Magnetic resonance imaging will be done after every 2 cycles of treatment (8 weeks) You will need these tests and procedures that are part of regular cancer care. They are being done more often because you are in this study. Blood will be taken to determine o Blood counts o Kidney function o Liver function o Electrolyte levels You will need this test to see how the study treatment is affecting your body. Urine evaluation for protein If you have not already participated in a Radiation Therapy Oncology Group glioblastoma study that required this, your study doctor will need to send some of the tissue obtained at the time of your brain tumor surgery to a central pathology site. There, a pathologist will confirm that the tumor is a glioblastoma. You will be "randomized" into one of the study groups described below. Randomization means that you are put into a group by chance. A computer program will place you in one of the study groups. Neither you nor your study doctor can choose the group you will be in. If you are in group 1 (often called "Arm 1") you will receive the combination of bevacizumab and temozolomide. The bevacizumab is given by vein (intravenously) every two weeks. For the first treatment, you will receive the bevacizumab for a period of 90 minutes. If you don’t experience fever or chills while you receive it, you will be able to receive the next bevacizumab treatments over a 60- or 30-minute period. This treatment arm contains temozolomide, a chemotherapy drug that was used for the initial treatment of your brain tumor. However, this drug is being tested in combination with bevacizumab to see if the treatment combination will generate tumor responses even when the tumor has previously not responded or stopped responding to the
temozolomide. The temozolomide is given by mouth (orally) daily for 21 days, then 7 days without treatment. Four weeks is considered one treatment cycle. If you are in group 1, you may also be asked to complete a medication diary while you are receiving temozolomide; this will help document when you take your medication and any side effects you experience. If you are in group 2 (often called "Arm 2") you will receive the combination of bevacizumab and irinotecan. Both treatments are given by vein (intravenously) once every 2 weeks. For the first treatment, you will receive the bevacizumab for a period of 90 minutes. If you don’t experience fever or chills while you receive it, you will be able to receive the next bevacizumab treatments over a 60- or 30-minute period. You will receive the irinotecan over a 90-minute period. Every 2 treatments (4 weeks) equals one cycle of treatment. Initially, twice as many people will go on Arm 2 versus Arm 1. The main goal (primary objective) of Arm 1 is to determine the side effects of the combination of bevacizumab and temozolomide. The main goal (primary objective) of Arm 2 is to test whether the combination of bevacizumab and irinotecan is effective at treating glioblastoma. More patients are needed to determine the main goal of Arm 2 than are needed to determine the main goal of Arm 1.
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- Summer '07
- Magnetic resonance imaging, bevacizumab, study doctor