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Blood, 1 January 2007, Vol. 109, No. 1, pp. 31-39. Prepublished online as a Blood First Edition Paper on September 7, 2006; DOI 10.1182/blood-2006-06-025999. This Article Full Text (PDF) Erratum (v109,p5086) All Versions of this Article: blood-2006-06-025999v1 109/1/31    most recent Alert me when this article is cited Alert me if a correction is posted Services Email this article to a friend Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Download to citation manager Rights and Permissions Citing Articles Citing Articles via HighWire Citing Articles via CrossRef Citing Articles via Google Scholar Google Scholar Articles by Duvic, M. Articles by Frankel, S. Search for Related Content PubMed PubMed Citation Articles by Duvic, M. Articles by Frankel, S. Social Bookmarking                   What's this?  Previous Article  |  Next Article  Submitted June 8, 2006 Accepted August 15, 2006 Phase II Trial of Oral Vorinostat (Suberoylanilide Hydroxamic Acid, SAHA) for Refractory Cutaneous T-cell Lymphoma (CTCL) Madeleine Duvic*, Rakhshandra Talpur, Xiao Ni, Chunlei Zhang, Parul Hazarika, Cecilia Kelly, Judy H. Chiao, John F Reilly, Justin L. Ricker, Victoria N. Richon, and Stanley Frankel Department of Dermatology, MD Anderson Cancer Center, Houston, TX Merck Research Laboratories, Whitehouse Station, NJ * Corresponding author; email: mduvic{at}mdanderson.org. The activity and safety of the histone deacetylase inhibitor vorinostat (suberoylanilide hydroxamic acid, SAHA) were evaluated in refractory cutaneous T-cell lymphoma (CTCL) patients. Group 1 received vorinostat 400 mg daily; group 2 received vorinostat 300 mg bid for 3 days with 4 days rest; and group 3 received vorinostat 300 mg bid for 14 days with 7 days rest followed by 200 mg bid. Treatment continued until disease progression or intolerable toxicity. The primary objective was to determine the complete and partial response (PR) rate. Time to response (TTR), time to progressive disease (TTP), response duration (DOR), pruritus relief, and safety were determined. Thirty-three patients who had received a median of 5 prior therapies were enrolled. Eight patients achieved a PR, including 7 with advanced disease and 4 with Sezary syndrome. The median TTR, DOR, and TTP for responders were 11.9, 15.1, and 30.2 weeks, respectively. Fourteen of 31 evaluable patients had pruritus relief. The most common drug-related AE were fatigue, thrombocytopenia, diarrhea, and nausea. The most common grade 3/4 drug-related AE were thrombocytopenia and dehydration. Vorinostat demonstrated activity in heavily pretreated CTCL patients. The 400 mg daily regimen had the most favorable safety profile and is being further evaluated. CiteULike    Connotea    Del.icio.us    Digg    Reddit    Technorati    What's this? This article has been cited by other articles: G. Garcia-Manero, S. Assouline, J. Cortes, Z. Estrov, H. Kantarjian, H. Yang, W. M. Newsome, W. H. Miller Jr, C. Rousseau, A. Kalita, et al. Phase 1 study of the oral isotype specific histone deacetylase inhibitor MGCD0103 in leukemia Blood, August 15, 2008; 112(4): 981 - 989. [Abstract] [Full Text] [PDF] C. K. Hahn, K. N. Ross, I. M. Warrington, R. Mazitschek, C. M. Kanegai, R. D. Wright, A. L. Kung, T. R. Golub, and K. Stegmaier Expression-based screening identifies the combination of histone deacetylase inhibitors and retinoids for neuroblastoma differentiation PNAS, July 15, 2008; 105(28): 9751 - 9756. [Abstract] [Full Text] [PDF] L. Ellis, Y. Pan, G. K. Smyth, D. J. George, C. 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