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

Sponsor

Boneca Corporation (Industry)

Overall Status

Terminated

CT.gov ID

NCT00927147

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

0.4

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Head and Neck Cancer	Radiation: BNCT Drug: cetuximab	Phase 1/Phase 2

Detailed 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.

Study Design

Study Type:

Interventional

Actual Enrollment :

17 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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.

Study Start Date :

Jun 1, 2009

Actual Primary Completion Date :

Jun 1, 2013

Actual Study Completion Date :

Jun 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: BNCT plus cetuximab Patients treated with BNCT followed by cetuximab administration	Radiation: BNCT Boronophenylalanine infusion followed by neutron irradiation Drug: cetuximab cetuximab infusion 250 to 400 mg/kg intravenously, 1 to 3 infusions Other Names: Erbitux

Arm

Intervention/Treatment

Experimental: BNCT plus cetuximab

Patients treated with BNCT followed by cetuximab administration

Radiation: BNCT

Boronophenylalanine infusion followed by neutron irradiation

Drug: cetuximab

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

Other Names:

Erbitux

Outcome Measures

Primary Outcome Measures

Response rate [December 2010]

Secondary Outcome Measures

Safety [December 2010]
Duration of treatment response [December 2010]
Time to progression [December 2010]
Survival [December 2010]
Adverse events [December 2010]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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