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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

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Primary Eligibility:

• Histologically proven intracranial malignant glioma:
  • Glioblastoma multiforme
  • Gliosarcoma
  • Anaplastic astrocytoma
  • Anaplastic oligodendroglioma
  • Anaplastic mixed oligoastrocytoma
  • Malignant astrocytoma
• Patients must have evidence for tumor progression by MRI or CT scan
• Patients having undergone recent resection of recurrent or progressive tumor will be eligible as long as all of the following conditions apply:
  • Recovered from the effects of surgery
  • Residual disease following resection of recurrent tumor (not required); post-operative CT/MRI should be done to access residual disease:
    • No later than 96 hours in the immediate post-operative period or
    • At least 4 weeks post-operatively, and
    • Within 14 days of registration, and
    • On a steroid dosage that has been stable for at least 5 days
• Patients must have progressed after radiation therapy
• Patients must sign an informed consent form
• Patients must be ≥ 18 years old
• Karnofsky performance status of ≥ 60
• Recovered from prior treatment
• WBC > 3,000/µl, ANC > 1,500/mm³, platelet count of > 100,000/mm³, and hemoglobin > 10 gm/dL, SGOT and bilirubin < 2 x ULN, creatinine < 1.5 mg/dL and/or creatinine clearance > 60 cc/min
• No illness that would preclude study participation
• Not pregnant or nursing; must use effective contraception during and for 6 months after completion of the study
• No malignancy that required treatment in the last 12 months and/or is expected to require treatment in the next 12 months (except non-melanoma skin cancer or carcinoma in situ in the cervix)
• No active infection
• No concurrent anti-coagulation or anti-platelet medication (including aspirin, non-steroidal anti-inflammatories, COX-2 inhibitors)
• No serious or non-healing wound, ulcer, or bone fracture
• No clinically significant cardiovascular disease
• No evidence of bleeding diathesis or coagulopathy
• No known hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies

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Study Outline:

• Patients receive bevacizumab by intravenous injection at a dose of 10 mg/kg every 2 weeks and daily oral enzastaurin at a dose of 500 mg/day (for patients on NEIAED) and 875 mg/day (for patients on EIAED) on a 4-week cycle
• Prior to the first dose of bevacizumab and enzastaurin, and at the completion of the first 4 weeks of treatment, patients will undergo a FDG-PET scan (in cycle one only and then as needed) and an MRI perfusion scan
• Peripheral blood cells will be collected at the time of each MRI-perfusion scan for the purpose of assaying phospho-GSK levels from peripheral blood mononuclear cells (PBMCs)
• Additionally, patients will undergo an MRI perfusion scan within 48–96 hours of their first dose of bevacizumab (in the first cycle only)
• For patients who are clinically/neurologically stable and with stable or responding radiographic disease at the end of each treatment cycle, treatment will continue with bevacizumab every 2 weeks and daily enzastaurin, repeating MRI-perfusion scans at the conclusion (e.g., prior to another administration of bevacizumab) of each 4-week cycle

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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: 5/14/09