NCT00005968

Irofulven in Treating Patients With Stage IV Melanoma

A Multicenter Phase II Trial of MGI-114 in Patients With Stage IV Malignant Melanoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: —
• Sponsor: University of Colorado, Denver · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Melanoma (Skin)

Interventions

Type	Name	Description
DRUG	irofulven

Timeline

• Start date: 1999-11-01
• Primary completion: 2002-12-01
• Completion: 2002-12-01
• First posted: 2004-06-21
• Last updated: 2013-05-30

Locations

5 sites across 1 country: United States