Original Article

You have full text access to this OnlineOpen article

Phase 2 trial of combination thalidomide plus temozolomide in patients with metastatic malignant melanoma: Southwest Oncology Group S0508†

  1. Joseph I. Clark MD1,‡,*,
  2. James Moon MS2,
  3. Laura F. Hutchins MD3,
  4. Jeffrey A. Sosman MD4,
  5. W. Martin Kast PhD5,
  6. Diane M. Da Silva PhD5,
  7. P. Y. Liu PhD2,
  8. John A. Thompson MD6,
  9. Lawrence E. Flaherty MD7,
  10. Vernon K. Sondak MD8

Article first published online: 13 NOV 2009

DOI: 10.1002/cncr.24739

Issue

Cancer

Cancer

Volume 116, Issue 2, pages 424–431, 15 January 2010

Additional Information

How to Cite

Clark, J. I., Moon, J., Hutchins, L. F., Sosman, J. A., Kast, W. M., Da Silva, D. M., Liu, P. Y., Thompson, J. A., Flaherty, L. E. and Sondak, V. K. (2010), Phase 2 trial of combination thalidomide plus temozolomide in patients with metastatic malignant melanoma: Southwest Oncology Group S0508. Cancer, 116: 424–431. doi: 10.1002/cncr.24739

Author Information

  1. 1

    Loyola University Stritch School of Medicine, Maywood, Illinois

  2. 2

    Southwest Oncology Group Statistical Center, Seattle, Washington

  3. 3

    University of Arkansas for Medical Sciences, Little Rock, Arkansas

  4. 4

    Vanderbilt University School of Medicine, Nashville, Tennessee

  5. 5

    University of Southern California, Los Angeles, California

  6. 6

    Seattle Cancer Care Alliance, Seattle, Washington

  7. 7

    Wayne State University, Detroit, Michigan

  8. 8

    H. Lee Moffitt Cancer Center, Tampa, Florida

  1. ‡

    Fax: (708) 327-3218

*Cardinal Bernardin Cancer Center, Loyola University Medical Center, Division of Hematology/Oncology, 2160 South First Avenue, Maywood, IL 60153

  1. †

    Presented at the American Society of Clinical Oncology (ASCO) 44th Annual Meeting , May 30–June 3, 2008, Chicago, Illinois.

Publication History

  1. Issue published online: 20 JAN 2010
  2. Article first published online: 13 NOV 2009
  3. Manuscript Accepted: 4 MAY 2009
  4. Manuscript Revised: 16 APR 2009
  5. Manuscript Received: 6 FEB 2009

Funded by

  • National Cancer Institute, DHHS. Grant Numbers: CA32102, CA38926, CA46282, CA20319, CA22433, CA35178, CA45807, CA35261, CA35176, CA35431, CA37981, CA74647, CA45808, CA58861, CA45461, CA04919, CA58416, CA67575, CA45560, CA76426, CA11083
  • Celgene Corporation

SEARCH

SEARCH BY CITATION

ARTICLE TOOLS

View Full Article (HTML) Get PDF (146K)

