Ignite Creation Date:
2024-05-05 @ 11:32 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00074243
Status:
COMPLETED
Last Update Posted:
2015-04-30
First Post:
2003-12-10
Brief Title:
CC-8490 in Treating Patients With Recurrent or Refractory High-Grade Gliomas
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase I Trial Of CC-8490 For The Treatment Of Patients With RecurrentRefractory High-Grade Gliomas
Status:
COMPLETED
Status Verified Date:
2006-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Drugs used in chemotherapy such as CC-8490 work in different ways to stop tumor cells from dividing so they stop growing or die
PURPOSE Phase I trial to study the effectiveness of CC-8490 in treating patients who have recurrent or refractory high-grade gliomas
PURPOSE Phase I trial to study the effectiveness of CC-8490 in treating patients who have recurrent or refractory high-grade gliomas
Detailed Description:
OBJECTIVES
Primary
Determine the maximum tolerated dose of CC-8490 in patients with recurrent or refractory high-grade gliomas
Determine preliminarily the toxic effects of this drug in these patients
Determine the pharmacokinetics of this drug in these patients
Secondary
Determine preliminarily the potential anti-glioma activity of this drug in these patients
OUTLINE This is a dose-escalation study
Patients receive oral CC-8490 once daily on days 1 and 3-28 course 1 only Beginning with course 2 and for all subsequent courses patients receive oral CC-8490 once daily on days 1-28 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 CC-8490 until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity Once the MTD is determined a total of 10 patients are treated at that dose
Patients are followed within 2 weeks
PROJECTED ACCRUAL A total of 34 patients will be accrued for this study
Primary
Determine the maximum tolerated dose of CC-8490 in patients with recurrent or refractory high-grade gliomas
Determine preliminarily the toxic effects of this drug in these patients
Determine the pharmacokinetics of this drug in these patients
Secondary
Determine preliminarily the potential anti-glioma activity of this drug in these patients
OUTLINE This is a dose-escalation study
Patients receive oral CC-8490 once daily on days 1 and 3-28 course 1 only Beginning with course 2 and for all subsequent courses patients receive oral CC-8490 once daily on days 1-28 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 CC-8490 until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity Once the MTD is determined a total of 10 patients are treated at that dose
Patients are followed within 2 weeks
PROJECTED ACCRUAL A total of 34 patients 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 |
|---|---|---|---|
| NCI-04-C-0035 | None | None | None |