Vaccine Therapy in Treating Patients With Stage IV Cutaneous Melanoma
Melanoma (Skin)
About this trial
This is an interventional treatment trial for Melanoma (Skin) focused on measuring stage IV melanoma, recurrent melanoma
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed cutaneous* melanoma Stage IV Incurable by surgical resection Progressive disease after at least 1 standard chemotherapy or chemoimmunotherapy regimen (e.g., dacarbazine or cisplatin monotherapy) Unidimensionally or bidimensionally measurable disease by physical examination (e.g., cutaneous metastases) and/or noninvasive radiological procedures No active CNS metastases by CT scan or MRI Previously treated (e.g., excision of a single metastasis) CNS metastases are allowed provided there are no signs of active CNS metastases NOTE: *Metastatic melanoma with unidentified primary tumor allowed provided an ocular melanoma can be definitely excluded and origin from the skin is likely PATIENT CHARACTERISTICS: Age 18 and over Performance status Karnofsky 60-100% Life expectancy At least 4 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 disorder Hepatic Bilirubin less than 2.0 mg/dL No evidence of hepatitis B or C infection Renal Creatinine less than 2.5 mg/dL Cardiovascular No clinically significant heart disease Pulmonary No respiratory disease Immunologic HIV-1 and HIV-2 negative HTLV-1 negative No active systemic infection No immunodeficiency disease No active autoimmune disease (e.g., lupus erythematosus, autoimmune thyroiditis or uveitis, multiple sclerosis, or inflammatory bowel disease) Vitiligo allowed Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for at least 4 weeks after study participation Stable medical condition No other major serious illness No contraindication to leukapheresis No organic brain syndrome or significant psychiatric abnormality that would preclude study participation or follow-up No other active malignant neoplasm PRIOR CONCURRENT THERAPY: Biologic therapy More than 4 weeks since prior immunotherapy No other concurrent immunotherapy during and for 2 weeks after study participation Chemotherapy More than 4 weeks since prior systemic chemotherapy (6 weeks for nitrosoureas [e.g., fotemustine]) No concurrent chemotherapy during and for 2 weeks after study participation Endocrine therapy No concurrent corticosteroids during and for 2 weeks after study participation Radiotherapy More than 2 weeks since prior radiotherapy No prior radiotherapy to the spleen Concurrent palliative radiotherapy to selected metastases (e.g., due to pain or local complications such as compression) is allowed Surgery Recovered from prior surgery No prior splenectomy No prior organ allografts Concurrent surgical therapy to selected metastases (e.g., due to pain or local complications such as compression) is allowed Selected accessible metastases may be removed for tumor infiltrating lymphocyte assay or other immunomonitoring investigations (e.g., expression of tumor antigens and HLA molecules) Other No other concurrent investigational drug or paramedical substance during and for 2 weeks after study participation No concurrent participation in another clinical trial Concurrent palliative medication allowed (e.g., acetaminophen, indomethacin, or opiates)
Sites / Locations
- Dermatologische Klinik mit Poliklinik - Universitaetsklinikum Erlangen