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Volumn 625, Issue 1-3, 2009, Pages 84-89

Design of clinical trials for therapeutic cancer vaccines development

Author keywords

Cancer vaccine; Clinical trial; Drug development; Efficacy trial; End point; Proof of principle trial; Whole cell cancer vaccine

Indexed keywords

AGI 101H; BIOLOGICAL MARKER; CANCER VACCINE; LACTATE DEHYDROGENASE; MELACINE; PROSTATE SPECIFIC ANTIGEN; PROVENGE; RENIALE; TUMOR CELL VACCINE; UNCLASSIFIED DRUG; VACCINE;

EID: 71749109195     PISSN: 00142999     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.ejphar.2009.09.069     Document Type: Review
Times cited : (22)

References (40)
  • 1
    • 45549096766 scopus 로고    scopus 로고
    • Cancer stem cells: a step toward the cure
    • Boman B.M., and Wicha M.S. Cancer stem cells: a step toward the cure. JCO 26 (2008) 2795-2799
    • (2008) JCO , vol.26 , pp. 2795-2799
    • Boman, B.M.1    Wicha, M.S.2
  • 2
    • 3242695961 scopus 로고    scopus 로고
    • Sequential immunization of melanoma patients with GD3 ganglioside vaccine and antiidiotypic monoclonal antibody that mimics GD3 ganglioside
    • 15
    • Chapman P.B., Wu D., Ragupathi G., Lu S., Williams L., Hwu W.J., Johnson D., and Livingston P.O. Sequential immunization of melanoma patients with GD3 ganglioside vaccine and antiidiotypic monoclonal antibody that mimics GD3 ganglioside. Clin. Cancer. Res. 10 14 (2004) 4717-4723 15
    • (2004) Clin. Cancer. Res. , vol.10 , Issue.14 , pp. 4717-4723
    • Chapman, P.B.1    Wu, D.2    Ragupathi, G.3    Lu, S.4    Williams, L.5    Hwu, W.J.6    Johnson, D.7    Livingston, P.O.8
  • 3
    • 34848896582 scopus 로고    scopus 로고
    • Cell based cancer vaccines: regulatory and commercial development
    • Copier J., Ward S., and Dalgleish A. Cell based cancer vaccines: regulatory and commercial development. Vaccine 25S (2007) B35-B46
    • (2007) Vaccine , vol.25 S
    • Copier, J.1    Ward, S.2    Dalgleish, A.3
  • 7
    • 59849122181 scopus 로고    scopus 로고
    • The cancer vaccine roller coaster
    • Goldman B., and DeFrancesco L. The cancer vaccine roller coaster. Nature Biotech. 27 2 (2009) 129-140
    • (2009) Nature Biotech. , vol.27 , Issue.2 , pp. 129-140
    • Goldman, B.1    DeFrancesco, L.2
  • 9
    • 71749115557 scopus 로고    scopus 로고
    • IL-6 and soluble IL-6 receptor gene modified tumor vaccine induces more effcient anti-melanoma immune responses and polarizes response towards Th1 type
    • Iżycki D., Nawrocki S., Filas V., Gryska K., Lamperska K., Wiznerowicz M., Rose-John S., and Mackiewicz A. IL-6 and soluble IL-6 receptor gene modified tumor vaccine induces more effcient anti-melanoma immune responses and polarizes response towards Th1 type. Pol. J. Environ. Stud. 14 S2 (2005) 139-159
    • (2005) Pol. J. Environ. Stud. , vol.14 , Issue.SUPPL.2 , pp. 139-159
    • Izycki, D.1    Nawrocki, S.2    Filas, V.3    Gryska, K.4    Lamperska, K.5    Wiznerowicz, M.6    Rose-John, S.7    Mackiewicz, A.8
  • 10
    • 10744230275 scopus 로고    scopus 로고
    • Adjuvant autologous renal tumor cell vaccine and risk of tumor progression in patients with renal-cell carcinoma after radical nephrectomy: phase III, randomized controlled trial
    • Jocham D., Richter A., Hoffmann L., Iwig K., Fahlenkamp D., Zakrzewski G., Schmitt E., Dannenberg T., Lechmacher W., von Wietersheim J., and Doehn C. Adjuvant autologous renal tumor cell vaccine and risk of tumor progression in patients with renal-cell carcinoma after radical nephrectomy: phase III, randomized controlled trial. Lancet 363 (2004) 594-599
    • (2004) Lancet , vol.363 , pp. 594-599
    • Jocham, D.1    Richter, A.2    Hoffmann, L.3    Iwig, K.4    Fahlenkamp, D.5    Zakrzewski, G.6    Schmitt, E.7    Dannenberg, T.8    Lechmacher, W.9    von Wietersheim, J.10    Doehn, C.11
  • 11
  • 13
    • 71749119491 scopus 로고    scopus 로고
    • Vaccine composition
    • International Patent. PCT/EP/00780
    • Mackiewicz, A. 2008. Vaccine composition. International Patent. PCT/EP/00780.
