Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2025-12-25 @ 11:46 PM
Study NCT ID:
NCT00036894
Status:
COMPLETED
Last Update Posted:
2015-04-30
First Post:
2002-05-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CC-5013 in Treating Patients With Recurrent Glioma
Sponsor:
National Cancer Institute (NCI)
Organization:
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 ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-02-C-0145 | None | None | View |