Last updated on September 2014

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


Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Melanoma (Skin)
  • Age: Between 18 - 100 Years
  • Gender: Male or Female
  • Other:
    DISEASE CHARACTERISTICS:
    Histologically or cytologically confirmed melanoma of 1 of the following subtypes:
    Acral melanoma (defined as occurring on the palms, soles, or subungual sites)
    Melanoma arising from the vagina and/or vulva
    Melanoma arising on other mucosal surface (not vagina or vulva)
    Unresectable locally advanced or metastatic disease
    c-KIT mutation identified by polymerase chain reaction (PCR) and sequencing meeting 1
    of the following criteria:
    At least 1 mutation in exon 9, 11, 13, 17, or 18
    At least 1 mutation in an exon not listed above
    Metastatic tumor blocks are required for the evaluation of KIT mutations or
    amplifications
    Measurable disease, defined as at least one measurable lesion by RECIST criteria
    Prior radiotherapy to a measurable lesion allowed provided there is radiographic
    evidence of progression of that lesion
    No ocular melanoma
    Baseline bone scan required for patients with known bone metastases, elevated
    alkaline phosphatase, or symptoms raising suspicion of bone metastases
    History or clinical evidence of brain metastasis allowed provided the following
    criteria are met:
    Completed radiotherapy or surgical treatment of brain lesions AND there is no
    evidence of CNS progression for ≥ 8 weeks
    Must not require corticosteroids for treatment of cerebral edema from brain
    metastases
    PATIENT CHARACTERISTICS:
    ECOG performance status 0-1
    WBC ≥ 3,000/mm³
    Absolute granulocyte count ≥ 1,500/mm³
    Platelet count ≥ 100,000/mm³
    Creatinine ≤ 2.0 times upper limit of normal (ULN) OR creatinine clearance ≥ 40
    mL/min
    Total bilirubin ≤ 1.5 times ULN (< 3.0 times ULN in the presence of Gilbert disease)
    AST and ALT ≤ 2.5 times ULN (≤ 5.0 times ULN in the presence of liver metastases)
    Serum potassium and magnesium normal (repletion allowed)
    Total serum calcium or ionized calcium normal
    INR ≤ 1.5 and PTT normal
    Therapeutic anticoagulation with warfarin allowed provided INR ≤ 1.5 or PTT
    normal prior to initiating anticoagulation therapy
    Not pregnant or nursing
    Negative pregnancy test
    Fertile patients must use effective contraception
    No evidence of bleeding diathesis
    No other malignancies except basal cell or squamous cell skin cancer, carcinoma in
    itu of the cervix, ductal or lobular carcinoma in situ of the breast, or other
    malignancies from which the patient has been continuously disease-free for ≥ 5 years
    Patients must not have any clinically significant cardiovascular disease including
    the following:
    Myocardial infarction or ventricular tachyarrhythmia within 6 months
    Prolonged QTc >480 msec (Fridericia correction)
    Ejection fraction less than institutional normal
    Major conduction abnormality (unless a cardiac pacemaker is present)
    Patients with any cardiopulmonary symptoms of unknown cause (e.g., shortness of
    breath, chest pain, etc.) are to be evaluated by a baseline echocardiogram with
    or without stress test as needed in addition to electrocardiogram (EKG) to rule
    out QTc prolongation
    Patients with underlying cardiopulmonary dysfunction are excluded from the study
    No uncontrolled hypertension, defined as systolic blood pressure ≥ 150 mm Hg or
    diastolic blood pressure ≥ 90 mm Hg
    Hypertension that is adequately controlled with medication allowed
    No QTc prolongation, defined as a QTc interval ≥ 450 msecs
    No concurrent serious illness including, but not limited to, ongoing or active
    infection requiring parenteral antibiotics
    No psychiatric illness or social situation that would limit compliance with study
    requirements
    PRIOR CONCURRENT THERAPY:
    See Disease Characteristics
    Recovered from prior therapy
    No prior treatment with targeted therapies directed to C-KIT/PDGFR (e.g., imatinib
    mesylate or sunitinib malate)
    Prior limb perfusion allowed
    Prior systemic therapy allowed
    At least 4 weeks since prior chemotherapy or immunotherapy
    Prior adjuvant or neoadjuvant chemotherapy or immunotherapy allowed
    At least 4 weeks since prior radiotherapy
    No concurrent cytochrome P450 enzyme-inducing antiepileptic drugs (i.e., phenytoin,
    carbamazepine, or phenobarbital), rifampin, or Hypericum perforatum (St. John wort)

Recruitment Status: Open


Brief Description Eligibility Contact Research Team


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