Ignite Creation Date:
2024-05-05 @ 12:05 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00234000
Status:
TERMINATED
Last Update Posted:
2020-07-31
First Post:
2005-10-05
Brief Title:
Azacitidine and Arsenic Trioxide in Treating Patients With Myelodysplastic Syndromes
Sponsor:
Jonsson Comprehensive Cancer Center
Organization:
Jonsson Comprehensive Cancer Center
Study Overview
Official Title:
A Phase I Multicenter Study of Arsenic Trioxide and Azacitidine in Patients With Myelodysplastic Syndromes
Status:
TERMINATED
Status Verified Date:
2012-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The study was closed due to poor enrollment
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 III trial is studying the side effects and best dose of azacitidine when given together with arsenic trioxide and to see how well they work in treating patients with myelodysplastic syndromes
PURPOSE This phase III trial is studying the side effects and best dose of azacitidine when given together with arsenic trioxide and to see how well they work in treating patients with myelodysplastic syndromes
Detailed Description:
OBJECTIVES
Primary
Determine the maximum tolerated dose of azacitidine when given in combination with arsenic trioxide in patients with myelodysplastic syndromes MDS Phase I
Determine the safety and tolerability of this regimen in these patients Phase I
Determine the major hematologic response erythroid response rate in patients with transfusion-dependent lower-risk MDS treated with this regimen Phase II
Determine complete and partial remission rates in patients with higher-risk MDS treated with this regimen Phase II
Determine the toxicity profile of this regimen in these patients Phase I
Secondary
Determine time to disease progression in patients treated with this regimen Phase I and II
Determine the overall and progression-free survival of patients treated with this regimen Phase I and II
OUTLINE This is an multicenter open-label phase I dose escalation study of azacitidine followed by a phase II study Patients enrolled in the phase II portion are stratified according to baseline International Scoring System score lower-risk myelodysplastic syndromes MDS vs higher-risk MDS
Phase I Patients receive azacitidine subcutaneously once daily on days 1-5 and arsenic trioxide IV over 1-4 hours on days 1 4 8 11 15 18 22 and 25 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity Patients with stable disease may receive up to 8 courses of therapy Patients with responding disease may continue to receive study therapy until a major response or a complete remission is achieved
Cohorts of 3-6 patients receive escalating doses of azacitidine until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity
Phase II Patients receive arsenic trioxide as in phase I and azacitidine as in phase I at one dose level below the MTD determined in phase I
After the completion of study treatment patients are followed at 4 weeks and then every 3-12 months for survival
PROJECTED ACCRUAL Approximately 3-18 patients will be accrued for the phase I portion of this study A total of 60 patients 30 per stratum will be accrued for the phase II portion of this study
Primary
Determine the maximum tolerated dose of azacitidine when given in combination with arsenic trioxide in patients with myelodysplastic syndromes MDS Phase I
Determine the safety and tolerability of this regimen in these patients Phase I
Determine the major hematologic response erythroid response rate in patients with transfusion-dependent lower-risk MDS treated with this regimen Phase II
Determine complete and partial remission rates in patients with higher-risk MDS treated with this regimen Phase II
Determine the toxicity profile of this regimen in these patients Phase I
Secondary
Determine time to disease progression in patients treated with this regimen Phase I and II
Determine the overall and progression-free survival of patients treated with this regimen Phase I and II
OUTLINE This is an multicenter open-label phase I dose escalation study of azacitidine followed by a phase II study Patients enrolled in the phase II portion are stratified according to baseline International Scoring System score lower-risk myelodysplastic syndromes MDS vs higher-risk MDS
Phase I Patients receive azacitidine subcutaneously once daily on days 1-5 and arsenic trioxide IV over 1-4 hours on days 1 4 8 11 15 18 22 and 25 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity Patients with stable disease may receive up to 8 courses of therapy Patients with responding disease may continue to receive study therapy until a major response or a complete remission is achieved
Cohorts of 3-6 patients receive escalating doses of azacitidine until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity
Phase II Patients receive arsenic trioxide as in phase I and azacitidine as in phase I at one dose level below the MTD determined in phase I
After the completion of study treatment patients are followed at 4 weeks and then every 3-12 months for survival
PROJECTED ACCRUAL Approximately 3-18 patients will be accrued for the phase I portion of this study A total of 60 patients 30 per stratum will be accrued for the phase II portion of this study
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 |
|---|---|---|---|
| UCLA-0408087 | None | None | None |