A live-attenuated listeria vaccine (ANZ-100) and a live-attenuated listeria vaccine expressing mesothelin (CRS-207) for advanced cancers: Phase I studies of safety and immune induction

Clinical Cancer Research

Volumn 18, Issue 3, 2012, Pages 858-868

  Le, Dung T ^a   Brockstedt, Dirk G ^d   Nir Paz, Ran ^e   Hampl, Johannes ^f   Mathur, Shruti ^f   Nemunaitis, John ^g   Sterman, Daniel H ^h   Hassan, Raffit ⁱ   Lutz, Eric ^a   Moyer, Bentley ^f   Giedlin, Martin ^f   Louis, Jana Lynn ^a   Sugar, Elizabeth A ^a,b   Pons, Alice ^a   Cox, Andrea L ^a,c   Levine, Jordana ^c   Murphy, Aimee Luck ^d   Illei, Peter ^a   Dubensky, Thomas W ^f   Eiden, Joseph E ^f   Jaffee, Elizabeth M ^a   Laheru, Daniel A ^a   more..

^a JOHNS HOPKINS UNIVERSITY   (United States)

^b JOHNS HOPKINS BLOOMBERG SCHOOL OF PUBLIC HEALTH   (United States)

^c JOHNS HOPKINS UNIVERSITY   (United States)

^d Aduro BioTech Inc   (United States)

^e HADASSAH HEBREW UNIVERSITY MEDICAL CENTER   (Israel)

^f CERUS CORPORATION   (United States)

^g Mary Crowley Cancer Center   (United States)

^h UNIVERSITY OF PENNSYLVANIA   (United States)

ⁱ NATIONAL CANCER INSTITUTE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ANZ 100; BACTERIAL VACCINE; CRS 207; GAMMA INTERFERON; GAMMA INTERFERON INDUCIBLE PROTEIN 10; INTERLEUKIN 10; INTERLEUKIN 12P70; INTERLEUKIN 1BETA; INTERLEUKIN 2; INTERLEUKIN 3; INTERLEUKIN 4; INTERLEUKIN 5; INTERLEUKIN 6; INTERLEUKIN 8; LISTERIA VACCINE; LISTERIOLYSIN O; LIVE VACCINE; LYMPHOTOXIN; MACROPHAGE INFLAMMATORY PROTEIN 1ALPHA; MACROPHAGE INFLAMMATORY PROTEIN 1BETA; MESOTHELIN; MONOCYTE CHEMOTACTIC PROTEIN 1; PARACETAMOL; TUMOR NECROSIS FACTOR ALPHA; UNCLASSIFIED DRUG;

ADAPTIVE IMMUNITY; ADULT; ADVANCED CANCER; AGED; ALANINE AMINOTRANSFERASE BLOOD LEVEL; ALKALINE PHOSPHATASE BLOOD LEVEL; ARTICLE; ASPARTATE AMINOTRANSFERASE BLOOD LEVEL; CANCER SURVIVAL; CELLULAR IMMUNITY; CHILL; CLINICAL ARTICLE; COLORECTAL CANCER; CYTOKINE RELEASE; DRUG CLEARANCE; DRUG DOSE ESCALATION; DRUG EFFICACY; DRUG FEVER; DRUG INDICATION; DRUG SAFETY; DRUG TOLERABILITY; FATIGUE; FEMALE; FLUID THERAPY; HUMAN; HYPERGLYCEMIA; HYPERTRANSAMINASEMIA; HYPOPHOSPHATEMIA; HYPOTENSION; IMMUNOGENICITY; IMMUNOSTIMULATION; INNATE IMMUNITY; LIVER METASTASIS; LUNG CANCER; LYMPHOCYTE ACTIVATION; LYMPHOCYTOPENIA; MALE; MAXIMUM TOLERATED DOSE; MELANOMA; MESOTHELIOMA; MULTICENTER STUDY; NATURAL KILLER CELL; NAUSEA; OVARY CANCER; PANCREAS CANCER; PHASE 1 CLINICAL TRIAL; PHENOTYPE; PRIORITY JOURNAL; RIGOR; SIDE EFFECT; SINGLE DRUG DOSE; SURVIVAL TIME;

