NCT00003828

S9804: Vinorelbine in Treating Patients With Stage IV Melanoma

Evaluation of Vinorelbine Tartrate (Navelbine) in Patients With Disseminated Malignant Melanoma and One Prior Systemic Therapy

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: SWOG Cancer Research Network · Network
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of vinorelbine in treating patients who have stage IV melanoma that has been previously treated.

Detailed description

OBJECTIVES: I. Evaluate the response rate (complete or partial) of patients with disseminated stage IV melanoma treated with vinorelbine. II. Assess the qualitative and quantitative toxic effects of vinorelbine in these patients. OUTLINE: Patients receive vinorelbine by IV over 6 to 10 minutes weekly. Treatment continues in the absence of disease progression, unacceptable toxicity, or complete response to therapy. Patients are followed every 3 months for 2 years and every 6 months thereafter. PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study.

Conditions

• Melanoma (Skin)

Interventions

Type	Name	Description
DRUG	vinorelbine

Timeline

• Start date: 1999-05-01
• Primary completion: 2001-12-01
• Completion: 2004-03-01
• First posted: 2004-08-04
• Last updated: 2012-08-22

Locations

86 sites across 1 country: United States