A Pilot Trial of Therapeutic Vaccination With a Modified gp100 Melanoma Peptide (gp100:209-217(210M)), Montanide ISA 51, and KLH With Reconstitution After Chemotherapy to Induce Lymphopenia in Patients With Metastatic Melanoma

Date de début de l'étude : 1 juillet 2004

DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed malignant melanoma * Metastatic or unresectable disease * Measurable disease * HLA-A2 positive * Received at least 1 prior immunotherapy and/or chemotherapy regimen for metastatic disease (first 6 patients only) * No known brain metastases unless previously treated with radiotherapy and/or surgery AND is stable for at least 1 month after treatment PATIENT CHARACTERISTICS: Age * 18 and over Performance status * ECOG 0-2 OR * Karnofsky 60-100% Life expectancy * More than 3 months Hematopoietic * WBC ≥ 3,000/mm\^3 * Absolute neutrophil count ≥ 1,500/mm\^3 * Absolute lymphocyte count ≥ 500/mm\^3 * Platelet count ≥ 100,000/mm\^3 * Hemoglobin ≥ 10 g/dL (transfusions allowed) * Hematocrit ≥ 24% * No other active bleeding Hepatic * Bilirubin \< 2 times upper limit of normal (ULN) (unless due to Gilbert's disease) * AST and ALT \< 3 times ULN * Hepatitis B surface antigen negative * Hepatitis C antibody negative Renal * Creatinine \< 2 mg/dL * No uncontrolled hypercalcemia Cardiovascular * No uncontrolled symptomatic congestive heart failure * No unstable angina pectoris * No uncontrolled cardiac arrhythmia * No uncontrolled hypertension Pulmonary * No uncontrolled bronchospasm * No hemoptysis Immunologic * Negative serology for all of the following: * HIV-1 and HIV-2 * HTLV-1 and -2 * Syphilis * Rheumatoid factor \< 43 units/μL * Anti-nuclear antibody \< 11 units/μL * No history of multiple sclerosis, systemic lupus erythematosus, or myasthenia gravis * No primary or secondary immunodeficiency * No active infection * No allergy to seafood or shellfish that would preclude study participation Other * No active gastrointestinal bleeding * No uncontrolled hyperglycemia * No other medical or psychiatric condition or social situation that would preclude study compliance * No other uncontrolled illness * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 3-4 months after study participation PRIOR CONCURRENT THERAPY: Biologic therapy * See Disease Characteristics * No prior immunization with gp100:209-217(210M) peptide Chemotherapy * See Disease Characteristics * More than 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) Endocrine therapy * More than 2 weeks since prior steroid therapy except replacement steroids or inhaled steroids * No concurrent corticosteroids except replacement steroids * No concurrent dexamethasone Radiotherapy * See Disease Characteristics * More than 2 weeks since prior radiotherapy Surgery * See Disease Characteristics * Recovered from prior surgery Other * No other concurrent investigational agents * No other concurrent anticancer therapy