Results of the first phase I clinical trial of the novel Ii-key hybrid preventive HER-2/neu peptide (AE37) vaccine

Journal of Clinical Oncology

Volumn 26, Issue 20, 2008, Pages 3426-3433

  Holmes, Jarrod P ^b   Benavides, Linda C ^b   Gates, Jeremy D ^b   Carmichael, Mark G ^b   Hueman, Matthew T ^b   Mittendorf, Elizabeth A ^b   Murray, James L ^b   Amin, Asna ^b   Craig, Dianna ^b   Von Hofe, Eric ^b   Ponniah, Sathibalan ^b   Peoples, George E ^a  

^a BROOKE ARMY MEDICAL CENTER   (United States)

^b NONE

Author keywords

[No Author keywords available]

Indexed keywords

EPIDERMAL GROWTH FACTOR RECEPTOR 2; GRANULOCYTE MACROPHAGE COLONY STIMULATING FACTOR; PEPTIDE VACCINE; THYMIDINE; AE37 VACCINE; CANCER VACCINE; PEPTIDE FRAGMENT;

ADULT; AGED; ARTICLE; BREAST CANCER; CANCER CHEMOTHERAPY; CANCER IMMUNIZATION; CHEMOPROPHYLAXIS; CLINICAL ARTICLE; CLINICAL TRIAL; CONTROLLED STUDY; DELAYED HYPERSENSITIVITY; DRUG DOSE ESCALATION; DRUG DOSE REDUCTION; HUMAN; HUMAN CELL; IMMUNE RESPONSE; PHASE 1 CLINICAL TRIAL; PRIORITY JOURNAL; UNSPECIFIED SIDE EFFECT; BREAST TUMOR; CANCER STAGING; CELLULAR IMMUNITY; DOSE RESPONSE; DRUG ADMINISTRATION; FEMALE; FOLLOW UP; IMMUNOLOGY; MAXIMUM TOLERATED DOSE; METHODOLOGY; MIDDLE AGED; MORTALITY; NONPARAMETRIC TEST; PROBABILITY; RISK ASSESSMENT; SURVIVAL; TREATMENT OUTCOME; TUMOR RECURRENCE; VACCINATION;

ADULT; AGED; BREAST NEOPLASMS; CANCER VACCINES; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG ADMINISTRATION SCHEDULE; FEMALE; FOLLOW-UP STUDIES; HUMANS; IMMUNITY, CELLULAR; MAXIMUM TOLERATED DOSE; MIDDLE AGED; NEOPLASM RECURRENCE, LOCAL; NEOPLASM STAGING; PEPTIDE FRAGMENTS; PROBABILITY; RECEPTOR, ERBB-2; RISK ASSESSMENT; STATISTICS, NONPARAMETRIC; SURVIVAL ANALYSIS; TREATMENT OUTCOME; VACCINATION;

EID: 49149117772     PISSN: 0732183X     EISSN: None     Source Type: Journal    
DOI: 10.1200/JCO.2007.15.7842     Document Type: Article

References (43)

