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