Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00036894
Status:
COMPLETED
Last Update Posted:
2015-04-30
First Post:
2002-05-13
Brief Title:
CC-5013 in Treating Patients With Recurrent Glioma
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase I Trial Of A Thalidomide Analog CC-5013 For The Treatment Of Patients With Recurrent High-Grade Gliomas
Status:
COMPLETED
Status Verified Date:
2003-11
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 CC-5013 may stop the growth of gliomas by stopping blood flow to the tumor
PURPOSE Phase I trial to study the effectiveness of CC-5013 in treating patients who have recurrent glioma
PURPOSE Phase I trial to study the effectiveness of CC-5013 in treating patients who have recurrent glioma
Detailed Description:
OBJECTIVES
Determine the maximum tolerated dose of CC-5013 in patients with recurrent high-grade gliomas
Determine the toxic effects of this drug in these patients
Determine the pharmacokinetics of this drug in these patients
Determine the antiangiogenic activity of this drug in these patients
OUTLINE This is a dose-escalation study Patients are stratified according to concurrent enzyme-inducing antiepileptic drugs yes vs no
Patients receive oral CC-5013 weekly for 3 weeks Treatment repeats every 4 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of CC-5013 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 at 2 weeks
PROJECTED ACCRUAL A maximum of 80 patients 40 per stratum will be accrued for this study within 20 months
Determine the maximum tolerated dose of CC-5013 in patients with recurrent high-grade gliomas
Determine the toxic effects of this drug in these patients
Determine the pharmacokinetics of this drug in these patients
Determine the antiangiogenic activity of this drug in these patients
OUTLINE This is a dose-escalation study Patients are stratified according to concurrent enzyme-inducing antiepileptic drugs yes vs no
Patients receive oral CC-5013 weekly for 3 weeks Treatment repeats every 4 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of CC-5013 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 at 2 weeks
PROJECTED ACCRUAL A maximum of 80 patients 40 per stratum will be accrued for this study within 20 months
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-02-C-0145 | None | None | None |