Irofulven in Treating Patients With Stage IV Melanoma
- Conditions
- Melanoma (Skin)
- Registration Number
- NCT00005968
- Lead Sponsor
- University of Colorado, Denver
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (5)
John Wayne Cancer Institute
🇺🇸Santa Monica, California, United States
Ellis Fischel Cancer Center - Columbia
🇺🇸Columbia, Missouri, United States
University of Colorado Cancer Center
🇺🇸Denver, Colorado, United States
Lutheran General Hospital
🇺🇸Park Ridge, Illinois, United States
Veterans Affairs Medical Center - Denver
🇺🇸Denver, Colorado, United States