Thalidomide and SU5416 in Treating Patients With Metastatic 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 or cytologically confirmed metastatic melanoma Bidimensionally measurable disease by MRI, CT scan, or chest x-ray No active brain metastases PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-1 Life expectancy: More than 12 weeks Hematopoietic: Absolute neutrophil count greater than 1,500/mm^3 Platelet count greater than 100,000/mm^3 Hemoglobin greater than 8.5 g/dL Hepatic: PT/PTT normal Bilirubin no greater than 1.5 mg/dL SGOT/SGPT no greater than 2.5 times upper limit of normal Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance greater than 60 mL/min Cardiovascular: No uncompensated coronary artery disease by electrocardiogram or physical exam No myocardial infarction or severe or unstable angina within the past 6 months No deep venous thrombosis within the past 3 months No arterial thrombosis within the past 6 months Pulmonary: No pulmonary embolism within the past 6 months Other: HIV negative No active infection No medical, psychological, or social problem that would preclude study participation No history of gastrointestinal disorder that would interfere with absorption or swallowing of study medication No emotional disorder or substance abuse No diabetes mellitus with severe peripheral vascular disease Not pregnant or nursing Negative pregnancy test Fertile patients must use 2 forms of effective contraception for 4 weeks before, during, and for 4 weeks after study participation PRIOR CONCURRENT THERAPY: Biologic therapy: No more than 1 prior biologic regimen No concurrent biologic response modifiers No concurrent hematopoietic growth factor support Concurrent epoetin alfa allowed Chemotherapy: No concurrent cytotoxic agents Endocrine therapy: No concurrent anticancer hormonal therapy except megestrol acetate for appetite stimulation Radiotherapy: No prior large field radiotherapy to more than 20% total bone marrow No concurrent radiotherapy Surgery: At least 14 days since major surgery No prior major upper gastrointestinal surgery Other: No other concurrent investigational therapy
Sites / Locations
- University of Texas Health Science Center at San Antonio
Arms of the Study
Arm 1
Experimental
Arm I
Patients receive SU5416 IV over 1 hour twice weekly and oral thalidomide daily beginning 1 day after the first dose of SU5416. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity.