Spots Global Cancer Trial Database for Carmustine in Treating Patients With Recurrent Malignant Glioma
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Trial Identification
Brief Title: Carmustine in Treating Patients With Recurrent Malignant Glioma
Official Title: PHASE I, OPEN LABEL, MULTICENTER DOSE ESCALATION STUDY OF GLIADEL IN PATIENTS WITH RECURRENT MALIGNANT GLIOMA
Study ID: NCT00004028
Conditions
Study Description
Brief Summary: 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.
Detailed Description: 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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
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
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
Contact Details
Name: Alessandro Olivi, MD
Affiliation: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Role: STUDY_CHAIR
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