VEGF Trap in Treating Patients With Recurrent Stage III or Stage IV Melanoma That Cannot Be Removed by Surgery
Condition: Ciliary Body and Choroid Melanoma, Medium/Large Size; Extraocular Extension Melanoma; Iris Melanoma; Metastatic Intraocular Melanoma; Recurrent Intraocular Melanoma; Recurrent Melanoma; Stage III Melanoma; Stage IV Melanoma
MeSH terms: Melanoma; Uveal Neoplasms; Recurrence
Intervention: ziv-aflibercept; pharmacological study
Intervention description: Given IV; Correlative studies
Intervention MeSH terms: Aflibercept; Endothelial Growth Factors
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 41.0
Sex: All
Minimum age: 18 Years
Maximum age: 120 Years
Healthy volunteers: No

Summary:

      This phase II trial is studying how well VEGF Trap works in treating patients with recurrent
      stage III or stage IV melanoma that cannot be removed by surgery. Combinations of biological
      substances in VEGF Trap may be able to carry tumor-killing substances directly to melanoma
      cells. It may also stop the growth of melanoma by blocking blood flow to the tumor.
    

Eligibility criteria:

        Inclusion Criteria:

          -  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)