L., Yannelli, J. R., Appella, E., and Rosenberg, S. A. Identification of the immunodominant peptides of the MART-1 human melanoma antigen recognized by the majority of HLA-A2-restricted tumor infiltrating lymphocytes. J. Exp. Med., 180: 347-352, 1994.
8. Valmori, D., Fonteneau, J. F., Lizana, C. M., Gervois, N., Lienard, D., Rimoldi, D., Jongeneel, V., Jotereau, F., Cerottini, J. C., and Romero, P. Enhanced generation of specific tumor-reactive CTL in vitro by selected Melan-A/MART-1 immunodominant peptide analogues. J. Immunol., 160: 1750-1758, 1998.
9. Skipper, J. C. A., Hendrickson, R. C., Gulden, P. H., Brichard, V., Van Pel, A., Chen, Y., Shabanowitz, J., Wolfel, T., Slingluff, Jr., C. L., Boon, T., Hunt, D. F., and Engelhard, V. H. An HLA-A2-restricted tyrosinase antigen on melanoma cells results from posttranslational modification and suggests a novel pathway for processing of membrane proteins. J. Exp. Med., 183: 527-534, 1996.
10. Jager, E., Ringhoffer, M., Dienes, H. P., Arand, M., Karbach, J., Jager, D., Ilsemann, C., Hagedorn, M., Oesch, F., and Knuth, A. Granulocyte-macrophage colony simulating factor enhances immune responses to melanoma-associated peptides in vivo. Int. J. Cancer, 67: 54-62, 1996.
11. Lee, P., Wang, F., Kuniyoshi, J., Rubio, V., Stuges, T., Groshen, S., Gee, C., Lau, R., Jeffery, G., Margolin, K., Marty, V., and Weber, J. Effects of interleukin-12 on the immune response to a multi-peptide vaccine for resected metastatic melanoma. J. Clin. Oncol., 19: 3836-3847, 2001.
12. Rosenberg, S. A., Yang, J. C., Schwartzentruber, D. J., Hwu, P., Marincola, F. M., Topalian, S. L., Restifo, N. P., Sznol, M., Schwarz, S. L., Spiess, P. J., Wunderlich, J. R., Seipp, C. A., Einhorn, J. H., Rogers-Freezer, L., and White, D. E. Impact of cytokine administration on the generation of antitumor reactivity in patients with metastatic melanoma receiving a peptide vaccine. J. Immunol., 163: 1690-1695, 1999.
13. Disis, M. L., Bernhard, H., Shiota, F. M., Hand, S. L., Gralow, J. R., Huseby, E. S., Gillis, S., and Cheever, M. A. Granulocyte-macrophage colony-stimulating factor: an effective adjuvant for protein and peptide-based vaccines. Blood, 88: 202-210, 1996.
14. Samanci, A., Yi, Q., Fagerberg, J., Strigard, K., Smith, G., Ruden, U., Wahren, B., and Mellstedt, H. 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: 131-142, 1998.
15. Bendandi, M., Gocke, C. D., Kobrin, C. B., Benko, F. A., Sternas, L. A., Pennington, R., Watson, T. M., Reynolds, C. W., Gause, B. L., Duffey, P. L., Jaffe, E. S., Creekmore, S. P., Longo, D. L., and Kwak, L. W. Complete molecular remissions induced by patient-specific vaccination plus granulocyte-monocyte colony-stimulating factor against lymphoma. Nat. Med., 5: 1171-1177, 1999.
16. Pulendran, B., Banchereau, J., Burkeholder, S., Kraus, E., Guinet, E., Chalouni, C., Caron, D., Maliszewski, C., Davoust, J., Fay, J., and Palucka, K. Flt-3 ligand and granulocyte stimulating factor mobilize distinct human dendritic cell subsets in vitro. J. Immunol., 165: 566-572, 2000.
17. Fong, L., Hou, Y., Rivas, A., Benike, C., Yuen, A., Fisher, G. A., Davis, M. M., and Engleman, E. G. Altered peptide ligand vaccination with Flt3 ligand expanded dendritic cells for tumor immunotherapy. Proc. Natl. Acad. Sci. USA, 98: 8809-8814, 2001.
18. Streeter, P. R., Minster, N. I., Kahn, L. E., Hood, W. F., Vickery, L. E., Thurman, T. L., Monahan, J. B., Welphy, J. K., McKearn, J. P., and Woulfe, S. L. Progenipoetins: biological characterization of a family of dual agonists of fetal liver tyrosine kinase-3 and the granulocyte colony-stimulating factor receptor. Exp. Hematol., 29: 41-50, 2001.
