Irofulven in Treating Patients With Stage IV 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.
|Study Design:||Primary Purpose: Treatment|
|Official Title:||A Multicenter Phase II Trial of MGI-114 in Patients With Stage IV Malignant Melanoma|
|Study Start Date:||November 1999|
|Study Completion Date:||December 2002|
|Primary Completion Date:||December 2002 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00005968
|United States, California|
|John Wayne Cancer Institute|
|Santa Monica, California, United States, 90404|
|United States, Colorado|
|University of Colorado Cancer Center|
|Denver, Colorado, United States, 80262|
|Veterans Affairs Medical Center - Denver|
|Denver, Colorado, United States, 80220|
|United States, Illinois|
|Lutheran General Hospital|
|Park Ridge, Illinois, United States, 60068|
|United States, Missouri|
|Ellis Fischel Cancer Center - Columbia|
|Columbia, Missouri, United States, 65203|
|Study Chair:||Rene Gonzalez, MD||University of Colorado, Denver|