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PHASE I, OPEN LABEL, MULTICENTER DOSE ESCALATION STUDY OF GLIADEL IN PATIENTS WITH RECURRENT MALIGNANT GLIOMA (NCT00004028)

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.
  • Drug: carmustine
    • Procedure: conventional surgery
      Ages eligible for Study
      18 Years and older
      Genders eligible for Study
      All
      Accepts Healthy Volunteers
      No
      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.

      9 locations

      United States (9)
      • University of Alabama at Birmingham Comprehensive Cancer Center
        Birmingham, Alabama, United States, 35294-3295
      • H. Lee Moffitt Cancer Center and Research Institute
        Tampa, Florida, United States, 33612-9497
      • Emory University Hospital - Atlanta
        Atlanta, Georgia, United States, 30322
      • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
        Baltimore, Maryland, United States, 21231-2410
      • Massachusetts General Hospital Cancer Center
        Boston, Massachusetts, United States, 02114
      • Henry Ford Hospital
        Detroit, Michigan, United States, 48202
      • Comprehensive Cancer Center at Wake Forest University
        Winston-Salem, North Carolina, United States, 27157-1082
      • University of Pennsylvania Cancer Center
        Philadelphia, Pennsylvania, United States, 19104-4283
      • University of Texas Health Science Center at San Antonio
        San Antonio, Texas, United States, 78284-7811
      Status:
      completed
      Type:
      Interventional
      Phase:
      Start:
      31 August, 1996
      Updated:
      05 February, 2009
      Participants:
      0
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