Phase II Trial of (IL-2) With Priming and (GM-CSF) in Patients With Advanced Melanoma
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|ClinicalTrials.gov Identifier: NCT00616564|
Recruitment Status : Completed
First Posted : February 15, 2008
Last Update Posted : May 3, 2012
|Condition or disease||Intervention/treatment||Phase|
|Malignant Melanoma||Drug: GM-CSF||Phase 2|
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 (Clinical Trial)|
|Actual Enrollment :||36 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Multicenter Phase II Trial of High-Dose Interleukin (IL-2) With Priming and Concomitant Sargramostim (GM-CSF) in Patients With Advanced Melanoma|
|Study Start Date :||February 2006|
|Actual Primary Completion Date :||September 2009|
|Actual Study Completion Date :||September 2009|
- Drug: GM-CSF
Concomitant Priming with GM-CSF
- Primary Objective [ Time Frame: one - two years ]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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|