Dasatinib in Treating Patients With Locally Advanced or Metastatic Mucosal Melanoma, Acral Melanoma, or Vulvovaginal Melanoma That Cannot Be Removed By Surgery

Melanoma (Skin) Clinical Trial

Official title: A Phase II Trial of Dasatinib in KIT-Positive Patients With Unresectable Locally Advanced or Stage IV Mucosal, Acral and Vulvovaginal Melanomas

Status Completed

Clinical Trial Summary

RATIONALE: Dasatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

PURPOSE: This phase II trial is studying how well dasatinib works in treating patients with locally advanced or metastatic mucosal melanoma or acral melanoma.

Clinical Trial Description

OBJECTIVES:

Primary

• To estimate the objective tumor response rate in patients with KIT-positive, unresectable, locally advanced or metastatic acral or mucosal melanoma treated with dasatinib monotherapy.

Secondary

• To estimate the response duration in patients treated with this drug.

• To estimate the progression-free survival of patients treated with this drug.

• To evaluate the safety profile of this drug in these patients.

• To evaluate the PDGFR expression and activation of Src family kinases in tumor samples and correlate these parameters with response to treatment.

OUTLINE: This is a multicenter study.

Patients receive oral dasatinib twice daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Tissue samples may be collected from some patients for correlative studies.

After completion of study therapy, patients are followed up periodically for up to 5 years. ;

Related Conditions & MeSH terms

• Melanoma
• Melanoma (Skin)

• NCT number: NCT00700882
• Study type: Interventional
• Source: Eastern Cooperative Oncology Group
• Status: Completed
• Phase: Phase 2
• Start date: July 2, 2009
• Completion date: December 28, 2020