Ignite Creation Date:
2025-12-24 @ 11:13 PM
Ignite Modification Date:
2025-12-25 @ 8:47 PM
Study NCT ID:
NCT00020969
Status:
TERMINATED
Last Update Posted:
2020-10-05
First Post:
2001-07-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Arsenic Trioxide in Treating Patients With Myelodysplastic Syndromes
Sponsor:
CTI BioPharma
Organization:
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:
True
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?: