NCT00072189

A Phase II Study of UCN-01 in Metastatic Melanoma

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

UCN-01 may stop the growth of tumor cells by blocking the enzymes necessary for their growth. This phase II trial is studying how well UCN-01 works in treating patients with metastatic melanoma.

Detailed description

PRIMARY OBJECTIVES: I. To assess the anti-tumor activity of UCN-01 (7-hydroxystaurosporine) in metastatic melanoma, as determined by the response rate. II. To assess the clinical and laboratory toxicities of UCN-01. III. To study the effects of UCN-01 administration on potential markers of specific G1-phase cell cycle regulators. OUTLINE: This is a multicenter study. Patients receive UCN-01 IV over 3 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients are followed for survival. PROJECTED ACCRUAL: A total of 17-33 patients will be accrued for this study within 18 months.

Conditions

• Recurrent Melanoma
• Stage IV Melanoma

Interventions

Type	Name	Description
DRUG	7-hydroxystaurosporine	Given IV
OTHER	laboratory biomarker analysis	Correlative studies
OTHER	pharmacological study	Correlative studies

Timeline

• Start date: 2003-11-01
• Primary completion: 2010-03-01
• Completion: 2010-03-01
• First posted: 2003-11-06
• Last updated: 2015-03-02
• Results posted: 2015-03-02

Locations

1 site across 1 country: United States