Dasatinib in Treating Patients With Stage III Melanoma That Cannot Be Removed By Surgery or Stage IV Melanoma
Condition: Recurrent Melanoma; Stage IIIA Melanoma; Stage IIIB Melanoma; Stage IIIC Melanoma; Stage IV Melanoma
MeSH terms: Melanoma
Intervention: dasatinib
Intervention MeSH terms: Dasatinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 39.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  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)

          -  No uncontrolled intercurrent illness including, but not limited to, any of the
             following:

               -  Ongoing or active infection

               -  History of significant congenital or acquired bleeding disorder, including any of
                  the following:

                    -  Von Willebrand's disease

                    -  Antifactor VIII antibodies

               -  Dyspnea at rest or with minimal exertion

               -  Uncontrolled seizure disorder

               -  Psychiatric illness or social situations that would preclude study compliance

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

          -  No other active malignancy within the past 3 years except curatively treated stage I
             malignancies or resected skin carcinomas

          -  Recovered from prior therapy

          -  Prior adjuvant therapy for stage II or III melanoma allowed

          -  No prior cytotoxic therapy for metastatic melanoma

          -  No prior dasatinib or other inhibitors of src, bcr-abl, c-Kit, EPHA2, and PDGFRβ

          -  No more than 2 prior immunomodulator therapies for metastatic melanoma

          -  At least 1 week since prior and no concurrent warfarin or other anticoagulants or
             medications that inhibit platelet function (including acetylsalicylic acid)

          -  At least 1 week since prior and no concurrent steroids or other immunosuppressive
             agents

               -  Concurrent steroids to treat induced pleural effusions allowed

          -  At least 3 weeks since prior immunomodulators including, but not limited to, any of
             the following:

               -  Aldesleukin

               -  Cancer vaccines

               -  T-cell-activating monoclonal antibodies

          -  At least 4 weeks since prior radiotherapy

               -  Prior palliative radiotherapy to a single site of disease allowed (tumor is not
                  considered evaluable for response unless there is tumor progression at the site
                  of radiation)

          -  More than 7 days since prior and no concurrent CYP3A4 inhibitors

          -  At least 7 days since prior and no concurrent agents with proarrhythmic potential

          -  No other concurrent investigational agents

          -  No other concurrent anticancer agents or therapies

          -  No concurrent enzyme-inducing anticonvulsant agents

          -  No concurrent grapefruit or grapefruit juice

          -  No concurrent combination antiretroviral therapy for HIV-positive patients

          -  No concurrent CYP3A4 inducers