Ignite Creation Date:
2024-05-05 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00083070
Status:
COMPLETED
Last Update Posted:
2014-02-20
First Post:
2004-05-14
Brief Title:
Temozolomide in Treating Young Patients With Refractory or Recurrent Leukemia
Sponsor:
Childrens Oncology Group
Organization:
Childrens Oncology Group
Study Overview
Official Title:
A Phase I Trial Of Temozolomide In Pediatric Patients With RefractoryRecurrent Leukemias
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 Drugs used in chemotherapy such as temozolomide work in different ways to stop cancer cells from dividing so they stop growing or die
PURPOSE This phase I trial is studying the side effects and best dose of temozolomide in treating young patients with refractory or recurrent leukemia
PURPOSE This phase I trial is studying the side effects and best dose of temozolomide in treating young patients with refractory or recurrent leukemia
Detailed Description:
OBJECTIVES
Primary
Determine the maximum tolerated dose and recommended phase II dose of temozolomide in pediatric patients with refractory or recurrent leukemia
Determine the toxic effects of this drug in these patients
Determine the pharmacokinetics of this drug in these patients
Secondary
Determine the antitumor activity of this drug in these patients
Determine the biologic activity and mechanisms of resistance to this drug in these patients
OUTLINE This is an open-label dose-escalation multicenter study
Patients receive oral temozolomide once daily on days 1-5 Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of temozolomide until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity
PROJECTED ACCRUAL A total of 3-36 patients will be accrued for this study within 18-24 months
Primary
Determine the maximum tolerated dose and recommended phase II dose of temozolomide in pediatric patients with refractory or recurrent leukemia
Determine the toxic effects of this drug in these patients
Determine the pharmacokinetics of this drug in these patients
Secondary
Determine the antitumor activity of this drug in these patients
Determine the biologic activity and mechanisms of resistance to this drug in these patients
OUTLINE This is an open-label dose-escalation multicenter study
Patients receive oral temozolomide once daily on days 1-5 Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of temozolomide until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity
PROJECTED ACCRUAL A total of 3-36 patients will be accrued for this study within 18-24 months
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 |
|---|---|---|---|
| COG-ADVL0411 | OTHER | Childrens Oncology Group | None |
| CDR0000362059 | OTHER | None | None |