Vaccine Therapy in Treating Patients With Melanoma of the Eye
Intraocular Melanoma
About this trial
This is an interventional treatment trial for Intraocular Melanoma focused on measuring ciliary body and choroid melanoma, medium/large size
Eligibility Criteria
DISEASE CHARACTERISTICS: Diagnosis of ocular melanoma No melanoma of the iris Disease adequately treated by prior surgery (enucleation or tumorectomy) and/or radiotherapy No more than 5 weeks since the beginning of primary tumor treatment Measurable disease At least 12.0 mm in largest diameter OR At least 6.0 mm in height HLA-A2 positive No distant metastases PATIENT CHARACTERISTICS: Age: Over 18 Performance status: ECOG 0-1 Life expectancy: Not specified Hematopoietic: Hemoglobin at least 9 g/dL Neutrophil count at least 2,000/mm^3 Lymphocyte count at least 700/mm^3 Platelet count at least 100,000/mm^3 No bleeding disorder Hepatic: Bilirubin no greater than 2.0 mg/dL AST and ALT no greater than 2 times upper limit of normal (ULN) Lactate dehydrogenase no greater than 2 times ULN Alkaline phosphatase no greater than 2 times ULN Gamma glutamyl transpeptidases no greater than 2 times ULN Hepatitis C antibody negative Hepatitis B antigen negative Renal: Creatinine no greater than 2.0 mg/dL Immunologic: No clinical immunodeficiency No autoimmune diseases No inflammatory bowel disease No active infection requiring antibiotics No multiple sclerosis Other: HIV negative No other malignancy except surgically cured carcinoma in situ of the cervix or basal cell or squamous cell carcinoma of the skin No other uncontrolled illness No psychological, familial, sociological, or geographical conditions that would preclude study participation Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for at least 3 months after study participation PRIOR CONCURRENT THERAPY: Biologic therapy: No other concurrent immunotherapy or biologic therapy Chemotherapy: No concurrent chemotherapy Endocrine therapy: At least 3 weeks since prior steroids No concurrent chronic therapy with high doses of corticosteroids (e.g., methylprednisolone at least 12 mg/day) Concurrent topical or inhalation steroids allowed No concurrent hormonal therapy Radiotherapy: See Disease Characteristics Prior proton beam therapy allowed Prior brachytherapy without tumor resection allowed Recovered from prior radiotherapy No prior radiotherapy to the spleen No prior pre-enucleation radiotherapy No prior ruthenium Ru 106 as primary therapy alone No concurrent radiotherapy Surgery: See Disease Characteristics Prior transcleral tumor resection allowed Recovered from prior surgery No prior major organ allograft No prior splenectomy Other: No other concurrent investigational drugs No concurrent systemic immunosuppressive drugs
Sites / Locations
- Cliniques Universitaires Saint-Luc
- University of Copenhagen