Spots Global Cancer Trial Database for Irofulven in Treating Patients With Stage IV Melanoma

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Trial Identification

Brief Title: Irofulven in Treating Patients With Stage IV Melanoma

Official Title: A Multicenter Phase II Trial of MGI-114 in Patients With Stage IV Malignant Melanoma

Study ID: NCT00005968

Conditions

Melanoma (Skin)

Interventions

irofulven

Study Description

Brief Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of irofulven in treating patients who have stage IV melanoma.

Detailed Description: OBJECTIVES: I. Determine the response rate and duration of response in patients with stage IV malignant melanoma treated with 6-hydroxymethylacylfulvene. II. Determine the toxicity of this regimen in these patients. OUTLINE: This is a multicenter study. Patients receive 6-hydroxymethylacylfulvene IV over 5 minutes on days 1-5. Treatment repeats every 4 weeks for a minimum of 2 courses in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease after completion of course 2 receive additional courses. Patients are followed every 3 months for 5 years, and then annually thereafter until death. PROJECTED ACCRUAL: Approximately 16-35 patients will be accrued for this study within 1 year.