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

This study has been terminated.
(The neutron facility closed down for financial reasons.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00927147
First Posted: June 24, 2009
Last Update Posted: January 31, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Boneca Corporation
  Purpose
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 Intervention Phase
Head and Neck Cancer Radiation: BNCT Drug: cetuximab Phase 1 Phase 2

Study Type: Interventional
Study Design: 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.

Resource links provided by NLM:


Further study details as provided by Boneca Corporation:

Primary Outcome Measures:
  • Response rate [ Time Frame: December 2010 ]

Secondary Outcome Measures:
  • Safety [ Time Frame: December 2010 ]
  • Duration of treatment response [ Time Frame: December 2010 ]
  • Time to progression [ Time Frame: December 2010 ]
  • Survival [ Time Frame: December 2010 ]
  • Adverse events [ Time Frame: December 2010 ]

Enrollment: 17
Study Start Date: June 2009
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Erbitux

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00927147


Locations
Finland
Department of Oncology, Helsinki University Central Hospital
Helsinki, Finland, FIN-00029
Sponsors and Collaborators
Boneca Corporation
Investigators
Study Chair: Heikki Joensuu, MD Department of Oncology, Helsinki University Central Hospital
  More Information

Publications:
Responsible Party: Boneca Corporation
ClinicalTrials.gov Identifier: NCT00927147     History of Changes
Other Study ID Numbers: HN-BPA-01-2008
First Submitted: June 21, 2009
First Posted: June 24, 2009
Last Update Posted: January 31, 2017
Last Verified: January 2017

Keywords provided by Boneca Corporation:
head and neck cancer
boron neutron capture therapy
cetuximab
epidermal growth factor receptor
safety
efficacy
survival

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms
Cetuximab
Boron
Antineoplastic Agents
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs