Bevacizumab With or Without Interferon Alfa in Treating Patients With Metastatic Malignant Melanoma
Recurrent Melanoma, Stage IV Skin Melanoma

About this trial
This is an interventional treatment trial for Recurrent Melanoma
Eligibility Criteria
Inclusion Criteria: Histologically or cytologically confirmed cutaneous malignant melanoma Must meet one of the following criteria: Clinical evidence of metastatic disease Unresectable regional lymphatic disease Extensive in transit recurrent disease Measurable disease At least 20 mm by conventional techniques OR at least 10 mm by spiral computed tomography (CT) scan No known brain metastases No ocular melanoma Performance status - Eastern Cooperative Oncology Group (ECOG) 0-2 Performance status - Karnofsky 60-100% More than 6 months White blood cells (WBC) at least 3,000/mm^3 Absolute neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 No clinical evidence of coagulopathy Bilirubin =< 2.0 mg/dL (3.0 mg/dL for patients with Gilbert's disease provided patient is stable and asymptomatic) Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) no greater than 2.5 times upper limit of normal (ULN) Prothrombin time (PT)/International normalized ratio (INR) less than 1.5 Creatinine =< 1.5 mg/dL Creatinine clearance at least 60 mL/min Protein < 1,000 mg on 24-hour urine collection for patients with proteinuria >= 1+ No symptomatic congestive heart failure No unstable angina pectoris No cardiac arrhythmia No history of thrombosis (e.g., deep vein thrombosis), unless the following criteria are met: INR in normal range (usually 2-3) AND on a stable dose of warfarin or low molecular weight heparin No active bleeding or pathologic condition that would confer a high risk of bleeding (e.g., known varices or tumor involving major vessels) No uncontrolled hypertension Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No prior allergic reactions to compounds of similar chemical or biologic composition to bevacizumab or interferon alfa No ongoing or active infection No other concurrent uncontrolled illness No psychiatric illness or social situation that would preclude study compliance Human immunodeficiency virus (HIV) allowed provided otherwise well At least 4 weeks since prior adjuvant interferon alfa No prior interferon alfa for metastatic disease No prior cytokine therapy for metastatic disease (e.g., high-dose interleukin-2 [IL-2]) Prior IL-2 allowed for patients randomized to arm III only No prior investigational antiangiogenic agents No more than 1 prior chemotherapy regimen for metastatic disease At least 4 weeks since prior chemotherapy and recovered At least 4 weeks since prior radiotherapy and recovered No other concurrent investigational agents
Sites / Locations
- University of Cincinnati
- Ohio State University Comprehensive Cancer Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Experimental
Arm I (monoclonal antibody and biological therapy)
Arm II (monoclonal antibody)
Arm III (monoclonal antibody and biological therapy)
Patients receive bevacizumab IV over 30-90 minutes on day 1. Patients also receive low-dose interferon alfa (IFN-alpha) SC on days 1-14.
Patients receive bevacizumab as in arm I.
Patients receive bevacizumab as in arm I. Patients also receive high-dose IFN-alpha SC on days 1, 3, 5, 8, 10, and 12.