Phase I trial of an enhanced prostate-specific antigen-based vaccine and anti-CTLA-4 antibody in patients with metastatic androgen-independent prostate cancer

Clinical Genitourinary Cancer

Volumn 5, Issue 5, 2007, Pages 347-350

  Theoret, Marc R ^a   Arlen, Philip M ^a   Pazdur, Mary ^a   Dahut, William L ^a   Schlom, Jeffrey ^a   Gulley, James L ^a  

^a NATIONAL CANCER INSTITUTE   (United States)

Author keywords

Autoimmunity; Co stimulation; Poxvirus; T cells

Indexed keywords

B7 ANTIGEN; CANCER VACCINE; CORTICOSTEROID; EPITOPE; FOWLPOX VIRUS VECTOR; GRANULOCYTE MACROPHAGE COLONY STIMULATING FACTOR VACCINE; INTERCELLULAR ADHESION MOLECULE 1; IPILIMUMAB; LYMPHOCYTE FUNCTION ASSOCIATED ANTIGEN 3; POXVIRAL VECTOR; PROSTATE SPECIFIC ANTIGEN; TUMOR ANTIGEN; UNCLASSIFIED DRUG; VACCINIA VIRUS VECTOR; VIRUS VECTOR;

ANOREXIA; ARTHRALGIA; ARTICLE; BONE PAIN; BONE SCINTISCANNING; CANCER CHEMOTHERAPY; CANCER GENE THERAPY; CANCER GROWTH; CANCER IMMUNIZATION; CANCER IMMUNOTHERAPY; CANCER STAGING; CANCER SURVIVAL; CLINICAL TRIAL; COLITIS; COMBINATION CHEMOTHERAPY; COMPUTER ASSISTED TOMOGRAPHY; COUGHING; DERMATITIS; DRUG DOSE ESCALATION; DRUG EFFICACY; DRUG MECHANISM; DRUG SAFETY; EPISCLERITIS; FATIGUE; FLU LIKE SYNDROME; HEPATITIS; HUMAN; HYPOPHYSITIS; IMMUNE RESPONSE; IMMUNOMODULATION; IN VITRO STUDY; INJECTION SITE REACTION; LEUKAPHERESIS; MELANOMA; METASTASIS; MONOTHERAPY; MULTIPLE CYCLE TREATMENT; MYALGIA; NAUSEA; NONHUMAN; NOSE CONGESTION; PROSTATE CANCER; PROTEIN BINDING; PROTEIN EXPRESSION; RASH; T LYMPHOCYTE; TREATMENT OUTCOME; TUMOR REGRESSION; UNSPECIFIED SIDE EFFECT; UVEITIS; VIRAL GENE DELIVERY SYSTEM; VITILIGO;

EID: 34547945462     PISSN: 15587673     EISSN: None     Source Type: Journal    
DOI: 10.3816/CGC.2007.n.017     Document Type: Article

References (34)

