Temozolomide and Thalidomide in Treating Patients With Stage III or Stage IV Melanoma
Intraocular Melanoma, Melanoma (Skin)
About this trial
This is an interventional treatment trial for Intraocular Melanoma focused on measuring iris melanoma, ciliary body and choroid melanoma, small size, ciliary body and choroid melanoma, medium/large size, extraocular extension melanoma, recurrent intraocular melanoma, stage III melanoma, stage IV melanoma, recurrent melanoma
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed metastatic malignant melanoma that is considered unresectable Stage III or IV ocular, mucosal, or cutaneous melanoma Measurable disease No CNS disease (phase I only) PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 70-100% Life expectancy: Not specified Hematopoietic: Absolute granulocyte count at least 1,500/mm^3 Platelet count at least 150,000/mm^3 Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) SGOT/SGPT no greater than 3 times ULN Alkaline phosphatase no greater than 3 times ULN Renal: Creatinine no greater than 1.5 times ULN Cardiovascular: No history of active angina No myocardial infarction within past 6 months No history of significant ventricular arrhythmia requiring medication with antiarrhythmics Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective barrier contraception during and for 4 weeks before and after study No frequent vomiting or medical condition that could interfere with oral medication intake (e.g., partial bowel obstruction) No preexisting neurotoxicity grade 2 or greater No serious concurrent infections treated with antibiotics No nonmalignant medical illnesses that are uncontrolled or whose control may be jeopardized by the complications of this study No psychiatric disorders that would preclude study compliance No other medical condition or reason that would preclude study No other malignancy within the past 2 years except: Nonmelanoma skin cancer Carcinoma in situ of the cervix History of T1a or b prostate cancer detected incidentally at TURP and comprising less than 5% of resected tissue with PSA normal since TURP No AIDS related illness HIV negative PRIOR CONCURRENT THERAPY: Recovered from prior therapy Biologic therapy: At least 4 weeks since prior biologic therapy At least 4 weeks since prior immunotherapy No concurrent immunotherapy Chemotherapy: No prior systemic chemotherapy for metastatic melanoma No other concurrent chemotherapy Endocrine therapy: Not specified Radiotherapy: At least 4 weeks since prior radiotherapy, interstitial brachytherapy, or radiosurgery At least 3 weeks since prior radiotherapy to the brain if brain metastases from melanoma Prior radiotherapy to only indicator lesion allowed provided recent evidence of disease progression at that site No concurrent radiotherapy Surgery: At least 2 weeks since prior surgery requiring general anesthesia
Sites / Locations
- Memorial Sloan-Kettering Cancer Center