Ignite Creation Date:
2024-05-05 @ 11:38 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00098943
Status:
COMPLETED
Last Update Posted:
2012-09-24
First Post:
2004-12-08
Brief Title:
NGR-TNF in Treating Patients With Advanced Solid Tumors
Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
Organization:
European Organisation for Research and Treatment of Cancer - EORTC
Study Overview
Official Title:
Phase I Trial of NGR-TNF Administered Every 3 Weeks as a 1 Hour Intravenous Infusion in Patients With Solid Tumor
Status:
COMPLETED
Status Verified Date:
2012-09
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 Targeted therapy with tumor necrosis factor combined with a fusion protein may stop the growth of solid tumors by stopping blood flow to the tumor
PURPOSE This phase I trial is studying the side effects and best dose of NGR-TNF in treating patients with advanced solid tumors
PURPOSE This phase I trial is studying the side effects and best dose of NGR-TNF in treating patients with advanced solid tumors
Detailed Description:
OBJECTIVES
Primary
Determine the dose-limiting toxicity and maximum tolerated dose of tumor vasculature-targeted tumor necrosis factor alpha NGR-TNF in patients with advanced solid tumors
Determine the recommended phase II dose of this drug in these patients
Secondary
Determine the mechanism of action of this drug in these patients
Determine response in patients treated with this drug
OUTLINE This is an open-label nonrandomized dose-escalation multicenter study
Patients receive tumor vasculature-targeted tumor necrosis factor alpha NGR-TNF IV over 1 hour on day 1 Courses repeat every 21 days in the absence of unacceptable toxicity or disease progression
Cohorts of 1-6 patients receive escalating doses of NGR-TNF until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity Up to 12 patients receive treatment at the MTD
Patients are followed every 8 weeks until disease progression or the start of a new anticancer treatment
PROJECTED ACCRUAL A total of 1-30 patients will be accrued for this study
Primary
Determine the dose-limiting toxicity and maximum tolerated dose of tumor vasculature-targeted tumor necrosis factor alpha NGR-TNF in patients with advanced solid tumors
Determine the recommended phase II dose of this drug in these patients
Secondary
Determine the mechanism of action of this drug in these patients
Determine response in patients treated with this drug
OUTLINE This is an open-label nonrandomized dose-escalation multicenter study
Patients receive tumor vasculature-targeted tumor necrosis factor alpha NGR-TNF IV over 1 hour on day 1 Courses repeat every 21 days in the absence of unacceptable toxicity or disease progression
Cohorts of 1-6 patients receive escalating doses of NGR-TNF until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity Up to 12 patients receive treatment at the MTD
Patients are followed every 8 weeks until disease progression or the start of a new anticancer treatment
PROJECTED ACCRUAL A total of 1-30 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 |
|---|---|---|---|
| EUDRACT-2004-000950-21 | None | None | None |
| EORTC-16041 | None | None | None |
| MOLMED-EORTC-16041 | None | None | None |