메뉴 건너뛰기




Volumn 41, Issue , 2015, Pages 172-179

A Phase I/II adaptive design to determine the optimal treatment regimen from a set of combination immunotherapies in high-risk melanoma

Author keywords

Biological agent; Immunotherapy; Oncology; Optimal dose; Phase I II

Indexed keywords

PEPTIDE VACCINE; TOLL LIKE RECEPTOR AGONIST; CANCER VACCINE; IMMUNOLOGICAL ADJUVANT; TOLL LIKE RECEPTOR;

EID: 84922262186     PISSN: 15517144     EISSN: 15592030     Source Type: Journal    
DOI: 10.1016/j.cct.2015.01.016     Document Type: Article
Times cited : (21)

References (35)
  • 1
    • 84922239156 scopus 로고    scopus 로고
    • The current design of oncology phase I clinical trials: progressing from algorithms to statistical models
    • Braun T. The current design of oncology phase I clinical trials: progressing from algorithms to statistical models. Chin Clin Oncol 2014, 3:2.
    • (2014) Chin Clin Oncol , vol.3 , pp. 2
    • Braun, T.1
  • 3
    • 84901048582 scopus 로고    scopus 로고
    • Using joint utilities of the times to response and toxicity to adaptively optimize schedule-dose regimes
    • Thall P.F., Nguyen H.Q., Braun T., Qazilbash M.H. Using joint utilities of the times to response and toxicity to adaptively optimize schedule-dose regimes. Biometrics 2013, 69:673-682.
    • (2013) Biometrics , vol.69 , pp. 673-682
    • Thall, P.F.1    Nguyen, H.Q.2    Braun, T.3    Qazilbash, M.H.4
  • 4
    • 84899906158 scopus 로고    scopus 로고
    • Phase I/II adaptive design for drug combination oncology trials
    • Wages N.A., Conaway M.R. Phase I/II adaptive design for drug combination oncology trials. Stat Med 2014, 33:1990-2003.
    • (2014) Stat Med , vol.33 , pp. 1990-2003
    • Wages, N.A.1    Conaway, M.R.2
  • 5
    • 84901271617 scopus 로고    scopus 로고
    • Adaptive designs for identifying optimal biological dose for molecularly targeted agents
    • Zang Y., Lee J.J., Yuan Y. Adaptive designs for identifying optimal biological dose for molecularly targeted agents. Clin Trials 2014, 11:319-327.
    • (2014) Clin Trials , vol.11 , pp. 319-327
    • Zang, Y.1    Lee, J.J.2    Yuan, Y.3
  • 7
    • 84856558003 scopus 로고    scopus 로고
    • Immunotherapy with PI3K inhibitor and Toll-like receptor agonist induces IFN-gamma+IL-17+ polyfunctional T cells that mediate rejection of murine tumors
    • Marshall N.A., Galvin K.C., Corcoran A.M., Boon L., Millis K.H. Immunotherapy with PI3K inhibitor and Toll-like receptor agonist induces IFN-gamma+IL-17+ polyfunctional T cells that mediate rejection of murine tumors. Cancer Res 2012, 72:581-591.
    • (2012) Cancer Res , vol.72 , pp. 581-591
    • Marshall, N.A.1    Galvin, K.C.2    Corcoran, A.M.3    Boon, L.4    Millis, K.H.5
  • 8
    • 67649220219 scopus 로고    scopus 로고
    • IFN-alpha enhances peptide vaccine-induced CD8+ T cell numbers, effector function, and antitumor activity
    • Sikora A.G., Jaffarzad N., Hailemichael Y., Gelbard A., Stonier S.W., Schluns K.S., et al. IFN-alpha enhances peptide vaccine-induced CD8+ T cell numbers, effector function, and antitumor activity. J Immunol 2009, 182:7398-7407.
    • (2009) J Immunol , vol.182 , pp. 7398-7407
    • Sikora, A.G.1    Jaffarzad, N.2    Hailemichael, Y.3    Gelbard, A.4    Stonier, S.W.5    Schluns, K.S.6
  • 9
    • 84889342609 scopus 로고    scopus 로고
    • Design issues for early-stage clinical trials
    • Humana Press, Totowa, New Jersey, M. Disis (Ed.)
    • Petroni G. Design issues for early-stage clinical trials. Immunotherapy of cancer 2006, 479-485. Humana Press, Totowa, New Jersey. M. Disis (Ed.).
