Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Genentech, Inc.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Signed Informed Consent Form
Age ≥ 18 years
Histologically confirmed GBM in first or second relapse
Radiographic demonstration of disease progression following prior therapy
Bi-dimensionally measurable disease with a minimum measurement of 1 cm (10 mm) in one diameter on MRI performed within 14 days prior to first treatment (Day 0)
An interval of ≥ 4 weeks since prior surgical resection
Prior standard radiation for GBM
Prior chemotherapy: first-relapse subjects
Prior chemotherapy: second-relapse subjects
Recovery from the effects of prior therapy, including the following: 4 weeks from cytotoxic agents (except 6 weeks from nitrosoureas, 3 weeks from procarbazine, 2 weeks from vincristine); 4 weeks from any investigational agent; 1 week from non-cytotoxic agents; 8 weeks from radiotherapy to minimize the potential for MRI changes related to radiation necrosis that might be misdiagnosed as progression of disease, or 4 weeks if a new lesion, relative to the pre-radiation MRI, develops that is outside the primary radiation field
Prior therapy with gamma knife or other focal high-dose radiation is allowed but the subject must have subsequent histologic documentation of recurrence, unless the recurrence is a new lesion outside the irradiated field
Karnofsky performance status ≥ 70
Life expectancy \> 12 weeks
Use of an effective means of contraception in males and in females of childbearing potential
Ability to comply with study and follow-up procedures
You may not be if
Prior treatment with irinotecan, bevacizumab, or another VEGF or VEGFR-targeted agent
Prior treatment with prolifeprospan 20 with carmustine wafer
Prior intracerebral agents
Need for urgent palliative intervention for primary disease (e.g., impending herniation)
Evidence of recent hemorrhage on baseline MRI of the brain with the following exceptions: Presence of hemosiderin; Resolving hemorrhagic changes related to surgery; Presence of punctate hemorrhage in the tumor
Received more than two treatment regimens for Grade III and/or Grade IV glioma
Blood pressure of \> 150 mmHg systolic and \> 100 mmHg diastolic
History of hypertensive encephalopathy
New York Heart Association (NYHA) Grade II or greater CHF
History of myocardial infarction or unstable angina within 6 months prior to Day 0
History of stroke or transient ischemic attack within 6 months prior to study enrollment
Significant vascular disease (e.g., aortic aneurysm, aortic dissection) or recent peripheral arterial thrombosis within 6 months prior to Day 0
Evidence of bleeding diathesis or coagulopathy
History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to Day 0
History of intracerebral abscess within 6 months prior to Day 0
Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 0, anticipation of need for major surgical procedure during the course of the study
Minor surgical procedures (excluding placement of a vascular access device), stereotactic biopsy, fine needle aspirations, or core biopsies within 7 days prior to Day 0
Serious non-healing wound, ulcer, or bone fracture
Pregnancy (positive pregnancy test) or lactation
Known hypersensitivity to any component of bevacizumab
History of any other malignancy within 5 years (except non-melanoma skin cancer or carcinoma in situ of the cervix)
Pregnant or nursing females
Unstable systemic disease, including active infection, uncontrolled hypertension, or serious cardiac arrhythmia requiring medication
Subjects unable to undergo an MRI with contrast
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