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

NCT00114790 | Completed Phase 1

• 1 other identifier: HN-BPA-01-2003
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Head and Neck Cancer

Keywords

head and neck cancer; boron neutron capture therapy; radiation therapy; boronophenylalanine

Outcome Measures

Primary Outcomes (1)

• treatment response

  1 year

Secondary Outcomes (2)

• time to progression

  2 years

• safety

  2 years

Study Arms (1)

BNCT.

EXPERIMENTAL

Boronophenylalanine-based BNCT.

Radiation: boronophenylalanine-based BNCT

Interventions

boronophenylalanine-based BNCT RADIATION

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

BNCT.

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Boneca Corporation: lead

Study Sites (1)

Department of Oncology, Helsinki University Central Hospital

Helsinki, FIN-00029, Finland

Location

Related Publications (4)

• 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 BACKGROUND

• 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.

  PMID: 36269660 DERIVED

• 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.

  PMID: 21300462 DERIVED

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Study Officials

• Heikki T Joensuu, M.D., prof.

  Helsinki University Central Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: June 17, 2005
• First Posted: June 20, 2005
• Study Start: December 1, 2003
• Primary Completion: October 1, 2008
• Study Completion: January 1, 2012
• Last Updated: May 6, 2013

Record last verified: 2013-05

Locations

FI (1)