EID: 84856519280     PISSN: 10780432     EISSN: 15573265     Source Type: Journal    
DOI: 10.1158/1078-0432.CCR-11-2121     Document Type: Article

References (31)

1. Slifka MK, Shen H, Matloubian M, Jensen ER, Miller JF, Ahmed R. Antiviral cytotoxic T-cell memory by vaccination with recombinant Listeria monocytogenes. J Virol 1996;70:2902-10. (Pubitemid 26121903)
2. Shen H, Slifka MK, Matloubian M, Jensen ER, Ahmed R, Miller JF. Recombinant Listeria monocytogenes as a live vaccine vehicle for the induction of protective anti-viral cell-mediated immunity. Proc Natl Acad Sci U S A 1995;92:3987-91.
3. Portnoy DA, Auerbuch V, Glomski IJ. The cell biology of Listeria monocytogenes infection: the intersection of bacterial pathogenesis and cell-mediated immunity. J Cell Biol 2002;158:409-14. (Pubitemid 34851698)
4. Bahjat KS, Liu W, Lemmens EE, Schoenberger SP, Portnoy DA, Dubensky TW Jr, et al. Cytosolic entry controls CD8+-T-cell potency during bacterial infection. Infect Immun 2006;74:6387-97. (Pubitemid 44657421)
5. Brockstedt DG, Giedlin MA, Leong ML, Bahjat KS, Gao Y, Luckett W, et al. Listeria-based cancer vaccines that segregate immunogenicity from toxicity. Proc Natl Acad Sci U S A 2004;101:13832-7. (Pubitemid 39298493)
6. Bahjat KS, Prell RA, Allen HE, Liu W, Lemmens EE, Leong ML, et al. Activation of immature hepatic NK cells as immunotherapy for liver metastatic disease. J Immunol 2007;179:7376-84.
7. Yoshimura K, Laird LS, Chia CY, Meckel KF, Slansky JE, Thompson JM, et al. Live attenuated Listeria monocytogenes effectively treats hepatic colorectal cancer metastases and is strongly enhanced by depletion of regulatory T cells. Cancer Res 2007;67:10058-66. (Pubitemid 47621257)
8. Hassan R, Bera T, Pastan I. Mesothelin: a new target for immunotherapy. Clin Cancer Res 2004;10:3937-42. (Pubitemid 38812466)
9. Hassan R, Kreitman RJ, Pastan I, Willingham MC. Localization of mesothelin in epithelial ovarian cancer. Appl Immunohistochem Mol Morphol 2005;13:243-7. (Pubitemid 41209017)
10. Hassan R, Laszik ZG, Lerner M, Raffeld M, Postier R, Brackett D. Mesothelin is overexpressed in pancreaticobiliary adenocarcinomas but not in normal pancreas and chronic pancreatitis. Am J Clin Pathol 2005;124:838-45. (Pubitemid 41740183)
11. Ho M, Bera TK, Willingham MC, Onda M, Hassan R, FitzGerald D, et al. Mesothelin expression in human lung cancer. Clin Cancer Res 2007;13:1571-5. (Pubitemid 46450449)
12. Yen MJ, Hsu CY, Mao TL, Wu TC, Roden R, Wang TL, et al. Diffuse mesothelin expression correlates with prolonged patient survival in ovarian serous carcinoma. Clin Cancer Res 2006;12:827-31. (Pubitemid 43259864)
13. Argani P I-DC, Ryu B. Mesothelin is overexpressed in the vast majority of ductal adenocarcinomas of the pancreas: identification of a new pancreatic cancer marker by serial analysis of gene expression (SAGE). Clin Cancer Res 2001;7:3862-8. (Pubitemid 34044602)
14. Chang K, Pastan I. Molecular cloning of mesothelin, a differentiation antigen present on mesothelium, mesotheliomas, and ovarian cancers. Proc Natl Acad Sci U S A 1996;93:136-40. (Pubitemid 26041483)
15. Ordonez NG. Application of mesothelin immunostaining in tumor diagnosis. Am J Surg Pathol 2003;27:1418-28. (Pubitemid 37315193)
