PMID- 24138944 OWN - NLM STAT- MEDLINE DCOM- 20140218 LR - 20181202 IS - 1873-5835 (Electronic) IS - 0145-2126 (Linking) VI - 37 IP - 12 DP - 2013 Dec TI - A phase I study of decitabine and rapamycin in relapsed/refractory AML. PG - 1622-7 LID - S0145-2126(13)00319-6 [pii] LID - 10.1016/j.leukres.2013.09.002 [doi] AB - A phase I study utilizing decitabine (DAC) followed by the mammalian target of rapamycin (mTOR) inhibitor, rapamycin, in patients with relapsed/refractory adult AML was undertaken to assess safety and feasibility. Patients received DAC 20mg/m(2) intravenously daily for 5 days followed by rapamycin from day 6 to day 25 at doses of 2 mg, 4 mg, and 6 mg/day in a standard 3+3 dose escalation design. Twelve patients completed treatment for safety evaluation. Maximum tolerated dose (MTD) was not reached, and except for grade 3 mucositis in 4 patients, no other significant unexpected non-hematologic toxicities have occurred indicating safety of this regimen. This trial is registered at clinical trials.gov as NCT00861874. CI - Copyright (c) 2013 Elsevier Ltd. All rights reserved. FAU - Liesveld, Jane L AU - Liesveld JL AD - Department of Medicine, Division of Hematology/Oncology, University of Rochester, Rochester, NY 14642, United States. Electronic address: jane_liesveld@urmc.rochester.edu. FAU - O'Dwyer, Kristen AU - O'Dwyer K FAU - Walker, Alison AU - Walker A FAU - Becker, Michael W AU - Becker MW FAU - Ifthikharuddin, J J AU - Ifthikharuddin JJ FAU - Mulford, Deborah AU - Mulford D FAU - Chen, Rui AU - Chen R FAU - Bechelli, Jeremy AU - Bechelli J FAU - Rosell, Karen AU - Rosell K FAU - Minhajuddin, Mohammed AU - Minhajuddin M FAU - Jordan, Craig T AU - Jordan CT FAU - Phillips, Gordon L 2nd AU - Phillips GL 2nd LA - eng SI - ClinicalTrials.gov/NCT00861874 PT - Clinical Trial, Phase I PT - Journal Article PT - Research Support, Non-U.S. Gov't DEP - 20130908 PL - England TA - Leuk Res JT - Leukemia research JID - 7706787 RN - 776B62CQ27 (Decitabine) RN - M801H13NRU (Azacitidine) RN - W36ZG6FT64 (Sirolimus) SB - IM MH - Aged MH - Antineoplastic Combined Chemotherapy Protocols/*therapeutic use MH - Azacitidine/administration & dosage/adverse effects/*analogs & derivatives MH - Decitabine MH - Dose-Response Relationship, Drug MH - Drug Administration Routes MH - Drug Administration Schedule MH - *Drug Resistance, Neoplasm/drug effects MH - Female MH - Humans MH - Leukemia, Myeloid, Acute/*drug therapy/pathology MH - Male MH - Maximum Tolerated Dose MH - Middle Aged MH - Pilot Projects MH - Recurrence MH - Sirolimus/*administration & dosage/adverse effects OTO - NOTNLM OT - AML OT - Decitabine OT - Phase I OT - Rapamycin OT - Refractory OT - Relapsed EDAT- 2013/10/22 06:00 MHDA- 2014/02/19 06:00 CRDT- 2013/10/22 06:00 PHST- 2013/07/02 00:00 [received] PHST- 2013/08/31 00:00 [revised] PHST- 2013/09/02 00:00 [accepted] PHST- 2013/10/22 06:00 [entrez] PHST- 2013/10/22 06:00 [pubmed] PHST- 2014/02/19 06:00 [medline] AID - S0145-2126(13)00319-6 [pii] AID - 10.1016/j.leukres.2013.09.002 [doi] PST - ppublish SO - Leuk Res. 2013 Dec;37(12):1622-7. doi: 10.1016/j.leukres.2013.09.002. Epub 2013 Sep 8.