Irofulven in Treating Patients With Stage IV Melanoma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00005968|
Recruitment Status : Completed
First Posted : June 21, 2004
Last Update Posted : May 30, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Melanoma (Skin)||Drug: irofulven||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||A Multicenter Phase II Trial of MGI-114 in Patients With Stage IV Malignant Melanoma|
|Study Start Date :||November 1999|
|Actual Primary Completion Date :||December 2002|
|Actual Study Completion Date :||December 2002|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00005968
|United States, California|
|John Wayne Cancer Institute|
|Santa Monica, California, United States, 90404|
|United States, Colorado|
|Veterans Affairs Medical Center - Denver|
|Denver, Colorado, United States, 80220|
|University of Colorado Cancer Center|
|Denver, Colorado, United States, 80262|
|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|