Melanoma (Skin) Clinical Trial
Official title:
A Multicenter Phase II Trial of MGI-114 in Patients With Stage IV Malignant Melanoma
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.
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.
;
Primary Purpose: Treatment
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