Ignite Creation Date:
2024-05-05 @ 11:42 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00118196
Status:
TERMINATED
Last Update Posted:
2018-05-11
First Post:
2005-07-08
Brief Title:
Azacitidine and Arsenic Trioxide in Treating Patients With Myelodysplastic Syndromes or Chronic Myelomonocytic Leukemia
Sponsor:
Medical University of South Carolina
Organization:
Medical University of South Carolina
Study Overview
Official Title:
A Phase II Study of Arsenic Trioxide in Combination With 5-Azacitidine in Myelodysplastic Syndromes
Status:
TERMINATED
Status Verified Date:
2018-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Due to limited resources available to conduct study
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Drugs used in chemotherapy such as azacitidine and arsenic trioxide work in different ways to stop the growth of cancer cells either by killing the cells or by stopping them from dividing Giving more than one drug combination chemotherapy may kill more cancer cells
PURPOSE This phase II trial is studying how well giving azacitidine together with arsenic trioxide works in treating patients with myelodysplastic syndromes or chronic myelomonocytic leukemia
PURPOSE This phase II trial is studying how well giving azacitidine together with arsenic trioxide works in treating patients with myelodysplastic syndromes or chronic myelomonocytic leukemia
Detailed Description:
OBJECTIVES
Primary
Determine the response rate in patients with myelodysplastic syndromes or chronic myelomonocytic leukemia treated with azacitidine and arsenic trioxide
Secondary
Determine time to treatment failure in patients treated with this regimen
Determine the tolerability and toxicity of this regimen in these patients
Determine progression-free survival of patients treated with this regimen
OUTLINE This a multicenter non-randomized open-label study
Patients receive azacitidine subcutaneously once daily on days 1-5 and arsenic trioxide IV over 1-2 hours on days 1 2 8 9 15 16 22 and 23 Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity Patients are evaluated for response on day 113 week 17 Patients with disease progression or no response are removed from the study Patients achieving a complete response CR receive 2 additional courses of therapy and then undergo observation Patients achieving a partial response receive 2 additional courses of therapy and then receive arsenic trioxide alone twice weekly in the absence of CR disease progression or unacceptable toxicity
After completion of study treatment patients are followed every 2 months for at least 1 year
PROJECTED ACCRUAL A total of 19-41 patients will be accrued for this study within 18 months
Primary
Determine the response rate in patients with myelodysplastic syndromes or chronic myelomonocytic leukemia treated with azacitidine and arsenic trioxide
Secondary
Determine time to treatment failure in patients treated with this regimen
Determine the tolerability and toxicity of this regimen in these patients
Determine progression-free survival of patients treated with this regimen
OUTLINE This a multicenter non-randomized open-label study
Patients receive azacitidine subcutaneously once daily on days 1-5 and arsenic trioxide IV over 1-2 hours on days 1 2 8 9 15 16 22 and 23 Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity Patients are evaluated for response on day 113 week 17 Patients with disease progression or no response are removed from the study Patients achieving a complete response CR receive 2 additional courses of therapy and then undergo observation Patients achieving a partial response receive 2 additional courses of therapy and then receive arsenic trioxide alone twice weekly in the absence of CR disease progression or unacceptable toxicity
After completion of study treatment patients are followed every 2 months for at least 1 year
PROJECTED ACCRUAL A total of 19-41 patients will be accrued for this study within 18 months
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| MUSC-15348 | None | None | None |
| MUSC-MDS2773 | None | None | None |