16. Miettinen M, Sarlomo-Rikala M. Expression of calretinin, thrombomodulin, keratin 5, and mesothelin in lung carcinomas of different types: an immunohistochemical analysis of 596 tumors in comparison with epithelioid mesotheliomas of the pleura. Am J Surg Pathol 2003;27: 150-8. (Pubitemid 36152223)
17. Jaffee EM, Hruban RH, Biedrzycki B, Laheru D, Schepers K, Sauter PR, 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 2001;19:145-56. (Pubitemid 32063491)
18. Thomas AM, Santarsiero LM, Lutz ER, Armstrong TD, Chen YC, Huang LQ, et al. Mesothelin-specific CD8(+) T cell responses provide evidence of in vivo cross-priming by antigen-presenting cells in vaccinated pancreatic cancer patients. J Exp Med 2004;200: 297-306. (Pubitemid 39031249)
19. Laheru D, Lutz E, Burke J, Biedrzycki B, Solt S, Onners B, et al. Allogeneic granulocyte macrophage colony-stimulating factor-secreting tumor immunotherapy alone or in sequence with cyclophosphamide for metastatic pancreatic cancer: a pilot study of safety, feasibility, and immune activation. Clin Cancer Res 2008;14:1455-63. (Pubitemid 351413929)
20. Lutz ER, Yeo CJ, Lillemoe KD, Biedrzycki B, Kobrin B, Herman J, et al.A lethally irradiated allogeneic granulocyte-macrophage colony stimulating factor-secreting tumor vaccine for pancreatic adenocarcinoma: a phase II trial of safety, efficacy, and immune activation. Ann Surg 2011;253:328-35.
21. Camilli A, Tilney LG, Portnoy DA. Dual roles of plcA in Listeria monocytogenes pathogenesis. Mol Microbiol 1993;8:143-57. (Pubitemid 23114830)
22. Le Tourneau C, Lee JJ, Siu LL. Dose escalation methods in phase I cancer clinical trials. J Natl Cancer Inst 2009;101:708-20.
23. O'Neill DW, Bhardwaj N. Differentiation of peripheral blood monocytes into dendritic cells. Curr Protoc Immunol 2005;Chapter 22:Unit 22F.4.
24. Ho WY, Nguyen HN, Wolfl M, Kuball J, Greenberg PD. In vitro methods for generating CD8+ T-cell clones for immunotherapy from the naive repertoire. J Immunol Methods 2006;310:40-52. (Pubitemid 43375974)
25. Maecker HT, Dunn HS, Suni MA, Khatamzas E, Pitcher CJ, Bunde T, et al. Use of overlapping peptide mixtures as antigens for cytokine flow cytometry. J Immunol Methods 2001;255:27-40.
26. Safley SA, Cluff CW, Marshall NE, Ziegler HK. Role of listeriolysin-O (LLO) in the T lymphocyte response to infection with Listeria mono-cytogenes. Identification of T cell epitopes of LLO. J Immunol 1991;146:3604-16.
27. Currier JR KE, Turk E. A panel of MHC class I restricted viral peptides for use as a quality control for vaccine trial ELISPOT assays. J Immunol Methods 2002;260:157-72. (Pubitemid 34132882)
28. Maciag PC, Radulovic S, Rothman J. The first clinical use of a live-attenuated Listeria monocytogenes vaccine: a phase I safety study of Lm-LLO-E7 in patients with advanced carcinoma of the cervix. Vaccine 2009;27:3975-83.
29. Flink HJ, Sprengers D, Hansen BE, van Zonneveld M, de Man RA, Schalm SW, et al. Flares in chronic hepatitis B patients induced by the host or the virus? Relation to treatment response during Peg-interferon {alpha}-2b therapy. Gut 2005;54:1604-9. (Pubitemid 41531780)
30. Kantoff PW, Higano CS, Shore ND, Berger ER, Small EJ, Penson DF, et al. Sipuleucel-T immunotherapy for castration-resistant prostate cancer. N Engl J Med 2010;363:411-22.
31. Hodi FS, O'Day SJ, McDermott DF, Weber RW, Sosman JA, Haanen JB, et al. Improved survival with ipilimumab in patients with metastatic melanoma. N Engl J Med 2010;363:711-23.