Trial Information

Summary: This study will evaluate the effectiveness and safety of a drug named Topotecan as it is given directly into brain tumors by a technique called "Intracerebral Clysis" (ICC) in patients with malignant brain tumors.

Study Purpose
This study will evaluate the effectiveness and safety of a drug named Topotecan as it is given directly into brain tumors by a technique called "Intracerebral Clysis" (ICC) in patients with malignant brain tumors. This drug has been used for different types of cancer treatments but is being used here by a special delivery system that is designed to maximize the amount of drug that gets into the tumor and minimize the side effects that occur in other parts of the body.

What is Required?
A five to six day stay in the hospital that involves a surgery to place two catheters into the brain tumor and four to five days of treatment with the chemotherapy drug called Topotecan.

Study Procedures

• Patients will first undergo screening evaluations including neurological and physical examinations to determine whether they are eligible to participate. A CT and/or MRI scan with and without contrast of the brain will also be performed.
• First, a standard stereotactic biopsy (surgically removing a small amount of tumor cells to analyze the exact cell type) will be performed and the specimen will be sent to the Pathology Department for diagnosis. The CT scan that is used as part of the stereotactic biopsy will be used to accurately decide where to place the plastic tube (catheter) that will deliver the drug. The plastic catheter is passed through a small hole drilled into the skull using the stereotactic head frame to make sure that the catheter is guided into the correct position. A second catheter will be placed for most patients.
• Within 24 hours of placement of the catheter, it will be connected to a small pump at the bedside and the infusion of the Topotecan will begin. The Topotecan will be infused for 4 to 5 days after which time the catheters will simply be pulled out.
• Patients will be monitored with blood tests and MRI scans during the treatment and at different time periods during the following months.

Who is Eligible?
Children & adults with a recurrent malignant brain tumor that have been treated with radiation and/or chemotherapy.

This site is run by CenterWatch, a publishing company that focuses on the clinical trials industry. The information provided in this service is designed to help patients find clinical trials that may be of interest to them, and to help patients contact the centers conducting the research. CenterWatch is neither promoting this research nor involved in conducting any of these trials.

Trial listings updated: June 1, 2008 at 5:43:48 AM