Spots Global Cancer Trial Database for PS-341 in Treating Patients With Metastatic Malignant Melanoma

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Trial Identification

Brief Title: PS-341 in Treating Patients With Metastatic Malignant Melanoma

Official Title: A Phase II Study of PS-341 in the Treatment of Metastatic Malignant Melanoma

Study ID: NCT00024011

Conditions

Recurrent Melanoma

Stage IV Melanoma

Interventions

bortezomib

laboratory biomarker analysis

Study Description

Brief Summary: Phase II trial to study the effectiveness of PS-341 in treating patients who have metastatic malignant melanoma. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die

Detailed Description: OBJECTIVES: I. Determine the progression-free survival at 18 weeks and overall survival of patients with metastatic malignant melanoma treated with PS-341. II. Determine the objective response rate of patients treated with this drug. III. Correlate p27 levels in tumor tissue with objective response rate in patients treated with this drug. OUTLINE: This is a multicenter study. Patients receive PS-341 IV over 3-5 seconds on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 3-6 months for up to 2 years after registration. PROJECTED ACCRUAL: A total of 22-50 patients will be accrued for this study within 12 months.