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

Completed · Phase 2

Conditions studied: Recurrent Melanoma, Stage IIIA Melanoma, Stage IIIB Melanoma, Stage IIIC Melanoma, Stage IV Melanoma

In brief

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.

Key facts

Study ID

NCT00436605

Run by

National Cancer Institute (NCI)

People needed

39

Starts

2006-12-01

Expected to finish

2010-11-01

Last updated by the study team

2014-05-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically confirmed stage III unresectable or stage IV melanoma
• Measurable disease
• Must have evidence of tumor growth or new lesions within the past 6 months
• No large pleural effusions
• No known brain metastases or leptomeningeal metastases
• Previously treated brain metastases allowed provided there is no requirement for steroids AND no evidence of progression for ≥ 8 weeks after treatment
• ECOG performance status (PS) 0-1 OR Karnofsky PS 70-100%
• Life expectancy > 3 months
• WBC ≥ 3,000/mm³
• Absolute neutrophil count ≥ 1,500/mm³
• Platelet count ≥ 100,000/mm³
• Hemoglobin ≥ 9.0 g/dL (transfusions allowed)
• Bilirubin ≤ 1.5 mg/mL
• AST and ALT ≤ 2.5 times upper limit of normal (ULN)
• PT/INR and PTT normal
• Creatinine ≤ 1.5 times ULN OR creatinine clearance ≥ 60 mL/min
• No medical condition that may affect the ability to swallow and retain dasatinib tablets, including any of the following:
• Gastrointestinal tract disease resulting in an inability to take oral medication
• Requirement for IV alimentation
• Prior surgical procedures affecting absorption
• Active peptic ulcer disease
• No clinically significant cardiovascular disease, including any of the following:
• Myocardial infarction or ventricular tachyarrhythmia within the past 6 months
• Prolonged QTc > 480 msec
• Major conduction abnormality (unless a cardiac pacemaker is present)

Where it is running

• Yale University — New Haven, Connecticut, United States
• Masonic Cancer Center, University of Minnesota — Minneapolis, Minnesota, United States

Full record on ClinicalTrials.gov

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