Ignite Creation Date:
2024-05-05 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00225992
Status:
TERMINATED
Last Update Posted:
2012-10-11
First Post:
2005-09-22
Brief Title:
Phase II Research Study of Arsenic Trioxide Trisenox in Patients With Myelodysplastic Syndrome MDS
Sponsor:
Oncology Specialties Alabama
Organization:
Oncology Specialties Alabama
Study Overview
Official Title:
A Phase II Research Study of Arsenic Trioxide Trisenox in Patients With Myelodysplastic Syndrome MDS
Status:
TERMINATED
Status Verified Date:
2012-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
terminated due to lack of accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
In this phase II study besides evaluating for safety the primary efficacy parameter is to evaluate the incidence of patients who have had a response to Trisenox by evidence of increased blood counts red white or platelets andor by decrease or transfusion dependency The secondary efficacy parameter is the assessment of the tolerability of the new dosing schedule
Arsenic trioxide will be administered intravenously over 1 to 2 hours with a loading dose of 030mgkg for days 1-5 of the first week and then twice weekly for 27 weeks for a total of 28 weeks
Arsenic trioxide will be administered intravenously over 1 to 2 hours with a loading dose of 030mgkg for days 1-5 of the first week and then twice weekly for 27 weeks for a total of 28 weeks
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None