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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 primary malignant high-grade* glioma, including the following types:
• Glioblastoma multiforme
• Gliosarcoma
• Anaplastic astrocytoma
• Anaplastic oligodendroglioma
• Anaplastic mixed oligoastrocytoma
• Malignant glioma/astrocytoma not otherwise specified (NOS)
• Failed prior radiation therapy
• WBC ≥ 3,000/mm³, absolute neutrophil count ≥ 1,500/mm³, platelet count ≥ 100,000/mm³, hemoglobin ≥ 10 g/dL (transfusion allowed)
• SGOT and bilirubin ≤ 2 times upper limit of normal
• Creatinine ≤ 1.5 mg/dL and/or creatinine clearance ≥ 60 mL/min
• No active or serious cardiac disease
• No significant active hepatic, renal, or psychiatric diseases
• No hypertension not controlled by medical therapy
• No concurrent steroids OR on a stable dose of steroids for ≥ 5 days before study entry
• No other severe or uncontrolled systemic disease that would preclude study participation

* Progressive low-grade gliomas or infiltrative brain stem gliomas diagnosed by radiography, instead of biopsy, are allowed in the phase I portion of the study only.

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Study Outline:

This is a phase I, dose-escalation study followed by a phase II study. Patients are stratified according to current use of enzyme-inducing anti-epileptic drugs (yes vs. no).

Phase I

• Patients receive oral ZD6474 once daily on days 1-28
• Treatment repeats every 28 days for approximately 1 year in the absence of disease progression or unacceptable toxicity
• Groups of 3-6 patients receive escalating doses of ZD6474 until the maximum tolerated dose (MTD) is determined

Phase II

• Patients receive ZD6474 as in phase I at an established dose

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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: 6/1/09