VEGF Trap in Treating Patients With Recurrent Stage III or Stage IV Melanoma That Cannot Be Removed by Surgery

You may be eligible if

• Histologically confirmed stage III or IV melanoma
• Cutaneous, ocular, or mucosal melanoma allowed
• Recurrent, inoperable disease
• Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
• No evidence of CNS disease, including primary brain tumor or brain metastases
• No brain metastases by MRI or CT scan within the past 4 weeks
• ECOG performance status (PS) 0-2 OR Karnofsky PS 60-100%
• Life expectancy \> 3 months
• WBC ≥ 3,000/mm³
• Absolute neutrophil count ≥ 1,500/mm³
• Platelet count ≥ 75,000/mm³
• Bilirubin \< 1.5 times upper limit of normal (ULN)
• AST and ALT ≤ 2.5 times ULN
• Creatinine ≤ 1.5 times ULN OR creatinine clearance ≥ 60 mL/min
• Urine protein:creatinine ratio \< 1 OR urine protein \< 500 mg by 24-hour urine collection
• PT INR ≤ 1.5 unless on full-dose warfarin
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception during and for ≥ 6 months after completion of study treatment
• No known hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies
• No history of allergic reactions attributed to compounds of similar chemical or biological composition to agents used in the study
• No serious or nonhealing wound, ulcer, or bone fracture
• No abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 28 days
• No significant traumatic injury within the past 28 days
• No clinically significant cardiovascular disease, including any of the following:
• * Cerebrovascular accident within the past 6 months
• * Uncontrolled hypertension, defined as blood pressure (BP) \> 150/100 mm Hg or systolic BP \> 180 mm Hg if diastolic BP \< 90 mm Hg within the past 3 months
• * Myocardial infarction, coronary artery bypass graft, or unstable angina within the past 6 months
• * New York Heart Association class III-IV congestive heart failure
• * Serious cardiac arrhythmia requiring medication
• * Unstable angina pectoris within the past 6 months
• * Clinically significant peripheral vascular disease within the past 6 months
• * Pulmonary embolism, deep vein thrombosis, or other thromboembolic event within the past 6 months
• * No evidence of bleeding diathesis or coagulopathy
• No concurrent uncontrolled illness, including, but not limited to any of the following:
• * Ongoing or active infection
• * Psychiatric illness or social situation that would preclude study compliance
• Recovered from all prior therapy and major surgery
• No prior chemotherapy or hormonal therapy
• More than 7 days since prior core visceral organ biopsy
• More than 4 weeks since prior biologic therapy or radiotherapy
• More than 28 days since prior major surgery or open biopsy
• No concurrent major surgery
• No other concurrent investigational agents
• No concurrent combination antiretroviral therapy for HIV-positive patients
• Concurrent full-dose warfarin with PT INR \> 1.5 allowed provided the following criteria are met:
• * INR in range (2-3) on a stable dose of oral anticoagulant or low molecular weight heparin
• * No active bleeding or pathological condition that carries a high risk of bleeding (e.g., tumor involving major vessels or known varices)