Brain Tumor
A Phase II Trial of Bevacizumab and Irinotecan for Patients With Recurrent High-Grade Gliomas Immediately Following Tumor Progression After Treatment With Bevacizumab Alone: A Companion Trial to NCI Study 06-C-0064
NCI-06-C-0250
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Investigator(s): |
Howard A. Fine, M.D.
Principal Investigator
Phone: 301-402-6298
hfine@mail.nih.gov
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Charisse Garcia, R.N.
Research Nurse
Phone: 301-402-6298
Fax: 301-480-2246
Toll free: 866-251-9686
garciacr@mail.nih.gov
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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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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:
- Patients with histologically proven intracranial malignant glioma
- Patients must have been treated on the NCI trial, NCI-06-C-0064, bevacizumab alone for recurrent gliomas, and now have evidence for tumor progression by MRI scan
- Patients must be ≥ 18 years of age
- Patients must be ≤ 4 weeks out from their last bevacizumab treatment and may have received no form of treatment for their progressive tumor between their last bevacizumab treatment and enrollment of this companion trial
- Patients must have adequate bone marrow function, liver function, renal function
- No concurrent anti-coagulation or anti-platelet medication (including aspirin, non-steroidal anti-inflammatories, COX-2 inhibitors)
- Males and females of reproductive potential must agree to use an effective contraceptive method during study therapy and for at least 6 months after the completion of bevacizumab therapy
Study Outline:
- Patients will be treated with bevacizumab by intravenous injection at a dose of 10 mg/kg and irinotecan at a dose of 125 mg/m² for patients on non-enzyme-inducing anti-epileptic drugs (NEIAED) and 340 mg/m² for patients on enzyme-inducing anti-epileptic drugs (EIAED) every 2 weeks on a 4-week cycle
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.
- PDQ (Physicians Data Query) - provides additional details about this study for health care providers.
Reviewed: 3/5/09
Updated: 5/14/09
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