Ignite Creation Date:
2024-05-05 @ 5:26 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00450255
Status:
COMPLETED
Last Update Posted:
2018-05-24
First Post:
2007-03-20
Brief Title:
VEGF Trap in Treating Patients With Recurrent Stage III or Stage IV Melanoma That Cannot Be Removed by Surgery
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase 2 Study Evaluating the Efficacy of VEGF Trap in Patients With Recurrent Inoperable Stage III or Stage IV Melanoma
Status:
COMPLETED
Status Verified Date:
2018-04
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 stage III or stage IV melanoma that cannot be removed by surgery Combinations of biological substances in VEGF Trap may be able to carry tumor-killing substances directly to melanoma cells It may also stop the growth of melanoma by blocking blood flow to the tumor
Detailed Description:
PRIMARY OBJECTIVES
I Determine the antitumor response rate complete and partial response in patients with recurrent inoperable stage III or IV melanoma treated with VEGF Trap
II Compare the progression-free survival of patients treated with this regimen vs historical controls
SECONDARY OBJECTIVES
I Determine the overall survival of patients treated with this regimen II Determine the toxicity and tolerability of this regimen in these patients III Determine the impact of this regimen on laboratory correlates including anti-VEGF Trap antibody testing and pharmacokinetics in these patients
OUTLINE This is a multicenter study
Patients receive VEGF Trap IV over 1 hour on day 1 Treatment repeats every 14 days for at least 6 courses in the absence of disease progression or unacceptable toxicity
Blood samples are collected at baseline prior to course 2 and 60 days after completion of study treatment for pharmacokinetic and pharmacodynamic studies Samples are analyzed by enzyme-linked immunosorbent assay
After completion of study treatment patients are followed periodically for 5 years
I Determine the antitumor response rate complete and partial response in patients with recurrent inoperable stage III or IV melanoma treated with VEGF Trap
II Compare the progression-free survival of patients treated with this regimen vs historical controls
SECONDARY OBJECTIVES
I Determine the overall survival of patients treated with this regimen II Determine the toxicity and tolerability of this regimen in these patients III Determine the impact of this regimen on laboratory correlates including anti-VEGF Trap antibody testing and pharmacokinetics in these patients
OUTLINE This is a multicenter study
Patients receive VEGF Trap IV over 1 hour on day 1 Treatment repeats every 14 days for at least 6 courses in the absence of disease progression or unacceptable toxicity
Blood samples are collected at baseline prior to course 2 and 60 days after completion of study treatment for pharmacokinetic and pharmacodynamic studies Samples are analyzed by enzyme-linked immunosorbent assay
After completion of study treatment patients are followed periodically for 5 years
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-2009-00182 | REGISTRY | None | None |
| PHII-77 | None | None | None |
| CDR0000535719 | None | None | None |
| PHII-77 | OTHER | None | None |
| 7522 | OTHER | None | None |
| N01CM62209 | NIH | None | None |
| P30CA033572 | NIH | CTEP | httpsreporternihgovquickSearchP30CA033572 |