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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:

• Age 18 and over
• Histologically confirmed malignant glioma, including any of the following:
• Glioblastoma multiforme and its variants (e.g., gliosarcoma)
• Anaplastic glioma, including any of the following types:
• Anaplastic astrocytoma; anaplastic oligodendroglioma; anaplastic mixed oligoastrocytoma; malignant astrocytoma or glioma not otherwise specified
• Must have failed prior radiotherapy
• Evidence of tumor progression by MRI or CT scan while on a steroid dosage that has been stable for ≥ 5 days
• Patients who have undergone prior surgical resection of recurrent or progressive tumor must have subsequent residual disease
• SGOT < 2 times upper limit of normal (ULN); bilirubin < 2 times ULN; creatinine < 1.5 mg/dL
• No tumor progression during prior treatment with Tamoxifen; no coronary artery disease; no congestive heart failure; no arrhythmia requiring medication; no other significant active cardiac disease; no hepatic disease
• No other active malignancy except nonmelanoma skin cancer or carcinoma in situ of the cervix
• Patients must not be on an enzyme-inducing anti-epileptic drug

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Study Outline:

• Patients receive oral Tamoxifen twice daily on days 1-42 and Bortezomib IV on days 3, 6, 10, 13, 24, 27, 31, and 34
• Treatment repeats every 42 days for up to 9 courses in the absence of disease progression or unacceptable toxicity

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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