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Spots Global Cancer Trial Database for Dasatinib in Treating Patients With Stage III Melanoma That Cannot Be Removed By Surgery or Stage IV Melanoma

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Trial Identification

Brief Title: Dasatinib in Treating Patients With Stage III Melanoma That Cannot Be Removed By Surgery or Stage IV Melanoma

Official Title: A Phase 2 Study of Dasatinib in Advanced Melanoma

Study ID: NCT00436605

Interventions

dasatinib

Study Description

Brief Summary: This phase II trial is studying how well dasatinib works in treating patients with stage III melanoma that cannot be removed by surgery or stage IV melanoma. Dasatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Detailed Description: PRIMARY OBJECTIVES: I. Determine the objective response rate in patients with stage III unresectable or stage IV melanoma treated with dasatinib. II. Determine the progression-free survival of patients treated with this drug. SECONDARY OBJECTIVES: I. To assess the expression of targets of Dasatinib prior to treatment by obtaining pre-treatment biopsies or examining paraffin-embedded tissues from previous tumor resections. II. In selected patients (approximately 5-10) where tumor tissue is available pre-treatment and can be obtained post-treatment with Dasatinib (21 days after initiation of therapy), to determine if Dasatinib induces changes in expression of selected targets and downstream mediators, including MEK, ERK and RSK-1. III. To assess toxicity. OUTLINE: Patients receive oral dasatinib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for 4 weeks.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Yale University, New Haven, Connecticut, United States

Masonic Cancer Center, University of Minnesota, Minneapolis, Minnesota, United States

Contact Details

Name: Harriet Kluger

Affiliation: Yale University

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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