Accelerator-based boron neutron capture therapy for recurrent head and neck cancer

Accelerator-based Boron Neutron Capture Therapy (BNCT) in the Treatment of Locally Recurrent Head and Neck Carcinoma: A Phase I Study.

This trial will try accelerator-based boron neutron capture therapy with intravenous L‑Boronophenylalanine in adults whose head and neck cancer has returned after radiation.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Neutron Therapeutics, LLC (Industry-sponsored)
• Drugs / interventions: chemotherapy, radiation
• Locations: 1 site (Helsinki)
• Trial ID: NCT07058116 on ClinicalTrials.gov

What this trial studies

This phase I study tests accelerator-based boron neutron capture therapy (BNCT) using intravenous L‑Boronophenylalanine and the nuBeam Suite in adults with locally recurrent head and neck carcinoma after prior radiotherapy. The primary goal is to demonstrate the safety and tolerability of delivering BNCT with the accelerator system, and secondary goals include confirming planned dose delivery and the functionality of trial treatment planning software and robotic CT-based positioning. Patients will receive L‑BPA infusion followed by targeted neutron irradiation with careful dosimetry, imaging-guided positioning, and monitoring for adverse events and tumor response. The trial is sponsored by Neutron Therapeutics in collaboration with Helsinki University Hospital and is conducted at Helsinki University Hospital in Finland.

Who should consider this trial

Good fit: Adults (≥18) with histologically confirmed, inoperable head and neck carcinoma that has locally recurred after prior radiotherapy, with expected survival of at least 6 months and acceptable performance status, are the ideal candidates.

Not a fit: Patients with distant metastases, poor performance status (WHO >2), or those who have an available, effective non-experimental treatment option are unlikely to benefit from this trial.

Why it matters

Potential benefit: If successful, BNCT could provide a more targeted salvage radiation option that kills tumor cells while sparing surrounding normal tissues.

How similar studies have performed: Previous reactor-based BNCT and early accelerator-based BNCT studies have shown promising local-control results in recurrent head and neck cancer, but randomized and long-term evidence remains limited.

Eligibility criteria

Inclusion Criteria:

1. The patient considered for the study has provided a written informed consent as approved by the EC prior to study specific screening procedures, with the understanding that the patient has the right to withdraw from the study at any time, without prejudice.
2. ≥ 18 years of age at the time of enrollment.
3. Histologically confirmed head and neck carcinoma.
4. Inoperable cancer, prior surgery may or may not have been done.
5. Prior radiotherapy or chemoradiotherapy has been given.
6. Anticipated life expectancy of at least 6 months.

Exclusion Criteria:

Patients who fulfill any of the following criteria will be excluded:

1. Presence of distant metastases.
2. World Health Organization (WHO) performance status \> 2 (see Appendix 2).
3. Concurrent uncontrolled localized cancer other than head and neck carcinoma or overtly metastatic cancer.
4. The patient has access to a non-experimental, effective treatment option and is a suitable candidate for such therapy.
5. Concomitant chemotherapy.
6. Concurrent experimental therapy or participation in a trial with an experimental therapy within 3 months prior to study inclusion.
7. Less than 3 months since prior radiation therapy.
8. Major surgery within 4 weeks prior to study inclusion.
9. Unremovable metal implants present in the head and neck region that will interfere with CT/MRI-based dose-planning.
10. Known sensitivity to the study drug.
11. One or more of the following:

    * Blood hemoglobin \< 100 g/L, neutrophils \< 1.5 x 109/L, platelet count \< 120 x 109/L
    * Serum/plasma creatinine \> 1.5 x Upper Limit of Normal (ULN)
    * Serum bilirubin 2.0 \> ULN
    * Serum ALT and/or AST \> 2.0 x ULN
    * Serum alkaline phosphatase \> 2.5 x ULN
12. Serious uncontrolled infection or other serious uncontrolled concomitant disease.
13. Collagen vascular disease or a disease that is considered to increase radiosensitivity of normal tissues to radiation (e.g., ataxia-telangiectasia)
14. The patient is unwilling or unable to comply with the CIP required follow-up visits for the duration of the study.
15. Untreated or severe treated congestive heart failure, cardiac pacemaker, or renal failure.
16. Restlessness or inability to lie in a cast for about 30 minutes.
17. Clinical follow-up after therapy cannot be arranged or the patient is not willing to participate in the follow-up.
18. Known pregnancy, breastfeeding, or planning of pregnancy; for women of childbearing potential, a negative urine pregnancy test must be obtained prior to enrollment.
19. The patient is not able to understand the nature of the study and trial treatment options.
20. Phenylketonuria.
21. Fructose intolerance.

Where this trial is running

Helsinki

• Helsinki University Hospital — Helsinki, Finland (Recruiting)

Study contacts

• Study coordinator: Anu Anttonen, MD, PhD

Conditions Head and Neck Carcinoma; L-Boronophenylalanine; BNCT; Boron Neutron Capture Therapy; Neutron Therapeutics; Helsinki University Hospital