A Randomized Phase II Trial of Multi-Epitope Vaccination With Melanoma Peptides For Cytotoxic T Cells And Helper T Cells For Patients With Metastatic Melanoma

Date de début de l'étude : 9 mai 2005

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