1. National Cancer Institute SEER Surveillance Epidemiology and End Results Cancer Statistics Review, 1975-2003: Summary Figures and Tables. 2006. http://seer.cancer.gov/csr/1975_2003/
2. Joensuu H, Kellokumpu-Lehtinen PL, Bono P, et al: Adjuvant docetaxol or vinorelbine with or without trastuzumab for breast cancer. N Engl J Med 354:809-820, 2006
3. Pritchard KI, Shepherd LE, O'Malley FP, et al: HER2 and responsiveness of breast cancer to adjuvant chemotherapy. N Engl J Med 354:2103-2111, 2006
4. Slamon DJ, Godolphin W, Jones LA, et al: Studies of the HER-2/neu proto-oncogene in human breast and ovarian cancer. Science 244:707-712, 1989
5. Fisk B, Blevins TL, Wharton JT, et al: Identification of immunodominant peptide of the HER2/neu proto-oncogene recognized by ovarian tumor-specific CTL lines. J Exp Med 181:2109-2117, 1995
6. Peoples GE, Goedegburre PS, Smith R, et al: Breast and ovarian cancer-specific cytotoxic T lymphocytes recognize the same HER2/ neu-derived peptide. Proc Natl Acad Sci U S A 92:432-436, 1995
7. Peoples GE, Gurney JM, Hueman MT, et al: Clinical trial results of a HER2/neu (E75) vaccine to prevent recurrence in high risk breast cancer patients. J Clin Oncol 23:7536-7545, 2005
8. Mittendorf E, Storrer C, Foley R: Evaluation of the HER2/neu-derived peptide GP2 for use in peptide-based breast cancer vaccine trial. Cancer 106:2309-2317, 2006
9. Peoples GE, Holmes JP, Hueman MT, et al: Combined clinical trial results of a HER2/neu (E75) vaccine for prevention of recurrence in high-risk breast cancer patients: United States Military Cancer Institute Clinical Trials Group Study I-01 & I-02. Clin Cancer Res 14:797-803, 2008
10. Knutson KL, Schiffman K, Cheever MA, et al: Immunization of cancer patients with a HER-2/neu, HLA-A2 peptide, p369-377, results in short-lived peptide-specific immunity. Clin Cancer Res 8:1014-1018, 2002
11. Knutson KL, Disis ML: Tumor antigen-specific T helper cells in cancer immunity and immunotherapy. Cancer Immunol Immunother 54:721-728, 2005
12. Knutson KL, Disis ML: Augmenting T helper cell immunity in cancer. Curr Drug Targets Immune Endocr Metabol Disord 5:365-371, 2005
13. Tuttle TM, Anderson BW, Thompson WE, et al: Proliferative and cytokine responses to class II HER-2/neu-associated peptides in breast cancer patients. Clin Cancer Res 4:2015-2024, 1998
14. Disis ML, Grabstein KH, Sleath PR, et al: Generation of immunity to the HER-2/neu oncogenic protein in patients with breast and ovarian cancer using a peptide-based vaccine. Clin Cancer Res 5:1289-1297, 1999
15. Adams S, Humphreys RE: Invariant chain peptides enhancing or inhibiting the presentation of antigenic peptides by major histocompatibility complex class II molecules. Eur J Immun 25:1693-1702, 1995
16. Xu M, Lis J, Gulfo JV, et al: MHC class II allosteric site drugs: New immunotherapeutics for malignant, infectious and autoimmune disease. Scan J Immunol 54:39-44, 2001
17. Humphreys RE, Adams S, Koldzic G, et al: Increasing the potentcy of MHC class II-presented epitopes by linking to Ii-Key peptide. Vaccine 18: 2693-2697, 2000
18. Gillogly ME, Kallinteris NL, et al: Ii-Key/HER-2/ neu MHC class-II antigenic epitope vaccine peptide for breast cancer. Cancer Immunol Immunother 53:490-496, 2004
19. Kallinteris NL, Wu S, Lu X, et al: Enhanced CD4+ T-cell response in DR4-transgenic mice to a hybrid peptide linking the Ii-Key segment of the invariant chain to the melanoma gp100(48-58) MHC class II epitope. J Immunother 28:352-358, 2005
20. Hueman MT, Dehqanzada ZA, Novak TE, et al: Phase I of a HER-2/neu peptide (E75) for the prevention of prostate-specific antigen recurrence in high-risk prostate cancer patients. Clin Cancer Res 11:7470-7479, 2005
21. Woll MM, Fisher CM, Ryan GB, et al: Direct measurement of peptide-specific CD8+ T cells using HLA-A2:Ig dimmer for monitoring the in vivo immune response to a HER2/neu vaccine in breast and prostate cancer patients. J Clin Immunol 24:449:461, 2004
22. Sokal JE: Measurement of delayed skin-test responses. N Engl J Med 293:501-502, 1975
23. Voutsas IF, Gritzapis AD, Mahaira LG, et al: Induction of potent CD4+ T cell-mediated antitumor responses by a helper HER-2/neu peptide linked to the Ii-Key moiety of the invariant chain. Int J Cancer 121:2031-2041, 2007
