SU011248 in Patients With Metastatic Mucosal or Acral/Lentiginous Melanoma
Condition: Mucosal Lentiginous Melanoma; Acral Lentiginous Malignant Melanoma
MeSH terms: Melanoma
Intervention: Sunitinib
Intervention MeSH terms: Sunitinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 52.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Sutent; malignant melanoma

Summary:

      The purpose of this study is to evaluate how effective Sunitinib works in treating acral
      lentiginous and mucosal melanoma which has spread beyond the local region. Suninitib is a
      protein-tyrosine kinase inhibitor and acts as a c-kit inhibitor drug. It is believed to work
      by blocking signals on certain cancer cells which allow the malignant cells to multiply and
      spread due to a change in the genetic make up of the cancer cell.
    

Eligibility criteria:

        Inclusion Criteria:

          -  History of primary mucosal or acral/lentiginous melanoma

          -  Histologically documented stage III unresectable or IV metastatic melanoma

          -  ECOG Performance Status 0,1 or 2

          -  Estimated life expectancy of 6 months or greater

          -  18 years of age or older

          -  Lab values as outlined in protocol

          -  Tumor blocks or slides must be available of either primary or metastatic tumor site
             for c-kit mutation testing

          -  Negative pregnancy test within 48 hours of starting treatment

          -  At least one measurable site of disease as defined by at least 1cm in greatest
             dimension

        Exclusion Criteria:

          -  Severe and/or uncontrolled medical disease

          -  Pregnant or nursing mothers

          -  Known brain metastasis. History of or known spinal cord compression, or carcinomatous
             meningitis, or evidence of symptomatic brain or leptomeningeal disease on screening CT
             or MRI scan

          -  Less than 5 years free of another primary malignancy except: if the other primary
             malignancy is not currently clinically significant nor requiring active intervention,
             or if other primary malignancy is a basal cell skin cancer or cervical carcinoma in
             situ

          -  Grade III/IV cardiac problems as defined by the New York Heart Association Criteria

          -  Ongoing cardiac dysrhythmias of grade 2 or greater, atrial fibrillation, QTc interval
             >450msec for males of >470 msec for females

          -  Hypertension that cannot be controlled by medication

          -  Any of the following within 12 months prior to starting treatment: myocardial
             infarction, severe/unstable angina, coronary/peripheral artery bypass graft,
             congestive heart failure, cerebrovascular accident or transient ischemic attack, or
             pulmonary embolism

          -  NCI CTCAE version 3.0 grade 3 hemorrhage within 4 weeks of starting the study
             treatment

          -  Concurrent treatment with warfarin

          -  Prior treatment with SU011248 or any other antiangiogenic agent

          -  No H2 blockers or proton pump inhibitors

          -  Known chronic liver disease

          -  Known HIV infection

          -  Previous radiotherapy to 25% or more of the bone marrow and/or radiation therapy
             within 4 weeks prior to study entry

          -  Major surgery within 4 weeks prior to study entry

          -  Pre-existing thyroid abnormality with thyroid function that cannot be maintained in
             the normal range with medication