Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00014677
Status:
COMPLETED
Last Update Posted:
2013-07-18
First Post:
2001-04-10
Brief Title:
NBI-3001 Followed by Surgery in Treating Patients With Recurrent Glioblastoma Multiforme
Sponsor:
Neurocrine Biosciences
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Randomized Dose-Ranging Safety and Tolerability Study of NBI-3001 Administered by Continuous Intratumoral Infusion Followed by Surgical Resection in Patients With Recurrent Glioblastoma Multiforme
Status:
COMPLETED
Status Verified Date:
2002-06
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 NBI-3001 may be able to locate cancer cells and stop them from growing This may be an effective treatment for glioblastoma multiforme
PURPOSE Randomized phase II trial to compare different regimens of NBI-3001 followed by surgery to remove the tumor in treating patients who have glioblastoma multiforme
PURPOSE Randomized phase II trial to compare different regimens of NBI-3001 followed by surgery to remove the tumor in treating patients who have glioblastoma multiforme
Detailed Description:
OBJECTIVES I Determine the safety tolerability and optimal clinical dose of interleukin-438-37-PE38KDEL cytotoxin NBI-3001 followed by surgical resection in patients with recurrent glioblastoma multiforme
OUTLINE This is an open-label dose-escalation multicenter study Patients receive interleukin-438-37-PE38KDEL cytotoxin NBI-3001 intratumorally as a continuous infusion over 4-5 days beginning within 12-36 hours after ventricular catheter placement Patients then undergo surgical tumor resection approximately 3 weeks after drug infusion Cohorts of 6 patients receive escalating doses of NBI-3001 until the maximum tolerated dose is determined Patients are followed within 1 week and then at 8 16 and 26 weeks
PROJECTED ACCRUAL Approximately 30-36 patients will be accrued for this study
OUTLINE This is an open-label dose-escalation multicenter study Patients receive interleukin-438-37-PE38KDEL cytotoxin NBI-3001 intratumorally as a continuous infusion over 4-5 days beginning within 12-36 hours after ventricular catheter placement Patients then undergo surgical tumor resection approximately 3 weeks after drug infusion Cohorts of 6 patients receive escalating doses of NBI-3001 until the maximum tolerated dose is determined Patients are followed within 1 week and then at 8 16 and 26 weeks
PROJECTED ACCRUAL Approximately 30-36 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 |
|---|---|---|---|
| CDR0000068586 | REGISTRY | None | None |
| NBI-BB-IND-7004 | None | None | None |
| SLUMC-11350 | Registry Identifier | PDQ Physician Data Query | None |