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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
36
Concomitant Priming with GM-CSF
Jose Lutzky, MD
Miami Beach, Florida, United States
David Lawson, MD
Atlanta, Georgia, United States
Primary Objective
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
Time frame: one - two years
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