A Phase III Multi-Institutional Randomized Study of Immunization With the gp100: 209-217 (210M) Peptide Followed by High Dose IL-2 vs. High Dose IL-2 Alone in Patients With Metastatic Melanoma

Inclusion Criteria:

- Any patient with measurable metastatic (stage IV or locally advanced stage III)
cutaneous melanoma and an expected survival of greater than three months will be
considered

- Serum creatinine of 1.6 mg/dl or less

- Total bilirubin 1.6 mg/dl or less

- WBC 3000/mm^3 or greater

- Platelet count 90,000 mm^3 or greater

- Serum AST/ALT less then three times normal

- ECOG performance status of 0 or 1

- Patients of both genders must be willing to practice effective birth control during
this trial

- Pathologic confirmation of cutaneous melanoma; patients may enter the study with a
pathologic diagnosis of cutaneous melanoma from any institution; all slides will be
reviewed at National Institutes of Health (NIH) (department of Anatomic Pathology)
and if the diagnosis is not confirmed, the patient will be excluded from the study

- Tissue type human leukocyte antigen (HLA) A0201

Exclusion Criteria:

- Patients who have types of melanoma other than cutaneous, i.e. ocular or mucosal

- Patients who are undergoing or have undergone in the past 4 weeks any other form of
therapy except surgery for their cancer, including radiation therapy to any site

- Patients who have active systemic infections, coagulation disorders, autoimmune
disease or history of other major medical illnesses such as insulin dependent
diabetes mellitus, cardiac ischemia, myocardial infarction, cardiac arrhythmias,
obstructive or restrictive pulmonary diseases and inflammatory bowel disorders

- Patients who have significant psychiatric disease which in the opinion of the
principal investigator would prevent adequate informed consent or render
immunotherapy unsafe or contraindicated

- Patients who require steroid therapy or steroid-containing compounds, or have used
systemic steroids in the past 4 weeks, or have used topical or inhalational steroids
in the past 2 weeks

- Patients who are pregnant

- Patients who are known to be positive for viral hepatitis B or C (HBsAg or Anti HCV)
or HIV (HIV antibody)

- Patients who have any form of primary or secondary immunodeficiency

- Patients who have received previous high dose IL-2 (> 600,000 IU/kg)

- Patients who have received previous gp100 vaccines

- Patients who have an abnormal stress cardiac test (stress thallium, stress MUGA,
dobutamine echocardiogram or other stress test that will rule out cardiac ischemia)

- Patients who have abnormal pulmonary function tests (FEV1 < 65% or FVC < 65% of
predicted)

- Patients who have brain metastasis or history of brain metastasis

- No prior malignancy is allowed except for adequately treated basal cell or squamous
cell skin cancer, in situ cervical cancer, or other cancer for which the patient has
been disease free for 5 years