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Investigator(s):
Teri Kreisl, M.D. Principal Investigator Phone: 301-402-3423 kreislt@mail.nih.gov	Howard A. Fine, M.D. Protocol Chair 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	Tracy Cropper, R.N. Research Nurse Phone: 301-496-8250 Fax: 301-480-2246 Toll free: 866-251-9686 tcropper@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

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Primary Eligibility:

• Histologically confirmed intracranial malignant glioma, including the following:
• Glioblastoma multiforme
• Gliosarcoma
• Anaplastic astrocytoma
• Anaplastic oligodendroglioma
• Anaplastic mixed oligoastrocytoma
• Malignant astrocytoma, not otherwise specified
• Disease progression after prior treatment with radiotherapy and temozolomide, as evidenced by contrast-enhanced perfusion MRI or CT scan within 14 days of enrollment
• Steroid dose must be stable for ≥ 5 days
• Patients who received prior treatment with stereotactic radiosurgery must demonstrate true tumor progression by FDG-PET or magnetic resonance spectroscopy imaging
• Recovered from toxicities of all prior therapy, including surgery
• Residual disease after resection of recurrent tumor is not required
• No major surgery or significant trauma within 4 weeks of study entry
• If patients were previously treated with bevacizumab, they must have progressed on therapy, and be > 6 weeks from their last dose of bevacizumab
• No other prior therapy directed against VEGF (e.g., sorafenib, pazopanib, vandetanib, or cediranib)
• Concurrent enzyme-inducing anti-epileptic drugs, potent CYP3A4 inhibitors, or potent CYP3A4 inducers are not allowed, and may not have been taken within 2 weeks of study entry
• No concurrent anti-coagulation, anti-platelet medication, antiretroviral HIV therapy, or other concurrent anticancer therapy
• ≥ 18 years of age
• Karnofsky performance status 60–100%
• Total leukocyte count ≥ 3,000/mm³, ANC ≥ 1,500/mm³, platelet count ≥ 100,000/mm³, and hemoglobin ≥ 9 g/dL (transfusion allowed)
• Serum creatinine ≤ 2 x upper limit of normal (ULN)
• Bilirubin, AST, and ALT ≤ 1.5 x ULN
• Serum calcium ≤ 12 mg/dL
• PT and INR ≤ 1.5 x ULN
• QTc interval ≤ 500 msec by EKG and ejection fraction ≥ 50% by echocardiogram at baseline or < 20% decrease from a prior echocardiogram
• No stroke, unstable angina, or myocardial infarction within the past 6 months, serious cardiac arrhythmia requiring medication, or New York Heart Association class II–IV congestive heart failure
• No active infection, serious or non-healing wound, ulcer, or bone fracture, bleeding diathesis or coagulopathy
• No uncontrolled hypertension while on antihypertensive medication
• Not pregnant or nursing; fertile patients must use effective contraception during and for ≥ 3 months after completion of study treatment
• No history of allergic reactions attributed to compounds of similar chemical or biological composition to sunitinib malate
• No other malignancy that has required treatment within the past 12 months and/or is expected to require treatment within the next 12 months, except nonmelanoma skin cancer or carcinoma in situ of the cervix
• No other medical condition that would preclude study participation

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Study Outline:

Patients are stratified according to prior treatment with bevacizumab (yes vs no) and disease histology (glioblastoma multiforme or gliosarcoma vs anaplastic astrocytoma, anaplastic oligodendroglioma, or anaplastic mixed oligoastrocytoma).

• Patients receive oral sunitinib malate once daily on Days 1–28
• Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
• Health-related quality of life is assessed at baseline, every 4 weeks during treatment, and within 2 weeks after completion of treatment
• After completion of study treatment, patients are followed within 2 weeks

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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: 8/27/09