A phase I trial of immunotherapy with lapuleucel-T (APC8024) in patients with refractory metastatic tumors that express HER-2/neu

Clinical Cancer Research

Volumn 15, Issue 18, 2009, Pages 5937-5944

  Peethambaram, Prema P ^a   Melisko, Michelle E ^b   Rinn, Kristine J ^c   Alberts, Steven R ^a   Provost, Nicole M ^d   Jones, Lori A ^d   Sims, Robert B ^d   Lin, Lisa R C ^d   Frohlich, Mark W ^d   Park, John W ^b  

^a MAYO CLINIC   (United States)

^b UNIVERSITY OF CALIFORNIA   (United States)

^c SWEDISH MEDICAL CENTER   (United States)

^d Dendreon   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ANTINEOPLASTIC AGENT; APC 8024; BISPHOSPHONIC ACID DERIVATIVE; EPIDERMAL GROWTH FACTOR RECEPTOR 2; GAMMA INTERFERON; GRANULOCYTE MACROPHAGE COLONY STIMULATING FACTOR; LAPULEUCEL T; TRASTUZUMAB; UNCLASSIFIED DRUG;

ABDOMINAL DISTENSION; ABDOMINAL PAIN; ADULT; AGED; ANEMIA; ANOREXIA; ANTIGEN PRESENTING CELL; ANXIETY; ARTHRALGIA; ARTICLE; BACKACHE; BREAST CANCER; BREAST METASTASIS; BREAST TUMOR; CANCER CHEMOTHERAPY; CANCER IMMUNOTHERAPY; CANCER PATIENT; CANCER RADIOTHERAPY; CLINICAL ARTICLE; CLINICAL STUDY; CLINICAL TRIAL; COLORECTAL CANCER; CONTROLLED STUDY; COUGHING; CYTOKINE PRODUCTION; DEPRESSION; DIARRHEA; DISEASE COURSE; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; EDEMA; ENZYME LINKED IMMUNOSPOT ASSAY; EX VIVO STUDY; FATIGUE; FECES IMPACTION; FEMALE; FEVER; HEADACHE; HUMAN; HYDRONEPHROSIS; HYPOKALEMIA; IMMUNE RESPONSE; IMMUNOSTIMULATION; LEUKAPHERESIS; LIMB PAIN; LIVER METASTASIS; LYMPHADENOPATHY; MALE; METASTASIS; MYALGIA; NAUSEA; OVARY CANCER; OVARY METASTASIS; PERIPHERAL BLOOD MONONUCLEAR CELL; PHASE 1 CLINICAL TRIAL; PRIORITY JOURNAL; PROTEIN EXPRESSION; PYLORUS STENOSIS; RIGOR; SIDE EFFECT; STOMACH ADENOCARCINOMA; T LYMPHOCYTE; TACHYCARDIA; TREATMENT DURATION; TREATMENT RESPONSE; UPPER RESPIRATORY TRACT INFECTION; UROSEPSIS; VOMITING;

ADULT; AGED; BREAST NEOPLASMS; CANCER VACCINES; COLORECTAL NEOPLASMS; FEMALE; HUMANS; IMMUNOTHERAPY; MALE; MIDDLE AGED; OVARIAN NEOPLASMS; RECEPTOR, ERBB-2;

EID: 70349456786     PISSN: 10780432     EISSN: None     Source Type: Journal    
DOI: 10.1158/1078-0432.CCR-08-3282     Document Type: Article

References (25)

