Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006092
Status:
TERMINATED
Last Update Posted:
2012-09-26
First Post:
2000-08-03
Brief Title:
Arsenic Trioxide for Induction Therapy of Adult Patients With Leukemia
Sponsor:
H Lee Moffitt Cancer Center and Research Institute
Organization:
H Lee Moffitt Cancer Center and Research Institute
Study Overview
Official Title:
A Phase II Study of Arsenic Trioxide for Induction Therapy of Adult Patients With Relapsed or Refractory Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia and Previously Untreated Chronic Myeloid Leukemia With Blast Crisis
Status:
TERMINATED
Status Verified Date:
2012-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
low accrual
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 recurrent or refractory acute lymphoblastic leukemia or chronic myelogenous leukemia
PURPOSE Phase II trial to study the effectiveness of arsenic trioxide in treating patients who have recurrent or refractory acute lymphoblastic leukemia or chronic myelogenous leukemia
Detailed Description:
OBJECTIVES
Determine the rate of clinical and hematologic response in patients with Philadelphia chromosome-positive recurrent or refractory acute lymphoblastic leukemia or previously untreated or recurrent or refractory blastic phase chronic myelogenous leukemia when treated with arsenic trioxide
Determine the duration of hematologic response and overall survival of these patients when treated with this regimen
Determine the pattern of clinical adverse experience in these patients when treated with this regimen
Determine the pharmacokinetic profile of this regimen in these patients
OUTLINE This is a multicenter study
Patients receive arsenic trioxide IV over 2-3 hours daily for 28 days Patients who respond may receive a second course of therapy beginning 28 days from the last dose of the first course
Patients are followed monthly for 3 months every 2 months for 6 months and then every 3 months thereafter
PROJECTED ACCRUAL A total of 24-49 patients will be accrued for this study within 25 years
Determine the rate of clinical and hematologic response in patients with Philadelphia chromosome-positive recurrent or refractory acute lymphoblastic leukemia or previously untreated or recurrent or refractory blastic phase chronic myelogenous leukemia when treated with arsenic trioxide
Determine the duration of hematologic response and overall survival of these patients when treated with this regimen
Determine the pattern of clinical adverse experience in these patients when treated with this regimen
Determine the pharmacokinetic profile of this regimen in these patients
OUTLINE This is a multicenter study
Patients receive arsenic trioxide IV over 2-3 hours daily for 28 days Patients who respond may receive a second course of therapy beginning 28 days from the last dose of the first course
Patients are followed monthly for 3 months every 2 months for 6 months and then every 3 months thereafter
PROJECTED ACCRUAL A total of 24-49 patients will be accrued for this study within 25 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-1230 | OTHER | NCI | None |