Clinical Trial: Examination of Changes on Magnetic Resonance Imaging (MRI) and Magnetic Resonance Spectroscopy (MRS) in Patients Who Receive Gliadel Wafers During Initial Surgery for Glioblastoma Multiforme. Response or Failure to Gliadel Wafers for Subjects With Glioblastoma Multiforme.
Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional
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 Res
Brief Summary:
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
Detailed Summary:
Sponsor: Weill Medical College of Cornell University
Current Primary Outcome: Stabilization or reduction of tumor on gadolinium enhanced MRI and changes in choline/creatine ratio and NAA on MR Spectroscopy [ Time Frame: June 2011 ]
Original Primary Outcome: Stabilization or reduction of tumor on gadolinium enhanced MRI and changes in choline/creatine ratio and NAA on MR Spectroscopy [ Time Frame: June 2009 ]
Current Secondary Outcome: Median survival, 6-month survival, and progression free survival. [ Time Frame: June 2011 ]
Original Secondary Outcome: Median survival, 6-month survival, and progression free survival. [ Time Frame: June 2009 ]
Information By: Weill Medical College of Cornell University
Dates:
Date Received: March 20, 2008
Date Started: June 2007
Date Completion: June 2011
Last Updated: August 26, 2009
Last Verified: August 2009
