Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00020969
Status:
TERMINATED
Last Update Posted:
2020-10-05
First Post:
2001-07-11
Brief Title:
Arsenic Trioxide in Treating Patients With Myelodysplastic Syndromes
Sponsor:
CTI BioPharma
Organization:
CTI BioPharma
Study Overview
Official Title:
Phase Two Multicenter Study Of Arsenic Trioxide In Patients With Myelodysplastic Syndromes
Status:
TERMINATED
Status Verified Date:
2020-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
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 use different ways to stop cancer cells from dividing so they stop growing or die
PURPOSE Phase II trial to study the effectiveness of arsenic trioxide in treating patients who have myelodysplastic syndromes
PURPOSE Phase II trial to study the effectiveness of arsenic trioxide in treating patients who have myelodysplastic syndromes
Detailed Description:
OBJECTIVES
Determine the percentage of patients with low-risk myelodysplastic syndromes MDS who achieve a major hematologic improvement after treatment with arsenic trioxide
Determine the percentage of patients with high-risk MDS who achieve complete or partial remission or major hematological improvement after treatment with this drug
Determine the durability of responses in patients treated with this drug
Determine the duration of overall and progression-free survival of patients treated with this drug
Assess the quality of life of patients treated with this drug
Assess the toxicity profile of this drug in these patients
OUTLINE This is a multicenter study Patients are stratified according to risk score low risk vs high risk
Patients receive arsenic trioxide IV 5 days a week on weeks 1-2 Treatment repeats every 4 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity Patients with stable disease or better may receive additional courses of treatment Patients who achieve a complete remission CR should receive 2 additional courses of treatment after documentation of CR
Quality of life is assessed at baseline every 8 weeks during study and then at 4 weeks after study completion
Patients are followed at 4 weeks every 3 months until completion of study treatment and then annually thereafter
PROJECTED ACCRUAL A total of 30-110 patients 15-55 per stratum will be accrued for this study
Determine the percentage of patients with low-risk myelodysplastic syndromes MDS who achieve a major hematologic improvement after treatment with arsenic trioxide
Determine the percentage of patients with high-risk MDS who achieve complete or partial remission or major hematological improvement after treatment with this drug
Determine the durability of responses in patients treated with this drug
Determine the duration of overall and progression-free survival of patients treated with this drug
Assess the quality of life of patients treated with this drug
Assess the toxicity profile of this drug in these patients
OUTLINE This is a multicenter study Patients are stratified according to risk score low risk vs high risk
Patients receive arsenic trioxide IV 5 days a week on weeks 1-2 Treatment repeats every 4 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity Patients with stable disease or better may receive additional courses of treatment Patients who achieve a complete remission CR should receive 2 additional courses of treatment after documentation of CR
Quality of life is assessed at baseline every 8 weeks during study and then at 4 weeks after study completion
Patients are followed at 4 weeks every 3 months until completion of study treatment and then annually thereafter
PROJECTED ACCRUAL A total of 30-110 patients 15-55 per stratum will be accrued for 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 |
|---|---|---|---|
| NCI-G01-1971 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000068734 | REGISTRY | None | None |
| UCLA-HSPC-010104701 | None | None | None |