Vaccine Therapy in Treating Patients With Stage III or Stage IV Melanoma
Melanoma (Skin)

About this trial
This is an interventional treatment trial for Melanoma (Skin) focused on measuring recurrent melanoma, stage IV melanoma, stage IIIA melanoma, stage IIIB melanoma, stage IIIC melanoma
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed locoregional or metastatic cutaneous malignant melanoma Stage III or IV disease Stage III: pT4b, N0, M0 (satellite metastases) or any pT, N1 or pT, N1 or N2a-c, M0 (lymph node metastases or in transit intralymphatic metastases) Stage IV: any pT, N1-2, M1a-b Surgically incurable Incurable with standard treatment (i.e., localized chemotherapy/limb perfusion for stage III, systemic chemotherapy for stage IV) Unidimensionally or bidimensionally measurable disease by physical examination (e.g., cutaneous metastases) and/or non-invasive radiologic procedures NOTE: Stage III lesions may be measurable lymph nodes after incomplete resection and/or inoperable in transit metastases HLA-A1 and/or HLA-A2 expression by serologic HLA typing HLA-A2.01 subtype must be confirmed by polymerase chain reaction on genomic DNA obtained from peripheral blood mononuclear cells No active CNS metastases Previously treated CNS metastases (e.g., excision of a single metastasis) allowed if no active disease present by CT scan or MRI PATIENT CHARACTERISTICS: Age Over 18 Performance status Karnofsky 60-100% Life expectancy At least 6 months Hematopoietic WBC greater than 2,500/mm^3 Neutrophil count greater than 1,000/mm^3 Lymphocyte count greater than 700/mm^3 Platelet count greater than 75,000/mm^3 Hemoglobin greater than 9 g/dL No bleeding disorders Hepatic Bilirubin less than 2.0 mg/dL No hepatitis B or C Renal Creatinine less than 2.5 mg/dL Cardiovascular No clinically significant heart disease Pulmonary No clinically significant respiratory disease Immunologic No active systemic infection No immunodeficiency disease No evidence of HIV-1, HIV-2, or human T-cell lymphocytic virus-1 No active autoimmune disease including, but not limited to: Lupus erythematosus Autoimmune thyroiditis or uveitis Multiple sclerosis Inflammatory bowel disease NOTE: Vitiligo allowed Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 4 weeks after study participation No organic brain syndrome or significant psychiatric abnormality that would preclude study participation and follow-up No contraindication to leukapheresis No other active malignant neoplasms PRIOR CONCURRENT THERAPY: Biologic therapy More than 4 weeks since prior systemic immunotherapy No concurrent immunotherapy during and for 2 weeks after last vaccination Chemotherapy See Disease Characteristics More than 4 weeks since prior systemic chemotherapy (6 weeks for nitrosoureas [e.g., fotemustine]) No concurrent chemotherapy during and for 2 weeks after last vaccination Endocrine therapy No concurrent corticosteroids during and for 2 weeks after last vaccination Radiotherapy No prior radiotherapy to the spleen Concurrent palliative radiotherapy allowed for selected metastases (e.g., pain or local complications such as compression) Surgery See Disease Characteristics Recovered from prior surgery No prior splenectomy No prior organ allografts Concurrent surgery of selected metastases (e.g., pain or local complications such as compression) allowed Other No other concurrent investigational drugs during and for 2 weeks after last vaccination No concurrent paramedical substance during and for 2 weeks after last vaccination No concurrent participation or intent to participate in another clinical trial
Sites / Locations
- Dermatologische Klinik mit Poliklinik - Universitaetsklinikum Erlangen