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Boron Neutron Capture Therapy in the Treatment of Glioblastoma Multiforme

Phase 1/Phase 2
18 Years
75 Years
Not Enrolling

Thank you

Trial Information

Boron Neutron Capture Therapy in the Treatment of Glioblastoma Multiforme

This is a single BNCT-facility, non-randomized, non-comparative, prospective, open-label,
phase I/II trial to determine the value of BNCT in the treatment of subjects who have
undergone surgery for glioblastoma, but glioblastoma has not been treated with radiation
therapy or chemotherapy. The neutron irradiation site is the FiR 1 reactor site, located at
Otaniemi, Espoo, Finland, about 6 kilometers from the Helsinki University Central Hospital,
Helsinki, where patient evaluation and post-irradiation care will take place.

BPA is infused as a fructose complex (BPA-F) into a peripheral vein over 2 hours prior to
neutron irradiation. Blood samples will be taken before starting the BPA infusion, and
thereafter at 20 to 40 minute intervals during the infusion, following infusion, and after
delivering neutron irradiation to monitor the blood boron concentration. The blood samples
will be analyzed for boron to estimate the average blood boron level during neutron
irradiation. The first 12 patients are treated using a BPA dose of 290 mg/kg, following
which the dose of BPA is increased stepwise to 500 mg/kg, provided that unacceptable
toxicity will not occur.

All patients will be evaluated for response using CT or magnetic resonance imaging (MRI).

Inclusion Criteria:

- Histologically confirmed glioblastoma multiforme

- Supratentorial location

- At least 30% of the tumor volume has been removed at craniotomy as judged from a
pre/perioperative MRI

- Ability to understand the concept of investigational therapy

- Tolerates dexamethasone treatment

- Adequate anti-epileptic medication

- BNCT can be delivered within 6 weeks from the date of brain surgery

- A written informed consent

Exclusion Criteria:

- Age less than 18 or greater than 75

- The tumor infiltrates into the optic chiasm or into the deep parts of the brain
prohibiting delivery of an adequate radiation dose with BNCT

- Prior radiation therapy to the brain

- Prior chemotherapy, immunotherapy, or gene therapy

- Karnofsky performance score <70

- Severe cardiac, liver, or kidney failure

- Severe infection

- A cardiac pace-maker, or a metal implant in the head and neck region that will
prohibit MRI examination

- Pregnancy or lactation

- Phenylketonuria

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:


Outcome Time Frame:

3 years

Safety Issue:


Principal Investigator

Heikki Joensuu, M.D., prof.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Helsinki University Central Hospital


Finland: Finnish Medicines Agency

Study ID:




Start Date:

May 1999

Completion Date:

August 2008

Related Keywords:

  • Glioblastoma
  • glioblastoma
  • boron neutron capture therapy
  • boronophenylalanine
  • brain tumor
  • Glioblastoma