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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 confirmed intracranial malignant glioma, including any of the following:
• Glioblastoma multiforme
• Gliosarcoma
• Anaplastic astrocytoma
• Anaplastic oligodendroglioma
• Anaplastic mixed oligoastrocytoma
• Malignant astrocytoma not otherwise specified
• Must have evidence of tumor progression by MRI or CT scan
• Prior recent resection of recurrent or progressive tumor allowed
• Must have disease progression after prior radiotherapy
• Recovered from all prior therapy
• No prior bevacizumab
• No concurrent chemotherapy, radiotherapy, immunotherapy, or investigational agents
• No prior coronary bypass surgery or angioplasty
• No concurrent anti-coagulation or anti-platelet medication
• No concurrent use of other standard chemotherapeutics or investigative agents or vasoconstrictors for the treatment of migraine
• No concurrent use of other drugs that have been shown to potentially prolong the QTc interval
• Karnofsky performance status 60–100%
• WBC ≥ 3,000μL
• ANC ≥ 1,500/mm³
• Platelet count ≥ 100,000/mm³
• Hemoglobin ≥ 10 g/dL (transfusion allowed)
• SGOT < 2 x upper limit of normal (ULN)
• Bilirubin < 2 x ULN
• Creatinine < 1.5 mg/dL OR creatinine clearance > 60 cc/min
• Serum sodium, calcium, potassium, chloride, and magnesium within normal limits
• Proteinuria ≤ 1+ and urine protein; creatinine ratio ≤ 1.0, OR 24-hour urine protein < 1,000 mg
• QTc < 460 msec by ECG
• Not pregnant or nursing; fertile patients must use effective contraception during and for at least 6 months after completion of study treatment
• PT/PTT ≤ 1.5 x ULN
• No medical condition that would preclude study participation
• No known malignancy that has required treatment in the last 12 months and/or is expected to require treatment in the next 12 months (except nonmelanoma skin cancer or carcinoma in situ in the cervix)
• No active infections
• No disease that will obscure toxicity
• No evidence of significant recent hemorrhage on mandatory CT scan (defined as 1 cm or more of acute blood) of the brain within 7 days of patient accrual with the following exceptions:
• Resolving hemorrhagic changes related to surgery
• Presence of punctate hemorrhages in the tumor
• No history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 6 months
• No known hypersensitivity of Chinese hamster ovary cell products or other recombinant human antibodies
• No evidence of bleeding diathesis or coagulopathy
• No known gastrointestinal (GI) disease or history of GI surgery that could interfere with the absorption of orally administered medication
• No ongoing vomiting
• No active cardiac disease
• No known or suspected primary muscular or neuromuscular disease (e.g., muscular dystrophy, myasthenia gravis)
• Steroid myopathy allowed

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Treatment Plan:

• Patients receive oral tandutinib twice daily for 2 weeks
• Patients then receive oral tandutinib twice daily in weeks 1–4 and bevacizumab IV over 30–90 minutes in Weeks 1 and 3
• Treatment with tandutinib and bevacizumab repeats every 4 weeks in the absence of disease progression or unacceptable toxicity
• Patients complete a health-related quality of life questionnaire
• After completion of study treatment, patients are periodically followed

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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: 8/26/08
Updated: 10/15/08