Patient case: 84-year-old male with glioblastoma; genetic feature: CDK6

Clinical trial: Boron Neutron Capture Therapy Following Surgery in Treating Patients With Glioblastoma Multiforme Removed During Surgery

Summary: 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.

Detailed description: 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.

Eligibility: DISEASE CHARACTERISTICS:
  -  Histologically proven glioblastoma multiforme for which conventional radiotherapy would be of little or no benefit
  -  Gross total resection of tumor confirmed by postoperative MRI performed within 48 hours of surgery
  -  Evaluable preoperative and postoperative MRI films with and without contrast must be available
  -  No prior brain malignancy
  -  No prior craniotomy except for glioblastoma
  PATIENT CHARACTERISTICS:
  Age:
  -  50 and over
  Performance status:
  -  Karnofsky 70-100%
  Life expectancy:
  -  Not specified
  Hematopoietic:
  -  Not specified
  Hepatic:
  -  Bilirubin, SGOT, SGPT, and alkaline phosphatase no greater than 2.5 times normal unless caused by reversible reaction to antiseizure medication
  Renal:
  -  Blood urea nitrogen and creatinine no greater than 2.5 times upper limit of normal
  Cardiovascular:
  -  No severe heart disease (e.g., congestive heart failure, angina pectoris)
  Pulmonary:
  -  No severe dyspnea at time of diagnosis
  -  No severe obstructive or restrictive lung disease
  Other:
  -  No other concurrent malignant tumor
  -  No severe gastrointestinal disease or active peptic ulcer disease
  -  No uncontrolled endocrine disease
  -  No serious mental disease, organic brain disease (e.g., preexisting epilepsy or serious aphasia), or legally incapacitated patients
  PRIOR CONCURRENT THERAPY:
  Biologic therapy:
  -  No prior biologic therapy for glioblastoma multiforme
  -  No concurrent biologic therapy
  Chemotherapy:
  -  No prior chemotherapy for glioblastoma multiforme
  -  No concurrent chemotherapy
  Endocrine therapy:
  -  No prior endocrine therapy for glioblastoma multiforme except corticosteroids
  -  No concurrent endocrine therapy
  Radiotherapy:
  -  See Disease Characteristics
  -  No prior radiotherapy for glioblastoma multiforme
  -  No prior radiotherapy to head and neck
  -  No other concurrent radiotherapy
  Surgery:
  -  See Disease Characteristics
  -  Prior stereotactic biopsy allowed for glioblastoma multiforme

Relevance to patient case: not relevant