title: A phase I study of decitabine and rapamycin in relapsed/refractory AML.
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 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.
authors.affiliation: Department of Medicine, Division of Hematology/Oncology, University of Rochester, Rochester, NY 14642, United States. Electronic address: jane_liesveld@urmc.rochester.edu.
authors.forename: Jane L
authors.initials: JL
authors.lastname: Liesveld
authors.forename: Kristen
authors.initials: K
authors.lastname: O'Dwyer
authors.forename: Alison
authors.initials: A
authors.lastname: Walker
authors.forename: Michael W
authors.initials: MW
authors.lastname: Becker
authors.forename: J J
authors.initials: JJ
authors.lastname: Ifthikharuddin
authors.forename: Deborah
authors.initials: D
authors.lastname: Mulford
authors.forename: Rui
authors.initials: R
authors.lastname: Chen
authors.forename: Jeremy
authors.initials: J
authors.lastname: Bechelli
authors.forename: Karen
authors.initials: K
authors.lastname: Rosell
authors.forename: Mohammed
authors.initials: M
authors.lastname: Minhajuddin
authors.forename: Craig T
authors.initials: CT
authors.lastname: Jordan
authors.forename: Gordon L
authors.initials: GL
authors.lastname: Phillips
mesh_terms: D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D001374:Azacitidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D000077209:Decitabine; D004305:Dose-Response Relationship, Drug; D004333:Drug Administration Routes; D004334:Drug Administration Schedule; D019008:Drug Resistance, Neoplasm / Q000187:drug effects; D005260:Female; D006801:Humans; D015470:Leukemia, Myeloid, Acute / Q000188:drug therapy* / Q000473:pathology; D008297:Male; D020714:Maximum Tolerated Dose; D008875:Middle Aged; D010865:Pilot Projects; D012008:Recurrence; D020123:Sirolimus / Q000008:administration & dosage* / Q000009:adverse effects
chemical_list: D000077209:Decitabine; D001374:Azacitidine; D020123:Sirolimus
keywords: AML; Decitabine; Phase I; Rapamycin; Refractory; Relapsed