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CLINICAL TRANSLATIONAL THERAPEUTICS

Phase 1 Results From a Study of Romidepsin in Combination With Gemcitabine in Patients With Advanced Solid Tumors

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Pages 481-486 | Published online: 26 Apr 2012

REFERENCES

  • Ueda H, Manda T, Matsumoto S, Mukumoto S, Nishigaki F, Kawamura I, Shimomura K. FR901228, a novel antitumor bicyclic depsipeptide produced by Chromobacterium violaceum No. 968. III. Antitumor activities on experimental tumors in mice. J Antibiot 1994;47:315–323.
  • Ueda H, Nakajima H, Hori Y, Fujita T, Nishimura M, Goto T, Okuhara M. FR901228, a novel antitumor bicyclic depsipeptide produced by Chromobacterium violaceum No. 968. I. Taxonomy, fermentation, isolation, physico-chemical and biological properties, and antitumor activity. J Antibiot 1994;47:301–310.
  • Luo RX, Dean DC. Chromatin remodeling and transcriptional regulation. J Natl Cancer Inst 1999;91:1288–1294.
  • Marks PA, Richon VM, Breslow R, Rifkind RA. Histone deacetylase inhibitors as new cancer drugs. Curr Opin Oncol 2001;13:477–483.
  • Melnick A, Licht JD. Histone deacetylases as therapeutic targets in hematologic malignancies. Curr Opin Hematol 2002;9:322–332.
  • Marks P, Rifkind RA, Richon VM, Breslow R, Miller T, Kelly WK, Histone deacetylases and cancer: causes and therapies. Nat Rev Cancer 2001;1:194–202.
  • Weidle UH, Grossmann A. Inhibition of histone deacetylases: a new strategy to target epigenetic modifications for anticancer treatment. Anticancer Res 2000;20:1471–1485.
  • Rasheed W, Bishton M, Johnstone RW, Prince HM. Histone deacetylase inhibitors in lymphoma and solid malignancies. Expert Rev Anticancer Ther 2008;8:413–432.
  • Bolden JE, Peart MJ, Johnstone RW, Anticancer activities of histone deacetylase inhibitors. Nat Rev Drug Discov 2006;5:769–784.
  • Cress WD, Seto E. Histone deacetylases, transcriptional control, and cancer. J Cell Physiol 2000;184:1–16.
  • Vigushin DM, Coombes RC. Histone deacetylase inhibitors in cancer treatment. Anticancer Drugs 2002;13:1–13.
  • Santini V, Gozzini A, Ferrari G. Histone deacetylase inhibitors: molecular and biological activity as a premise to clinical application. Curr Drug Metab 2007;8:383–393.
  • Whittaker S, Demierre M, Kim EJ, Rook AH, Lerner A, Duvic M, Scarisbrick J, Reddy S, Robak T, Becker JC, Samstov A, McCulloch W, Kim YH. Final results from a multicenter, international, pivotal study of romidepsin in refractory cutaneous T-cell lymphoma. J Clin Oncol 2010;28:4485–4491.
  • Piekarz RL, Frye R, Turner M, Wright JJ, Allen SL, Kirschbaum MH, Zain J, Prince HM, Leonard JP, Geskin LJ, Reeder C, Joske D, Figg WD, Gardner ER, Steinberg SM, Jaffe ES, Stetler-Stevenson M, Lade S, Fojo AT, Bates SE. Phase II multi-institutional trial of the histone deacetylase inhibitor romidepsin as monotherapy for patients with cutaneous T-cell lymphoma. J Clin Oncol 2009;27:5410–5417.
  • Coiffier B, Pro B, Prince HM, Foss F, Sokol L, Greenwood M, Caballero D, Borchmann P, Morschhauser F, Wilheim M, Pinter-Brown L, Padmanabhan S, Shuster A, Nichols J, Carroll S, Balser J, Balser B, Horwitz S. Results from a pivotal open-label phase II study of romidepsin in relapsed or refractory peripheral T-cell lymphoma after prior systemic therapy. J Clin Oncol 2012;30:631–636.
  • Piekarz RL, Frye R, Prince HM, Kirschbaum MH, Zain J, Allen AL, Jaffe ES, Ling A, Turner M, Peer CJ, Figg WD, Steinberg SM, Smith S, Joske D, Lewis I, Hutchins L, Craig M, Fojo AT, Wright JJ, Bates SE. Phase II trial of romidepsin in patients with peripheral T-cell lymphoma. Blood 2011;117:5827–5834.
  • Rosato RR, Grant S. Histone deacetylase inhibitors: insights into mechanisms of lethality. Expert Opin Ther Targets 2005;9: 809–824.
  • Xu WS, Parmigiani RB, Marks PA. Histone deacetylase inhibitors: molecular mechanisms of action. Oncogene 2007;26:5541–5552.
  • Ma X, Ezzeldin HH, Diasio RB. Histone deacetylase inhibitors: current status and overview of recent clinical trials. Drugs 2009;69:1911–1934.
  • Frew AJ, Johnstone RW, Bolden JE. Enhancing the apoptotic and therapeutic effects of HDAC inhibitors. Cancer Lett 2009;280:125–133.
  • Gemzar (gemcitabine) [package insert]. Indianapolis, IN: Eli Lilly and Company; 2010.
  • Lowell W, Wick MJ, Campos DR, Sepulveda M, Diaz A, Marty J, Keegan M, Izbicka E, Takimoto C. In vivo evaluation of depsipeptide (FK228) alone or in combination with gemcitabine in two human pancreas tumor xenograft models. Proc Amer Assoc Cancer Res 2006;47:900–901.
  • Piekarz RL, Frye AR, Wright JJ, Steinberg SM, Liewehr DJ, Rosing DK, Sachdev V, Fojo T, Bates SE. Cardiac studies in patients treated with depsipeptide, FK228, in a phase II trial for T-cell lymphoma. Clin Cancer Res 2006;12:3762–3773.
  • Tripathy D. Overview: gemcitabine as a single-agent therapy for advanced breast cancer. Clin Breast Cancer 2002;3(Suppl 1):8–11.
  • ISTODAX (romidepsin) [package Insert]. Summit, NJ: Celgene Corporation; 2011.
  • Sandor V, Bakke S, Robey RW, Kang MH, Blagosklonny MV, Bender J, Brooks R, Piekarz RL, Tucker E, Figg WD, Chan KK, Goldspiel B, Fojo AT, Balcerzak SP, Bates SE. Phase I trial of the histone deacetylase inhibitor, depsipeptide (FR901228, NSC 630176), in patients with refractory neoplasms. Clin Cancer Res 2002;8:718–728.
  • Piekarz RL, Robey R, Sandor V, Bakke S, Wilson WH, Dahmoush L, Kingma DM, Turner ML, Altemus R, Bates SE. Inhibition of histone deacetylation, depsipeptide (FR 901228), in the treatment of peripheral and cutaneous T-cell lymphoma: a case report. Blood 2001;98:2865–2868.

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