Multicenter Phase II Trial of High-Dose Interleukin (IL-2) With Priming and Concomitant Sargramostim (GM-CSF) in Patients With Advanced Melanoma
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.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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
one - two years
Jose Lutzky, M.D.
Mount Sinai Medical Center Miami Beach
United States: Institutional Review Board
|Jose Lutzky, MD||Miami Beach, Florida 33140|
|David Lawson, MD||Atlanta, Georgia 30322|