RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase I trial to study the effectiveness of carmustine in treating patients who are undergoing surgery for recurrent malignant glioma.
OBJECTIVES: * Determine the safety of polifeprosan 20 with carmustine implant (GLIADEL) in patients undergoing surgery for recurrent malignant glioma. OUTLINE: This is a dose escalation study. All patients undergo maximal tumor resection. At the time of surgery, groups of 6 patients receive up to 8 polifeprosan 20 wafers containing increasing doses of carmustine implanted into the resection cavity. Patients with an intraoperative diagnosis other than glioblastoma multiforme or anaplastic astrocytoma do not receive wafer implantation, and are removed from study. Patients are followed 3, 6, and 12 months after implantation. PROJECTED ACCRUAL: A total of 52 patients will be accrued for this study.
Study Type
INTERVENTIONAL
Purpose
TREATMENT
University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham, Alabama, United States
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States
Emory University Hospital - Atlanta
Atlanta, Georgia, United States
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Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States
Henry Ford Hospital
Detroit, Michigan, United States
Comprehensive Cancer Center at Wake Forest University
Winston-Salem, North Carolina, United States
University of Pennsylvania Cancer Center
Philadelphia, Pennsylvania, United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States