• Return to search results
• Start new search

Investigator(s):
Howard A. Fine, M.D. Principal Investigator Phone: 301-402-6298 hfine@mail.nih.gov
Referral Contact(s):
Charisse Garcia, R.N. Research Nurse Phone: 301-402-6298 Fax: 301-480-2246 Toll free: 866-251-9686 garciacr@mail.nih.gov	Julie Peretti, R.N. Research Nurse Phone: 301-402-6298 Fax: 301-480-2246 Toll free: 866-251-9686 jperetti@mail.nih.gov	Tracy Cropper, R.N. Research Nurse Phone: 301-496-8250 Fax: 301-480-2246 Toll free: 866-251-9686 tcropper@mail.nih.gov

---

Primary Eligibility:

• Histologically proven intracranial malignant glioma, including the following:
• Glioblastoma multiforme
• Gliosarcoma
• Anaplastic astrocytoma
• Anaplastic oligodendroglioma
• Anaplastic mixed oligoastrocytoma
• Malignant astrocytoma not otherwise specified
• Recurrent disease
• Patients must have evidence of tumor progression by MRI or CT scan (performed within the past 14 days and while on a fixed dose of steroids for at least 5 days)
• Progressive disease after radiation therapy
• No evidence of acute intracranial/intratumoral bleeding
• No evidence of bleeding diathesis or coagulopathy
• No clinically significant cardiovascular disease
• No significant active cardiac, hepatic, renal, or psychiatric diseases
• WBC ≥ 3,000/mm³, absolute neutrophil count ≥ 1,500/mm³, platelet count ≥ 100,000/mm³, hemoglobin ≥ 10 g/dL
• SGOT and bilirubin < 2 times upper limit of normal
• Creatinine < 1.5 mg/dL and/or creatinine clearance ≥ 60 mL/min
• No serious or nonhealing wound, ulcer, or bone fracture
• No significant traumatic injury within the past 28 days
• No cerebrovascular accident (stroke) within the past 6 months
• No uncontrolled hypertension
• No active infections
• No known hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies

---

Study Outline:

This is an open-label study. Patients are stratified according to tumor type.

• Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15
• Courses repeat every 28 days for up to approximately 1 year in the absence of disease progression or unacceptable toxicity
• Quality of life is assessed at the baseline, prior to each course of study treatment, and then within 2 weeks after completion of study treatment
• After completion of study treatment, patients are followed within 2 weeks

---

Additional Information:

• This trial will be conducted at the NIH Clinical Center in Bethesda, MD. It is open to patients who meet the eligibility requirements, regardless of where they live in the United States.
• There is no charge for medical care received at NIH Clinical Center.
• FAQs about this study - provides information for patients about the trial such as frequency and duration of visits, costs, how to enroll, treatment plan.
• PDQ (Physicians Data Query) - provides additional details about this study for health care providers.

Reviewed: 3/5/09
Updated: 6/1/09