SU011248 in Patients With Metastatic Mucosal or Acral/Lentiginous Melanoma

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