NCT00616564

Phase II Trial of (IL-2) With Priming and (GM-CSF) in Patients With Advanced Melanoma

Multicenter Phase II Trial of High-Dose Interleukin (IL-2) With Priming and Concomitant Sargramostim (GM-CSF) in Patients With Advanced Melanoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Mt. Sinai Medical Center, Miami · Academic / Other
• Sex: All
• Age: 16 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Malignant Melanoma

Interventions

Type	Name	Description
DRUG	GM-CSF	Concomitant Priming with GM-CSF

Timeline

• Start date: 2006-02-01
• Primary completion: 2009-09-01
• Completion: 2009-09-01
• First posted: 2008-02-15
• Last updated: 2012-05-03

Locations

2 sites across 1 country: United States