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

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.

Sex

All

Minimum age

18 Years

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

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