    • (2008)
    • Mackiewicz, A.1
  • 14
    • 0026782577 scopus 로고
    • Soluble human IL-6-receptor/IL-6 up-regulates expression of acute phase proteins
    • Mackiewicz A., Schooltink H., Heinrich P., and Rose-John S. Soluble human IL-6-receptor/IL-6 up-regulates expression of acute phase proteins. J. Immunol. 149 (1992) 2021-2027
    • (1992) J. Immunol. , vol.149 , pp. 2021-2027
    • Mackiewicz, A.1    Schooltink, H.2    Heinrich, P.3    Rose-John, S.4
  • 15
    • 0028982471 scopus 로고
    • Gene therapy of human melanoma. Immunization of patients with autologous tumor cells admixed with allogeneic melanoma cells secreting interleukin 6 and soluble interleukin 6 receptor
    • Mackiewicz A., Gorny A., Laciak M., Malicki J., Murawa P., Nowak J., Wiznerowicz M., Hawley R.G., Heinrich P.C., and Rose-John S. Gene therapy of human melanoma. Immunization of patients with autologous tumor cells admixed with allogeneic melanoma cells secreting interleukin 6 and soluble interleukin 6 receptor. Hum. Gene Ther 6 (1995) 805-811
    • (1995) Hum. Gene Ther , vol.6 , pp. 805-811
    • Mackiewicz, A.1    Gorny, A.2    Laciak, M.3    Malicki, J.4    Murawa, P.5    Nowak, J.6    Wiznerowicz, M.7    Hawley, R.G.8    Heinrich, P.C.9    Rose-John, S.10
  • 18
    • 33646357786 scopus 로고    scopus 로고
    • Measuring response in a post-RECIST world: from black and white to shades of grey
    • Michaelis L.C., and Ratain M.J. Measuring response in a post-RECIST world: from black and white to shades of grey. Nat. Rev. Cancer 6 (2006) 409-414
    • (2006) Nat. Rev. Cancer , vol.6 , pp. 409-414
    • Michaelis, L.C.1    Ratain, M.J.2
  • 22
    • 45949108923 scopus 로고    scopus 로고
    • Cancer vaccines: accomplishments and challenges
    • Pejwar-Gaddy S., and Finn O.J. Cancer vaccines: accomplishments and challenges. Crit. Rev. Oncol/Hematol. 67 (2008) 93-102
    • (2008) Crit. Rev. Oncol/Hematol. , vol.67 , pp. 93-102
    • Pejwar-Gaddy, S.1    Finn, O.J.2
  • 23
    • 33646348754 scopus 로고    scopus 로고
    • A Phase II trial of vaccination with autologous, tumor-derived heat-shock protein peptide complex Gp96, in combination with GM-SCF and interferon-alfa in metastatic melanoma patients
    • Pilla L., Patuzzo R., Rivoltini L., et al. A Phase II trial of vaccination with autologous, tumor-derived heat-shock protein peptide complex Gp96, in combination with GM-SCF and interferon-alfa in metastatic melanoma patients. Cancer Immunol. Immunother. 55 8 (2006) 958-968
    • (2006) Cancer Immunol. Immunother. , vol.55 , Issue.8 , pp. 958-968
    • Pilla, L.1    Patuzzo, R.2    Rivoltini, L.3
  • 25
    • 4644324025 scopus 로고    scopus 로고
    • Cancer immunotherapy: moving beyond current vaccines
    • Rosenberg S.A., Yang J.C., and Restifo N. Cancer immunotherapy: moving beyond current vaccines. Nat. Med. 10 (2004) 909-915
    • (2004) Nat. Med. , vol.10 , pp. 909-915
    • Rosenberg, S.A.1    Yang, J.C.2    Restifo, N.3
  • 26
    • 41049111969 scopus 로고    scopus 로고
    • Cancer stem cells and human malignant melanoma
    • Schatton T., and Frank M.H. Cancer stem cells and human malignant melanoma. Pigment Cell Melanoma Res. 21 (2007) 39-55
    • (2007) Pigment Cell Melanoma Res. , vol.21 , pp. 39-55
    • Schatton, T.1    Frank, M.H.2
  • 29
    • 33746012881 scopus 로고    scopus 로고
    • Placebo-controlled phase III trial of immunologic therapy with sipuleucel-T (APC8015) in patients with metastatic, asymptomatic hormone refractory prostate cancer
    • Small E.J., Schellhammer P.F., and Higano C.S. Placebo-controlled phase III trial of immunologic therapy with sipuleucel-T (APC8015) in patients with metastatic, asymptomatic hormone refractory prostate cancer. J. Clin. Oncol. 24 (2006) 3089-3094
    • (2006) J. Clin. Oncol. , vol.24 , pp. 3089-3094
    • Small, E.J.1    Schellhammer, P.F.2    Higano, C.S.3
  • 30
    • 0742321971 scopus 로고    scopus 로고
    • Results of clinical trial with an allogeneic melanoma tumor cell lysate vaccine: Melacine