    • (2006) Immunotherapy of cancer , pp. 479-485
    • Petroni, G.1
  • 10
    • 0345424863 scopus 로고    scopus 로고
    • [cited 2011 October 2011]. Available from:
    • FDA USDoHaHS, Administration FaD, Research CfBEa Guidance for industry clinical considerations for therapeutic cancer vaccines [cited 2011 October 2011]. Available from:. http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInfor-mation/Guidances/default.htm.
    • Guidance for industry clinical considerations for therapeutic cancer vaccines
  • 11
    • 84907907834 scopus 로고    scopus 로고
    • Is the "3+3" dose-escalation phase I clinical trial design suitable for therapeutic cancer vaccine development? A recommendation for alternative design
    • Rahma O.E., Gammoh E., Simon R.M., Khleif S.M. Is the "3+3" dose-escalation phase I clinical trial design suitable for therapeutic cancer vaccine development? A recommendation for alternative design. Clin Cancer Res 2014, 20:4758-4767.
    • (2014) Clin Cancer Res , vol.20 , pp. 4758-4767
    • Rahma, O.E.1    Gammoh, E.2    Simon, R.M.3    Khleif, S.M.4
  • 12
    • 0035868647 scopus 로고    scopus 로고
    • Clinical trial designs for the early clinical development of therapeutic cancer vaccines
    • Simon R., Steinberg S., Hamilton M. Clinical trial designs for the early clinical development of therapeutic cancer vaccines. J Clin Oncol 2001, 19:1848-1854.
    • (2001) J Clin Oncol , vol.19 , pp. 1848-1854
    • Simon, R.1    Steinberg, S.2    Hamilton, M.3
  • 13
    • 3242721608 scopus 로고    scopus 로고
    • Nontoxicity endpoints in phase I trial designs for targeted, non-cytotoxic agents
    • Korn E. Nontoxicity endpoints in phase I trial designs for targeted, non-cytotoxic agents. J Natl Cancer Inst 2004, 96:977-978.
    • (2004) J Natl Cancer Inst , vol.96 , pp. 977-978
    • Korn, E.1
  • 14
    • 3242679103 scopus 로고    scopus 로고
    • Phase I trial design for solid tumors studies of targeted, non-cytotoxic agents: theory and practice
    • Parulekar W.R., Eisenhauer E.A. Phase I trial design for solid tumors studies of targeted, non-cytotoxic agents: theory and practice. J Natl Cancer Inst 2004, 96:970-977.
    • (2004) J Natl Cancer Inst , vol.96 , pp. 970-977
    • Parulekar, W.R.1    Eisenhauer, E.A.2
  • 15
    • 66849118694 scopus 로고    scopus 로고
    • Dose escalation methods in phase I cancer clinical trials
    • Le Tourneau C., Lee J.J., Siu L.L. Dose escalation methods in phase I cancer clinical trials. J Natl Cancer Inst 2009, 101:708-720.
    • (2009) J Natl Cancer Inst , vol.101 , pp. 708-720
    • Le Tourneau, C.1    Lee, J.J.2    Siu, L.L.3
  • 16
    • 77949669232 scopus 로고    scopus 로고
    • An overview of the optimal planning, design, and conduct of phase I studies of new therapeutics
    • LoRusso P., Boerner S., Seymour L. An overview of the optimal planning, design, and conduct of phase I studies of new therapeutics. Clin Cancer Res 2010, 16:1710-1718.
    • (2010) Clin Cancer Res , vol.16 , pp. 1710-1718
    • LoRusso, P.1    Boerner, S.2    Seymour, L.3
  • 17
    • 21844458704 scopus 로고    scopus 로고
    • Dose escalation trial designs based on a molecularly targeted endpoint
    • Hunsberger S., Rubinstein L., Dancey J., Korn E. Dose escalation trial designs based on a molecularly targeted endpoint. Stat Med 2005, 24:2171-2181.
    • (2005) Stat Med , vol.24 , pp. 2171-2181
    • Hunsberger, S.1    Rubinstein, L.2    Dancey, J.3    Korn, E.4
