Glioblastoma Multiforme Clinical Trial
Official title:
Treatment Of Newly Diagnosed, High-Grade, Malignant Glioma With Polifeprosan 20 Containing Carmustine Implant (Gliadel® Wafer) Using MR Spectroscopy Data As A Primary Indicator Of Therapeutic Response.
Subjects with newly diagnosed brain tumors who undergo surgical resection and whose pathology
in the operating room shows a high grade glioma will be eligible.
During a screening visit, the study will be discussed, inform consent discussed and signed, a
medical history will be taken and a physical examination and laboratory tests will be
performed. If these tests are all within acceptable ranges, the subject will be considered
for inclusion on this treatment protocol. If the results of any tests are extremely different
from normal expected values, she/he may not be able to participate.
Prior to surgery, the subject will have a contrast enhanced MRI and MRS. The neurosurgeon
will attempt to remove the majority of the tumor in the operating room and will send a
portion of the specimen removed to the pathologist immediately. This is called a "frozen
section". If the pathologist believes that the tumor is a high-grade malignant brain tumor,
then the surgeon will place up to 8 dime-sized chemotherapy wafers in the tumor cavity of the
brain. The remainder of the tumor specimen will be given to the pathologist to review more
closely in the laboratory. If the frozen section does not show that the tumor is a high-grade
malignant brain tumor, the subject will not receive the Gliadel wafers and will be removed
from the study. The surgeon will then discuss with the subject the appropriate treatment
options for the disease he or she has.
During recovery in the hospital, another contrast enhanced MRI will be performed within the
first 72 hours after surgery. This is a standard of care for patients who are not involved on
this protocol as well. The subject will have another contrast enhanced MRI and MRS performed
at the 21st Day after his or her surgery. After Day 21, He or she may begin other forms of
treatment. The last contrast enhanced MRI and MRS assessment will be performed 12 weeks after
the surgery and the implantation of the Gliadel wafers. Further MRI and MRS may be performed
subsequently at the discretion of the doctor.
Throughout the course of treatment, clinical data will be collected.
n/a
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