1. Tannock IF, de Wit R, Berry WR, et al. Docetaxel plus prednisone or mitoxantrone plus prednisone for advanced prostate cancer. N Engl J Med 2004; 351:1502-1512.
2. Petrylak DP, Tangen CM, Hussain MH, et al. Docetaxel and estramustine compared with mitoxantrone and prednisone lor advanced refractory prostate cancer. N Engl J Med 2004; 351:1513-1520.
3. Tannock IF, Osoba D, Stockier MR, et al. Chemotherapy with mitoxantrone plus prednisone or prednisone alone for symptomatic hormone-resistant prostate cancer: a Canadian randomized trial with palliative end points. J Clin Oncol 1996; 14:1756-1764.
4. Novellino L, Castelli C, Parmiani G. A listing of human tumor antigens recognized by T cells: March 2004 update. Cancer Immunol Immunother 2005; 54:187-207.
5. Thompson CB, Lindsten T, Ledbetter JA, et al. CD28 activation pathway regulates the production of multiple T-cell-derived lymphokines/cytokines. Proc Natl Acad Sci U S A 1989;86:1333-1337.
6. Linsley PS, Brady W, Grosmaire L, et al. Binding of the B cell activation antigen B7 to CD28 costimulates T cell proliferation and interleukin 2 mRNA accumulation. J Exp Med 1991; 173:721-730.
7. Freeman GJ, Gribben JG, Boussiotis VA, et al. Cloning of B7-2: a CTLA-4 counter-receptor that costimulates human T cell proliferation. Science 1993; 262:909-911.
8. Walunas TL, Lenschow DJ, Bakker CY, et al. CTLA-4 can function as a negative regulator of T cell activation. Immunity 1994; 1:405-413.
9. Linsley PS, Brady W, Urnes M, et al. CTLA-4 is a second receptor for the B cell activation antigen B7. J Exp Med 1991; 174:563-569.
10. Linsley PS, Greene JL, Tan P, et al. Coexpression and functional cooperation of CTLA-4 and CD28 on activated T lymphocytes. J Exp Med 1992; 176:1595-1604.
11. Krummel MF, Allison JP. CTLA-4 engagement inhibits IL-2 accumulation and cell cycle progression upon activation of resting T cells. J Exp Med 1996; 183:2533-2540.
12. Krummel MF, Allison JP. CD28 and CTLA-4 have opposing effects on the response of T cells to stimulation. J Exp Med 1995; 182:459-465.
13. +) T lymphocytes. Proc Natl Acad Sci U S A 1999; 96:2982-2987.
14. Kass E, Schlom J, Thompson J, et al. Induction of protective host immunity to carcinoembryonic antigen (CEA), a self-antigen in CEA transgenic mice, by immunizing with a recombinant vaccinia-CEA virus. Cancer Res 1999; 59:676-683.
15. Eder JP, Kantoff PW, Roper K, et al. A phase I trial of a recombinant vaccinia virus expressing prostate-specific antigen in advanced prostate cancer. Clin Cancer Res 2000; 6:1632-1638.
16. Marshall JL, Gulley JL, Arlen PM, et al. Phase 1 study of sequential vaccinations with fowlpox-CEA(6D)-TRICOM alone and sequentially with vaccinia-CEA(6D)-TRICOM, with and without granulocyte-macrophage colony-stimulating factor, in patients with carcinoembryonic antigen-expressing carcinomas. J Clin Oncol 2005; 23:720-731.
17. Grosenbach DW, Barrientos JC, Schlom J, et al. Synergy of vaccine strategies to amplify antigen-specific immune responses and antitumor effects. Cancer Res 2001; 61:4497-4505.
18. Hodge JW, McLaughlin JP, Kantor JA, et al. Diversified prime and boost protocols using recombinant vaccinia virus and recombinant non-replicating avian pox virus to enhance T-cell immunity and antitumor responses. Vaccine 1997; 15:759-768.
19. Kaufman HL, Wang W, Manola J, et al. Phase II randomized study of vaccine treatment of advanced prostate cancer (E7897): a trial of the Eastern Cooperative Oncology Group. J Clin Oncol 2004; 22:2122-2132.
20. Hodge JW, Sabzevari H, Yafal AG, et al. A triad of costimulatory molecules synergize to amplify T-cell activation. Cancer Res 1999; 59:5800-5807.
21. Hodge JW, Chakraborty M, Kudo-Saito C, et al. Multiple costimulatory modalities enhance CTL avidity. J Immunol 2005; 174:5994-6004.
22. Terasawa H, Tsang KY, Gulley J, et al. Identification and characterization of a human agonist cytotoxic T-lymphocyte epitope of human prostate-specific antigen. Clin Cancer Res 2002; 8:41-53.
23. DiPaola RS, Plante M, Kaufman H, et al. A phase I trial of Pox PSA vaccines (PROSTVAC®-VF) with B7-1, ICAM-1, and LFA-3 co-stimulatory molecules (TRICOM™) in patients with prostate caner. J Transl Med 2006; 4:1-5.
24. Arlen PM, Skarupa L, Pazdur M, et al. Clinical safety of a viral vector-based prostate caner vaccine strategy. J Urol. In press.
25. Kantoff PW, Glode LM, Tannenbaum SI, et al. Randomized, double-blind, vector-controlled study of a targeted immunotherapy in patiens (pts) with hormone-refractory prostate cancer (HRPC). J Clin Oncol 2006; 24(18 suppl):100s (Absract #2501).
26. Gulley JL, Todd N, Dahut W, et al. A phase II study of PROSTVAC-VF vaccine, and the role of GM-CSF, in patients (pts) with metastatic androgen insensitive prostate cancer (AIPC). J Clin Oncol 2005; 23(17 suppl):166s (Abstract #2504).
27. Hurwitz AA, Foster BA, Kwon ED, et al. Combination immunotherapy of primary prostate cancer in a transgenic mouse model using CTLA-4 blockade. Cancer Res 2000; 60:2444-2448.
28. van Elsas A, Hurwitz AA, Allison JP. Combination immunotherapy of B16 melanoma using anti-cytotoxic T lymphocyte-associated antigen 4 (CTLA-4) and granulocyte/macro phage colony-stimulating factor (GM-CSF)-producing vaccines induces rejection of subcutaneous and metastatic tumors accompanied by autoimmune depigmentation. J Exp Med 1999; 190:355-366.
29. Hurwitz AA, Yu TF, Leach DR, et al. CTLA-4 blockade synergizes with tumor-derived granulocyte-macrophage colony-stimulating factor for treatment of an experimental mammary carcinoma. Proc Natl Acad Sci U S A 1998; 95:10067-10071.
30. Small EJ, Tchekmedyian NS, Rini IB, et al. A pilot trial of CTLA-4 blockade with human anti-CTLA-4 in patients with hormone-refractory prostate cancer. Clin Cancer Res 2007; 13:1810-1815.
31. Attia P, Phan GQ, Maker AV, et al. Autoimmunity correlates with tumor regression in patients with metastatic melanoma treated with anti-cytotoxic T-lymphocyte antigen-4. J Clin Oncol 2005; 23:6043-6053.
32. Rosenberg SA, Yang JC, Restifo NP. Cancer immunotherapy: moving beyond current vaccines. Nat Med 2004; 10:909-915.
33. National Cancer Institute Web site. Available at: http://www.cancer.gov/ search/viewclinicaltrials.aspx?cdrid=437785&version=healthprofessional& protocolsearchid=1925113. Accessed October 24, 2005.
34. Hodi FS, Mihm MC, Soiffer RJ, et al. Biologic activity of cytotoxic T lymphocyte-associated antigen 4 antibody blockade in previously vaccinated metastatic melanoma and ovarian carcinoma patients. Proc Natl Acad Sci U S A 2003; 100:4712-4717.