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Blood, 1 March 2004, Vol. 103, No. 5, pp. 1635-1640. Prepublished online as a Blood First Edition Paper on November 6, 2003; DOI 10.1182/blood-2003-03-0687. This Article Full Text (PDF) All Versions of this Article: 2003-03-0687v1 103/5/1635    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 Issa, J.-P. J Articles by Kantarjian, H. M Search for Related Content PubMed PubMed Citation Articles by Issa, J.-P. J Articles by Kantarjian, H. M Social Bookmarking                   What's this? Submitted March 4, 2003 Accepted October 29, 2003 Phase I study of low-dose prolonged exposure schedules of the hypomethylating agent 5-aza-2'-deoxycytidine (Decitabine) in hematopoietic malignancies Jean-Pierre J Issa*, Guillermo Garcia-Manero, Francis J Giles, Rajan Mannari, Deborah Thomas, Stefan Faderl, Emel Bayar, John Lyons, Craig S Rosenfeld, Jorge Cortes, and Hagop M Kantarjian Department of Leukemia, University of Texas M. D. Anderson Cancer Center, Houston, TX, USA SuperGen Inc., Dublin, CA, USA * Corresponding author; email: jpissa{at}mdanderson.org. Rationale: 5-aza-2'-deoxycytidine (decitabine) inhibits DNA methylation and has dual effects on neoplastic cells: reactivation of silenced genes and differentiation at low doses, cytotoxicity at high doses. Objectives: To evaluate, in a phase I study, low dose prolonged exposure schedules of decitabine in relapsed/refractory leukemias. Findings: Patient cohorts received decitabine at 5, 10, 15 or 20 mg/m2 IV over 1 hour daily, 5 days a week for two consecutive weeks, doses 5 to ~30-fold lower than the MTD. Two groups also received 15 mg/m2 daily for 15 or 20 days. Fifty patients were treated (44 with AML/MDS, 5 with CML, 1 with ALL) and the drug was well tolerated at all dose levels, with myelosuppression being the major side-effect. Responses were seen at all dose levels. However, the dose of 15 mg/m2 for 10 days appeared to induce the most responses (11/18 or 61%), with fewer responses seen when the dose was escalated or prolonged (2/19 or 11%). There was no correlation between P15 methylation at baseline or after therapy and response to decitabine. Conclusions: Decitabine is effective in myeloid malignancies, and low doses are as or more effective than higher doses. CiteULike    Connotea    Del.icio.us    Digg    Reddit    Technorati    What's this? This article has been cited by other articles: V. Pistoia, C. 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