Ignite Creation Date:
2025-12-24 @ 4:15 PM
Ignite Modification Date:
2025-12-28 @ 1:08 PM
Study NCT ID:
NCT00045266
Status:
COMPLETED
Last Update Posted:
2016-06-03
First Post:
2002-09-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
VEGF Trap in Treating Patients With Solid Tumors or Non-Hodgkin's Lymphoma
Sponsor:
Regeneron Pharmaceuticals
Organization:
Study Overview
Official Title:
An Open-Label, Long Term, Safety, and Tolerability Study of VEGF Trap in Patients With Incurable, Relapsed or Refractory 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-Hodgkin's lymphoma by stopping blood flow to the cancer.
PURPOSE: Phase I trial to study the effectiveness of VEGF Trap in treating patients who have relapsed or refractory solid tumors or non-Hodgkin's lymphoma.
PURPOSE: Phase I trial to study the effectiveness of VEGF Trap in treating patients who have relapsed or refractory solid tumors or non-Hodgkin's lymphoma.
Detailed Description:
OBJECTIVES:
* Determine the long-term safety and tolerability of VEGF Trap in patients with incurable relapsed or refractory solid tumors or non-Hodgkin's lymphoma with stable or responding disease after receiving treatment on protocol MSKCC-01131.
* Determine the biological effect of this therapy on suppressing tumor growth or progression in these patients.
* Determine the steady state concentration of VEGF Trap over time in these patients.
* Determine whether patients develop antibodies to this therapy during extended exposure.
OUTLINE: This is an extension study for patients who showed evidence of stable disease or complete or partial remission after completing treatment on protocol MSKCC-01131.
Patients continue to receive VEGF Trap subcutaneously once weekly for up to an additional 6 months in the absence of unacceptable toxicity. Patients receive treatment at the same dose level as on protocol MSKCC-01131.
Patients are followed at approximately 30 days.
PROJECTED ACCRUAL: A maximum of 30 patients will be accrued for this study.
* Determine the long-term safety and tolerability of VEGF Trap in patients with incurable relapsed or refractory solid tumors or non-Hodgkin's lymphoma with stable or responding disease after receiving treatment on protocol MSKCC-01131.
* Determine the biological effect of this therapy on suppressing tumor growth or progression in these patients.
* Determine the steady state concentration of VEGF Trap over time in these patients.
* Determine whether patients develop antibodies to this therapy during extended exposure.
OUTLINE: This is an extension study for patients who showed evidence of stable disease or complete or partial remission after completing treatment on protocol MSKCC-01131.
Patients continue to receive VEGF Trap subcutaneously once weekly for up to an additional 6 months in the absence of unacceptable toxicity. Patients receive treatment at the same dose level as on protocol MSKCC-01131.
Patients are followed at approximately 30 days.
PROJECTED ACCRUAL: A maximum of 30 patients will be accrued for this study.
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?: