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The Treatment of One or Two Supratentorial Brain Metastases With Surgical Resection and BCNU-Polymer Wafers (NCT00003878)

National Cancer Institute (NCI)
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.
  • Drug: polifeprosan 20 with carmustine implant
    • Procedure: conventional surgery
      Ages eligible for Study
      18 Years and older
      Genders eligible for Study
      All
      Accepts Healthy Volunteers
      No
      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.

      11 locations

      United States (11)
      • University of Alabama at Birmingham Comprehensive Cancer Center
        Not specified
        Birmingham, Alabama, United States, 35294-3295
      • H. Lee Moffitt Cancer Center and Research Institute
        Not specified
        Tampa, Florida, United States, 33612-9497
      • Emory University Hospital - Atlanta
        Not specified
        Atlanta, Georgia, United States, 30322
      • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
        Not specified
        Baltimore, Maryland, United States, 21231-2410
      • Massachusetts General Hospital Cancer Center
        Not specified
        Boston, Massachusetts, United States, 02114-2617
      • Henry Ford Hospital
        Not specified
        Detroit, Michigan, United States, 48202
      • Lineberger Comprehensive Cancer Center, UNC
        Not specified
        Chapel Hill, North Carolina, United States, 27599-7295
      • Comprehensive Cancer Center at Wake Forest University
        Not specified
        Winston-Salem, North Carolina, United States, 27157-1030
      • Cleveland Clinic Taussig Cancer Center
        Not specified
        Cleveland, Ohio, United States, 44195
      • University of Pennsylvania Cancer Center
        Not specified
        Philadelphia, Pennsylvania, United States, 19104-4283
      • University of Texas Health Science Center at San Antonio
        Not specified
        San Antonio, Texas, United States, 78284-7811
      Status:
      completed
      Type:
      Interventional
      Phase:
      Start:
      31 March, 2002
      Updated:
      19 June, 2013
      Participants:
      0
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