Skip to main content

Clinical Trial Designs for Therapeutic Cancer Vaccines

  • Chapter

Part of the book series: Cancer Treatment and Research ((CTAR,volume 123))

This is a preview of subscription content, log in via an institution.

Buying options

Chapter
USD   29.95
Price excludes VAT (USA)
  • Available as PDF
  • Read on any device
  • Instant download
  • Own it forever
eBook
USD   169.00
Price excludes VAT (USA)
  • Available as PDF
  • Read on any device
  • Instant download
  • Own it forever
Softcover Book
USD   219.99
Price excludes VAT (USA)
  • Compact, lightweight edition
  • Dispatched in 3 to 5 business days
  • Free shipping worldwide - see info
Hardcover Book
USD   219.99
Price excludes VAT (USA)
  • Durable hardcover edition
  • Dispatched in 3 to 5 business days
  • Free shipping worldwide - see info

Tax calculation will be finalised at checkout

Purchases are for personal use only

Learn about institutional subscriptions

Preview

Unable to display preview. Download preview PDF.

Unable to display preview. Download preview PDF.

References

  1. Simon, R.M., S.M. Steinberg, M. Hamilton, A. Hildesheim, S. Khleif, L.W. Kwak, C.L. Mackall, J. Schlom, S.L. Topalian, and J.A. Berzofsky. 2001. Clinical trial designs for the early clinical development of therapeutic cancer vaccines. J Clin Oncol 19:1848–1854.

    PubMed  CAS  Google Scholar 

  2. Salgaller, M.L., F. Marincola, J.N. Cormier, and S.A. Rosenberg. 1996. Immunization against epitopes in the human melanoma antigen gp100 following patient immunization with synthetic peptides. Cancer Res 56:4749–4757.

    PubMed  CAS  Google Scholar 

  3. Cormier, J.N., M.L. Salgaller, T. Prevette, K.C. Barracchini, L. Rivoltini, N.P. Restifo, S.A. Rosenberg, and F.M. Marincola. 1997. Enhancement of cellular immunity in melanoma patients immunized with a peptide from MART-1/Melan A. Cancer J Sci Am 3:37–44.

    PubMed  CAS  Google Scholar 

  4. Korn, E.L., L.V. Rubinstein, S.A. Hunsberger et al.: Clinical trial designs for cytostatic agents and agents directed at novel molecular targets. In J.K. Buolamwini, and A.A. Adjei eds. Novel Anticancer Drug Protocols (Methods in Molecular Medicine Series), Humana Press, 2003 (In Press).

    Google Scholar 

  5. Casagrande, J.T., M.C. Pike, and P.G. Smith. 1978. The power function of the “exact” test for comparing two binomial distributions. Appl Stat 27:176–180.

    Article  Google Scholar 

  6. Anderson, J.R., K.C. Cain, R.D. Gelber. 1983. Analysis of survival by tumor response. J Clin Oncol 1:710.

    PubMed  CAS  Google Scholar 

  7. Simon, R., and R.W. Makuch. 1984. A nonparametric graphical representation of the relationship between survival and the occurrence of an event: application to responder versus non-responder bias. Stat Med 3:1.

    Article  Google Scholar 

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

    Article  PubMed  CAS  Google Scholar 

  9. Fleming, T.R. 1982. One sample multiple testing procedure for phase II clinical trials. Biometrics 38:143.

    Article  PubMed  CAS  Google Scholar 

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

    Article  PubMed  CAS  Google Scholar 

  11. Garnsey-Ensign L., E.A. Gehan, D. Kamen, and P.F. Thall. 1994. An optimal three-stage design for phase II clinical trials. Stat Med 13:1727.

    Article  Google Scholar 

  12. Thall, P.F., R. Simon, E. Estey. 1996. A new statistical strategy for monitoring safety and efficacy in single-arm clinical trials. J Clin Oncol 14:296–303.

    PubMed  CAS  Google Scholar 

  13. Makuch, R.W., and R.M. Simon. 1980. Sample size considerations for non-randomized comparative studies. J Chron Dis 33:175–181.

    Article  PubMed  CAS  Google Scholar 

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

    Article  PubMed  CAS  Google Scholar 

  15. Thall, P.F., and R. Simon. 1990. Incorporating historical control data in planning phase II clinical trials. Stat Med 9:215–228.

    Article  PubMed  CAS  Google Scholar 

  16. Simon, R., R.E. Wittes, and S.S. Ellenberg. 1985. Randomized phase II clinical trials. Cancer Treatment Rep 69:1375–1381.

    CAS  Google Scholar 

  17. Strauss, N. and R. Simon. 1995. Investigating a sequence of randomized phase II trials to discover promising treatments. Stat Med 14:1479–1489.

    Article  PubMed  CAS  Google Scholar 

  18. Yao, T.J., C.B. Begg, and P.O. Livingston. 1996. Optimal sample size for a series of pilot trials of new agents. Biometrics 52:992–1001.

    Article  PubMed  CAS  Google Scholar 

  19. Rubinstein, L.V., M.H. Gail, and T.J. Santner. 1981. Planning the duration of a comparative clinical trial with loss to follow-up and a period of continued observation. J Chronic Dis 34:469–479.

    Article  PubMed  CAS  Google Scholar 

  20. Thall, P.F., R. Simon, S.S. Ellenberg, and R. Shrager. 1988. Optimal two-stage designs for clinical trials with binary response. Stat Med 7:571–579.

    Article  PubMed  CAS  Google Scholar 

  21. Lan, G., R. Simon, and M. Halperin. 1982. Stochastically curtailed tests in Long-term clinical trials. Commun Stat—Sequential Anals 1:207–219.

    Google Scholar 

Download references

Author information

Authors and Affiliations

Authors

Editor information

Editors and Affiliations

Rights and permissions

Reprints and permissions

Copyright information

© 2005 Kluwer Academic Publishers

About this chapter

Cite this chapter

Simon, R. (2005). Clinical Trial Designs for Therapeutic Cancer Vaccines. In: Khleif, S.N. (eds) Tumor Immunology and Cancer Vaccines. Cancer Treatment and Research, vol 123. Springer, Boston, MA. https://doi.org/10.1007/0-387-27545-2_14

Download citation

  • DOI: https://doi.org/10.1007/0-387-27545-2_14

  • Publisher Name: Springer, Boston, MA

  • Print ISBN: 978-1-4020-8119-4

  • Online ISBN: 978-0-387-27545-1

  • eBook Packages: MedicineMedicine (R0)

Publish with us

Policies and ethics