Carmustine Implants in Treating Patients With Brain Metastases
|ClinicalTrials.gov Identifier: NCT00003878|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : June 21, 2013
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving the drugs in different ways may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of implanted carmustine wafers in treating patients who have brain metastases and who are undergoing surgery to remove the tumor.
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Cancer Unspecified Adult Solid Tumor, Protocol Specific||Drug: polifeprosan 20 with carmustine implant Procedure: conventional surgery||Phase 2|
- Determine the local recurrence rate in patients with supratentorial metastatic brain tumors undergoing surgical resection treated with polifeprosan 20 with carmustine implant (Gliadel wafers).
- Determine the incidence and time to recurrence at distant sites within the CNS in these patients after this treatment.
- Determine the median, 6-month, 1-year, and 2-year survival of these patients on this regimen.
- Determine the incidence and severity of cognitive function loss of these patients on this regimen.
- Determine the incidence and severity of CNS and systemic toxic effects of these patients on this regimen.
OUTLINE: Patients receive up to 8 polifeprosan 20 with carmustine implants (Gliadel wafers) implanted in the resected tumor cavity.
Patients are followed on day 7 or day of discharge, at 1 month, 3 months, every 3 months for 21 months, and then for survival.
PROJECTED ACCRUAL: A total of 90 patients will be accrued for this study within 30 months.
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||The Treatment of One or Two Supratentorial Brain Metastases With Surgical Resection and BCNU-Polymer Wafers|
|Study Start Date :||April 2002|
|Actual Study Completion Date :||April 2003|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003878
|United States, Alabama|
|University of Alabama at Birmingham Comprehensive Cancer Center|
|Birmingham, Alabama, United States, 35294-3295|
|United States, Florida|
|H. Lee Moffitt Cancer Center and Research Institute|
|Tampa, Florida, United States, 33612-9497|
|United States, Georgia|
|Emory University Hospital - Atlanta|
|Atlanta, Georgia, United States, 30322|
|United States, Maryland|
|Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins|
|Baltimore, Maryland, United States, 21231-2410|
|United States, Massachusetts|
|Massachusetts General Hospital Cancer Center|
|Boston, Massachusetts, United States, 02114-2617|
|United States, Michigan|
|Henry Ford Hospital|
|Detroit, Michigan, United States, 48202|
|United States, North Carolina|
|Lineberger Comprehensive Cancer Center, UNC|
|Chapel Hill, North Carolina, United States, 27599-7295|
|Comprehensive Cancer Center at Wake Forest University|
|Winston-Salem, North Carolina, United States, 27157-1030|
|United States, Ohio|
|Cleveland Clinic Taussig Cancer Center|
|Cleveland, Ohio, United States, 44195|
|United States, Pennsylvania|
|University of Pennsylvania Cancer Center|
|Philadelphia, Pennsylvania, United States, 19104-4283|
|United States, Texas|
|University of Texas Health Science Center at San Antonio|
|San Antonio, Texas, United States, 78284-7811|
|Study Chair:||Alessandro Olivi, MD||Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins|