Intravenous or Hepatic Arterial Infusion of Fotemustine in Treating Patients With Unresectable Liver Metastases From Eye Melanoma
Intraocular Melanoma, Metastatic Cancer
About this trial
This is an interventional treatment trial for Intraocular Melanoma focused on measuring liver metastases, ciliary body and choroid melanoma, medium/large size, iris melanoma, extraocular extension melanoma, recurrent intraocular melanoma, metastatic intraocular melanoma
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed liver metastases secondary to uveal melanoma Surgically incurable or unresectable disease No detectable extrahepatic metastases PATIENT CHARACTERISTICS: Age 18 and over Performance status WHO 0-2 Life expectancy Not specified Hematopoietic Absolute neutrophil count ≥ 2,000/mm^3 Platelet count ≥ 100,000/mm^3 Hemoglobin ≥ 10 g/dL Hepatic Bilirubin < 1.5 times upper limit of normal (ULN) ALT and AST < 5 times ULN Alkaline phosphatase < 5 times ULN Gamma-glutamyltransferase < 5 times ULN Lactic dehydrogenase < 5 times ULN Renal BUN < 1.5 times ULN Creatinine ≤ 1.5 times ULN Cardiovascular No uncontrolled angina pectoris No myocardial infarction within the past 6 months No uncontrolled high blood pressure No evolutive intracranial hypertension No other severe cardiac disease Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No active gastroduodenal ulcer No diabetes No active or uncontrolled infection No psychological, familial, sociological, or geographical condition that would preclude study compliance and follow-up No other uncontrolled severe medical condition No other malignancy within the past 5 years except surgically cured carcinoma in situ of the cervix or basal cell or squamous cell skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy No concurrent immunologic or biologic therapy Chemotherapy No other concurrent chemotherapy Endocrine therapy Not specified Radiotherapy No prior radiotherapy for metastatic disease No concurrent radiotherapy Surgery Recovered from prior major surgery Other No prior antineoplastic drugs for metastatic disease More than 4 weeks since prior investigational drugs No other concurrent anticancer agents or therapies
Sites / Locations
- European Institute of Oncology
- Istituto Nazionale per lo Studio e la Cura dei Tumori
- Azienda Ospedaliera di Padova
- Universita di Siena
- Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology - Warsaw
- Centre Hospitalier Universitaire Vaudois
- Clatterbridge Centre for Oncology
- Ninewells Hospital