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Sponsored by: |
Weill Medical College of Cornell University |
Information provided by: | Weill Medical College of Cornell University |
ClinicalTrials.gov Identifier: | NCT00572065 |
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.
Condition | Intervention | Phase |
Myelofibrosis |
Drug: arsenic trioxide Drug: cytarabine |
Phase 0 |
MedlinePlus related topics: | Arsenic |
Drug Information available for: | Cytarabine Cytarabine hydrochloride Arsenic trioxide |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment |
Official Title: | Prospective Pilot Trial of Arsenic Trioxide (Trisenox®) in Combination With Cytosine Arabinoside in Patients With Advanced or Transformed Myelofibrosis |
Estimated Enrollment: | 20 |
Study Start Date: | December 2007 |
Estimated Study Completion Date: | June 2009 |
Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
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.
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Tania Curcio, RN | tjc9003@med.cornell.edu |
United States, New York | |||||
Weill Cornell Medical College | Recruiting | ||||
New York, New York, United States, 10021 |
Weill Medical College of Cornell University |
Principal Investigator: | Gail Roboz, MD | Weill Cornell Medical College |
Related Info 
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Responsible Party: | Weill Cornell Medical College ( Dr. Gail Roboz ) |
Study ID Numbers: | 0707009291 |
First Received: | December 11, 2007 |
Last Updated: | September 15, 2008 |
ClinicalTrials.gov Identifier: | NCT00572065 |
Health Authority: | United States: Institutional Review Board |
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