Combined Treatment of Sorafenib and Pegylated Interferon α2b in Stage IV Metastatic Melanoma

You may not qualify if:

• Ocular or mucosal melanoma.
• History or evidence of brain metastasis.
• Patients with LDH values higher than 2x upper limit of institutional values.
• Patients with thyroid dysfunctions not responsive to therapy.
• Patients with uncontrolled diabetes mellitus.
• Patients with prior or active autoimmune disease or autoimmune hepatitis.
• Cardiac disease: congestive heart failure \> class II NYHA, patients must not have unstable angina or new onset of angina or myocardial infarction within the past 6 months. Cardiac ventricular arrhythmias requiring antiarrhythmic therapy.
• Uncontrolled hypertension defined as systolic blood pressure \> 150 mm Hg or diastolic pressure \> 90 mm Hg, despite optimal management.
• Active clinically serious infections \> CTCAE Grade 2.
• Patients who are HIV positive or have AIDS.
• Thrombotic or embolic events including transient ischemic attacks within the past 6 months.
• Evidence or history of bleeding diathesis or coagulopathy.
• Therapeutic anticoagulation with Vitamin K antagonists such as warfarin, or with heparins or heparinoids. Low dose warfarin is permitted if INR is \< 1.5. Low dose aspirin is permitted.
• Known or suspected allergy to Sorafenib or any ingredient of Sorafenib or PEG-IFN-α -2b or any ingredient of PEG-IFN-α -2b or to any interferone.
• Previous cancer that is distinct in primary site or histology from melanoma except cervical cancer in situ, treated basal cell carcinoma, superficial bladder tumors or any cancer curatively treated 3 years prior to study entry.
• +6 more criteria