- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00115453
Boron Neutron Capture Therapy (BNCT) as Treatment of Glioblastoma
Boron Neutron Capture Therapy in the Treatment of Glioblastoma Multiforme
Study Overview
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 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).
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
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-
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Helsinki, Finland, FIN-00029
- Department of Oncology, Helsinki University Central Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NON_RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: A
Active treatment arm.
|
Boronophenylalanine is infused into a peripheral vein prior to neutron irradiation.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
safety
Time Frame: 3 years
|
3 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
tumor response
Time Frame: one year
|
one year
|
effect on brain tissue
Time Frame: 3 years
|
3 years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Heikki Joensuu, M.D., prof., Helsinki University Central Hospital
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BNCT-P01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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