Ignite Creation Date:
2024-05-05 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00083213
Status:
COMPLETED
Last Update Posted:
2016-06-03
First Post:
2004-05-14
Brief Title:
Intravenous VEGF Trap in Treating Patients With Relapsed or Refractory Advanced Solid Tumors or Non-Hodgkins Lymphoma
Sponsor:
Regeneron Pharmaceuticals
Organization:
Regeneron Pharmaceuticals
Study Overview
Official Title:
An Open Label Sequential Cohort Dose-Escalation Safety Tolerability and Pharmacokinetic Study of VEGF Trap Administered Intravenously in Patients With Advanced Solid Tumors or Lymphoma
Status:
COMPLETED
Status Verified Date:
2016-06
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 VEGF Trap may stop the growth of solid tumors or non-Hodgkins lymphoma by stopping blood flow to the tumor
PURPOSE This phase I trial is studying the side effects and best dose of intravenous VEGF Trap in treating patients with relapsed or refractory advanced solid tumors or non-Hodgkins lymphoma
PURPOSE This phase I trial is studying the side effects and best dose of intravenous VEGF Trap in treating patients with relapsed or refractory advanced solid tumors or non-Hodgkins lymphoma
Detailed Description:
OBJECTIVES
Primary
Determine the safety and tolerability of intravenous VEGF Trap in patients with relapsed or refractory advanced solid tumors or non-Hodgkins lymphoma
Secondary
Determine the maximum tolerated intravenous dose of this drug in these patients
Determine the pharmacokinetics of this drug in these patients
Determine the ability of this drug to bind circulating vascular endothelial growth factor in these patients
Determine preliminarily the ability of this drug to alter tumor blood flow and tumor vascular permeability in these patients
Determine whether antibodies to this drug develop in these patients
OUTLINE This is an open-label dose-escalation multicenter study
Patients receive VEGF Trap IV over 1 hour on days 1 and 15 for a total of 2 doses
Cohorts of 3-6 patients receive escalating doses of VEGF Trap 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 Once the MTD is determined an additional 6 patients are treated at that dose level
In the absence of dose-limiting toxicity patients with stable disease or partial or complete remission may continue to receive VEGF Trap on a separate extension protocol
Patients are followed at weeks 1 3 and 7 and then at 3 months
PROJECTED ACCRUAL A maximum of 25 patients will be accrued for this study
Primary
Determine the safety and tolerability of intravenous VEGF Trap in patients with relapsed or refractory advanced solid tumors or non-Hodgkins lymphoma
Secondary
Determine the maximum tolerated intravenous dose of this drug in these patients
Determine the pharmacokinetics of this drug in these patients
Determine the ability of this drug to bind circulating vascular endothelial growth factor in these patients
Determine preliminarily the ability of this drug to alter tumor blood flow and tumor vascular permeability in these patients
Determine whether antibodies to this drug develop in these patients
OUTLINE This is an open-label dose-escalation multicenter study
Patients receive VEGF Trap IV over 1 hour on days 1 and 15 for a total of 2 doses
Cohorts of 3-6 patients receive escalating doses of VEGF Trap 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 Once the MTD is determined an additional 6 patients are treated at that dose level
In the absence of dose-limiting toxicity patients with stable disease or partial or complete remission may continue to receive VEGF Trap on a separate extension protocol
Patients are followed at weeks 1 3 and 7 and then at 3 months
PROJECTED ACCRUAL A maximum of 25 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 |
|---|---|---|---|
| CDR0000360856 | REGISTRY | PDQ Physician Data Query | None |
| MSKCC-03137 | None | None | None |