Dasatinib in Treating Patients With Locally Advanced or Metastatic Mucosal Melanoma, Acral Melanoma, or Vulvovaginal Melanoma That Cannot Be Removed By Surgery
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|ClinicalTrials.gov Identifier: NCT00700882|
Recruitment Status : Active, not recruiting
First Posted : June 19, 2008
Last Update Posted : December 14, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Melanoma (Skin)||Drug: dasatinib Other: laboratory biomarker analysis||Phase 2|
- 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.
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||87 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Trial of Dasatinib in Patients With Unresectable Locally Advanced or Stage IV Mucosal, Acral and Vulvovaginal Melanomas|
|Actual Study Start Date :||May 1, 2009|
|Actual Primary Completion Date :||May 6, 2016|
|Estimated Study Completion Date :||May 6, 2021|
- Objective tumor response rate (complete and partial response)
- Response duration
- Progression-free survival
- Safety profile
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00700882
Show 153 Study Locations
|Study Chair:||Donald P. Lawrence, MD||Massachusetts General Hospital|
|Principal Investigator:||Kevin Kalinsky, MD||Tufts Medical Center Cancer Center|