Phase II Trial of (IL-2) With Priming and (GM-CSF) in Patients With Advanced Melanoma

Inclusion Criteria:

Histologically confirmed diagnosis of melanoma with measurable disease
Patients with stage IV or unresectable advanced melanoma
Age at least 16 years.
ECOG performance status of 0-1
Life expectancy > 3 months

Adequate major organ function to tolerate therapy, as defined by:

Total bilirubin 2.0 mg/dL.
Creatinine 1.8 mg/dL.
WBC 3,000/mm3.
Platelet count 100,000/mm3.
Patients 50 years of age with one or more cardiac risk factors must demonstrate normal exercise stress test, stress thallium test, or comparable cardiac ischemia evaluation
Left ventricular ejection fraction > 40%
Women of childbearing age must agree to use barrier method birth control and demonstrate a negative pregnancy test prior to initiation of protocol therapy. Periodic negative urine pregnancy tests will also be required.
Patients must give written informed consent

Exclusion Criteria:

No prior HD- IL-2 for stage IV/unresectable advanced disease. Prior low dose IL-2 is allowed.
No more than 2 prior chemotherapy regimens are allowed.
No active CNS metastases. Treated CNS metastases without recurrence or progression for > 8 weeks are allowed.
No concurrent use of systemic corticosteroids
Pregnant and/or lactating are excluded
No concurrent antineoplastic treatments, including chemotherapy, biologic response modifiers, radiation, vaccines, or other experimental therapies.
No treatment for melanoma within the previous 4 weeks.