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Home > "C" Clinical Trials Conditions > Carmustine Implants in Treating Patients With Brain Metastases  Carmustine Implants in Treating Patients With Brain Metastases
Carmustine Implants in Treating Patients With Brain Metastases
For Condition: unspecified adult solid tumor, protocol specific,brain metastases
Status: Completed
Sponsor(s): National Cancer Institute (NCI) ,
Synopsis: 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.
Details: OBJECTIVES: - 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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Supratentorial brain metastases for which surgery is recommended - Solitary, unilateral, intracranial mass consistent with metastasis on MRI scan OR - Two brain lesions consistent with metastases on MRI scan - Lesions must be accessible through a single craniotomy - Metastatic lesions clearly distinct from tumor bed of any benign lesions - Intraoperative frozen section diagnosis of metastatic tumor from CNS lesion - No prior malignant intracranial neoplasm - No lesion(s) in the brainstem - No open communication of the resection cavity with the ventricle following resection PATIENT CHARACTERISTICS: Age - 18 and over Performance status - Karnofsky 60-100% Life expectancy - At least 3 months Hematopoietic - No concurrent hematologic disorders Hepatic - No concurrent hepatic disease Renal - No concurrent renal disease Cardiovascular - No concurrent cardiac disease Pulmonary - No concurrent pulmonary disorders Other - Not pregnant or nursing - Fertile patients must use effective contraception - Mini mental score at least 15 - No known hypersensitivity to carmustine or Gliadel wafers - No other serious concurrent medical illness or infection PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - Not specified Endocrine therapy - Not specified Radiotherapy - No prior cranial irradiation Surgery - See Disease Characteristics - No prior surgery involving brain metastases or primary brain tumor(s) (except for benign intracranial lesions such as pituitary adenoma, meningioma, or schwannoma) Other - Concurrent systemic therapy allowed
Total Enrollment:
Location and Contact Information:
Overall Study Official:
AlessandroOlivi, Study Chair, Sidney Kimmel Cancer Center
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612-9497
United States
Comprehensive Cancer Center at Wake Forest University
Winston Salem, North Carolina, 27157-1030
United States
University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham, Alabama, 35294-3295
United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78284-7811
United States
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, 44195
United States
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02114-2617
United States
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, 27599-7295
United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21231-2410
United States
University of Pennsylvania Cancer Center
Philadelphia, Pennsylvania, 19104-4283
United States
Henry Ford Hospital
Detroit, Michigan, 48202
United States
Emory University Hospital - Atlanta
Atlanta, Georgia, 30322
United States
Additional Information:
Study ID Numbers: CDR0000067044; NABTT-9802,JHOC-NABTT-9802
Study Start Date:
Record last reviewed: April 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003878
Other Brain Metastases Studies:
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2. BMS-188797 and Carboplatin in Treating Patients With Advanced Nonhematologic Cancer
3. 10-Propargyl-10-Deazaaminopterin Plus Probenecid in Treating Patients With Advanced Solid Tumors
4. Paclitaxel in Treating Older Patients With Solid Tumors
5. UCN-01 and Cisplatin in Treating Patients With Advanced or Metastatic Solid Tumors
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Carmustine Implants in Treating Patients With Brain Metastases
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