Status:
TERMINATED
Boron Neutron Capture Therapy (BNCT) as Treatment of Glioblastoma
Lead Sponsor:
Boneca Corporation
Conditions:
Glioblastoma
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
PHASE2
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, b...
Detailed Description
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 gl...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 1999
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2008
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00115453
Start Date
May 1 1999
End Date
August 1 2008
Last Update
August 18 2008
Active Locations (1)
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1
Department of Oncology, Helsinki University Central Hospital
Helsinki, Finland, FIN-00029