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Clinical Trial Designs for Therapeutic Vaccine Studies

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Book cover Handbook of Cancer Vaccines

Part of the book series: Cancer Drug Discovery and Development ((CDD&D))

Abstract

Cancer vaccines are different in many ways from cytotoxic drugs. Consequently some of the paradigms for the early clinical development of cytotoxics are not applicable to the development of therapeutic vaccines. In contrast, many of the principles of phase III clinical trials are applicable to cancer vaccines. In this chapter we will describe design strategies for the efficient early clinical development of cancer vaccines.

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References

  1. Salgaller ML, Marincola F, Cormier, JN, Rosenberg, SA. Immunization against epitopes in the human melanoma antigen gp100 following patient immunization with synthetic peptides. Cancer Res 1996; 56:4749–4757.

    PubMed  CAS  Google Scholar 

  2. Cormier JN, Salgaller ML, Prevette T, Barracchini KC, Rivoltini L, Restifo NP, Rosenberg SA, Marincola FM. Enhancement of cellular immunity in melanoma patients immunized with a peptide form MART-1/Melan A. Cancer J Sci Am 1997; 3:37–44.

    PubMed  CAS  Google Scholar 

  3. Casagrande JT, Pike MC, Smith PG. The power function of the “exact” test for comparing two binomial distributions. Appl Stat 1978; 27:176–180.

    Article  Google Scholar 

  4. Anderson JR, Cain KC, Gelber RD. Analysis of survival by tumor response. J Clin Oncol 1983; 1:710–719.

    PubMed  CAS  Google Scholar 

  5. Simon R, Makuch RW. A non-parametric graphical representation of the relationship between survival and the occurrence of an event: application to responder versus non-responder bias. Stat Med 1984; 3:35–44.

    Article  PubMed  CAS  Google Scholar 

  6. Toni V, Simon R, Russek-Cohen E, Midthune D, Friedman M. Relationship of response and survival in advanced ovarian cancer patients treated with chemotherapy. J Natl Cancer Inst 1992; 84:407–414.

    Article  Google Scholar 

  7. Fleming TR. One sample multiple testing procedure for phase II clinical trials. Biometrics 1982; 38:143.

    Article  PubMed  CAS  Google Scholar 

  8. Simon R. Optimal two-stage designs for phase II clinical trials. Control Clin Trials 1989; 10:1–10.

    Article  PubMed  CAS  Google Scholar 

  9. Ensign LG, Gehan EA, Kamen DS, Thall PF. An optimal three-stage design for phase II clinical trials. Stat Med 1994: 13:1727–1736.

    Article  PubMed  CAS  Google Scholar 

  10. Bendandi M, Gocke CD, Kobrin CB, Benko FA, Sternas LA, Pennington R, et al. Complete molecular remissions induced by patient specific vaccination plus granulocyte-monocyte colony stimulating factor against lymphoma. Nature Med 1999; 5:1171–1177.

    Article  PubMed  CAS  Google Scholar 

  11. Dixon DO, Simon R. Sample size considerations for studies comparing survival curves using historical controls. J Clin Epidemiol 1988; 41:1209–1213.

    Article  PubMed  CAS  Google Scholar 

  12. Rubinstein LV, Gail MH, Santner TJ. Planning the duration of a comparative clinical trial with loss to follow-up and a period of continued observation. J Chronic Dis 1981; 34:469–479.

    Article  PubMed  CAS  Google Scholar 

  13. Simon RM, Steinberg SM, Hamilton M, Hildesheim A, Khleif S, Kwak LW, et al. Clinical trial designs for the early clinical development of therapeutic cancer vaccines. J Clin Oncol 2001; 19:1848–1854.

    PubMed  CAS  Google Scholar 

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© 2004 Humana Press Inc.

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Simon, R. (2004). Clinical Trial Designs for Therapeutic Vaccine Studies. In: Morse, M.A., Clay, T.M., Lyerly, H.K. (eds) Handbook of Cancer Vaccines. Cancer Drug Discovery and Development. Humana Press, Totowa, NJ. https://doi.org/10.1007/978-1-59259-680-5_34

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  • DOI: https://doi.org/10.1007/978-1-59259-680-5_34

  • Publisher Name: Humana Press, Totowa, NJ

  • Print ISBN: 978-1-4684-9818-9

  • Online ISBN: 978-1-59259-680-5

  • eBook Packages: Springer Book Archive

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