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Postoperative Treatment of Glioblastoma With BNCT at the Petten Irradiation Facility (NCT00004015)

RATIONALE: Boron neutron capture therapy may selectively kill tumor cells without harming normal tissue. PURPOSE: This phase I trial is studying the side effects and best dose of boron neutron capture therapy following surgery in treating patients with glioblastoma multiforme removed during surgery.
  • Drug: sodium borocaptate
    • Procedure: adjuvant therapy
      Ages eligible for Study
      50 Years and older
      Genders eligible for Study
      All
      Accepts Healthy Volunteers
      No
      OBJECTIVES:

      - Determine systemic and local toxicity of borocaptate sodium with boron neutron capture therapy (BNCT) following craniotomy with gross total resection in patients with glioblastoma multiforme.

      - Determine the qualitative and quantitative dose-limiting toxicity and maximum tolerated dose of this regimen in these patients.

      - Determine the maximum tolerated radiation dose of BNCT in cranial localization to healthy tissues in these patients under defined conditions.

      OUTLINE: This is a dose escalation, multicenter study.

      Within 6 weeks of surgery, patients receive borocaptate sodium followed 12-18 hours later by neutron irradiation. Treatment repeats daily for 4 days.

      Cohorts of 3-9 patients receive escalating doses of neutron irradiation. The maximum tolerated dose is defined as the dose preceding that at which 3 or more patients experience dose limiting toxicity.

      Patients are followed weekly for 4 weeks, monthly for 2 months, every 6 weeks for 15 months and then every 3 months thereafter.

      PROJECTED ACCRUAL: Approximately 30-36 patients will be accrued for this study.

      8 locations

      Status:
      completed
      Type:
      Interventional
      Phase:
      Start:
      31 May, 2002
      Updated:
      16 July, 2012
      Participants:
      36
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