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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 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 Citation Map 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. R. Search for Related Content PubMed PubMed Citation Articles by Duvic, M. Articles by Frankel, S. R. Related Collections Neoplasia Clinical Trials and Observations Social Bookmarking                   What's this?  Previous Article  |  Table of Contents  |  Next Article  CLINICAL TRIALS AND OBSERVATIONS Phase 2 trial of oral vorinostat (suberoylanilide hydroxamic acid, SAHA) for refractory cutaneous T-cell lymphoma (CTCL) Madeleine Duvic1,, Rakshandra Talpur1, Xiao Ni1, Chunlei Zhang1, Parul Hazarika1, Cecilia Kelly1, Judy H. Chiao2, John F. Reilly2, Justin L. Ricker2, Victoria M. Richon2, and Stanley R. Frankel2 1 Department of Dermatology, MD Anderson Cancer Center, Houston, TX; and 2 Merck Research Laboratories, Whitehouse Station, NJ The activity and safety of the histone deacetylase inhibitor vorinostat (suberoylanilide hydroxamic acid, SAHA) were evaluated in patients with refractory cutaneous T-cell lymphoma (CTCL). Group 1 received vorinostat 400 mg daily, group 2 received vorinostat 300 mg twice daily for 3 days with 4 days rest, and group 3 received vorinostat 300 mg twice daily for 14 days with 7 days rest followed by 200 mg twice daily. 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 Sézary 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 AEs were fatigue, thrombocytopenia, diarrhea, and nausea. The most common grade 3 or 4 drug-related AEs were thrombocytopenia and dehydration. Vorinostat demonstrated activity in heavily pretreated patients with CTCL. 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. 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