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

Phase 2

Completed

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 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.

Recruitment & Eligibility

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arm && Interventions

Group	Intervention	Description
Dasatinib	dasatinib	Patients receive oral dasatinib at 70 mg twice daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measures

Name	Time	Method
Objective Response Rate Among KIT-positive Patients	Every 6 weeks; up to 5 years	Objective response is defined as complete response (CR) or partial response (PR) per Solid Tumor Response Criteria (RECIST). Complete response is defined as disappearance of all target and non-target lesions. Partial response is defined as at least 30% decrease in the sum of the longest diameters of target lesions, taking as reference the baseline sum longest diameter.

Secondary Outcome Measures

Name	Time	Method
Duration of Response for Dasatinib Monotherapy in This Patient Population	Every 6 weeks; up to 5 years	Duration of response is defined as the period measured from the time that measurement criteria are met for complete or partial response (whichever status is recorded first) until the first date that progressive disease is objectively documented, taking as reference the smallest measurements recorded since treatment started. Progressive disease is defined as at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum longest diameter recorded since the baseline measurements, or the appearance of one or more new lesion(s).
Progression-free Survival	Every 6 weeks; up to 5 years	Progression-free survival is defined as the time from registration to development of progressive disease. Patients without documented progressive disease are censored at the date of last disease assessment. Progressive disease is defined as at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum longest diameter recorded since the baseline measurements, or the appearance of one or more new lesion(s).

Locations (151): Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
🇺🇸
Little Rock, Arkansas, United States
Stanford Cancer Center
🇺🇸
Stanford, California, United States
Michael and Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital
🇺🇸
Fort Lauderdale, Florida, United States
Baptist Cancer Institute - Jacksonville
🇺🇸
Jacksonville, Florida, United States
Ella Milbank Foshay Cancer Center at Jupiter Medical Center
🇺🇸
Jupiter, Florida, United States
CCOP - Mount Sinai Medical Center
🇺🇸
Miami Beach, Florida, United States
Florida Hospital Cancer Institute at Florida Hospital Orlando
🇺🇸
Orlando, Florida, United States
Winship Cancer Institute of Emory University
🇺🇸
Atlanta, Georgia, United States
Kapiolani Medical Center at Pali Momi
🇺🇸
'Aiea, Hawaii, United States
Oncare Hawaii, Incorporated - Pali Momi
🇺🇸
'Aiea, Hawaii, United States
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Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
🇺🇸Little Rock, Arkansas, United States