  • 18
    • 33745956991 scopus 로고    scopus 로고
    • An adaptive dose-finding design incorporating both toxicity and efficacy
    • Zhang W., Sargent D., Mandrekar S. An adaptive dose-finding design incorporating both toxicity and efficacy. Stat Med 2006, 25:2365-2383.
    • (2006) Stat Med , vol.25 , pp. 2365-2383
    • Zhang, W.1    Sargent, D.2    Mandrekar, S.3
  • 19
    • 39849090451 scopus 로고    scopus 로고
    • Two-stage designs for dose-finding trials with a biologic endpoint using stepwise tests
    • Polley M.Y., Cheung Y.K. Two-stage designs for dose-finding trials with a biologic endpoint using stepwise tests. Biometrics 2008, 64:232-241.
    • (2008) Biometrics , vol.64 , pp. 232-241
    • Polley, M.Y.1    Cheung, Y.K.2
  • 20
    • 84939260930 scopus 로고    scopus 로고
    • Seamless phase I/II adaptive design for oncology trials of molecularly targeted agents
    • [Epub ahead of print]
    • Wages N.A., Tait C. Seamless phase I/II adaptive design for oncology trials of molecularly targeted agents. J Biopharm Stat June 6 2014, [Epub ahead of print]. 10.1080/10543406.2014.920873.
    • (2014) J Biopharm Stat
    • Wages, N.A.1    Tait, C.2
  • 21
    • 49249113717 scopus 로고    scopus 로고
    • Challenges and pitfalls of combining targeted agents in phase I studies
    • Cannistra S. Challenges and pitfalls of combining targeted agents in phase I studies. J Clin Oncol 2008, 26:3665-3667.
    • (2008) J Clin Oncol , vol.26 , pp. 3665-3667
    • Cannistra, S.1
  • 22
    • 79960706708 scopus 로고    scopus 로고
    • A randomized multicenter trial of the effects of melanoma-associated helper peptides and cyclophosphamide on the immunogenicity of a multipeptide melanoma vaccine
    • Slingluff C.L., Petroni G.R., Chianese-Bullock K.A., Smolkin M.E., Ross M.I., Haas N.B., et al. A randomized multicenter trial of the effects of melanoma-associated helper peptides and cyclophosphamide on the immunogenicity of a multipeptide melanoma vaccine. J Clin Oncol 2011, 29:2924-2932.
    • (2011) J Clin Oncol , vol.29 , pp. 2924-2932
    • Slingluff, C.L.1    Petroni, G.R.2    Chianese-Bullock, K.A.3    Smolkin, M.E.4    Ross, M.I.5    Haas, N.B.6
  • 23
    • 0025148278 scopus 로고
    • Continual reassessment method: a practical design for phase I clinical trials in cancer
    • O'Quigley J., Pepe M., Fisher L. Continual reassessment method: a practical design for phase I clinical trials in cancer. Biometrics 1990, 46:33-48.
    • (1990) Biometrics , vol.46 , pp. 33-48
    • O'Quigley, J.1    Pepe, M.2    Fisher, L.3
  • 24
    • 80051695896 scopus 로고    scopus 로고
    • Dose finding design for multi-drug combinations
    • Wages N.A., Conaway M.R., O'Quigley J. Dose finding design for multi-drug combinations. Clin Trials 2011, 8:380-389.
    • (2011) Clin Trials , vol.8 , pp. 380-389
    • Wages, N.A.1    Conaway, M.R.2    O'Quigley, J.3
  • 25
    • 67649321803 scopus 로고    scopus 로고
    • Mdel calibration in the continual reassessment method
    • Lee S.M., Cheung Y.K. Mdel calibration in the continual reassessment method. Clin Trials 2009, 6:227-238.
    • (2009) Clin Trials , vol.6 , pp. 227-238
    • Lee, S.M.1    Cheung, Y.K.2
  • 26
    • 84863484374 scopus 로고    scopus 로고
    • Adaptive randomization to improve utility-based dose-finding with bivariate ordinal outcomes
    • Thall P.F., Nguyen H.Q. Adaptive randomization to improve utility-based dose-finding with bivariate ordinal outcomes. J Biopharm Stat 2012, 22:785-801.
