NCT00024011

PS-341 in Treating Patients With Metastatic Malignant Melanoma

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Recurrent Melanoma
• Stage IV Melanoma

Interventions

Type	Name	Description
DRUG	bortezomib	Given IV
OTHER	laboratory biomarker analysis	Correlative studies

Timeline

• Start date: 2001-07-01
• Primary completion: 2006-09-01
• First posted: 2004-02-06
• Last updated: 2013-01-16

Locations

1 site across 1 country: United States