AzTrials
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Head and Neck CancerPhase 1/2NCT00114790

Boronophenylalanine (BPA)-Based Boron Neutron Capture Therapy (BNCT) in the Treatment Head and Neck Tumors

A Phase 1/2 study testing boronophenylalanine-based BNCT in people with Head and Neck Cancer, run by Boneca Corporation at 1 site in Finland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Boron Neutron Capture Therapy (BNCT) is an experimental radiation therapy technique which 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Head and Neck Cancer
What is being tested?
boronophenylalanine-based BNCT
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteFinland
Study dates
Dec 2003to Jan 2012
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically confirmed, malignant head and neck cancer.
  • Inoperable tumor, prior surgery may or may not have been done.
  • Prior radiotherapy or chemoradiotherapy has been given.
  • If prior SPECT or PET with 18F-BFA has been done, BPA needs to accumulate at least 2.5 times more in the tumor than in the corresponding contralateral normal tissue.
  • WHO performance status <3.
  • WBC >2,500/mm3, platelets >75,000/mm3, serum creatinine <180 umol/L.
  • A written informed consent.

Who cannot join

  • Lymphoma or other tumor type that is expected to respond to cancer chemotherapy or to a dose of conventional radiation therapy that can be safely given.
  • A non-experimental, effective treatment option is available.
  • Expected survival less than 3 months.
  • Concomitant systemic chemotherapy (prior cancer chemotherapy is allowed).
  • Other concurrent experimental therapy, or such therapy is being planned to be given.
  • Less than 3 months since prior radiation therapy.
Show all 13Show fewer
  • Untreated or severe, treated congestive heart failure or renal failure.
  • A cardiac pace-maker or an unremovable metal implant present in the head and neck region that will interfere with MRI-based dose-planning.
  • Restlessness or inability to lie in a cast for 30 to 60 minutes.
  • Clinical follow-up after therapy cannot be arranged or the patient is not willing to participate in follow-up.
  • Pregnancy.
  • Age less than 18.
  • The patient is not able to understand the treatment options.

Trial locations and contacts

1 site in 1 country.

Finland1 site

  • Department of Oncology, Helsinki University Central Hospital

    Helsinki, FIN-00029

Other trials in Finland

About this study

Official title: Boronophenylalanine (BPA)-Based Boron Neutron Capture Therapy (BNCT) in the Treatment of Inoperable and Irradiated Head and Neck Tumors: A Feasibility Study

Boron Neutron Capture Therapy (BNCT) is an experimental radiation therapy technique which 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 will be repeated, and the 2 treatments will be given 3 to 5 weeks apart. The study hypothesis is that head and neck cancers that have recurred following conventional radiotherapy might accumulate the boron carrier compound, and might respond to BNCT.

Read the detailed description

This is a single BNCT-facility, non-randomized, non-comparative, open-label, phase I to II trial to determine the value of BNCT in the treatment of inoperable, irradiated, locally advanced cancers of the head and neck region. An attempt to perform 18F-labeled boronophenylalanine (18F-BPA) SPECT or PET imaging will be made before BNCT. Patients whose tumor uptake is >2.5 times that of the corresponding normal head and neck tissue will be enrolled, and treated with a single fraction BPA-based BNCT twice, 3 to 5 weeks apart. Another 18F-BPA SPECT or PET study may be performed 1 to 3 months after BNCT to determine the SPECT/PET response.

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.

Prior to BNCT, BPA is infused as a fructose complex (l-BPA-F) into a peripheral vein over 2 hours. Blood samples will be taken for monitoring whole blood boron concentration before starting the BPA infusion, and thereafter at 20 to 40 minute intervals during the infusion, following infusion, and after delivering neutron irradiation. The blood samples will be analyzed for blood boron concentration to estimate the average blood boron concentration during neutron irradiation.

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

Being tested
boronophenylalanine-based BNCT
Keywords
head and neck cancer, boron neutron capture therapy, radiation therapy, boronophenylalanine
Medical subject headings
Head and Neck Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • boronophenylalanine-based BNCTRadiation

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

Study groups in NCT00114790
Study groupRoleWhat they receive
BNCT.ExperimentalBoronophenylalanine-based BNCT.
Receives: Radiation: boronophenylalanine-based BNCT

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. treatment response

    Measured: 1 year

Secondary outcomes (2)

  1. time to progression

    Measured: 2 years

  2. safety

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jun 2005 (estimated)
  2. Study startDec 2003
  3. Primary completionOct 2008
  4. Study completionJan 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00114790
Sponsor's protocol ID
HN-BPA-01-2003
Status last verified
May 2013
First submitted
17 Jun 2005
Last updated
6 May 2013
Results posted
No
Data monitoring committee
No

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.

    PubMed 15236879

  • 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.

    PubMed 12749708

  • Porra L, Wendland L, Seppala T, Koivunoro H, Revitzer H, Tervonen J, Kankaanranta L, Anttonen A, Tenhunen M, Joensuu H. From Nuclear Reactor-Based to Proton Accelerator-Based Therapy: The Finnish Boron Neutron Capture Therapy Experience. Cancer Biother Radiopharm. 2023 Apr;38(3):184-191. doi: 10.1089/cbr.2022.0059. Epub 2022 Oct 21.

    PubMed 36269660

  • Kankaanranta L, Seppala T, Koivunoro H, Saarilahti K, Atula T, Collan J, Salli E, Kortesniemi M, Uusi-Simola J, Valimaki P, Makitie A, Seppanen M, Minn H, Revitzer H, Kouri M, Kotiluoto P, Seren T, Auterinen I, Savolainen S, Joensuu H. Boron neutron capture therapy in the treatment of locally recurred head-and-neck cancer: final analysis of a phase I/II trial. Int J Radiat Oncol Biol Phys. 2012 Jan 1;82(1):e67-75. doi: 10.1016/j.ijrobp.2010.09.057. Epub 2011 Feb 6.

    PubMed 21300462

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing boronophenylalanine-based BNCT in people with Head and Neck Cancer, run by Boneca Corporation at 1 site in Finland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 May 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

treatment response (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00114790, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2013.

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