Results of the first phase 1 clinical trial of the HER-2/neu peptide (GP2) vaccine in disease-free breast cancer patients: United States Military Cancer Institute Clinical Trials Group Study I-04

Cancer

Volumn 116, Issue 2, 2010, Pages 292-301

  Carmichael, Mark G ^a   Benavides, Linda C ^b   Holmes, Jarrod P ^c   Gates, Jeremy D ^b   Mittendorf, Elizabeth A ^d   Ponniah, Sathibalan ^a   Peoples, George E ^a,b  

^a Uniformed Services University of the Health Sciences and the Walter Reed National Military Medical Center   (United States)

^b BROOKE ARMY MEDICAL CENTER   (United States)

^c NAVAL MEDICAL CENTER SAN DIEGO   (United States)

^d UNIVERSITY OF TEXAS MD ANDERSON CANCER CENTER   (United States)

Author keywords

Breast cancer; GP2; HER 2 neu; Peptide; Vaccine

Indexed keywords

CANCER VACCINE; DIMER; EPIDERMAL GROWTH FACTOR RECEPTOR 2; GP2 PEPTIDE VACCINE; GRANULOCYTE MACROPHAGE COLONY STIMULATING FACTOR; HLA A2 ANTIGEN; UNCLASSIFIED DRUG;

ADJUVANT THERAPY; ADULT; AGED; ARTHRALGIA; ARTICLE; BREAST CANCER; CANCER ADJUVANT THERAPY; CANCER IMMUNIZATION; CANCER PATIENT; CANCER RECURRENCE; CD8+ T LYMPHOCYTE; CLINICAL ARTICLE; CLINICAL TRIAL; CONTROLLED STUDY; DELAYED HYPERSENSITIVITY; DRUG DOSE COMPARISON; DRUG DOSE ESCALATION; DRUG DOSE REDUCTION; DRUG HYPERSENSITIVITY; DRUG SAFETY; EPITOPE MAPPING; EX VIVO STUDY; FATIGUE; HUMAN; IMMUNE RESPONSE; IN VIVO STUDY; INJECTION SITE ERYTHEMA; INJECTION SITE INDURATION; INJECTION SITE INFLAMMATION; INJECTION SITE PRURITUS; MYALGIA; PHASE 1 CLINICAL TRIAL; PRIORITY JOURNAL; TREATMENT RESPONSE; UNSPECIFIED SIDE EFFECT;

ADULT; AGED; BREAST NEOPLASMS; CANCER VACCINES; EPITOPES; FEMALE; GRANULOCYTE-MACROPHAGE COLONY-STIMULATING FACTOR; HUMANS; MIDDLE AGED; PEPTIDE FRAGMENTS; RECEPTOR, ERBB-2; VACCINES, SUBUNIT;

EID: 75649136936     PISSN: 0008543X     EISSN: 10970142     Source Type: Journal    
DOI: 10.1002/cncr.24756     Document Type: Article

References (22)

1. American Cancer Society. Cancer Facts and Figures 2008. Atlanta, GA: American Cancer Society; 2008.
2. Slamon DJ, Godolphin W, Jones LA, et al. Studies of the HER-2/neu proto-oncogene in human breast and ovarian cancer. Science. 1989;244:707-712.
3. Toikkanen S, Helin H, Isola J, et al. Prognostic significance of HER-2 oncoprotein expression in breast cancer: a 30-year follow-up. J Clin Oncol. 1992;10:1044-1048.
4. Rammensee HG, Falk K, Rotzschke O. Peptides naturally presented by MHC class I molecules. Annu Rev Immunol. 1993;11:213-244.
5. 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. 2005; 23:7536-7545.
6. Fisk B, Blevins TL, Wharton JT, et al. Identification of an immunodominant peptide of HER-2/neu protooncogene recognized by ovarian tumor-specific cytotoxic T lymphocyte lines. J Exp Med. 1995;181:2109-2117.
7. Peoples GE, Goedegebuure 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. 1995;92:432-436.
8. Brossart P, Wirths S, Stuhler G, et al. Induction of cytotoxic T-lymphocyte response in vivo after vaccinations with peptide-pulsed dendritic cells. Blood. 2000;96:3102-3108.
9. Mittendorf EA, Gurney JM, Storrer CE, et al. Vaccination with a HER2/neu peptide induces intra- and inter-antigenic epitope spreading in patients with early stage breast cancer. Surgery. 2006;139:407-418.
10. Mittendorf EA, Storrer CE, Foley RJ, et al. Evaluation of the HER2/neu-derived peptide GP2 for use in a peptidebased breast cancer vaccine trial. Cancer. 2006;106:2309-2317.
11. Dees EC, McKinnon KP, Kuhns JJ, et al. Dendritic cells can be rapidly expanded ex vivo and safely administered in patients with metastatic breast cancer. Cancer Immunol Immunother. 2004;53:777-785.
12. Hueman MT, Dehqanzada ZA, Novak TE, et al. Phase I clinical trial of a HER-2/neu peptide (E75) for the prevention of prostate-specific antigen recurrence in high-risk prostate cancer patients. Clin Cancer Res. 2005;11:7470-7479.
13. Woll MM, Fisher CM, Ryan GB, et al. Direct measurement of peptide-specific CD8+ T cells using HLA-A2:Ig dimer for monitoring the in vivo immune response to a HER2/ neu vaccine in breast and prostate cancer patients. J Clin Immunol. 2004;24:449-461.
14. Sokal JE. Measurement of delayed skin- test responses. N Engl J Med. 1975;293:501-502.
15. Linehan DC, Goedegebuure PS, Peoples GE, et al. Tumorspecific and HLA-A2-restricted cytolysis by tumor-associated lymphocytes in human metastatic breast cancer. J Immunol. 1995;155:4486-4491.
16. Peiper M, Goedegebuure PS, Eberlein TJ. Generation of peptide-specific cytotoxic T-lymphocytes using allogeneic dendritic cells capable of lysing human pancreatic cancer cells. Surgery. 1997;122:235-242.
17. Yoshino I, Goedegebuure PS, Peoples GE, et al. HER2/neu-derived peptides are shared antigens among human nonsmall cell lung cancer and ovarian cancer. Cancer Res. 1994;54:3387-3390.
18. Peiper M, Goedegebuure PS, Linehan DC, et al. The HER2/neu-derived peptide p654-662 is a tumor-associated antigen in human pancreatic cancer recognized by cytotoxic T lymphocytes. Eur J Immunol. 1997;27:1115-1123.
19. Fisk B, Savary C, Hudson JM, et al. Changes in an HER-2 peptide upregulating HLA-A2 expression affect both conformational epitopes and CTL recognition: implications for optimization of antigen presentation and tumor-specific CTL induction. J Immunother Emphasis Tumor Immunol. 1995;18:197-209.
20. Kawano K, Efferson CL, Peoples GE, et al. Sensitivity of undifferentiated, high-TCR density CD8+ cells to methylene groups appended to tumor antigen determines their differentiation or death. Cancer Res. 2005;65:2930-2937.
21. Peoples GE, Holmes JP, Hueman MT, et al. Combined clinical trial results of a HER2/neu (E75) vaccine for the prevention of recurrence in high-risk breast cancer patients: U.S. Military Cancer Institute Clinical Trials Group Study I-01 and I-02. Clin Cancer Res. 2008;14:797-803.
22. Mittendorf EA, Storrer CE, Shriver CD, et al. Investigating the combination of trastuzumab and HER2/neu peptide vaccines for the treatment of breast cancer. Ann Surg Oncol. 2006;13:1085-1098.