Boron Neutron Capture Therapy in Treating Patients With Glioblastoma Multiforme or Melanoma Metastatic to the Brain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00039572
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : June 26, 2013
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

RATIONALE: Radiation therapy such as boron neutron capture therapy may kill tumor cells without harming normal tissue.

PURPOSE: Phase I/II trial to study the effectiveness of boron neutron capture therapy in treating patients who have glioblastoma multiforme or melanoma metastatic to the brain.

Condition or disease Intervention/treatment Phase
Brain and Central Nervous System Tumors Melanoma (Skin) Metastatic Cancer Drug: boronophenylalanine-fructose complex Phase 1 Phase 2

Detailed Description:


  • Determine the time course, uniformity, and severity of acute and chronic normal tissue reactions in patients with glioblastoma multiforme or intracranial melanoma treated with boronophenylalanine-fructose complex (BPA-f) followed by cranial neutron irradiation using a new fission converter beam facility.
  • Determine the maximum tolerated dose of cranial neutron capture therapy in these patients.
  • Determine, through serial objective measurements, the clinical response in patients treated with this therapy.
  • Determine the pharmacokinetics of BPA-f in these patients.

OUTLINE: This is a dose-escalation study of cranial neutron capture therapy (NCT).

Patients receive boronophenylalanine-fructose complex IV over 90 minutes followed by cranial NCT on days 1 and 2.

Cohorts of 3-6 patients receive escalating doses of NCT until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, additional patients are treated at the MTD.

Patients are followed at 1, 2, 4, 6, 9, and 12 months and then every 6 months for 2 years.

PROJECTED ACCRUAL: A total of 16 patients will be accrued for this study within 2 years.

Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment
Official Title: A Phase I/II Trial For Neutron Capture Therapy In Glioblastoma Multiforme And Intracranial Melanoma
Study Start Date : May 2002
Study Completion Date : January 2005

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically confirmed glioblastoma multiforme OR
  • Radiographically diagnosed brain metastases after a diagnosis of melanoma
  • Contrast-enhanced tumor volume must not exceed 60 mL



  • 18 and over

Performance status:

  • ECOG 0-2

Life expectancy:

  • At least 6 months


  • Not specified


  • Not specified


  • Creatinine normal


  • No prior severe cardiac disease, including the following:

    • Uncontrolled arrhythmias or conduction defects
    • Unstable or newly diagnosed angina pectoris
    • Recent coronary artery disease
    • Congestive heart failure


  • Not pregnant
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for at least 6 months after study
  • No prior phenylketonuria
  • No cognitive impairment that would preclude informed consent


Biologic therapy:

  • Not specified


  • No concurrent chemotherapy

Endocrine therapy:

  • Not specified


  • No prior cranial irradiation


  • Not specified

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00039572

United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Massachusetts Institute of Technology
Cambridge, Massachusetts, United States, 02139
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
National Cancer Institute (NCI)
Study Chair: Paul M. Busse, MD, PhD Beth Israel Deaconess Medical Center Identifier: NCT00039572     History of Changes
Other Study ID Numbers: BIDMC-E-010284FB
CDR0000069398 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: June 26, 2013
Last Verified: July 2002

Keywords provided by National Cancer Institute (NCI):
adult glioblastoma
stage IV melanoma
tumors metastatic to brain
adult giant cell glioblastoma
adult gliosarcoma

Additional relevant MeSH terms:
Neoplasm Metastasis
Nervous System Neoplasms
Central Nervous System Neoplasms
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas
Neoplasms, Neuroepithelial
Neoplasms, Glandular and Epithelial
Neoplastic Processes
Pathologic Processes
Neoplasms by Site
Nervous System Diseases