cropped color_logo_with_background.png

Clinical Trial Finder

Boron Neutron Capture Therapy (BNCT) as Treatment of Glioblastoma

Study Purpose

Boron Neutron Capture Therapy (BNCT) is an experimental radiation therapy technique that is based on the principle of irradiating boron atoms with neutrons. When neutrons have relatively low energy, boron atoms that have been targeted to cancerous tissue using a suitable boron carrier (an amino acid derivative called BPA, boronophenylalanine) will capture the neutrons. As a result from the neutron capture the boron atoms will split into two, producing helium and lithium ions. The helium and lithium ions, in turn, have only a short pathlength in tissue (about 5 micrometers) and will deposit their cell damaging effect mainly within the tumor provided that the boron carrier (BPA) has accumulated in the tumor. In practice, the study participants will receive BPA as an approximately 2-hour intravenous infusion, following which the tumor is irradiated with low energy (epithermal) neutrons obtained from a nuclear reactor at the BNCT facility. BNCT requires careful radiation dose planning, but neutron irradiation will last approximately only for one hour. In this study BNCT is given only once. The study hypothesis is that glioblastoma tissue may accumulate the boron carrier compound, and glioblastoma might respond to BNCT.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years - 75 Years
Gender All
More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT00115453
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 1/Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Boneca Corporation
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Heikki Joensuu, M.D., prof.
Principal Investigator Affiliation Helsinki University Central Hospital
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Industry
Overall Status Terminated
Countries Finland
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Glioblastoma
Study Website: View Trial Website
Additional Details

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).

Arms & Interventions

Arms

Experimental: A

Active treatment arm.

Interventions

Radiation: - irradiation

Boronophenylalanine is infused into a peripheral vein prior to neutron irradiation.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Helsinki, Finland

Status

Address

Department of Oncology, Helsinki University Central Hospital

Helsinki, , FIN-00029

Powered By