19. O'Keefe, M., Hochrein, H., Vremec, D., Pooley, J., Evans, R., Woulfe, S., and Shortman, K. Effects of administration of progenipoietin 1, Flt-3 ligand, granulocyte colony-stimulating factor, and pegylated granulocyte-macrophage colony-stimulating factor on dendritic cell subsets in mice. Blood, 99: 2122-2130, 2002.
20. Ishioka, G. Y., Fikes, J., Qin, M., Gianfrani, C., Chesnut, R. W., Kahn, L. E., Streeter, P. R., Woulfe, S. L., and Sette, A. Dendritic cells generated in vivo by a chimeric hematopoetic growth factor, progenipoetin-4, demonstrate potent immunological function. Vaccine, 19: 3710-3719, 2001.
21. Altman, J. D., Moss, P. A. H., Goulder, P. J. R., Barouch, D. H., McHeyzer-Williams, M. G., Bell, J. I., McMichael, A. J., and Davis, M. M. Phenotypic analysis of antigen-specific T lymphocytes [erratum in Science (Wash. DC), 280: 1821. 1998]. Science (Wash. DC), 274: 94-96, 1996.
22. Puccetti, P., Bianchi, R., Fioretti, M., Ayroldi, E., Uyttenhove, C., Van Pel, A., Boon, T., and Grohmann, U. Use of a skin test assay to determine tumor specific CD8+ T cell reactivity. Eur. J. Immunol., 24: 1446-1452, 1994.
23. Lee, P. P., Yee, C., Savage, P. A., Fong, L., Brockstedt, D., Weber, J. S., Johnson, D. S., Swetter, S., Thompson, J., Greenberg, P. D., Roederer, M., and Davis, M. Characterization of circulating T cells specific for tumor-associated antigens in melanoma patients. Nat. Med., 5: 677-685, 1999.
24. Pass, E., Panicali, D. L., Mazzara, G., Schlom, J., and Grenier, J. W. Granulocyte macrophage-colony stimulating factor produced by recombinant avian pox virus enriches the regional lymph nodes with antigen presenting cells and acts as an immunoadjuvant. Cancer Res., 61: 206-214, 2001.
25. Haddad, D., Ramprakash, J., Sedegah, M., Charoenvit, Y., Baumgartner, R., Kumar, S., Hoffman, S. L., and Weiss, W. R. Plasmid vaccine expressing granulocyte-macrophage colony stimulating factor attracts infiltrates including immature dendritic cells into injected muscles. J. Immunol., 165: 3772-3781, 2000.
26. Ludewig, B., Barchiesi, F., Pericin, M., Zinkernagel, R. M., Hengartner, H., and Schwendener, R. A. In vivo antigen loading and activation of dendritic cells via a liposomal peptide vaccine mediates protective antiviral and antitumor immunity. Vaccine, 19: 23-32, 2001.
27. Roberts, A. W., Gunawardana, D., Rosenthal, M. A., Green, M., Basser, R. L., Davis, I. D., Olver, I., Toner, G., Uren, S., Fitzgerald, L., Chakrabarti, D., Tang, M., and Ashley, D. Phase I study of the effects of progenipoietin (SD-9427) on hematopoiesis. Blood, 98: 299a, 2001.
28. Penna, G., Sozzani, S., and Adorini, L. Selective usage of chemokine receptors by plasmacytoid dendritic cells. J. Immunol., 167: 1862-1866, 2001.
29. Cella, M., Facchetti, F., Lanzavecchia, A., and Colonna, M. Plasmacytoid dendritic cells activated by influenza virus and CD40L drive a potent Th1 polarization, Na. Immunol., 1: 305-310, 2000.
30. Bjorck, P. Isolation and characterization of plasmacytoid dendritic cells from Flt3 ligand and granulocyte-macrophage colony-stimulating factor treated mice. Blood. 98: 3520-3526, 2001.
31. Ladd, A., Farese, A. M., Redinger, C. J., Douek, D., Woulfe, S. L., and MacVittie, T. J. Radiation-induced T cell deficiencies can be abbreviated with administration of the chimeric growth factor receptor agonist progenipoeitin. Blood, 98: 296a, 2001.
32. Sloand, E. M., Kim, S., Maciejewski, J. P., Chaudhuri, A., Barrett, J., and Young, N. S. Pharmacologic doses of granulocyte colony-stimulating factor affect cytokine production by lymphocytes in vitro and in vivo. Blood, 95: 2269-2274, 2000.
33. Fleming, W. H., Mulcahy, J. M., McKearn, J. P., and Streeter, P. R. Progenipoietin-1: a multifunctional agonist of the granulocyte colony-stimulating factor receptor and fetal liver tyrosine kinase-3 is a potent mobilizer of hematopoietic stem cells. Exp. Hematol., 29: 943-951, 2001.