A Phase II Study of UCN-01 in Metastatic Melanoma

Status Terminated

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00072189
Study type	Interventional
Source	National Cancer Institute (NCI)
Contact
Status	Terminated
Phase	Phase 2
Start date	November 2003
Completion date	March 2010

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See also
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