Vaccine Therapy Using Melanoma Peptides for Cytotoxic T Cells and Helper T Cells in Treating Patients With Metastatic Melanoma

Inclusion Criteria:

Histologically confirmed stage IV melanoma

Multiple primary melanomas allowed
Metastasis may be from a cutaneous, mucosal, ocular, or unknown primary site
Measurable disease by Response Evaluation Criteria In Solid Tumors (RECIST criteria)
Must have 2 extremities uninvolved with tumor

Must have at least 2 intact (undissected) axillary and/or inguinal lymph node basins

Prior sentinel node biopsy may not have violated the integrity of a nodal basin

This extremity may still be considered for vaccination
Human Lymphocyte Antigen (HLA)-A1, -A2, or -A3 positive

Prior brain metastases allowed provided all of the following are true:

Surgically resected or treated with gamma-knife or stereotactic radiosurgery
No disease progression in the brain for the past 3 months
More than 30 days since prior steroids for the management of brain metastases
Age: 18 and over
Eastern Cooperative Oncology Group (ECOG) performance status of 0-1

Adequate organ function measured within 4 weeks before randomization:

White blood cell (WBC) at least 4,000/mm^3
Platelet count at least 100,000/mm^3
Lymphocyte count at least 700/mm^3
Serum glutamic oxaloacetic transaminase (SGOT) and serum glutamic pyruvic transaminase (SGPT) no greater than 2 times upper limit of normal (ULN)
Bilirubin no greater than 2 times ULN
Alkaline phosphatase no greater than 2 times ULN
Lactic dehydrogenase no greater than 2 times ULN
Creatinine no greater than 1.8 mg/dL
Negative pregnancy test
Fertile patients must use effective contraception
No other malignancy within the past 5 years except nonmetastatic squamous cell or basal cell skin cancer, ductal or lobular carcinoma in situ of the breast, or carcinoma in situ of the cervix
At least 4 weeks since prior sargramostim (GM-CSF), interferon alfa-2b, or interleukin-2
More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)

More than 30 days since prior systemic corticosteroids, including any of the following:

Therapeutic doses of oral steroids (e.g., prednisone or dexamethasone)

Steroid inhalers (e.g., Advair)

Topical steroids and nasal steroids with low systemic absorption (e.g., fluticasone) or steroids with low systemic absorption (e.g., triamcinolone hexacetonide) injected into a joint space allowed
At least 4 weeks since prior local control or palliative radiotherapy and recovered
Recovered from prior major surgery

Exclusion criteria:

More than 3 brain metastases
Metastatic lesions greater than 2 cm
Concurrent radiotherapy
Prior radiotherapy to measurable disease
Concurrent surgery
Concurrent corticosteroids
Concurrent topical or systemic steroids
Concurrent chemotherapy
Prior vaccination with any of the study peptides
Recent (within the past year) or concurrent addiction to alcohol or illicit drugs
Pregnant or nursing
Known or suspected major allergy to any components of the study vaccine
Significant detectable infection
Immunosuppression conditions

Prior or active autoimmune disorder requiring cytotoxic or mmunosuppressive therapy, except for any of the following:

Presence of laboratory evidence of autoimmune disease (e.g., positive antinuclear antibody (ANA) titer) without symptoms
Clinical evidence of vitiligo or other forms of depigmenting illness
Mild arthritis requiring nonsteroidal anti-inflammatory medication
Autoimmune disorder with visceral involvement