24. Sotiriadou NN, Kallinteris NL, Gritzapis AD, et al: Ii-Key/HER-2/neu(776-790) hybrid peptides induce more effective immunological responses over the native peptide in lymphocyte cultures from patients with HER-2/neu+ tumors. Cancer Immunol Immunother 56:601-613, 2007
25. Disis ML, Bernhard H, Shiota FM, et al: Granulocyte-macrophage colony-stimulating factor: An effective adjuvant for protein and peptide-based vaccines. Blood 88:202-210, 1996
26. Shaed SG, Klimek VM, Panageas KS, et al: T-cell responses against tyrosinase 368-376(370D) peptide in HLA*A0201+ melanoma patients: Randomized trial comparing incomplete Freund's adjuvant, granulocyte macrophage colony-stimulating factors and QS-21 as immunological adjuvants. Clin Cancer Res 8:967-972, 2002
27. Parmiani G, Castelli C, Pilla L, et al: Opposite immune functions of GM-CSF administered as vaccine adjuvant in cancer patients. Ann Oncol 18:226-232, 2007
28. Kalams SA, Walker BD: The critical need for CD4 help in maintaining effective cytotoxic T lymphocyte responses. J Exp Med 188:2199-2204, 1998
29. Disis ML, Gooley TA, Rinn K, et al: Generation of T-cell immunity to the HER-2/neu protein after immunization with HER-2/neu peptide-based vaccines. J Clin Oncol 20:2624-2632, 2002
30. Wong R, Lau R, Change J, et al: Immune responses to a class II helper peptide epitope in patients with stage III/IV resected melanoma. Clin Cancer Res 10:5004-5013, 2004
31. Phan GQ, Touloukian CE, Yang JC, et al: Immunization of patients with metastatic melanoma using both class I- and class II-restricted peptides from melanoma-associated antigens. J Immunother 26:349-356, 2003
32. Kobayashi H, Lu J, Celis E: Identification of helper T-cell epitopes that encompass or lie proximal to cytotoxic T-cell epitopes in the gp100 melanoma tumor antigen. Cancer Res 61:7577-7584, 2001
33. Kallinteris NL, Lu X, Wu S, et al: Ii-Key/MHC class II epitope hybrid peptide vaccines for HIV. Vaccine 21:4128-4132, 2003
34. Jäeger E, Bernhard H, Romero P, et al: Generation of cytotoxic T-cell responses with synthetic melanoma-associated peptides in vivo: Implications for tumor vaccines with melanoma-associated antigens. Int J Cancer 66:162-169, 1996
35. Marchand M, Van Baren N, Weynants P, et al: Tumor regressions observed in patients with metastatic melanoma treated with an antigenic peptide encoded by gen MAGE-3 and presented by HLA-A1. Int J Cancer 80:219-230, 1999
36. Sakaguchi S, Sakaguchi N, Asano M, et al: Immunologic self-tolerance maintained by activated T cells expressing IL-2 receptor α-chains (CD25). Breakdown of a single mechanism of self-tolerance causes various autoimmune diseases. J Immunol 155:1151-1164, 1995
37. Fontenot JD, Gavin MA, Rudensky AY: Foxp3 programs the development and function of CD4+CD25+ regulatory T cells. Nat Immunol 4:330-336, 2003
38. Liyanage UK, Moore TT, Joo H, et al: Prevalence of regulatory T cells is increased in peripheral blood and tumour microenvironment of patients with pancreas or breast adenocarcinoma. J Immunol 169:2756-2761, 2002
39. Hueman MT, Stojadinovic A, Storrer CE, et al: Levels of circulating regulatory CD4+CD25+ T cells are decreased in breast cancer patients after vaccination with a HER2/neu peptide (E75) and GM-CSF vaccine. Br Cancer Res Treat 98:17-29, 2006
40. Hueman MT, Holmes JP, Storrer CE, et al: Immune monitoring of CD4+CD25+FoxP3+ regulatory T cells in a novel HLA Class-II HER2/neu peptide vaccine clinical trial in breast cancer patients. Ann Surg Oncol S14:91, 2007 (suppl; abstr)
41. Parker KC, Bednarek MA, Coligan JE: Scheme for ranking potential HLA-A2 binding peptides based on independent binding of individual peptide side chains. J Immunol 152:163-175, 1994
42. Patil R, Holmes JP, Amin A, et al: Clinical and immunologic responses of HLA-A3+ breast cancer patients vaccinated with the HER2/neu-derived peptide vaccine, E75, in a phase I clinical trial. Br Cancer Res Treat 106:S123-S124, 2007 (suppl)
43. Salazar LG, Fikes J, Southwood S, et al: Immunization of cancer patients with HER-2/neu-derived peptides demonstrating high-affinity binding to multiple class II alleles. Clin Cancer Res 9:5559-5565, 2003