REFERENCES

  • 1
    Chapman PB, Einhorn LH, Meyers ML, et al. Phase III multicenter randomized trial of the Dartmouth regimen versus dacarbazine in patients with metastatic melanoma. J Clin Oncol. 1999; 17: 2745-2751.
  • 2
    Atkins MB, Lotze MT, Dutcher JP, et al. High-dose recombinant interleukin-2 therapy for patients with metastatic melanoma: Analysis of 270 patients treated between 1985 and 1993. J Clin Oncol. 1999; 17: 2105-2116.
  • 3
    Atkins MB, Hsu J, Lee S, et al. Phase III trial comparing concurrent biochemotherapy with cisplatin, vinblastine, dacarbazine, interleukin-2, and interferon alfa-2b with cisplatin, vinblastine, and dacarbazine alone in patients with metastatic malignant melanoma (E3695): A trial coordinated by the Eastern Cooperative Oncology Group. J Clin Oncol. 2008; 26: 5748-5754.
  • 4
    Middleton MR, Grob JJ, Aaronson N, et al. Randomized phase III study of temozolomide versus dacarbazine in the treatment of patients with advanced metastatic melanoma. J Clin Oncol. 2000; 18: 158-166.
  • 5
    Rajkumar SV. Current status of thalidomide in the treatment of cancer. Oncology. 2001; 15: 867-874.
  • 6
    Eisen T, Boshoff C, Mak I, et al. Continuous low dose thalidomide: A phase II study in advanced melanoma, renal cell, ovarian and breast cancer. Br J Cancer. 2000; 82: 812-817.
  • 7
    Kudva GC, Collins BT, Dunphy FR. Thalidomide for malignant melanoma. N Engl J Med. 2001; 345: 1214-1215.
  • 8
    Reiriz AB, Richter MF, Fernandes S, et al. Phase II study of thalidomide in patients with metastatic malignant melanoma. Mel Res. 2004; 14: 527-531.
  • 9
    Hwu WJ, Krown SE, Panageas KS, et al. Temozolomide plus thalidomide in patients with advanced melanoma: Results of a dose-finding trial. J Clin Oncol. 2002; 20: 2610-2615.
  • 10
    Hwu WJ, Krown SE, Menell JH, et al. Phase II study of temozolomide plus thalidomide for the treatment of metastatic melanoma. J Clin Oncol. 2003; 21: 3351-3356.
  • 11
    Danson S, Lorigan P, Arance A, et al. Randomized phase II study of temozolomide given every 8 hours or daily with either interferon alfa-2b or thalidomide in metastatic malignant melanoma. J Clin Oncol. 2003; 21: 2551-2557.
  • 12
    McHugh SM, Rifkin IR, Deighton J, et al. The immunosuppressive drug thalidomide induces T helper cell type 2 (Th2) and concomitantly inhibits Th1 cytokine production in mitogen- and antigen-stimulated human peripheral blood mononuclear cell cultures. Clin Exp Immunol. 1995; 99: 160-167.
  • 13
    Haslett PAJ, Corral LG, Albert M, et al. Thalidomide costimulates primary human T lymphocytes, preferentially inducing proliferation, cytokine production, and cytotoxic responses in the CD8+ subset. J Exp Med. 1998; 187: 1885-1892.
  • 14
    Corral LG, Haslett PAJ, Muller GW, et al. Differential cytokine modulation and T cell activation by 2 distinct classes of thalidomide analogues that are potent inhibitors of TNF-α. J Immunol. 1999; 163: 380-386.
  • 15
    Verbon A, Juffermans NP, Speelman P, et al. A single oral dose of thalidomide enhances the capacity of lymphocytes to secrete gamma interferon in healthy humans. Antimicrob Agents Chemother. 2000; 44: 2286-2290.
  • 16
    Ng WF, Duggan PJ, Ponchel F, et al. Human CD4+CD25+ cells: A naturally occurring population of regulatory T cells. Blood. 2001; 98: 2736-2744.
  • 17
    Annunziato F, Cosmi L, Liotta F, et al. Phenotype, localization, and mechanism of suppression of CD4+CD25+ human thymocytes. J Exp Med. 2002; 196: 379-387.
  • 18
    Bach JF. Regulatory T cells under scrutiny. Nature Rev Immunol. 2003; 3: 189-198.
  • 19
    Belkald Y, Piccirillo GA, Mendez S, et al. CD4+CD25+ regulatory T cells control Leishmania major persistence and immunity. Nature. 2002; 420: 502-507.
  • 20
    Shevach EM. CD4+CD25+ suppressor T cells: More questions than answers. Nature Rev Immunol. 2002; 2: 389-400.
  • 21
    Gray CP, Arosio P, Hersey P. Association of increased levels of heavy-chain ferritin with increased CD4+ CD25+ regulatory T-cell levels in patients with melanoma. Clin Cancer Res. 2003; 9: 2551-2559.
  • 22
    Kaplan EL, Meier P. Nonparametric estimation from incomplete observations. JASA. 1958; 53: 457-481.
  • 23
    Cox DR. Regression models and life tables. JR Stat Soc Ser B. 1972; 34: 187-202.
  • 24
    Lambeck AJ, Crijns AP, Leffers N, et al. Serum cytokine profiling as a diagnostic and prognostic tool in ovarian cancer: a potential role for interleukin 7. Clin Cancer Res. 2007; 13: 2385-2391.
  • 25
    Matijevic M, Uban RG. Use of interferon-gamma ELISPOT in monitoring immune responses in humans. Methods Mol Biol. 2005; 302: 237-252.
  • 26
    Korn EL, Liu PY, Lee SJ, et al. Meta-analysis of phase II cooperative group trials in metastatic stage IV melanoma to determine progression-free and overall survival benchmarks for future phase II trials. J Clin Oncol. 2008; 26: 527-534.
  • 27
    Calabrese L, Fleischer AB. Thalidomide: current and potential clinical applications. Am J Med. 2000; 108: 487-495.
  • 28
    Rosenberg SA. Overcoming obstacles to the effective immunotherapy of human cancer. Proc Natl Acad Sci USA. 2008; 105: 12643-12644.
  • 29
    Kirkwood JM, Lorigan P, Hersey P, et al. A phase II trial of tremilimumab (CP-675,206) in patients with advanced refractory or relapsed melanoma [abstract]. J Clin Oncol. 2008; 26( suppl): 488s. Abstract 9023.
View Full Article (HTML) Get PDF (146K)