A Phase II Study of SU011248 in Patients With Metastatic Mucosal or Acral/Lentiginous Melanoma

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