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

January 30, 2017 updated by: Boneca Corporation

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.

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.

Study Overview

Status

Terminated

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

17

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Helsinki, Finland, FIN-00029
        • Department of Oncology, Helsinki University Central Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Response rate
Time Frame: December 2010
December 2010

Secondary Outcome Measures

Outcome Measure
Time Frame
Safety
Time Frame: December 2010
December 2010
Duration of treatment response
Time Frame: December 2010
December 2010
Time to progression
Time Frame: December 2010
December 2010
Survival
Time Frame: December 2010
December 2010
Adverse events
Time Frame: December 2010
December 2010

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: Heikki Joensuu, MD, Department of Oncology, Helsinki University Central Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2009

Primary Completion (Actual)

June 1, 2013

Study Completion (Actual)

June 1, 2013

Study Registration Dates

First Submitted

June 21, 2009

First Submitted That Met QC Criteria

June 23, 2009

First Posted (Estimate)

June 24, 2009

Study Record Updates

Last Update Posted (Estimate)

January 31, 2017

Last Update Submitted That Met QC Criteria

January 30, 2017

Last Verified

January 1, 2017

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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