Ignite Creation Date:
2024-05-05 @ 5:01 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00369590
Status:
COMPLETED
Last Update Posted:
2015-10-02
First Post:
2006-08-24
Brief Title:
VEGF Trap in Treating Patients With Recurrent Malignant Gliomas That Did Not Respond to Temozolomide
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase II Single Arm Trial of VEGF Trap in Patients With Recurrent Temozolomide-Resistant Malignant Gliomas
Status:
COMPLETED
Status Verified Date:
2015-08
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:
This phase II trial is studying how well VEGF Trap works in treating patients with recurrent malignant or anaplastic gliomas that did not respond to temozolomide VEGF Trap may stop the growth of malignant or anaplastic gliomas by blocking blood flow to the tumor
Detailed Description:
PRIMARY OBJECTIVES
I Determine the therapeutic efficacy of VEGF Trap in patients with temozolomide-resistant malignant gliomas at first recurrence as measured by 6-month progression-free survival PFS
II Determine the safety profile of VEGF Trap in these patients
SECONDARY OBJECTIVES
I Determine the efficacy of this regimen as measured by radiographic response PFS time to progression and overall survival
II Characterize the single-dose and repeated-dose pharmacokinetic profiles of VEGF Trap in these patients
OUTLINE This is a multicenter study Patients are stratified according to histology glioblastoma vs anaplastic glioma
Patients receive VEGF Trap IV over 1 hour on day 1 Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed periodically
I Determine the therapeutic efficacy of VEGF Trap in patients with temozolomide-resistant malignant gliomas at first recurrence as measured by 6-month progression-free survival PFS
II Determine the safety profile of VEGF Trap in these patients
SECONDARY OBJECTIVES
I Determine the efficacy of this regimen as measured by radiographic response PFS time to progression and overall survival
II Characterize the single-dose and repeated-dose pharmacokinetic profiles of VEGF Trap in these patients
OUTLINE This is a multicenter study Patients are stratified according to histology glioblastoma vs anaplastic glioma
Patients receive VEGF Trap IV over 1 hour on day 1 Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed periodically
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-2009-00677 | REGISTRY | None | None |
| CDR0000495275 | None | None | None |
| NABTC06-01 | OTHER | None | None |
| NABTC-06-01 | OTHER | None | None |
| U01CA062399 | NIH | CTEP | httpsreporternihgovquickSearchU01CA062399 |