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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
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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
John Wayne Cancer Institute, Santa Monica, California, United States
Veterans Affairs Medical Center - Denver, Denver, Colorado, United States
University of Colorado Cancer Center, Denver, Colorado, United States
Lutheran General Hospital, Park Ridge, Illinois, United States
Ellis Fischel Cancer Center - Columbia, Columbia, Missouri, United States
Name: Rene Gonzalez, MD
Affiliation: University of Colorado, Denver
Role: STUDY_CHAIR