Boron Neutron Capture Therapy (BNCT) Combined With Cetuximab in the Treatment of Locally Recurred Head and Neck Cancer

Head and Neck Cancer Clinical Trial

Official title:

Boronophenylalanine (BPA)-Based Boron Neutron Capture Therapy (BNCT) Combined With Anti-erbB1 Antibody Therapy in the Treatment of Locally Recurred Head and Neck Cancer: A Phase I/II Study.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00927147
• Other study ID #: HN-BPA-01-2008
• Status: Terminated
• Phase: Phase 1/Phase 2
• First received: June 21, 2009
• Last updated: January 30, 2017
• Start date: June 2009
• Est. completion date: June 2013

Study information

• Verified date: January 2017
• Source: Boneca Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to investigate efficacy and safety boron neutron capture therapy (BNCT) administered in combination with cetuximab in the treatment of head and neck cancer that has recurred locally following conventional cancer treatment (surgery and radiation therapy). Boron neutron capture therapy is a special form of radiation therapy, which is based on interaction between boron atoms taken up by the cancerous tissue and neutron irradiation. The boron atoms, located within cancer cells, may capture low-energy neutrons obtained from a nuclear accelerator, which results in splitting up (fission) of the boron atoms, and a high radiation effect within the tumor. Cetuximab is an antibody directed against certain proteins found on cancer cell surface (epidermal growth factor receptors). When administered immediately after BNCT, cetuximab may or may not improve treatment efficacy.

Description:

This is a single-center, non-randomized, non-comparative, open-label, phase I/II trial to determine safety and efficacy of BNCT in the treatment of nonoperable, irradiated, locally advanced cancers of the head and neck region. Patients will be treated with a single-fraction boronophenylalanine (BPA)-based BNCT. All patients will be evaluated for response using CT or magnetic resonance imaging (MRI).

Neutron irradiation will first be planned based on the available tumor imaging examinations, following which the head and body position will be determined for irradiation, and head fixation will be prepared and tested. On the irradiation day 400 mg/m2 L-BPA-F will be infused intravenously over 2 hours. Cetuximab doses will be administered following completion of BNCT. The cetuximab doses will be escalated in cohorts of 3 patients.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 17
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Histologically confirmed invasive squamous cell carcinoma of the head and neck

• Inoperable tumor or the patient is not a candidate for surgery for medical reasons; prior surgery may or may not have been done

• Prior radiotherapy or chemoradiotherapy has been given to the tumor

• If prior 18F-boronophenylalanine (BPA) PET (positron emission tomography)has been done, BPA needs to accumulate at least 2 times more in the tumor than in the corresponding normal tissue

• A written informed consent

Exclusion Criteria:

• Presence of distant metastases

• A non-experimental, effective treatment op-tion is available

• WHO performance status >3

• WBC <2,500/mm3, platelets <75,000/mm3, serum creatinine >180 umol/L

• Concomitant systemic cancer chemotherapy (except cetuximab).

• Other concurrent experimental therapy

• Less than 1 month since prior radiation therapy

• Untreated or severe treated congestive heart failure or renal failure

• A cardiac pace-maker or unremovable metal implants 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

• Known allergy/hypersensitivity to cetuximab

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms

Intervention

Radiation:
• BNCT
Boronophenylalanine infusion followed by neutron irradiation

Drug:
• cetuximab
cetuximab infusion 250 to 400 mg/kg intravenously, 1 to 3 infusions

Locations

Country	Name	City	State
Finland	Department of Oncology, Helsinki University Central Hospital	Helsinki

Sponsors (1)

Lead Sponsor	Collaborator
Boneca Corporation

Country where clinical trial is conducted

Finland, 

References & Publications (1)

Kankaanranta L, Seppälä T, Koivunoro H, Saarilahti K, Atula T, Collan J, Salli E, Kortesniemi M, Uusi-Simola J, Mäkitie A, Seppänen M, Minn H, Kotiluoto P, Auterinen I, Savolainen S, Kouri M, Joensuu H. Boron neutron capture therapy in the treatment of locally recurred head and neck cancer. Int J Radiat Oncol Biol Phys. 2007 Oct 1;69(2):475-82. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response rate		December 2010
Secondary	Safety		December 2010
Secondary	Duration of treatment response		December 2010
Secondary	Time to progression		December 2010
Secondary	Survival		December 2010
Secondary	Adverse events		December 2010