Inclusion Criteria

- Metastatic melanoma with measurable disease

- Patients must be at least 4 weeks from their last immunotherapy, radiation, surgery
or chemotherapy (6 weeks for nitrosoureas) and recovered from all ill

- Karnofsky Performance Status ≥60%

- Life expectancy ≥ twelve weeks

- Adequate end organ function

- Women should not be lactating and, if of childbearing age, have a negative pregnancy
test within two weeks of entry to the study.

- Appropriate Contraception in both sexes

- The patient must be competent and signed informed consent.

EXCLUSION CRITERIA

- Concomitant second malignancy except for non-melanoma skin cancer, and non-invasive
cancer such as cervical CIS, superficial bladder cancer without local recurrence,
breast CIS.

- In patients with a prior history of invasive malignancy, less than five years in
complete remission.

- Have evidence of significant co-morbid illness such as uncontrolled diabetes -
Uncontrolled brain metastasis: Patients with brain metastasis most have been treated
with brain radiation therapy or surgery and remain clinically stable for a minimum of
4 weeks.