NCT00572065

Pilot Trial of Arsenic + Cytarabine in Patients With Myelofibrosis

Prospective Pilot Trial of Arsenic Trioxide (Trisenox®) in Combination With Cytosine Arabinoside in Patients With Advanced or Transformed Myelofibrosis

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Weill Medical College of Cornell University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Myelofibrosis

Interventions

Type	Name	Description
DRUG	arsenic trioxide	Cytarabine will be administered at a dose of 10 mg/m2 subcutaneously (sc) twice daily (bid) from days 1-14. Triseonx will be administered at a dose of 0.25 mg/kg on days 1-5 and days 8-12. Trisenox will be restarted only when the QT interval returns to less than 500 msec. One treatment cycle consists of 2 weeks, with 14 days of cytarabine and 10 days of ATO. Subsequent cycles will be administered at the investigator's discretion, depending on response and tolerability. Patients may continue to receive treatment with Trisenox /LDAC for a period of up to 2 years as long as stable disease or clinical benefit and absence of unacceptable toxicity can be demonstrated.
DRUG	cytarabine	Cytarabine will be administered at a dose of 10 mg/m2 subcutaneously (sc) twice daily (bid) from days 1-14. Trisenox will be administered at a dose of 0.25 mg/kg on days 1-5 and days 8-12. Trisenox will be restarted only when the QT interval returns to less than 500 msec. One treatment cycle consists of 2 weeks, with 14 days of cytarabine and 10 days of ATO. Subsequent cycles will be administered at the investigator's discretion, depending on response and tolerability. Patients may continue to receive treatment with Trisenox /LDAC for a period of up to 2 years as long as stable disease or clinical benefit and absence of unacceptable toxicity can be demonstrated.

Timeline

• Start date: 2008-02-29
• Primary completion: 2009-12-01
• Completion: 2010-02-08
• First posted: 2007-12-12
• Last updated: 2017-03-03

Locations

1 site across 1 country: United States