    • (2012) J Biopharm Stat , vol.22 , pp. 785-801
    • Thall, P.F.1    Nguyen, H.Q.2
  • 27
    • 72549116845 scopus 로고    scopus 로고
    • Effect of GM-CSF on circulating CD8+ and CD4+ T cell responses to a multipeptide melanoma vaccine: outcome of a multicenter randomized trial
    • Slingluff C.L., Petroni G.R., Olson W.C., Smolkin M.E., Ross M.I., Haas N.B., et al. Effect of GM-CSF on circulating CD8+ and CD4+ T cell responses to a multipeptide melanoma vaccine: outcome of a multicenter randomized trial. Clin Cancer Res 2009, 15:7036-7044.
    • (2009) Clin Cancer Res , vol.15 , pp. 7036-7044
    • Slingluff, C.L.1    Petroni, G.R.2    Olson, W.C.3    Smolkin, M.E.4    Ross, M.I.5    Haas, N.B.6
  • 29
    • 77955862482 scopus 로고    scopus 로고
    • Retrospective robustness of the continual reassessment method
    • O'Quigley J., Zohar S. Retrospective robustness of the continual reassessment method. J Biopharm Stat 2010, 5:1013-1025.
    • (2010) J Biopharm Stat , vol.5 , pp. 1013-1025
    • O'Quigley, J.1    Zohar, S.2
  • 30
    • 84863304598 scopus 로고    scopus 로고
    • R Foundation for Statistical Computing, Vienna, Austria, [URL]
    • R Core Team R: a language and environment for statistical computing 2013, R Foundation for Statistical Computing, Vienna, Austria, [URL http://www.R-project.org].
    • (2013) R: a language and environment for statistical computing
  • 31
    • 84922211984 scopus 로고    scopus 로고
    • Dfcrm: dose-finding by the continual reassessment method
    • Cheung K. dfcrm: dose-finding by the continual reassessment method. R package version 0.2-2 2013 2013, [http://CRAN.R-project.org/package=dfcrm].
    • (2013) R package version 0.2-2 2013
    • Cheung, K.1
  • 32
    • 79959937219 scopus 로고    scopus 로고
    • Extended model-based designs for more complex phase I clinical trials
    • O'Quigley J., Conaway M.R. Extended model-based designs for more complex phase I clinical trials. Stat Med 2011, 30:2062-2069.
    • (2011) Stat Med , vol.30 , pp. 2062-2069
    • O'Quigley, J.1    Conaway, M.R.2
  • 33
    • 84877926031 scopus 로고    scopus 로고
    • Principles of dose finding studies in cancer: a comparison of trial designs
    • Jaki T., Clive S., Weir C.J. Principles of dose finding studies in cancer: a comparison of trial designs. Cancer Chemother Pharmacol 2013, 71:1107-1114.
    • (2013) Cancer Chemother Pharmacol , vol.71 , pp. 1107-1114
    • Jaki, T.1    Clive, S.2    Weir, C.J.3
  • 34
    • 84905829258 scopus 로고    scopus 로고
    • Adaptive dose-finding studies: a review of model-guided phase I clinical trials
    • Iasonos A., O'Quigley J. Adaptive dose-finding studies: a review of model-guided phase I clinical trials. J Clin Oncol 2014, 32:2505-2511.
    • (2014) J Clin Oncol , vol.32 , pp. 2505-2511
    • Iasonos, A.1    O'Quigley, J.2
  • 35
    • 35948972459 scopus 로고    scopus 로고
    • Immunologic and clinical outcomes of a randomized phase II trial of two multipeptide vaccines for melanoma in the adjuvant setting
    • Slingluff C.L., Petroni G.R., Chianese-Bullock K.A., Smolkin M.E., Hibbitts S., Murphy C., et al. Immunologic and clinical outcomes of a randomized phase II trial of two multipeptide vaccines for melanoma in the adjuvant setting. Clin Cancer Res 2007, 13:6386-6395.
    • (2007) Clin Cancer Res , vol.13 , pp. 6386-6395
    • Slingluff, C.L.1    Petroni, G.R.2    Chianese-Bullock, K.A.3    Smolkin, M.E.4    Hibbitts, S.5    Murphy, C.6


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.