Melanoma (Skin) Clinical Trial
Official title:
Evaluation of Vinorelbine Tartrate (Navelbine) in Patients With Disseminated Malignant Melanoma and One Prior Systemic Therapy
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.
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.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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