1. Hsu FJ, Benike C, Fagnoni F, et al. Vaccination of patients with B-cell lymphoma using autologous antigen-pulsed dendritic cells. Nat Med 1996;2:52-58 (Pubitemid 26028073)
2. Murphy G, Tjoa B, Ragde H, Kenny G, Boynton A. Phase I clinical trial: T-cell therapy for prostate cancer using autologous dendritic cells pulsed with HLA-A0201-specific peptides from prostate-specific membrane antigen. Prostate 1996;29:371-380 (Pubitemid 27014352)
3. Burch PA, Breen JK, Buckner JC, et al. Priming tissue-specific cellular immunity in a phase I trial of autologous dendritic cells for prostate cancer. Clin Cancer Res 2000;6:2175-2182
4. Small EJ, Fratesi P, Reese DM, et al. Immunotherapy of hormone-refractory prostate cancer with antigen-loaded dendritic cells. J Clin Oncol 2000;18:3894-3903
5. Nestle FO, Alijagic S, Gilliet M, et al. Vaccination of melanoma patients with peptide- or tumor lysate-pulsed dendritic cells. Nat Med 1998;4:328-332 (Pubitemid 28144092)
6. Arnaout AH, Dawson PM, Soomro S, et al. HER2 (c-erbB-2) oncoprotein expression in colorectal adenocarcinoma: an immunohistological study using three different antibodies. J Clin Pathol 1992;45:726-727
7. Morse MA, Deng Y, Coleman D, et al. A phase I study of active immunotherapy with carcinoembryonic antigen peptide (CAP-1)-pulsed, autologous human cultured dendritic cells in patients with metastatic malignancies expressing carcinoembryonic antigen. Clin Cancer Res 1999;5:1331-1338 (Pubitemid 29282936)
8. Park JW, Melisko ME, Esserman LJ, Jones LA, Wollan JB, Sims R. Treatment with autologous antigen-presenting cells activated with the HER-2 based antigen lapuleucel-T: results of a phase I study in immunologic and clinical activity in HER-2 overexpressing breast cancer. J Clin Oncol 2007;25:3680-3687 (Pubitemid 47372607)
9. Small EJ, Schellhammer PF, Higano CS, et al. Placebo-controlled phase III trial of immunologic therapy with sipuleucel-T (APC8015) in patients with metastatic, asymptomatic hormone refractory prostate cancer. J Clin Oncol 2006;24:3089-3094
10. Park JW, Neve RM, Szollosi J, Benz CC. Unraveling the biologic and clinical complexities of HER2. Clin Breast Cancer 2008;8:392-401.
11. Seidman JD, Frisman DM, Norris HJ. Expression of the HER-2/neu proto-oncogene in serous ovarian neoplasms. Cancer 1992;70:2857-2860
12. Yu D, Wolf JK, Scanlon M, Price JE, Hung MC. Enhanced c-erbB-2/neu expression in human ovarian cancer cells correlates with more severe malignancy that can be suppressed by E1A. Cancer Res 1993;53:891-898 (Pubitemid 23077880)
13. 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 (Pubitemid 19147683)
14. Pegram MD, Konecny G, Slamon DJ. Use of HER2 for predicting response to breast cancer therapy. Dis Breast 1999;3:1-9.
15. Slamon DJ, Leyland-Jones B, Shak S, et al. Use of chemotherapy plus a monoclonal antibody against HER2 for metastatic breast cancer that overexpresses HER2. N Engl J Med 2001;344:783-792 (Pubitemid 32222155)
16. Hudis CA. Trastuzumab - mechanism of action and use in clinical practice. N Engl J Med 2007;357:39-51. (Pubitemid 47026733)
17. Ritter CA, Perez-Torres M, Rinehart C, et al. Human breast cancer cells selected for resistance to trastuzumab in vivo overexpress epidermal growth factor receptor and ErbB ligands and remain dependent on the ErbB receptor network. Clin Cancer Res 2007;13:4909-4919 (Pubitemid 47294799)
18. Mittendorf EA, Storrer CE, Shriver CD, Ponniah S, Peoples GE. Investigating the combination of trastuzumab and HER2/neu peptide vaccines for the treatment of breast cancer. Ann Surg Oncol 2006;13:1085-1098 (Pubitemid 44337968)
19. Czerniecki BJ, Carter C, Rivoltini L, et al. Calcium ionophore-treated peripheral blood monocytes and dendritic cells rapidly display characteristics of activated dendritic cells. J Immunol 1997;159:3823-3837 (Pubitemid 127469638)
20. Disis ML, Goodell V, Schiffman K, Knutson KL. Humoral epitope-spreading following immunization with a HER-2/neu peptide based vaccine in cancer patients. J Clin Immunol 2004;24:571-578 (Pubitemid 39221675)
21. Holmes JP, Benavides LC, Gates JD, et al. Results of the first phase I clinical trial of the novel II-key hybrid preventive HER-2/neu peptide (AE37) vaccine. J Clin Oncol 2008;26:3426-3433
22. 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.
23. Coveler AL, Goodell V, Webster DJ, et al. Common adjuvant breast cancer therapies do not inhibit cancer vaccine induced T cell immunity. Breast Cancer Res Treat 2008;113:95-100.
24. Brossart P, Wirths S, Stuhler G, Reichardt VL, Kanz L, Brugger W. Induction of cytotoxic T-lymphocyte responses in vivo after vaccinations with peptide-pulsed dendritic cells. Blood 2000;96:3102-3108 (Pubitemid 30815219)
25. Jemal A, Siegel R, Ward E, et al. Cancer statistics, 2008. CA Cancer J Clin 2008;58:71-96.