    • Sondak V.K., and Sosman J.A. Results of clinical trial with an allogeneic melanoma tumor cell lysate vaccine: Melacine. Semin. Cancer. Biol. 13 (2003) 409-415
    • (2003) Semin. Cancer. Biol. , vol.13 , pp. 409-415
    • Sondak, V.K.1    Sosman, J.A.2
  • 31
    • 39749132274 scopus 로고    scopus 로고
    • Cancer vaccines: clinical development challenges and proposed regulatory approaches for patient access to promising treatments
    • Stebbing J., Eood Ch., Atkins M., Bukowski R., Litwin S., Bower M., Parsa A., and H. L. Cancer vaccines: clinical development challenges and proposed regulatory approaches for patient access to promising treatments. Cancer 112 (2008) 955-961
    • (2008) Cancer , vol.112 , pp. 955-961
    • Stebbing, J.1    Eood, Ch.2    Atkins, M.3    Bukowski, R.4    Litwin, S.5    Bower, M.6    Parsa, A.7    H., L.8
  • 32
    • 14844309609 scopus 로고    scopus 로고
    • Immunotherapy with autologous tumor cell-BCG vaccine in patients with colon cancer: a prospective study of medical and economic benefits
    • Uyl-de Groot C.A., Vermorken J.B., Hanna M.G., Verboom P., Groot M.T., Bonsel G.J., Meijer C.J., and Pinedo H.M. Immunotherapy with autologous tumor cell-BCG vaccine in patients with colon cancer: a prospective study of medical and economic benefits. Vaccine 23 (2005) 2379-2387
    • (2005) Vaccine , vol.23 , pp. 2379-2387
    • Uyl-de Groot, C.A.1    Vermorken, J.B.2    Hanna, M.G.3    Verboom, P.4    Groot, M.T.5    Bonsel, G.J.6    Meijer, C.J.7    Pinedo, H.M.8
  • 33
    • 0031896592 scopus 로고    scopus 로고
    • There are no bad anticancer agents, only bad clinical trial designs - twenty-first Richard and Hinda Rosenthal Foundation Award Lecture
    • Von Hoff D.D. There are no bad anticancer agents, only bad clinical trial designs - twenty-first Richard and Hinda Rosenthal Foundation Award Lecture. Clin. Cancer Res. 4 (1998) 1079-1089
    • (1998) Clin. Cancer Res. , vol.4 , pp. 1079-1089
    • Von Hoff, D.D.1
  • 34
    • 0032724112 scopus 로고    scopus 로고
    • Phase I trial of a MART-1 peptide vaccine with incomplete Freund's adjuvant for resected high-risk melanoma
    • Wang F., Bade E., Kuniyoshi C., Spears L., Jeffery G., Marty V., Groshen S., and Weber J. Phase I trial of a MART-1 peptide vaccine with incomplete Freund's adjuvant for resected high-risk melanoma. Clin. Cancer Res. 5 10 (1999) 2756-2765
    • (1999) Clin. Cancer Res. , vol.5 , Issue.10 , pp. 2756-2765
    • Wang, F.1    Bade, E.2    Kuniyoshi, C.3    Spears, L.4    Jeffery, G.5    Marty, V.6    Groshen, S.7    Weber, J.8
  • 38
    • 45549100605 scopus 로고    scopus 로고
    • Melanoma stem cells: the dark seed of melanoma
    • Zabierowski S.E., and Herlyn M. Melanoma stem cells: the dark seed of melanoma. JCO 28 17 (2008) 2890-2894
    • (2008) JCO , vol.28 , Issue.17 , pp. 2890-2894
    • Zabierowski, S.E.1    Herlyn, M.2
  • 39
    • 71749106456 scopus 로고    scopus 로고
    • Guideline for Potency Testing of Cell-Based Immunotherapy Medicinal Products for Treatment of Cancer: EMEA/CHMP/410869/2006. Committee For Medicinal Products for Human Use, European Medicines Agency, London UK 2006
    • Guideline for Potency Testing of Cell-Based Immunotherapy Medicinal Products for Treatment of Cancer: EMEA/CHMP/410869/2006. Committee For Medicinal Products for Human Use, European Medicines Agency, London UK (2006). http://www.emea.europa.eu/pdfs/human/bwp/27147506en.pdf.
  • 40
    • 71749121171 scopus 로고    scopus 로고
    • Regulation (EC) No 1394/2007 of the European Parliament and of The Council of 13 November 2007 on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004. http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/1/reg_2007_1394/reg_2007_1394_en.pdf.
    • Regulation (EC) No 1394/2007 of the European Parliament and of The Council of 13 November 2007 on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004. http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/vol-1/reg_2007_1394/reg_2007_1394_en.pdf.


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.