Article ID | Journal | Published Year | Pages | File Type |
---|---|---|---|---|
2137054 | Leukemia Research | 2013 | 6 Pages |
Abstract
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 20 mg/m2 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.
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Authors
Jane L. Liesveld, Kristen O’Dwyer, Alison Walker, Michael W. Becker, J.J. Ifthikharuddin, Deborah Mulford, Rui Chen, Jeremy Bechelli, Karen Rosell, Mohammed Minhajuddin, Craig T. Jordan, Gordon L. Phillips II,