Trial Search Results

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

The purpose of this study is to determine whether patients with melanoma will benefit from dasatinib. Patients with the following types of melanoma can be enrolled in this study: acral melanomas (those that occur on the palms, soles, or underneath the fingernails), mucosal melanomas (those that occur on surfaces of the body such as the mouth, sinuses, rectum or vagina), and skin melanomas which have evidence of chronic sun damage. Dasatinib is not chemotherapy and is an oral medication which targets proteins that are thought to be present on the melanoma cells.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Eastern Cooperative Oncology Group

Collaborator: National Cancer Institute (NCI)

Stanford Investigator(s):

Intervention(s):

  • Drug: dasatinib
  • Other: laboratory biomarker analysis

Phase:

Phase 2

Eligibility


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
   situ 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)

Ages Eligible for Study

18 Years - 120 Years

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
CCTO
650-498-7061
Not Recruiting