Dinaciclib in Treating Patients With Stage IV Melanoma

Status Active, not recruiting

Clinical Trial Summary

This phase II trial is studying the side effects and how well dinaciclib works in treating patients with stage IV melanoma. Dinaciclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Clinical Trial Description

PRIMARY OBJECTIVES: I. To assess the 1-year overall survival rate in patients with stage IV melanoma treated with dinaciclib. SECONDARY OBJECTIVES: I. To assess the 6-month progression-free survival rate in these patients. II. To evaluate the response rate (confirmed and unconfirmed complete and partial responses) in the subset of patients with measurable disease. III. To assess the safety and tolerability of dinaciclib given to patients with stage IV melanoma. OUTLINE: This is a multicenter study. Patients receive dinaciclib IV over 2 hours on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 6 months for up to 3 years. ;

Study Design

Related Conditions & MeSH terms

Acral Lentiginous Melanoma
Cutaneous Nodular Melanoma
Lentigo
Lentigo Maligna Melanoma
Low-CSD Melanoma
Melanoma
Mucosal Melanoma
Recurrent Melanoma
Stage IV Cutaneous Melanoma AJCC v6 and v7

Clinical Trial Details

NCT number	NCT00937937
Study type	Interventional
Source	National Cancer Institute (NCI)
Contact
Status	Active, not recruiting
Phase	Phase 2
Start date	July 1, 2009
Completion date	March 8, 2025

View Details

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