Ignite Creation Date:
2024-05-05 @ 11:28 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00053248
Status:
COMPLETED
Last Update Posted:
2012-05-28
First Post:
2003-01-27
Brief Title:
Arsenic Trioxide and Imatinib Mesylate in Treating Patients With Chronic Myelogenous Leukemia
Sponsor:
OHSU Knight Cancer Institute
Organization:
OHSU Knight Cancer Institute
Study Overview
Official Title:
A Phase III Study To Determine The Safety Tolerability And Anti-Leukemic Effects of Trisenox Arsenic Trioxide In Combination With Gleevec STI571 In Patients With Resistant Chronic Myelogenous Leukemia In Chronic Phase
Status:
COMPLETED
Status Verified Date:
2010-06
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 Imatinib mesylate may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth Combining chemotherapy with imatinib mesylate may kill more cancer cells
PURPOSE Phase III trial to study the effectiveness of combining arsenic trioxide with imatinib mesylate in treating patients who have chronic phase chronic myelogenous leukemia
PURPOSE Phase III trial to study the effectiveness of combining arsenic trioxide with imatinib mesylate in treating patients who have chronic phase chronic myelogenous leukemia
Detailed Description:
OBJECTIVES
Determine the safety and tolerability of arsenic trioxide and imatinib mesylate in patients with resistant chronic phase chronic myelogenous leukemia
Determine potential dose-limiting toxic effects in patients treated with this regimen
Determine the pharmacokinetics of this regimen in these patients
OUTLINE This is a multicenter study
Patients receive oral imatinib mesylate once daily and arsenic trioxide IV over 1-2 hours on days 1-5 of week 1 and then twice weekly Treatment continues for 1 year in the absence of disease progression or unacceptable toxicity
PROJECTED ACCRUAL A total of 18-24 patients at least 6 patients for phase I and at least 12 patients for phase II will be accrued for this study
Determine the safety and tolerability of arsenic trioxide and imatinib mesylate in patients with resistant chronic phase chronic myelogenous leukemia
Determine potential dose-limiting toxic effects in patients treated with this regimen
Determine the pharmacokinetics of this regimen in these patients
OUTLINE This is a multicenter study
Patients receive oral imatinib mesylate once daily and arsenic trioxide IV over 1-2 hours on days 1-5 of week 1 and then twice weekly Treatment continues for 1 year in the absence of disease progression or unacceptable toxicity
PROJECTED ACCRUAL A total of 18-24 patients at least 6 patients for phase I and at least 12 patients for phase II 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 |
|---|---|---|---|
| OHSU-1096 | None | None | None |
| OHSU-UCLA-0206062 | None | None | None |
| OHSU-HEM-02001-L | None | None | None |