A phase I study of decitabine and rapamycin in relapsed/refractory AML

Leuk Res. 2013 Dec;37(12):1622-7. doi: 10.1016/j.leukres.2013.09.002. Epub 2013 Sep 8.

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.

Keywords: AML; Decitabine; Phase I; Rapamycin; Refractory; Relapsed.

Publication types

  • Clinical Trial, Phase I
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Antineoplastic Combined Chemotherapy Protocols / therapeutic use*
  • Azacitidine / administration & dosage
  • Azacitidine / adverse effects
  • Azacitidine / analogs & derivatives*
  • Decitabine
  • Dose-Response Relationship, Drug
  • Drug Administration Routes
  • Drug Administration Schedule
  • Drug Resistance, Neoplasm* / drug effects
  • Female
  • Humans
  • Leukemia, Myeloid, Acute / drug therapy*
  • Leukemia, Myeloid, Acute / pathology
  • Male
  • Maximum Tolerated Dose
  • Middle Aged
  • Pilot Projects
  • Recurrence
  • Sirolimus / administration & dosage*
  • Sirolimus / adverse effects

Substances

  • Decitabine
  • Azacitidine
  • Sirolimus

Associated data

  • ClinicalTrials.gov/NCT00861874