Vaccine Therapy in Treating Patients With Stage IV 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 disease (i.e., distant metastasis) Not curable by surgical resection NOTE: *Metastatic melanoma with an unknown primary tumor allowed provided ocular melanoma can be definitely excluded and origin from the skin is likely Unidimensionally or bidimensionally measurable disease by physical examination and/or noninvasive radiological procedures At least 1 measurable metastasis that has not been previously excised or biopsied Failed ≥ 1 standard chemotherapy or chemoimmunotherapy regimen (e.g., dacarbazine or cisplatin monotherapy) At least 1 metastatic lesion surgically accessible* for excision or biopsy to obtain tumor material for RNA isolation** NOTE: *Surgically accessible metastatic lesion not required provided properly processed tumor material or isolated tumor RNA is available from a metastasis excised or biopsied within the past 6 months NOTE: **Major surgery not allowed for the acquisition of metastatic material solely for RNA isolation No active CNS metastases by CT scan or MRI Previously treated CNS metastases (e.g., by excision of a single metastasis, gamma knife radiosurgery, or stereotactic radiotherapy) allowed provided there is no evidence of active CNS metastasis by CT scan or MRI PATIENT CHARACTERISTICS: Age Over 18 Performance status Karnofsky 60-100% Life expectancy At least 4 months Hematopoietic WBC > 2,500/mm^3 Neutrophil count > 1,000/mm^3 Lymphocyte count > 700/mm^3 Platelet count > 75,000/mm^3 Hemoglobin > 9 g/dL No bleeding disorders Hepatic Bilirubin < 2.0 mg/dL Hepatitis B surface antigen negative Hepatitis C antibody negative Renal Creatinine < 2.5 mg/dL Cardiovascular No clinically significant heart disease Pulmonary No respiratory disease Immunologic HIV-1 or -2 negative Human T-cell lymphotropic virus type I negative No known hypersensitivity to dimethylsulfoxide No immunodeficiency disease No active systemic infection No active autoimmune disease (except vitiligo), including any of the following: Lupus erythematosus Scleroderma Rheumatoid arthritis (i.e., rheumatoid factor-positive arthritis with current or recent flare) Ankylosing spondylitis Autoimmune thyroiditis or uveitis Autoimmune hemolytic anemia Immune thrombocytopenic purpura Multiple sclerosis Inflammatory bowel disease Other Not pregnant or nursing Negative pregnancy test Fertile female patients must use effective contraception during and for ≥ 4 weeks after completion of study treatment Willing to undergo excision or biopsy of metastasis Willing to be hospitalized for ≥ 24 hours after each vaccination Medical condition stable No contraindication to leukapheresis No organic brain syndrome No significant psychiatric abnormality that would preclude study participation No other active malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix No other major serious illness PRIOR CONCURRENT THERAPY: Biologic therapy See Disease Characteristics More than 4 weeks since prior systemic immunotherapy No systemic immunotherapy during and for 2 weeks after completion of study treatment Chemotherapy See Disease Characteristics More than 4 weeks since prior systemic chemotherapy No systemic chemotherapy during and for 2 weeks after completion of study treatment Endocrine therapy No systemic corticosteroids, including steroid-containing inhalers or chronic use of topical steroids over large areas of the body (if systemic effects are likely or obvious) during and for 2 weeks after completion of study treatment Radiotherapy See Disease Characteristics More than 2 weeks since prior radiotherapy No prior radiotherapy to the spleen Concurrent palliative radiotherapy to selected metastases for pain or local complications (e.g., compression) allowed Surgery See Disease Characteristics Recovered from prior surgery No prior splenectomy No prior organ allograft Concurrent palliative surgery to selected metastases for pain or local complications (e.g., compression) allowed Other Concurrent palliative hyperthermic therapy to selected metastases for pain or local complications (e.g., compression) allowed No concurrent participation in any other clinical trial No other systemic immunosuppressive agents (e.g., azathioprine or cyclosporine) during and for 2 weeks after completion of study treatment No other investigational drugs or paramedical substances during and for 2 weeks after completion of study treatment
Sites / Locations
- Dermatologische Klinik mit Poliklinik - Universitaetsklinikum Erlangen