Ignite Creation Date:
2024-05-05 @ 9:57 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006008
Status:
COMPLETED
Last Update Posted:
2013-06-21
First Post:
2000-07-05
Brief Title:
Arsenic Trioxide in Treating Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia
Sponsor:
Eastern Cooperative Oncology Group
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Trial of Arsenic Trioxide NSC 706363 for Relapsed or Refractory Acute Lymphoblastic Leukemia
Status:
COMPLETED
Status Verified Date:
2002-08
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 acute lymphoblastic leukemia
PURPOSE Phase II trial to study the effectiveness of arsenic trioxide in treating patients who have relapsed or refractory acute lymphoblastic leukemia
Detailed Description:
OBJECTIVES
Determine the complete remission rate of patients with relapsed or refractory acute lymphoblastic leukemia treated with arsenic trioxide
Determine the toxic effects of induction arsenic trioxide in this patient population
OUTLINE Patients are stratified according to administration schedule of arsenic trioxide 5 days a week vs 7 days a week
Patients receive arsenic trioxide IV over 1 hour daily until bone marrow blasts are less than 5 or for a maximum of 60 days Beginning 3-6 weeks after induction patients achieving a complete remission receive arsenic trioxide IV over 1 hour daily either 5 days or 7 days a week for 25 days Subsequent consolidation courses are given with 4 week treatment-free intervals between courses Treatment continues for a maximum of 5 consolidation courses in the absence of unacceptable toxicity or disease progression
Patients are followed every 3 months for 2 years every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL A total of 13-40 patients will be accrued for this study within 3 years
Determine the complete remission rate of patients with relapsed or refractory acute lymphoblastic leukemia treated with arsenic trioxide
Determine the toxic effects of induction arsenic trioxide in this patient population
OUTLINE Patients are stratified according to administration schedule of arsenic trioxide 5 days a week vs 7 days a week
Patients receive arsenic trioxide IV over 1 hour daily until bone marrow blasts are less than 5 or for a maximum of 60 days Beginning 3-6 weeks after induction patients achieving a complete remission receive arsenic trioxide IV over 1 hour daily either 5 days or 7 days a week for 25 days Subsequent consolidation courses are given with 4 week treatment-free intervals between courses Treatment continues for a maximum of 5 consolidation courses in the absence of unacceptable toxicity or disease progression
Patients are followed every 3 months for 2 years every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL A total of 13-40 patients will be accrued for this study within 3 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 |
|---|---|---|---|
| E-9998 | None | None | None |