drugset / Trial / NCT00572065

Pilot Trial of Arsenic + Cytarabine in Patients With Myelofibrosis

NCT00572065

Phase 0 Completed 21 enrolled Weill Medical College of Cornell University
NaSingle-groupOpen-labelTreatment

Summary

This is an open-label, one arm, single institution study. Arsenic trioxide \[TrisenoxTM Injection\], 0.25mg/kg/dose administered intravenously over 2 hours. 20 patients Complete remission, partial remission, clinical improvement, progressive disease, stable disease, relapse (per IWG consensus criteria, 2006) Clinical chemistry, hematology and ECGs will be assessed at least weekly during study treatments. Adverse events will be assessed in accordance with the NCI Common Toxicity Criteria, Version 2 at each study visit.

Timeline

Start
2008-02-29
Primary completion
2009-12
Completion
2010-02-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Cytarabine Small molecule 10 mg/m2 Subcutaneous
Subject arsenic trioxide Small molecule 0.25 mg/kg Intravenous

Indications