CHRONIC CONVECTION ENHANCED DELIVERY OF TOPOTECAN FOR RECURRENT MALIGNANT GLIOMA
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The purpose of this study is to determine the safety of directly injecting a chemotherapy drug called Topotecan and a contrast agent called Gadolinium into malignant brain tumors. Currently there is no effective treatment for recurrent malignant brain tumors, which means the brain tumor has returned after the original tumor has been treated. Most systemic chemotherapy drugs have toxic side effects, which make them difficult to use for brain tumors. However, we are doing this study to find out if using an experimental method of directly infusing the drug into the tumor, allows research subjects to avoid the side effects and achieve high levels of the drug directly into the tumor where it can be more effective. Currently, there is no standard of care treatment for recurrent glioblastoma. Of note, topotecan is currently approved by the United States Food and Drug Administration (FDA) for the treatment of certain cancer types. However, it is not approved for infusion directly into tumors of patients with recurrent malignant gliomas. It is therefore an investigational drug in this study. In addition to looking at safety, this research study will also look at new ways to monitor the progress of this experimental treatment using magnetic resonance imaging scans (MRIs).
Are you Eligible? (Inclusion Criteria)
- need to have a performance status where they may require occasional assistance, but is able to care for most of their personal needs. - must be willing to and medically capable of undergoing the surgical operation. - must use birth control during participation in study - must be at least 18 years of age