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

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

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

Brief 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.


Detailed Summary:

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.


Sponsor: Eastern Cooperative Oncology Group

Current Primary Outcome: Objective tumor response rate (complete and partial response)

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Response duration
  • Progression-free survival
  • Safety profile


Original Secondary Outcome: Same as current

Information By: Eastern Cooperative Oncology Group

Dates:
Date Received: June 18, 2008
Date Started: May 2009
Date Completion:
Last Updated: September 16, 2014
Last Verified: September 2014