Boron Neutron Capture Therapy (BNCT) as Treatment of Glioblastoma

NCT00115453 | Terminated Phase 1

• 1 other identifier: BNCT-P01
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Glioblastoma

Keywords

glioblastoma; boron neutron capture therapy; boronophenylalanine; brain tumor

Outcome Measures

Primary Outcomes (1)

• safety

  3 years

Secondary Outcomes (2)

• tumor response

  one year

• effect on brain tissue

  3 years

Study Arms (1)

A

EXPERIMENTAL

Active treatment arm.

Radiation: irradiation

Interventions

irradiation RADIATION

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

A

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boneca Corporation: lead

Study Sites (1)

Department of Oncology, Helsinki University Central Hospital

Helsinki, FIN-00029, Finland

Location

Related Publications (2)

• Kouri M, Kankaanranta L, Seppala T, Tervo L, Rasilainen M, Minn H, Eskola O, Vahatalo J, Paetau A, Savolainen S, Auterinen I, Jaaskelainen J, Joensuu H. Undifferentiated sinonasal carcinoma may respond to single-fraction boron neutron capture therapy. Radiother Oncol. 2004 Jul;72(1):83-5. doi: 10.1016/j.radonc.2004.03.016.

  PMID: 15236879 BACKGROUND

• Joensuu H, Kankaanranta L, Seppala T, Auterinen I, Kallio M, Kulvik M, Laakso J, Vahatalo J, Kortesniemi M, Kotiluoto P, Seren T, Karila J, Brander A, Jarviluoma E, Ryynanen P, Paetau A, Ruokonen I, Minn H, Tenhunen M, Jaaskelainen J, Farkkila M, Savolainen S. Boron neutron capture therapy of brain tumors: clinical trials at the finnish facility using boronophenylalanine. J Neurooncol. 2003 Mar-Apr;62(1-2):123-34. doi: 10.1007/BF02699939.

  PMID: 12749708 RESULT

MeSH Terms

Conditions

Glioblastoma; Brain Neoplasms

Interventions

Radiation

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Physical Phenomena

Study Officials

• Heikki Joensuu, M.D., prof.

  Helsinki University Central Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 22, 2005
• First Posted: June 23, 2005
• Study Start: May 1, 1999
• Primary Completion: August 1, 2008
• Study Completion: August 1, 2008
• Last Updated: August 18, 2008

Record last verified: 2008-08

Locations

FI (1)