Phase II Trial of (IL-2) With Priming and (GM-CSF) in Patients With Advanced Melanoma
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.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Multicenter Phase II Trial of High-Dose Interleukin (IL-2) With Priming and Concomitant Sargramostim (GM-CSF) in Patients With Advanced Melanoma|
- Primary Objective [ Time Frame: one - two years ] [ Designated as safety issue: No ]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
|Study Start Date:||February 2006|
|Study Completion Date:||September 2009|
|Primary Completion Date:||September 2009 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00616564
|United States, Florida|
|Jose Lutzky, MD|
|Miami Beach, Florida, United States, 33140|
|United States, Georgia|
|David Lawson, MD|
|Atlanta, Georgia, United States, 30322|
|Study Chair:||Jose Lutzky, M.D.||Mount Sinai Medical Center Miami Beach|