Bevacizumab With or Without Interferon Alfa in Treating Patients With Metastatic Malignant Melanoma
Condition: Recurrent Melanoma; Stage IV Skin Melanoma
MeSH terms: Melanoma
Intervention: Recombinant Interferon Alfa; Bevacizumab
Intervention description: Given SC; Given IV
Intervention MeSH terms: Interferons; Interferon-alpha; Bevacizumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 57.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This randomized phase II trial is studying giving bevacizumab together with interferon alpha
      to see how well it works compared to giving bevacizumab alone in treating patients with
      metastatic malignant melanoma. Monoclonal antibodies, such as bevacizumab, can block cancer
      growth in different ways. Some block the ability of cancer cells to grow and spread. Others
      find cancer cells and help kill them or deliver cancer-killing substances to them. Interferon
      alpha may interfere with the growth of the cancer cells and slow the growth of the tumor.
      Combining bevacizumab with interferon alpha may kill more tumor cells.
    

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