Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005618
Status:
COMPLETED
Last Update Posted:
2013-06-21
First Post:
2000-05-02
Brief Title:
Arsenic Trioxide in Treating Patients With Relapsed or Refractory Chronic Myelogenous Leukemia
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase II Study of Arsenic Trioxide NSC 706363 in Relapsed of Refractory Chronic Myelogenous Leukemia
Status:
COMPLETED
Status Verified Date:
2001-10
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 relapsed or refractory chronic myelogenous leukemia
PURPOSE Phase II trial to study the effectiveness of arsenic trioxide in treating patients who have relapsed or refractory chronic myelogenous leukemia
Detailed Description:
OBJECTIVES I Determine the antileukemic efficacy of arsenic trioxide in patients with relapsed andor refractory chronic accelerated or blastic phase chronic myelogenous leukemia II Determine the pattern of clinical adverse experience in this patient population administered this drug
OUTLINE Patients are stratified according to disease stage chronic phase vs accelerated phase or blastic phase Patients receive arsenic trioxide IV over 1 hour on consecutive days or weekdays only for a total of 25 days followed by 3-5 weeks of rest Treatment continues for a maximum of 6 courses in the absence of unacceptable toxicity or disease progression Patients with responding disease are followed at least monthly
PROJECTED ACCRUAL A total of 10-27 patients will be accrued for the chronic phase stratum of this study within 2 years A total of 17-37 patients will be accrued for the accelerated and blastic phases stratum of this study within 2 years
OUTLINE Patients are stratified according to disease stage chronic phase vs accelerated phase or blastic phase Patients receive arsenic trioxide IV over 1 hour on consecutive days or weekdays only for a total of 25 days followed by 3-5 weeks of rest Treatment continues for a maximum of 6 courses in the absence of unacceptable toxicity or disease progression Patients with responding disease are followed at least monthly
PROJECTED ACCRUAL A total of 10-27 patients will be accrued for the chronic phase stratum of this study within 2 years A total of 17-37 patients will be accrued for the accelerated and blastic phases stratum of this study within 2 years
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-190 | None | None | None |
| MSKCC-99076A | None | None | None |