D0320: High Dose Interleukin-2 (IL-2) Therapy in "Lymphodepleted Primed" Patients With Metastatic Melanoma

Inclusion Criteria:

- Histologically confirmed metastatic melanoma with measurable disease

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

- Karnofsky Performance Status greater than or equal to 60%

- Life expectancy greater than or equal to 12 weeks

- Adequate end organ function as defined in text of protocol

- Women must not be pregnant or breastfeeding

- Must agree to use appropriate contraception

- Patient must be competent and must sign informed consent

Exclusion Criteria:

- Patients may not have been treated previously with IL-2

- 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

- Positive serology for HIV, hepatitis B or hepatitis C

- Significant co-morbid illness such as uncontrolled diabetes or active infection that
would preclude treatment on this regimen

- Use of corticosteroids or other immunosuppression (if patient had been taking
steroids, at lease 4 weeks must have passed since the last dose)

- History of autoimmune disease

- Creatinine Clearance of less than 50ml/min