Ignite Creation Date:
2024-05-05 @ 11:08 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004932
Status:
COMPLETED
Last Update Posted:
2014-02-21
First Post:
2000-03-07
Brief Title:
STI571 in Treating Patients With Recurrent Leukemia
Sponsor:
Childrens Oncology Group
Organization:
Childrens Oncology Group
Study Overview
Official Title:
A Phase I Study of STI571 in Ph Leukemia
Status:
COMPLETED
Status Verified Date:
2014-02
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 Imatinib mesylate may interfere with the growth of cancer cells and may be an effective treatment for leukemia
PURPOSE Phase I trial to study the effectiveness of imatinib mesylate in treating patients who have recurrent leukemia
PURPOSE Phase I trial to study the effectiveness of imatinib mesylate in treating patients who have recurrent leukemia
Detailed Description:
OBJECTIVES
Determine the maximum tolerated dose and dose-limiting toxicity of imatinib mesylate in patients with recurrent Philadelphia chromosome-positive leukemia
Characterize the pharmacokinetic behavior of this drug in this patient population
Determine preliminarily the antileukemic activity of this drug in these patients
OUTLINE This is a dose-escalation multicenter study
Patients receive oral imatinib mesylate STI571 once daily for 28 days Treatment continues in the absence of unacceptable toxicity or disease progression
Cohorts of 3-6 patients receive escalating doses of STI571 until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity
Patients are followed every 6 months for 4 years and then annually thereafter
PROJECTED ACCRUAL A maximum of 32 patients will be accrued for this study within 35 years
Determine the maximum tolerated dose and dose-limiting toxicity of imatinib mesylate in patients with recurrent Philadelphia chromosome-positive leukemia
Characterize the pharmacokinetic behavior of this drug in this patient population
Determine preliminarily the antileukemic activity of this drug in these patients
OUTLINE This is a dose-escalation multicenter study
Patients receive oral imatinib mesylate STI571 once daily for 28 days Treatment continues in the absence of unacceptable toxicity or disease progression
Cohorts of 3-6 patients receive escalating doses of STI571 until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity
Patients are followed every 6 months for 4 years and then annually thereafter
PROJECTED ACCRUAL A maximum of 32 patients will be accrued for this study within 35 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 |
|---|---|---|---|
| CDR0000067616 | OTHER | Clinical Trialsgov | None |
| COG-P9973 | OTHER | None | None |
| POG-9973 | OTHER | None | None |
| CCG-P9973 | OTHER | None | None |