VEGF Trap in Treating Patients With Recurrent Malignant Gliomas That Did Not Respond to Temozolomide

Inclusion Criteria

• International Normalized Ratio (INR) 100,000/mm³
• Hemoglobin => 10 g/dL (transfusion allowed)
• Serum glutamic oxaloacetic transaminase (SGOT)/Serum glutamic pyruvic transaminase (SGPT) 8 weeks
• White blood count (WBC) = >3,000/mm³
• Absolute neutrophil count = > 1,500/mm³
• Bilirubin 60 mL/min
• Urine protein: creatinine ratio 6 months after completion of study treatment
• No significant medical illnesses that, in the opinion of the investigator, cannot be adequately controlled with appropriate therapy or would preclude compliance with 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 other agents used in the study
• No history of any other cancer (except nonmelanoma skin cancer or carcinoma in situ of the cervix), unless in complete remission and off of all therapy for that disease for = >3 years
• At least 7 days since prior noncytotoxic agents (e.g., interferon, tamoxifen, thalidomide, or isotretinoin [radiosensitizer does not count])
• At least 7 days since prior core biopsy
• At least 28 days since prior investigational agents
• No prior bevacizumab or vascular endothelial growth factor receptor inhibitors
• No concurrent full-dose anticoagulants (e.g., warfarin or low molecular-weight heparin)
• No clinically significant cardiovascular disease, including any of the following:
• Cerebrovascular accident within the past 6 months
• Uncontrolled hypertension, defined as blood pressure (BP) > 140/90 mm Hg or systolic BP > 180 mm Hg if diastolic BP < 90 mm Hg, on ≥ 2 repeated determinations on separate days within the past 3 months
• Myocardial infarction, coronary artery bypass graft (CABG), or unstable angina pectoris within the past 6 months
• New York Heart Association class III-IV congestive heart failure
• No serious cardiac arrhythmia requiring medication
• 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 more than 1 prior chemotherapy regimen (initial treatment and treatment for 1 relapse)
• Surgical resection for relapsed disease with no anticancer therapy instituted for up to 12 weeks followed by another surgical resection is considered 1 relapse
• If prior therapy for a grade 3 glioma was given, surgical diagnosis of a high-grade glioma is considered the first relapse
• Prior surgical, interstitial brachytherapy, or stereotactic radiosurgery not considered prior therapy
• If prior therapy included interstitial brachytherapy or stereotactic radiosurgery, must have confirmation of true progressive disease rather than radiation necrosis based upon either positron emission tomography (PET) scan, thallium scanning, Magnetic Resonance (MR) spectroscopy, or surgical documentation of disease
• Must show unequivocal radiographic evidence of tumor progression by MRI
• Recent resection of recurrent or progressive tumor allowed
• Residual disease not required
• Temozolomide-resistant recurrent glioblastoma is defined as tumor progression or tumor recurrence during or after treatment with temozolomide-based chemotherapy regimens
• Recovered from prior therapy
• No other disease that would obscure toxicity or dangerously alter drug metabolism
• No uncontrolled intercurrent illness, including, but not limited to, any of the following:
• Ongoing or active infection
• Psychiatric illness or social situations that would limit compliance with study requirements
• No serious or nonhealing wound, ulcer, or bone fracture
• No history of intracerebral or intratumoral hemorrhage
• No abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 28 days
• No significant traumatic injury within the past 28 days
• At least 28 days