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A Multi-Center, Open-Label Clinical Study to Evaluate the Safety and Performance of the Proxima GliaSite RTS, a Radiation Delivery System, in Patients With Recurrent Malignant Brain Tumors Undergoing Surgical Resection (NCT00003574)

National Cancer Institute (NCI)
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Giving radiation therapy in different ways may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of radiation therapy in treating patients who are undergoing surgical removal of progressive or recurrent malignant brain tumors.
  • Procedure: surgical procedure
    • Radiation: brachytherapy
      • Radiation: intraoperative radiation therapy
        • Radiation: iodine I 125
          Ages eligible for Study
          18 Years and older
          Genders eligible for Study
          All
          Accepts Healthy Volunteers
          No
          OBJECTIVES: I. Evaluate the safety of the GliaSite RTS in patients with progressive or recurrent malignant brain tumors undergoing surgical resection. II. Evaluate the performance of the GliaSite RTS in these patients.

          OUTLINE: This is an open label, multicenter study. Patients undergo surgical resection of the tumor followed by surgical placement of the GliaSite device in the resection cavity. One to 2 weeks after surgery, patients receive brachytherapy consisting of an infusion of iodine I-125. The I-125 solution is removed and collected 5-7 days later. The device is surgically removed within 24 hours. Patients are followed at 24 hours, 14 days, and 1 year post device removal.

          PROJECTED ACCRUAL: Approximately 20-40 patients will be accrued for this study.

          9 locations

          United States (9)
          • University of Alabama Comprehensive Cancer Center
            Not specified
            Birmingham, Alabama, United States, 35294
          • H. Lee Moffitt Cancer Center and Research Institute
            Not specified
            Tampa, Florida, United States, 33612
          • Emory University Hospital - Atlanta
            Not specified
            Atlanta, Georgia, United States, 30322
          • Johns Hopkins Oncology Center
            Not specified
            Baltimore, Maryland, United States, 21287
          • Massachusetts General Hospital Cancer Center
            Not specified
            Boston, Massachusetts, United States, 02114
          • Henry Ford Hospital
            Not specified
            Detroit, Michigan, United States, 48202
          • Comprehensive Cancer Center of Wake Forest University Baptist Medical Center
            Not specified
            Winston-Salem, North Carolina, United States, 27157-1082
          • University of Pennsylvania Cancer Center
            Not specified
            Philadelphia, Pennsylvania, United States, 19104
          • 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, 1999
          Updated:
          19 June, 2013
          Participants:
          0
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