Ignite Creation Date:
2024-05-05 @ 7:10 PM
Last Modification Date:
2024-10-26 @ 9:44 AM
Study NCT ID:
NCT00616564
Status:
COMPLETED
Last Update Posted:
2012-05-03
First Post:
2008-02-04
Brief Title:
Phase II Trial of IL-2 With Priming and GM-CSF in Patients With Advanced Melanoma
Sponsor:
Mt Sinai Medical Center Miami
Organization:
Mt Sinai Medical Center Miami
Study Overview
Official Title:
Multicenter Phase II Trial of High-Dose Interleukin IL-2 With Priming and Concomitant Sargramostim GM-CSF in Patients With Advanced Melanoma
Status:
COMPLETED
Status Verified Date:
2012-05
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:
High-dose IL-2 treatment for metastatic melanoma has been approved by the FDA in 1998 Studies of GM-CSF plus IL-2 have not addressed the approved dose and schedule This protocol will study the combination of HD-IL2 and GM-CSF given the potential synergistic interactions discussed above
Detailed Description:
The primary objectives of this phase II multicenter trial are to
Determine the 1 and 2-year survival of patients treated according to protocol Assess the safety and toxicity of this regimen in this patient population
The secondary objectives are to
Determine the freedom from progression FFP Measure the response rate RR Obtain immunological data from the use of this regimen in vivo as separate project Moffitt
The proposed study is a multicenter phase II trial of HD-IL-2 in combination with GM-CSF GM-CSF will be started 7 days before day 1 of HD-IL-2 and will be continued for 4 weeks to day 28 encompassing two cycles of HD-IL2 The first 9 patients will be closely monitored for unexpected toxicity
Determine the 1 and 2-year survival of patients treated according to protocol Assess the safety and toxicity of this regimen in this patient population
The secondary objectives are to
Determine the freedom from progression FFP Measure the response rate RR Obtain immunological data from the use of this regimen in vivo as separate project Moffitt
The proposed study is a multicenter phase II trial of HD-IL-2 in combination with GM-CSF GM-CSF will be started 7 days before day 1 of HD-IL-2 and will be continued for 4 weeks to day 28 encompassing two cycles of HD-IL2 The first 9 patients will be closely monitored for unexpected toxicity
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