NCT00278122

Paclitaxel and GM-CSF in Treating Patients With Stage III or Stage IV Melanoma That Cannot Be Removed By Surgery

Evaluation of the Clinical Efficacy of Leukine® Administered in Conjunction With Paclitaxel in Patients With Advanced Melanoma

• Status: Suspended
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 42 (estimated)
• Sponsor: University of Virginia · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Biological therapies, such as GM-CSF, may stimulate the immune system in different ways and stop tumor cells from growing. Giving paclitaxel together with GM-CSF may be effective in treating melanoma. PURPOSE: This phase II trial is studying how well giving paclitaxel together with GM-CSF works in treating patients with stage III or stage IV melanoma that cannot be removed by surgery.

Detailed description

OBJECTIVES: Primary * Assess the activity of paclitaxel and sargramostim (GM-CSF), in terms of objective clinical response rate (complete response \[CR\] and partial response \[PR\]), in patients with advanced unresectable melanoma. Secondary * Evaluate the duration of response, time to progression, and overall survival of patients treated with this regimen. * Determine serum cytokine levels (GM-CSF, IFN-γ, aldesleukin, recombinant interleukin-4, and IL-10) in these patients. OUTLINE: This is an open-label study. Patients receive paclitaxel IV over 3 hours on day 1 and sargramostim (GM-CSF) subcutaneously on days 4-17. Treatment repeats every 21 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. Patients achieving complete response (CR) receive 2 additional courses of therapy beyond CR for up to 12 courses. After study treatment, patients are followed every 3-6 months for at least 3 years. PROJECTED ACCRUAL: A total of 42 patients will accrued for this study.

Conditions

• Melanoma (Skin)

Interventions

Type	Name	Description
BIOLOGICAL	sargramostim
DRUG	paclitaxel

Timeline

• Start date: 2005-07-01
• Primary completion: 2015-12-01
• First posted: 2006-01-18
• Last updated: 2013-12-10

Locations

1 site across 1 country: United States